Archive for September, 2009

Sunair Services Corp. (SNR) Announces Proposed Merger With Massey Services

DEERFIELD BEACH, Fla., Sept. 29 /PRNewswire-FirstCall/ — Sunair Services Corporation (AMEX: SNR) today announced that it has entered into a definitive merger agreement with Massey Services, Inc. pursuant to which Massey would acquire all of the outstanding common stock of Sunair in an all-cash transaction valued at $2.75 per share, which represents a premium of approximately 47% over the stock’s closing price on September 25, 2009. Massey’s operations would merge with Middleton Pest Control, Inc., a wholly owned subsidiary of Sunair with headquarters located in Orlando, Florida, which provides pest control and lawn care services to both residential and commercial customers. The transaction is expected to close in November subject to the approval of Sunair’s shareholders, customary regulatory approvals and other closing conditions. Following the closing, Harvey L. Massey will be the Chairman and CEO of the combined companies, which will be privately held.

Massey Services is headquartered in Orlando, Florida and provides residential and commercial pest control services, termite protection and lawn, tree and shrub care services in Florida, Georgia and Louisiana. Massey is a shareholder of Sunair and owns approximately 9.63% of Sunair’s common stock.

Sunair Chairman, Richard C. Rochon commented that “Sunair’s board of directors has concluded a lengthy evaluation of numerous strategic alternatives to enhance shareholder value and has concluded that joining forces with Massey is in the best interests of our shareholders.” Massey Chairman, Harvey L. Massey, said “we believe the new organization created by this merger will build upon the complimentary strengths of both companies to provide superior value for our customers, employees and all stakeholders.”

Hyde Park Capital is acting as Sunair’s financial advisor, Akerman Senterfitt is acting as Sunair’s legal counsel, and Shuffield Lowman is acting as Massey’s legal counsel.

About Sunair

Sunair Services Corporation, a Florida corporation, through its wholly owned subsidiary, Middleton Pest Control, Inc., with headquarters located in Orlando, Florida, provides pest control and lawn care services to both residential and commercial customers. Middleton provides essential pest control services and protection against termites and insects to homes and businesses. In addition, Middleton supplies lawn care services to homes and businesses, which includes fertilization treatments and protection against disease, weeds and insects for lawns and shrubs. For more information about Sunair, please visit http://www.sunairservices.com.

Cautionary Note Regarding Forward-looking Statements

This release contains one or more forward-looking statements, within the meaning of the Private Securities Litigation Reform Act of 1995, including, without limitation, the expected timing of the closing of the transaction. Forward-looking statements are identified by words such as “will,” “expected,” “believe” and other similar words. Sunair cautions readers not to place undue reliance on any forward-looking statements, which speak only as of the date made. A variety of known and unknown risks and uncertainties could cause actual results to differ materially from the anticipated results which include, but are not limited to: satisfaction of all regulatory and other conditions required for closing, the ability to obtain the approval of Sunair’s shareholders, adverse developments in Sunair’s business, and unanticipated expenses. In addition, other risks and uncertainties not presently known to us or that we consider immaterial could affect the accuracy of any such forward-looking statements. Sunair does not undertake any obligation to update any forward-looking statements to reflect events that occur or circumstances that exist after the date on which they were made. Additional risks and uncertainties include those detailed from time to time in Sunair’s publicly filed documents, including its annual report on Form 10-K for its fiscal year ended September 30, 2008.

Important Merger Information

This communication may be deemed to be solicitation material in respect of the proposed acquisition of Sunair by Massey Services, Inc. In connection with the proposed acquisition, Sunair intends to file a proxy statement on Schedule 14A with the Securities and Exchange Commission, or SEC, and Sunair intends to file other relevant materials with the SEC. Shareholders of Sunair are urged to read all relevant documents filed with the SEC when they become available, including Sunair’s proxy statement, because they will contain important information about the proposed transaction, Sunair and Massey Services, Inc. A definitive proxy statement will be sent to holders of Sunair common stock seeking their approval of the proposed transaction. This communication is not a solicitation of a proxy from any security holder of Sunair.

Investors and security holders will be able to obtain the documents (when available) free of charge at the SEC’s web site, http://www.sec.gov. In addition, Sunair shareholders may obtain free copies of the documents filed with the SEC when available by contacting Edward M. Carriero, Jr., Sunair’s Chief Financial Officer, at (561) 208-7400. Such documents are not currently available. You may also read and copy any reports, statements and other information filed by Sunair with the SEC at the SEC public reference room at 100 F Street, N.E. Room 1580, Washington, D.C. 20549. Please call the SEC at 1-800-SEC-0330 or visit the SEC’s website for further information on its public reference room.

Sunair and its directors and executive officers may be deemed to be participants in the solicitation of proxies from the holders of Sunair common stock in respect of the proposed transaction. Information about the directors and executive officers of Sunair is set forth in Sunair’s proxy statement which was filed with the SEC on January 28, 2009. Investors may obtain additional information regarding the interest of Sunair and its directors and executive officers in the proposed transaction by reading the proxy statement regarding the acquisition when it becomes available.

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Marshall Edwards, Inc.’s NV-128, a Novel mTOR Inhibitor, Demonstrates Good Safety Profile and High Anti-Cancer Activity In Vivo Marshall Edwards, Inc.’s NV-128, a Novel mTOR Inhibitor, Demonstrates Good Safety Profile and High Anti-Cancer Activity In Vivo

SYDNEY, AUSTRALIA and NEW CANAAN, CT — (Marketwire) — 09/29/09 — Marshall Edwards, Inc. (NASDAQ: MSHL), a pharmaceutical company specializing in clinical development of oncology drugs, today released data demonstrating that the efficacy of NV-128 in animal xenograft models is achieved without apparent toxicity.

NV-128 is a novel flavonoid small molecule mTOR inhibitor, capable of inhibiting both mTORC1 and mTORC2 pathways which are central to the aberrant proliferative capacity of both mature cancer cells and cancer stem cells.

The data demonstrated that NV-128 has much greater safety than some other mTOR inhibitors in mice bearing human ovarian cancer xenografts.

Most of the current compounds acting on this pathway are analogs of rapamycin, known as rapalogs. Rapamycin and its analogs are regarded as the archetypal inhibitors of mammalian target of rapamycin or mTOR. In addition to their reported toxicities, rapalogs have been shown to contribute to the development of drug resistant tumors and ultimately reduced effectiveness over time due to their inability to efficiently inhibit mTORC2, a complex of mTOR with “rictor” (rapamycin-insensitive companion of mTOR).

NV-128 administered daily resulted in a reduction in tumor volume of 51 per cent relative to untreated control animals after 15 days, compared to a 50 per cent reduction in mice given rapamycin every other day. However, whereas rapamycin treated mice lost 8 per cent of body weight over this period, NV-128 treated mice gained weight, finishing at 6 per cent above their starting weight after the 15 day period. This is a significant indicator of lack of toxicity for NV-128, whereas the weight loss in the rapamycin-treated mice was judged to be a reflection of the well documented toxicity of rapamycin in both animal and human studies. After 21 days the tumors were removed and weighed. In NV-128 treated mice, tumor mass was reduced by 41 per cent compared to vehicle controls, an effect equivalent to rapamycin treated animals in which tumor mass was reduced by 44 per cent.

In additional data released today by Marshall Edwards Inc., the Company reported that NV-128 was judged to be without cardiac toxicity, further indicating the likely safety of NV-128 in clinical use.

One limitation of many drugs in clinical application, including some mTOR inhibitors, is their interference with heart function causing the interval between heart beats to increase (known as the QTc interval). In carefully controlled studies undertaken by an independent contract laboratory, using guinea pigs attached to recording devices to monitor heart function (electrocardiograms), NV-128 administration was shown to have no impact on the QTc interval and was judged therefore to be devoid of cardiac toxicity.

“The combined findings of high level efficacy and good safety profile, including a lack of interference with heart functioning, is a significant step forward in the search for safe and effective cancer drugs that target mTOR,” said Professor Alan Husband, Group Director of Research for Marshall Edwards, Inc.

“mTOR inhibitors have been given a high priority by many pharmaceutical companies working in the oncology field in recent times but none have been able to produce clinical efficacy in the absence of toxicities. We are encouraged that the novel mTOR inhibitor, NV-128, has great potential in human cancer management and we are moving as rapidly as possible to obtain approvals for human clinical trials to commence,” Professor Husband said.

The Marshall Edwards cancer biology group, headed by Dr. David Brown, is currently also exploring the utility of NV-128 in non-small cell lung cancer (NSCLC) models.

“While broadly acting against most cancer cell lines, of all the cell lines we have tested with NV-128, NSCLC lines appear to be the most sensitive to the anti-cancer effects of the drug,” said Dr. Brown.

“More recently we have also obtained evidence of the anti-cancer effect of NV-128 in vivo in mice bearing human NSCLC xenografts. Since lung cancer is one of the most prevalent forms of human cancer, we are excited at the prospect in due course of taking the compound into the clinic to evaluate it as a treatment option for this priority target indication,” Dr. Brown said.

About NV-128:

Structurally, NV-128 is an analog of triphendiol and phenoxodiol, both of which are investigational drugs that have been licensed by Novogen Limited to Marshall Edwards, Inc. Phenoxodiol is in development for ovarian and prostate cancer and triphendiol has been granted orphan drug status by the FDA for pancreatic and bile duct cancers, and late stage melanoma.

In contrast to phenoxodiol and triphendiol, NV-128 has been shown to induce caspase-independent DNA degradation and cancer cell death. It appears that in conjunction with autophagy induction, NV-128 induces caspase independent cell death via the AKT-mTOR pathway resulting in beclin sequestration of Bcl-2, Bax up-regulation and mitochondrial depolarization. As a consequence, endonuclease G translocates to the nucleus where it initiates DNA degradation and cell death. This offers an opportunity for use as a monotherapy in chemoresistant cancers and enhanced efficacy against cancer targets less susceptible to phenoxodiol. The option for co-administration of combinations of these drugs is also under investigation to extend the potential therapeutic range of this unique class of oncology compounds.

About Marshall Edwards, Inc:

Marshall Edwards, Inc. (NASDAQ: MSHL) is a specialist oncology company focused on the clinical development of novel anti-cancer therapeutics. These derive from a flavonoid technology platform, which has generated a number of novel compounds characterized by broad ranging activity against a range of cancer cell types with few side effects. Marshall Edwards, Inc. has licensed rights from Novogen Limited (ASX: NRT) (NASDAQ: NVGN) to bring four oncology drugs — phenoxodiol, triphendiol, NV-143 and NV-128 — to market globally.

Marshall Edwards, Inc. is majority owned by Novogen Limited, an Australian biotechnology company that is specializing in the development of therapeutics based on a flavonoid technology platform. Novogen is developing a range of therapeutics across the fields of oncology, cardiovascular disease and inflammatory diseases. More information on the Novogen group of companies can be found at www.marshalledwardsinc.com and www.novogen.com.

Under U.S. law, a new drug cannot be marketed until it has been investigated in clinical trials and approved by the FDA as being safe and effective for the intended use. Statements included in this press release that are not historical in nature are “forward-looking statements” within the meaning of the “safe harbor” provisions of the Private Securities Litigation Reform Act of 1995. You should be aware that our actual results could differ materially from those contained in the forward-looking statements, which are based on management’s current expectations and are subject to a number of risks and uncertainties, including, but not limited to, our failure to successfully commercialize our product candidates; costs and delays in the development and/or FDA approval, or the failure to obtain such approval, of our product candidates; uncertainties in clinical trial results; our inability to maintain or enter into, and the risks resulting from our dependence upon, collaboration or contractual arrangements necessary for the development, manufacture, commercialization, marketing, sales and distribution of any products; competitive factors; our inability to protect our patents or proprietary rights and obtain necessary rights to third arty patents and intellectual property to operate our business; our inability to operate our business without infringing the patents and proprietary rights of others; general economic conditions; the failure of any products to gain market acceptance; our inability to obtain any additional required financing; technological changes; government regulation; changes in industry practice; and one-time events. We do not intend to update any of these factors or to publicly announce the results of any revisions to these forward-looking statements.

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Astrotech Corp. (ASTC) Reports Financial Results for Fourth Quarter and Fiscal Year 2009

Sep. 28, 2009 (Business Wire) — Astrotech Corporation (NASDAQ:ASTC) today announced financial results for its fourth quarter and fiscal year ended June 30, 2009.

“This reporting period commemorates our return to profitable earnings and the completion of the turnaround for Astrotech that started in January 2007,” said Thomas B. Pickens III, Chairman and CEO. “The Company is now on a firm foundation and I feel very confident about the future of Astrotech and its expected earnings going forward.”

Fourth Quarter Results

The Company posted a fourth quarter fiscal year 2009 net income of $2.6 million, or $0.15 per diluted share on revenue of $10.4 million compared with a fourth quarter fiscal year 2008 net loss of $1.5 million, or $(0.11) per diluted share on revenue of $6.1 million.

Fiscal Year Results

Astrotech’s net income for the fiscal year ended June 30, 2009 was $4.7 million, or $0.28 per diluted share on revenue of $32.0 million compared to a net loss of $36.0 million, or $(4.26) per diluted share on revenue of $25.5 million for the prior fiscal year. These results represent a 25.2% increase in revenue over fiscal year 2008. Additionally, this marks the first time since 2005 that the Company has reported net income for the fiscal year.

Liquidity

As of June 30, 2009, we had cash on hand of $4.7 million and our working capital was approximately $8.4 million. The Company maintains a $6.0 million financing facility with Green Bank, N.A., consisting of a $4.0 million term loan and a $2.0 million revolving credit facility. On June 30, 2009, $3.6 million of the term loan, which expires in February 2011, was outstanding. During third quarter fiscal year 2009, the Company renewed the one-year revolving credit facility through February 2010 on terms substantially similar to the previous facility. At June 30, 2009, the Company had no outstanding liability under the revolving credit facility.

Update of Ongoing Operations

Astrotech’s growth strategy is to build on its industry-leading ground support operations and offer a more comprehensive set of services to government and commercial satellite customers through its wholly owned and largest subsidiary, Astrotech Space Operations (“ASO”). Specifically, the Company has developed and has begun to offer an End-to-End Mission Assurance capability that leverages Astrotech’s core-competency in ground processing services to provide pre-launch mission design and planning services and post-launch command-and-control and data management services. This initiative offers new opportunities to meet what the Company believes is an increasing demand from commercial and government customers for a cost-effective and reliable provider of these services.

The Company has a backlog of $25.4 million as of June 30, 2009. The majority of this backlog is for ASO pre-launch satellite processing services, which include hardware launch preparation; advance planning; use of unique satellite preparation facilities; and, spacecraft checkout, encapsulation, fueling, transport, and remote control through launch.

Strategic Financial and Business Alternatives

Astrotech also announced today that its Board of Directors has engaged investment banking firm Lazard Ltd. to advise the Company in exploring strategic financial and business alternatives to enhance shareholder value. Lazard Middle Market is the midcap focused financial advisory business of Lazard.

The range of alternatives which may be considered could include strategic acquisitions, a sale of some or all of the company’s assets or a variety of other possible transactions. There can be no assurance regarding the timing of or whether the Company will elect to pursue any of the strategic alternatives it may consider, or that any such alternatives will result in changes to the Company’s plans or will be consummated.

About Astrotech Corporation

Astrotech is one of the first space commerce companies and remains a strong entrepreneurial leader in the aerospace industry. The Company serves our government and commercial satellite and spacecraft customers with our pre-launch services from our Astrotech Space Operations (ASO) subsidiary and incubates space technology businesses having formed three companies; the 1st Detect Corporation is developing what we believe is a breakthrough mini-mass spectrometer; Astrogenetix, Inc. expects to produce biotech products in space and has recently developed a vaccine candidate for Salmonella; and AirWard Corporation is drawing on Astrotech’s space heritage of sending cargo to space by selling hazardous material containers for the airline industry.

This press release contains forward-looking statements that are made pursuant to the Safe Harbor provisions of the Private Securities Litigation Reform Act of 1995. Such forward-looking statements are subject to risks, trends, and uncertainties that could cause actual results to be materially different from the forward-looking statement. These factors include, but are not limited to, continued government support and funding for key space programs, the ability to expand ASO, product performance and market acceptance of products and services, as well as other risk factors and business considerations described in the Company’s Securities and Exchange Commission filings including the annual report on Form 10-K. Any forward-looking statements in this document should be evaluated in light of these important risk factors. The Company assumes no obligation to update these forward-looking statements.

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Euro Tech Holdings Company Limited (CLWT) Reports on Activities of Subsidiary and Associated Companies

HONG KONG, Sept. 28 /PRNewswire-Asia/ — Euro Tech Holdings Company Limited (Nasdaq: CLWTNews) today announced that its subsidiary company, PACT Environmental Equipment Co., Ltd. (“PACT”) is going to take part in Water Environmental Federation Technical Exhibition and Conference (“WEFTEC”) in Orlando Florida (October 12 – 14, 2009), in order to promote and expand environmental protection business outside China.

WEFTEC is the world’s largest exhibition covering water and wastewater equipment and services. PACT’s main products exhibited in poster form are MBRs, Belt Filter Presses, Rotating Drum Screens, Clarifier Scrapers, Floating Decanters and custom manufacturing.

Zhejiang Tianlan Environmental Technology Co. Ltd., (“Blue Sky”), an associated company of Euro Tech, has recently been awarded two contracts totally US$3.3 million by two companies in China. The contracts cover design, manufacture, supply, and commissioning of desulphurization equipment for various applications. The contracts are for five FGD equipment, (Flue Gas Desulphurization equipment), for boilers of 75 tons/hour of steam for applications in paper and cogeneration (heat and power) plants in Zhejiang. To cope with expansion, Blue Sky has recently moved into its self owned and new factory with area of approximately 20,000 square metres in Hangzhou, Zhejiang.

Zhejiang Jia Huan Electronic co. Ltd. (“Jia Huan”), an associated company of Euro Tech, has recently formed a 80% owned subsidiary company to develop, manufacture and sell energy saving products, such as solar and LED lighting products. To fully utilize the existing resources, Jia Huan wants to diversify into energy saving business.

About PACT:

PACT, based in Shanghai, is a global provider of environmental solutions for industrial and municipal clients, focusing on water and wastewater treatment. PACT’s capabilities cover design, manufacturing, sourcing, installation and servicing of water/wastewater treatment, water desalination plants and equipment.

About Blue Sky

Blue Sky (formerly known as Zhejiang Tianlan Desulfurization and Dust- Removal Co. Ltd.), found in 2000, is a fast growing company which provides a comprehensive service for design, general contract, equipment manufacturing, installation, testing and operation management of the treatment of waste gases emitted from various boilers and industrial furnaces of power plants, steel works and chemical plants.

About Jia Huan

Jia Huan, an established and profitable company, has been in business since 1969. 95% of Jia Huan’s business is related to air pollution control and less than 5% is for water and wastewater treatment. Jia Huan designs and manufactures automatic control systems and electric voltage control equipment for electrostatic precipitators which are major air purification equipment for power plants, cement plants and incinerators to remove and collect dust and pollutants from the exhaust stacks

Certain statements in this news release regarding the Company’s expectations, estimates, present view of circumstances or events, and statements containing words such as estimates, anticipates, intends, or expects, or words of similar import, constitute forward looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. Such statements indicate uncertainty and the Company can give no assurance with regard to actual outcomes. Specific risk factors may include, without limitation, having the Company’s offices and operations situated in Hong Kong and China, doing business in China, competing with Chinese manufactured products, competing with the Company’s own suppliers, dependence on vendors, and lack of long term written agreements with suppliers and customers, development of new products, entering new markets, possible downturns in business conditions, increased competition, loss of significant customers, availability of qualified personnel, negotiating definitive agreements, new marketing efforts and the timely development of resources. See the “Risk Factor” discussions in the Company’s filings with the Securities and Exchange Commission, including its Annual Report on Form 20-F for its fiscal year ended December 31, 2008.

Monday, September 28th, 2009 Uncategorized 1 Comment

Gander Mountain Company (GMTN) Announces Intent to Go Private

ST. PAUL, Minn., Sept. 28 /PRNewswire-FirstCall/ — Gander Mountain Company (www.GanderMtn.com) (Nasdaq: GMTN), the nation’s largest retail network of stores for hunting, fishing, camping, and marine products and services and outdoor lifestyle apparel and footwear, today announced its intent to cease its public company status.

A special committee of the company’s board of directors, comprised of independent directors, has recommended, and the board of directors has approved, plans to cease the registration of its common stock with the Securities and Exchange Commission under the Securities Exchange Act of 1934. The company expects that, as a result of this deregistration, its shares of common stock will cease to be listed on the Nasdaq Global Market.

Going-Private Transaction

In order to ensure that it will be eligible to deregister its shares of common stock, in accordance with SEC rules and regulations, Gander Mountain will reduce its number of beneficial shareholders to below 300. To accomplish this, the special committee of the board recommended, and the board of directors approved, an amendment to the company’s articles of incorporation to effect a 1-for-30,000 reverse stock split of its common stock. After the reverse stock split, any shareholder holding less than one share will receive a cash payment of $5.15 for each share held prior to the reverse split. Immediately following the reverse stock split, the company will file a second amendment to its articles of incorporation to effect a 30,000-for-1 forward stock split. As a result, shareholders owning 30,000 or more shares of common stock at the time of the reverse split will retain their current numbers of shares of common stock without change and not receive cash in the transaction. The funding for the cash payment for the fractional shares described above will be provided by the company’s two largest shareholders, Gratco LLC and Holiday Stationstores, Inc.

Gander Mountain’s board of directors decided to pursue taking the company private after concluding that the disadvantages of remaining an SEC-reporting company, including the costs associated with ongoing regulatory requirements, outweighed the benefits of public company status to the company and its shareholders. Greene Holcomb & Fisher LLC, independent financial advisor to the special committee, determined that the cash-out price of fractional shares is fair from a financial point of view to those shareholders who would be cashed out in the proposed transaction.

Under Minnesota law, Gander Mountain’s board may amend its articles of incorporation to conduct the stock splits without the approval of the company’s shareholders, therefore it is not seeking the approval of the going-private transaction from our shareholders.

Once Gander Mountain becomes a private company, it intends to continue its efforts to improve operating performance and reduce its outstanding indebtedness. The company’s two largest shareholders have agreed to make an offer to purchase shares held by remaining shareholders following the going private transaction at the same price of $5.15 per share following effectiveness of the stock splits described above.

Prior to consummating the going-private transaction described above, the company must file a preliminary information statement and a transaction statement with the Securities and Exchange Commission. Following review by the SEC, the company intends to distribute a definitive information statement to its shareholders and to effect the going-private transaction as soon as practicable following the date that is 20 days after the distribution of the information statement to shareholders. The company anticipates the transaction will be completed in early 2010. If the transaction is completed, the company would no longer file periodic reports with the SEC. This release is not an offer to acquire or sell any securities.

The special committee and the board of directors each have reserved the right to change the terms of the proposed reverse stock split, including the split ratio, to the extent they believe it is necessary or desirable in order to accomplish the goal of reducing the number of beneficial holders to fewer than 300. The special committee may also abandon the proposed transaction at any time prior to its completion if it believes that the proposed transaction is no longer in the best interests of the company or its shareholders.

About Gander Mountain Company:

Gander Mountain Company (Nasdaq: GMTN), headquartered in Saint Paul, Minnesota, is the nation’s largest retail network of stores for hunting, fishing, camping, marine, and outdoor lifestyle apparel and footwear, products and services. Established in 1960, the Gander Mountain brand has offered an expanding assortment of outdoor equipment, technical apparel and footwear, as well as gunsmith and archery services. The stores feature national, regional and local brands as well as the company’s owned brands. Focused on a “We Live Outdoors” culture, Gander Mountain dedicates itself to creating outdoor memories. There are 116 conveniently located Gander Mountain outdoor lifestyle stores in 23 states and three outlet stores. Customers may also shop at www.GanderMtn.com. For the nearest store location call 800-282-5993 or visit www.GanderMtn.com. Gander Mountain is also the parent company of Overton’s (www.overtons.com), a leading catalog and Internet based retailer of products for boating and other water sports enthusiasts.

Cautionary Note Regarding Forward-Looking Statements

Any statements in this release that are not historical or current facts are forward-looking statements. All forward-looking statements in this release are made pursuant to the safe harbor provisions of the Private Securities Litigation Reform Act of 1995. These statements involve known and unknown risks, uncertainties and other factors that may cause our actual results, performance or achievements to be materially different from any future results, performances or achievements expressed or implied by the forward-looking statements. In addition to the risk the transactions described herein will not be completed, certain of these risks and uncertainties are described in the “Risk Factors” section of the company’s Annual Report on Form 10-K for fiscal 2008 and other required reports, as filed with the SEC, which are available at http://www.GanderMtn.com and at the SEC’s Website at http://www.sec.gov.

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Covidien (COV) Announces Definitive Agreement to Acquire Aspect Medical Systems, Inc. (ASPM)

Sep. 28, 2009 (Business Wire) — Covidien (NYSE: COV) and Aspect Medical Systems, Inc. (NASDAQ: ASPM) today announced that Covidien has reached a definitive agreement to acquire Aspect, a global market leader in brain monitoring technology.

The Boards of Directors of both companies have unanimously approved the transaction, pursuant to which a wholly owned subsidiary of Covidien will pay $12.00 in cash per Aspect share for a total of approximately $210 million, net of cash and short-term investments acquired. The transaction, which will take the form of an all cash tender offer followed by a second-step merger, is subject to customary closing conditions, including receipt of certain regulatory approvals, and is expected to be completed by the end of calendar 2009.

Founded in 1987, Aspect is recognized as a pioneer and global market leader in brain monitoring, with 2008 revenues of $99 million. Aspect’s premier product — Bispectral Index™ (BIS™) technology — became the first clinically proven and commercially available direct measure of the effects of anesthetics and sedatives on the brain. Aspect led the way to develop proprietary technologies that directly measure these effects and ultimately improve the quality and cost effectiveness of patient care. BIS technology is designed to allow medical professionals to reliably gauge the precise amount of anesthetic medication required by each patient, resulting in better overall patient care.

“The acquisition of Aspect will allow Covidien to broaden its product offerings and add a market leading brain monitoring technology to its portfolio,” said Pete Wehrly, President, Respiratory & Monitoring Solutions, Covidien. “Aspect will bring us enhanced clinical expertise, a strong research & development organization and expand our presence in the operating room. The acquisition is consistent with our strategy of expanding into adjacent market segments and will help us achieve our mission of enhancing the quality of life for patients and improving outcomes for our customers.”

“Joining Covidien provides Aspect with the scale and resources to accelerate growth of BIS and other Aspect products, to continue to invest in outcomes research, comparative effectiveness and innovation, and to support the strategy of providing products that are designed to improve patient outcomes,” said Nassib Chamoun, President and Chief Executive Officer, Aspect Medical Systems. “Above all, we are pleased to become part of a company that shares our commitment to evidence-based medicine and the development of products that help clinicians cost-effectively deliver better care.”

Assuming a December 31, 2009, closing, Covidien expects this transaction to dilute fiscal 2010 GAAP earnings per share, primarily due to a one-time charge for restructuring. On a non-GAAP basis, excluding the restructuring charge, the transaction is expected to be slightly dilutive to 2010 earnings per share; however, the underlying strength of Covidien’s existing businesses is expected to offset this dilution. As a result, Covidien does not anticipate this transaction will have a material impact on its fiscal 2010 sales or operating margin outlook.

Once the transaction has been completed, Covidien will report the Aspect business as part of its Oximetry and Monitoring product line in the Medical Devices segment.

ABOUT COVIDIEN

Covidien is a leading global healthcare products company that creates innovative medical solutions for better patient outcomes and delivers value through clinical leadership and excellence. Covidien manufactures, distributes and services a diverse range of industry-leading product lines in three segments: Medical Devices, Pharmaceuticals and Medical Supplies. With 2008 revenue of $10 billion, Covidien has more than 41,000 employees worldwide in 59 countries, and its products are sold in over 140 countries. Please visit www.covidien.com to learn more about our business.

ABOUT ASPECT MEDICAL SYSTEMS, INC.

Aspect Medical Systems, Inc. is a global market leader in brain monitoring technology. To date, the Company’s Bispectral Index (BIS) technology has been used to assess approximately 34 million patients and has been the subject of more than 3,300 published articles and abstracts. BIS technology is installed in approximately 78 percent of hospitals listed in the July 2009 U.S. News and World Report ranking of America’s Best Hospitals and in approximately 74 percent of all U.S. operating rooms. In the last twelve months, BIS technology was used in approximately 19 percent of all U.S. surgical procedures requiring general anesthesia or deep sedation. Aspect Medical Systems has OEM agreements with nine leading manufacturers of patient monitoring systems. For more information, visit Aspect’s Web site at http://www.aspectmedical.com.

FORWARD-LOOKING STATEMENTS

Any statements contained in this communication that do not describe historical facts may constitute forward-looking statements as that term is defined in the Private Securities Litigation Reform Act of 1995. This release contains forward-looking information about Covidien’s proposed acquisition of Aspect Medical Systems, Inc., the timing of the anticipated transaction, the potential benefits of the anticipated transaction, Aspect’s clinical trials, products and product candidates and the potential benefits of such products and product candidates, and expected dilutive effect. Any forward-looking statements contained herein are based on Covidien’s and Aspect’s management’s current beliefs and expectations, but are subject to a number of risks, uncertainties and changes in circumstances, which may cause actual results or actions to differ materially from what is expressed or implied by these statements. The factors that could cause actual future results to differ materially from current expectations include, but are not limited to, the satisfaction of conditions to closing the agreement; the ability to successfully integrate Aspect’s operations and programs with Covidien’s and the time and resources required to do so, the uncertainties inherent in commercial, research and development activities, decisions by regulatory authorities regarding whether and when to approve any applications for such product candidates and other matters that could affect the availability or commercial potential of such product candidates; and competitive developments. These and other factors are identified and described in more detail in Covidien’s and Aspect’s filings with the SEC. We caution investors not to place undue reliance on the forward-looking statements contained in this press release. We disclaim any obligation to update these forward-looking statements other than as required by law.

NON-GAAP Financial Information

This release contains a non-GAAP financial measure. This non-GAAP financial measure, which is used a measure of Covidien’s performance, should be considered in addition to, not as a substitute for, or superior to, measures of Covidien’s financial performance prepared in accordance with GAAP. A reconciliation of this non-GAAP financial measure to GAAP is provided in the text of this release. Covidien’s non-GAAP measures may be defined differently than similar terms used by other companies, and accordingly, care should be exercised in understanding how Covidien defines its non-GAAP financial measures.

Specifically, any one-time charge for restructuring is excluded from the projected earnings per share dilution.

Covidien management uses this non-GAAP financial measure to gain an understanding of its comparative operating performance (when comparing such results with previous periods or forecasts) and future prospects. This non-GAAP financial measure is also used by Covidien’s management in their financial and operating decision-making because management believes it reflects the underlying economics of Covidien’s ongoing business in a manner that allows meaningful period-to-period comparisons. Such comparisons may be more meaningful because operating results presented under GAAP may include, from time to time, items that are not necessarily relevant to understand Covidien’s business and may, in some cases, be difficult to forecast accurately for future periods. Covidien’s management believes that this non-GAAP financial measure provides useful information to investors and others in understanding and evaluating Covidien’s current operating performance and future prospects in the same manner as management does if they so choose. Non-GAAP financial measures have limitations, however, because they do not include all items of income and expense that affect Covidien’s operations. Covidien’s management compensates for this and other limitations by also considering Covidien’s financial results as determined in accordance with GAAP.

IMPORTANT INFORMATION ABOUT THE TENDER OFFER

This press release is neither an offer to purchase nor a solicitation of an offer to sell shares of Aspect. Transformer Delaware Corp. (the “Merger Sub”), an indirect, wholly-owned subsidiary of Covidien, has not commenced the tender offer for the shares of Aspect stock described in this press release.

Upon commencement of the tender offer, the Merger Sub will file with the SEC a tender offer statement on Schedule TO and related exhibits, including the offer to purchase, letter of transmittal, and other related documents. Following commencement of the tender offer, Aspect will file with the SEC a tender offer solicitation/recommendation statement on Schedule 14D-9. These documents will contain important information about Covidien, Aspect, the transaction and other related matters. Investors and security holders are urged to read each of these documents carefully when they are available.

Investors and security holders will be able to obtain free copies of the tender offer statement, the tender offer solicitation/recommendation statement and other documents filed with the SEC by the Merger Sub and Aspect through the web site maintained by the SEC at www.sec.gov. In addition, investors and security holders will be able to obtain free copies of these documents by contacting:

Monday, September 28th, 2009 Uncategorized Comments Off on Covidien (COV) Announces Definitive Agreement to Acquire Aspect Medical Systems, Inc. (ASPM)

Baldwin Technology Co., Inc. (BLD) and technotrans End Patent Dispute

SHELTON, Conn.–(BUSINESS WIRE)–Baldwin Technology Company, Inc. (NYSE Amex:BLD), a global leader in process automation technology for the printing industry, announced the settlement of its patent dispute with technotrans.

Baldwin Germany GmbH, Friedberg, as the plaintiff and technotrans AG, Sassenberg, as the defendant, have agreed to an out-of-court settlement to terminate the proceedings that have been continuing for a number of years in connection with the infringement of a patent. Technotrans is to pay an amount of EURO 6.5million (approximately $9.6 million) in compensation to Baldwin. In return, Baldwin undertakes to declare the proceedings before the Dusseldorf district court in respect of the amount as settled.

The Boards of Management of both parties have reached the conclusion that this solution is in the best interests of both companies.

About Baldwin

Baldwin Technology Company, Inc. is a leading international supplier of process automation equipment for the printing and publishing industries. Baldwin offers its customers a broad range of market-leading technologies, products and systems that enhance the quality of printed products and improve the economic and environmental efficiency of printing presses. Headquartered in Shelton, Connecticut, the company has operations strategically located in the major print markets and distributes its products via a global sales and service infrastructure. Baldwin’s technology and products include cleaning systems, fluid management and ink control systems, web press protection systems and drying systems and the related consumables. For more information, visit http://www.baldwintech.com.

Information for investors, including an investment profile about Baldwin is available at www.hawkassociates.com/profile/bld.cfm. Investors may contact Julie Marshall or Frank Hawkins, Hawk Associates, at (305) 451-1888, e-mail: baldwin@hawkassociates.com. An online investor kit including press releases, current price quotes, stock charts and other valuable information for investors are available at http://www.hawkassociates.com.

This release contains certain forward-looking statements that involve known and unknown risks, uncertainties or other factors not under the company’s control, which may cause actual results, performance or achievements of the company to be materially different from the results, performance, or other expectations implied by these forward-looking statements. These factors include, but are not limited to, those detailed in the company’s periodic filings with the Securities and Exchange Commission.

Friday, September 25th, 2009 Uncategorized 1 Comment

The Finish Line, Inc. (FINL) Reports Second Quarter Results

INDIANAPOLIS, Sept. 24 /PRNewswire-FirstCall/ — The Finish Line, Inc. (Nasdaq: FINL) today reported results for its second fiscal quarter, representing the 13-week period ended August 29, 2009. As previously disclosed, the company exited the Man Alive business effective July 4, 2009. Therefore, all financial results of the Man Alive operations are included in discontinued operations for all periods presented.

Second Quarter Results

Comparable store sales declined 9.9% in the second quarter compared to a 4.9% increase last year. Net sales declined 11.4% to $298.7 million for the period compared to $337.0 million as a result of fewer stores and the comparable store sales decline.

Finish Line reported income from continuing operations of $11.7 million, or $0.21 per diluted share, compared to income from continuing operations of $14.9 million, or $0.27 per diluted share, in the second quarter last year. Diluted weighted average shares outstanding for the second quarter were 54.6 million versus 54.3 million for the same period a year ago.

Consolidated merchandise inventories were reduced 18% to $221.4 million as of August 29, 2009 compared to $269.9 million a year ago. Finish Line inventory declined 13.4% overall and 10.1% on a per-square-foot basis.

At quarter end, the company had no interest-bearing debt and $142.9 million in cash and cash equivalents, up from $65.0 million at the end of the second quarter a year ago.

“In the second quarter, we continued to manage the business conservatively by controlling costs and increasing efficiencies, but we also made and will continue to make appropriate investments in our business to drive sales and profitable growth,” said Finish Line Chief Executive Officer Glenn Lyon. “Our online business and cross-channel strategies are growing, and we are focused on building upon that growth by improving the customer experience wherever and whenever they shop with us. Overall, our focus at Finish Line is to sustain the health of our balance sheet, maintain our premium brand position, and within the realities of what remains a cautious consumer environment, position ourselves for future profit growth.”

Year-to-Date Results

For the 26 weeks ended August 29, 2009, Finish Line reported income from continuing operations of $13.5 million, or $0.24 per diluted share, versus income from continuing operations of $17.3 million, or $0.32 per diluted share for the same period a year ago.

Year-to-date comparable store sales declined 7.2% versus a 3.4% increase last year. Net sales declined 8.6% to $557.8 million, compared to $610.0 million a year ago.

Conference Call

The Company will host a conference call for investors Friday, September 25 at 8:30 a.m. EDT. To participate in the call, dial (660) 422-4970, conference ID#29769719. To listen online, visit www.finishline.com. A replay of the conference call can be accessed at (706) 645-9291, conference ID#29769719. This replay will be available beginning at approximately 9:45 a.m. EDT Friday, September 25, and will remain available through Monday, September 28. In addition, the replay will be available on the Web at www.finishline.com.

Forward Looking Statements

The company has experienced, and expects to continue to experience, significant variability in net sales, net income (loss) and comparable store net sales from quarter to quarter. Therefore, the results of the periods presented herein are not necessarily indicative of the results to be expected for any other future period or year.

Certain statements contained in this press release regard matters that are not historical facts and are forward looking statements (as such term is defined in the rules promulgated pursuant to the Securities Act of 1933, as amended). Because such forward looking statements contain risks and uncertainties, actual results may differ materially from those expressed in or implied by such forward looking statements.

Factors that could cause results of the company to differ materially include, but are not limited to: changing consumer preferences; the company’s inability to successfully market its footwear, apparel, accessories and other merchandise; price, product and other competition from other retailers (including internet and direct manufacturer sales); the unavailability of products; the inability to locate and obtain favorable lease terms for the company’s stores; the loss of key employees; the effect of economic conditions including current conditions in the financial services industry, depressed demand in the housing market and unemployment rates; management of growth, the outcome of litigation, and the other risks detailed in the company’s Securities and Exchange Commission filings.

Readers are cautioned not to place undue reliance on forward-looking statements, which speak only as of the date hereof. The company undertakes no obligation to release publicly the results of any revisions to these forward looking statements that may be made to reflect events or circumstances after the date hereof or to reflect the occurrence of unanticipated events.

The Company expects to report Q3 results on Tuesday, December 22, 2009 after the market closes followed by a live conference call on Wednesday, December 23, 2009 at approximately 8:30 a.m. EDT.

About Finish Line

The Finish Line, Inc. is a premium athletic footwear store and one of the nation’s largest mall-based specialty retailers, offering a large selection of performance and sport-style footwear, apparel and accessories for men, women and kids. The Finish Line, Inc. is publicly traded on the NASDAQ Global Select Market under the symbol FINL. The company operates 680 Finish Line stores in 47 states and offers online shopping at www.finishline.com.

Friday, September 25th, 2009 Uncategorized Comments Off on The Finish Line, Inc. (FINL) Reports Second Quarter Results

Keryx Biopharmaceuticals, Inc. (KERX) Reports Results of Open Label Extension Study Examining Long-Term Use of Zerenex

NEW YORK, Sept. 23 /PRNewswire-FirstCall/ — Keryx Biopharmaceuticals, Inc. (Nasdaq: KERX) today announced results of the Open Label Extension (OLE) trial of Zerenex (ferric citrate) for the treatment of elevated serum phosphorous levels, or hyperphosphatemia, in patients with end-stage renal disease (ESRD) on dialysis. The OLE trial, conducted in Taiwan, enrolled 29 of the 37 Taiwanese patients that had completed the randomized, multi-center, multi-national (United States and Taiwan) dose-ranging Phase 2 study. This OLE represents the first trial to examine the long-term safety and efficacy of Zerenex as a phosphate binder. The treatment period in all previous Zerenex Phase 2 clinical trials did not exceed 28 days.

The OLE trial provided for a daily dose, ranging from 2 to 6 g/day of Zerenex, for a period of up to one year following completion of the 28-day, dose-ranging Phase 2 study. The average duration of the patients’ participation in the OLE trial was 306 +/- 85 days.

Data from the OLE trial indicate that the mean serum phosphorus level throughout the trial was 5.22 +/- 0.18 mg/dL, and the mean product of calcium times phosphate (CaxP) was 49.06 +/- 2.15 mg(2)/dL(2), both within the normal range as recommended by the KDOQI guidelines. In addition, during the OLE trial, the administration of IV iron as a supplement was withheld in 8 patients (27.6%) for periods ranging from 3 to 6 months and the administration of EPO was withheld in 8 patients (27.6%) for short periods because the hemoglobin, hematocrit, and iron parameters were within normal clinical ranges as assessed by the investigator. There were no signs of potential iron overload in the study patients, and there were no Zerenex-related serious adverse events as noted by either the patient or investigator.

Ron Bentsur, CEO of Keryx Biopharmaceuticals, stated, “We are very excited about this long-term data for Zerenex. The study suggests that Zerenex can maintain patients within the normal serum phosphorous range for extended periods of time and that the drug appears to be well-tolerated.” Mr. Bentsur added, “We are also very encouraged by the emerging data suggesting that Zerenex may reduce the need for IV iron or EPO in this dialysis patient population, and should the results be replicated in the upcoming Phase 3 program, this could represent a significant clinical and cost advantage to the patient and the doctor.”

ABOUT HYPERPHOSPHATEMIA

In the United States, according to data from the U.S. Renal Data System, there are approximately 485,000 patients with end-stage renal disease, or ESRD, and the number of ESRD patients is projected to rise 60% to approximately 785,000 by 2020. The majority of ESRD patients, over 350,000, require dialysis. Phosphate retention and the resulting hyperphosphatemia in patients with ESRD on dialysis are usually associated with secondary hyperparathyroidism (and its related cardiovascular complications), renal osteodystrophy and soft tissue mineralization. ESRD patients usually require treatment with phosphate-binding agents to lower and maintain serum phosphorus at acceptable levels. The need for alternative phosphate-binding agents has long been recognized, especially given the increasing prevalence of ESRD as well as shortcomings with current therapies. Zerenex has the potential to be an effective and safe treatment in lowering and/or maintaining normal serum phosphorus levels in patients with ESRD and hyperphosphatemia.

The market for phosphate binders to treat hyperphosphatemia in ESRD patients in the U.S. exceeded $600 million in 2008, and has grown approximately 25% per annum over the last five years.

ABOUT KERYX BIOPHARMACEUTICALS, INC.

Keryx Biopharmaceuticals is focused on the acquisition, development and commercialization of medically important pharmaceutical products for the treatment of life-threatening diseases, including cancer and renal disease. Keryx is developing KRX-0401 (perifosine), a novel, potentially first-in-class, oral anti-cancer agent that inhibits the phosphoinositide 3-kinase (PI3K)/Akt pathway, a key signaling cascade that has been shown to induce cell growth and cell transformation. KRX-0401 has demonstrated both safety and clinical efficacy in several tumor types, both as a single agent and in combination with novel therapies. KRX-0401 also modulates a number of other key signal transduction pathways, including the JNK and MAPK pathways, which are pathways associated with programmed cell death, cell growth, cell differentiation and cell survival. KRX-0401 is currently in Phase 2 clinical development for multiple tumor types, with a Phase 3 in multiple myeloma, under Special Protocol Assessment (SPA), pending commencement by year-end. Keryx is also developing Zerenex(TM) (ferric citrate), an oral, iron-based compound that has the capacity to bind to phosphate and form non-absorbable complexes. Zerenex has recently completed a Phase 2 clinical program as a treatment for hyperphosphatemia (elevated phosphate levels) in patients with end-stage renal disease, and Keryx is in the process of finalizing the U.S. Phase 3 program for Zerenex in consultation with the FDA. Keryx is headquartered in New York City.

Cautionary Statement

Some of the statements included in this press release, particularly those anticipating future clinical and business prospects for Zerenex (ferric citrate), may be forward-looking statements that involve a number of risks and uncertainties. For those statements, we claim the protection of the safe harbor for forward-looking statements contained in the Private Securities Litigation Reform Act of 1995. Among the factors that could cause our actual results to differ materially are the following: our ability to successfully complete clinical trials for Zerenex; our ability to meet anticipated development timelines for Zerenex due to recruitment, clinical trial results, manufacturing capabilities or other factors; our ability to replicate in our planned Phase 3 clinical program the efficacy and safety of Zerenex observed in the previous Phase 2 and the OLE clinical trials, and the effects on IV iron and EPO use observed in the OLE trial; and other risk factors identified from time to time in our reports filed with the Securities and Exchange Commission. Any forward-looking statements set forth in this press release speak only as of the date of this press release. We do not intend to update any of these forward-looking statements to reflect events or circumstances that occur after the date hereof. This press release and prior releases are available at www.keryx.com. The information in our website is not incorporated by reference into this press release and is included as an inactive textual reference only.

Wednesday, September 23rd, 2009 Uncategorized Comments Off on Keryx Biopharmaceuticals, Inc. (KERX) Reports Results of Open Label Extension Study Examining Long-Term Use of Zerenex

New Online Tool Gives YRC Customers Greater Flexibility to Meet Must Arrive By Dates (MABD) and Windows via Service Day Calculator New Online Tool Gives YRC Customers Greater Flexibility to Meet Must Arrive By Dates (MABD) and Windows via Service Day Calculator

OVERLAND PARK, Kan., Sept. 23 /PRNewswire-FirstCall/ — YRC Inc., a subsidiary of YRC Worldwide Inc. (Nasdaq: YRCW), announced today the launch of a new Service Day Calculator that can be accessed through its customer Web site, my.yrc.com . Ideal for retailers – but available to any shipper or consignee – the online tool helps customers determine when goods need to be available for pick up, to have shipments arrive at the destination precisely when needed.

“Our customers’ success drives our success. That’s why we’re committed to providing flexible solutions and tools that help them better manage their inventories and production schedules,” said Greg Reid, executive vice president and chief marketing officer – YRC Worldwide. “The my.yrc.com Service Day Calculator does just that by placing focus on the desired delivery date and time and working backwards from there. This helps improve the consistency and precision of deliveries. For our retail customers it improves their vendor scorecards and mitigates costly charge backs.”

Customers can access the Service Day Calculator by logging into my.yrc.com. New customers simply need to register for a my.yrc.com login if they do not currently have one. Once in the application, service day results are displayed in a matrix that includes transit days and all service options: Standard Ground, Fastest Ground, and Expedited Precision. From the matrix options, customers can easily access links to online Rate Quotes and Bills of Lading to book and ship online.

About YRC Worldwide

YRC Worldwide Inc., a Fortune 500 company and one of the largest transportation service providers in the world, is the holding company for a portfolio of successful brands including YRC, YRC Reimer, YRC Glen Moore, YRC Logistics, New Penn, Holland and Reddaway. YRC Worldwide has the largest, most comprehensive network in North America with local, regional, national and international capabilities. Through its team of experienced service professionals, YRC Worldwide offers industry-leading expertise in heavyweight shipments and flexible supply chain solutions, ensuring customers can ship industrial, commercial and retail goods with confidence. The company is headquartered in Overland Park, Kan.

Web site: www.yrcw.com

Wednesday, September 23rd, 2009 Uncategorized Comments Off on New Online Tool Gives YRC Customers Greater Flexibility to Meet Must Arrive By Dates (MABD) and Windows via Service Day Calculator New Online Tool Gives YRC Customers Greater Flexibility to Meet Must Arrive By Dates (MABD) and Windows via Service Day Calculator

Neuralstem, Inc. (CUR) Receives FDA Approval to Commence First ALS Stem Cell Trial

ROCKVILLE, Md., Sept. 21 /PRNewswire-FirstCall/ — Neuralstem, Inc. (NYSE Amex: CUR) today announced that the U.S. Food and Drug Administration (FDA) has approved its Investigational New Drug (IND) application to commence a Phase I trial to treat Amyotrophic Lateral Sclerosis (ALS or Lou Gehrig’s disease) with its spinal cord stem cells.

(Logo: http://www.newscom.com/cgi-bin/prnh/20061221/DCTH007LOGO )

Neuralstem is the first company to commence a stem cell trial to treat ALS. The trial will study the safety of Neuralstem’s cells and the surgical procedures and devices required for multiple injections of Neuralstem’s cells directly into the grey matter of the spinal cord. The FDA’s approval represents a significant step toward delivering regenerative medicine directly to damaged neural cells in humans. ALS affects roughly 30,000 people in the U.S., with about 7,000 new diagnoses per year.

Neuralstem CEO and President, Richard Garr, stated, “The beginning of our clinical trial program is a major step towards achieving Neuralstem’s goal of treating ALS, a fatal neurodegenerative disease for which currently there is no effective treatment or cure. While this trial aims to primarily establish safety and feasibility data in treating ALS patients, we also hope to be able to measure a slowing down of the ALS degenerative process. This trial will be in the extremely capable hands of Dr. Eva L. Feldman, M.D., Ph.D., Director of the University of Michigan Health System ALS Clinic and the Program for Neurology Research & Discovery, and Dr. Jonathan Glass, Director of the Emory Neuromuscular Laboratory and Director of the Emory ALS Center, world-renowned for their study and treatment of ALS patients. We believe that there is no better team to conduct this study for us,” said Garr. Their participation is subject to formal IRB approval by their institutions.

“We are very excited about this clinical trial,” said Dr. Eva L. Feldman, who will direct the Neuralstem clinical trial program for ALS. “This is a major advancement in what still could be a long road to a new and improved treatment for ALS. ALS is a terrible disease that ultimately kills by paralysis,” said Feldman, who also directs the A. Alfred Taubman Medical Research Institute. “In work with animals, these spinal cord stem cells both protected at-risk motor neurons and made connections to the neurons controlling muscles. We don’t want to raise expectations unduly, but we believe these stem cells could produce similar results in patients with ALS,” Dr. Feldman concluded.

About the Trial

The ALS patients will be treated through spinal injections of its patented human neural stem cells.

This first trial, which will primarily evaluate safety of the cells and the surgery procedure, will ultimately consist of 18 ALS patients with varying degrees of the disease. The FDA has approved the first stage of the trial, which consists of 12 patients who will receive five-to-ten stem cell injections in the lumbar area of the spinal cord. The patients will be examined at regular intervals post-surgery, with final review of the data to come about 24 months later.

Neuralstem expects to conduct the trial at Emory University with Dr. Jonathan Glass, M.D., Director of the Emory Neuromuscular Laboratory and Director of the Emory ALS Center, as site Principal Investigator (PI) and with Dr. Nicholas Boulis, M. D. performing the neurosurgery. The overall PI for the ALS trial program is Dr. Eva Feldman, M.D., Ph.D., Director of the University of Michigan Health System ALS Clinic and the Program for Neurology Research & Discovery.

About Neuralstem, Inc.

Neuralstem’s patented technology enables, for the first time, the ability to produce neural stem cells of the human brain and spinal cord in commercial quantities, and the ability to control the differentiation of these cells into mature, physiologically relevant human neurons and glia. The company is targeting major central nervous system diseases including: Ischemic Spastic Paraplegia, Traumatic Spinal Cord Injury, Huntington’s disease and Amyotrophic Lateral Sclerosis (ALS), often referred to as Lou Gehrig’s disease. Neuralstem plans to initiate a Phase I clinical trial to treat ALS with its stem cells. ALS is a progressive fatal neurodegenerative disease that affects nerve cells in the brain, leading to the degeneration and death of the motor neurons in the spinal cord that control muscle movement. Pre-clinical work has shown Neuralstem’s cells to extend the life of rats with ALS (as reported the journal TRANSPLANTATION, October 16, 2006, in collaboration with Johns Hopkins University researchers), and also reversed paralysis in rats with Ischemic Spastic Paraplegia, (as reported in NEUROSCIENCE, June 29, 2007, in collaboration with researchers at University of California San Diego).

Cautionary Statement Regarding Forward Looking Information

This news release may contain forward-looking statements made pursuant to the “safe harbor” provisions of the Private Securities Litigation Reform Act of 1995. Investors are cautioned that such forward-looking statements in this press release regarding potential applications of Neuralstem’s technologies constitute forward-looking statements that involve risks and uncertainties, including, without limitation, risks inherent in the development and commercialization of potential products, uncertainty of clinical trial results or regulatory approvals or clearances, need for future capital, dependence upon collaborators and maintenance of our intellectual property rights. Actual results may differ materially from the results anticipated in these forward- looking statements. Additional information on potential factors that could affect our results and other risks and uncertainties are detailed from time to time in Neuralstem’s periodic reports, including the annual report on Form 10-K for the year ended December 31, 2008 and the quarterly report on form 10-Q for the period ended June 30, 2009.

Monday, September 21st, 2009 Uncategorized Comments Off on Neuralstem, Inc. (CUR) Receives FDA Approval to Commence First ALS Stem Cell Trial

YM BioSciences, Inc. (YMI) Reports Nimotuzumab Approved For Marketing in Mexico

MISSISSAUGA, Sept. 17 /PRNewswire-FirstCall/ – YM BioSciences Inc. (NYSE Amex:YMI, TSX:YM, AIM:YMBA), a life sciences product development company that identifies and advances a diverse portfolio of promising cancer-related products at various stages of development, today reported that nimotuzumab has been approved for marketing in Mexico. YM BioSciences also announced that it has enrolled the first two patients in its randomized, double-blind trial evaluating nimotuzumab in patients with brain metastases from non-small-cell lung cancer (NSCLC).

“Mexico is the 21st country to have approved nimotuzumab for marketing and, while YM’s license for major market territories for nimotuzumab does not include Mexico, this approval reflects the growing recognition throughout much of the world of the value to patients of our drug and the progress being made in its commercialization,” said David Allan, Chairman and CEO of YM BioSciences. “As part of YM’s registration strategy for nimotuzumab, we were also pleased to report the opening of this second of two randomized, double-blind trials that YM is conducting in Canada and which are both now being expanded internationally.”

Nimotuzumab is a humanized monoclonal antibody that targets the epidermal growth factor receptor (EGFR), licensed to YM’s majority-owned subsidiary, CIMYM BioSciences Inc., by CIMAB S.A., and developed at the Center of Molecular Immunology in Cuba. Nimotuzumab is approved in two of the countries in YM’s territories. The drug has demonstrated efficacy in clinical trials without producing the numerous and severe toxicities observed with the other marketed EGFR-targeting drugs. Mexican regulatory authorities have approved nimotuzumab for the treatment of squamous cell carcinoma of the head and neck (SCCHN), adult glioma and pediatric glioma. The approval was granted to Laboratorios PiSA in Guadalajara, Mexico and nimotuzumab will be commercialized under the name VECTHIX(R).

    First patients enrolled in multinational randomized, double-blind brain
metastases trial

YM BioSciences recently enrolled and treated the first two patients in its multinational randomized, double-blind trial evaluating nimotuzumab plus whole-brain radiation therapy (WBRT) to WBRT alone in patients with brain metastases from NSCLC. The trial is designed enroll approximately 88 patients over twelve months followed by a twelve-month follow-up period and will likely include 12 investigational centers in Canada plus additional centers in other countries. The patients were enrolled at the L’Hopital Maisonneuve-Rosemont in Montreal, Canada.

Nimotuzumab (200 mg IV infusions) will be administered weekly during radiotherapy and following radiotherapy until disease progression, unacceptable toxicity or at the discretion of the physician. Radiotherapy will consist of 30 Gy, in 10 fractions of 3 Gy/day. Patients will be assessed by laboratory tests, imaging studies, standardized neurologic examination, and neurologic symptoms. The primary efficacy endpoint is intracranial disease progression over six months. The secondary endpoints are overall survival (OS); time to neurologic progression (TNP) or death with evidence of neurologic progression; OS rate at six months; time to intracranial disease progression; and time to overall progression.

“This randomized, double-blinded, multicentric trial was based on a randomized pilot open-label trial from which encouraging, preliminary results were presented at the EORTC-NCI-AACR “Molecular Targets and Cancer Therapeutics” meeting held on October 21-24, 2008 in Geneva. YM is preparing to imminently open the first international centers on both this and the ongoing palliative NSCLC randomized trial. In this trial, as with the others being conducted by YM, extensive samples are being collected and stored in anticipation of a comprehensive program of translational analysis,” said Dr. Leonardo Viana Nicacio, YM’s Director of Clinical Affairs.

Nimotuzumab is reported to have been has been administered to more than 5,000 patients worldwide and is currently in 32 trials internationally of which 11 are being conducted by YM and its four licensees. Three of the latter are Phase III trials, including one being conducted by the internationally recognized National Cancer Center of Singapore, which selected nimotuzumab over the alternative antibodies because of its benign side effect profile. Nimotuzumab is also available on a compassionate use basis in the US for children with pediatric glioma and is designated an Orphan Drug for adult and pediatric glioma by the FDA as well as the EMEA for Europe.

About YM BioSciences

YM BioSciences Inc. is a life sciences product development company that identifies and advances a diverse portfolio of promising cancer-related products at various stages of development. The Company is currently developing two late-stage products: nimotuzumab, an EGFR-targeting Affinity-Optimized Antibody(TM), and AeroLEF(R), a proprietary, inhaled-delivery composition of free and liposome-encapsulated fentanyl. YM has proven regulatory and clinical trial expertise and a diversified business model designed to reduce risk while advancing clinical products toward international approval, marketing and commercialization.

This press release may contain forward-looking statements, which reflect the Company’s current expectation regarding future events. These forward-looking statements involve risks and uncertainties that may cause actual results, events or developments to be materially different from any future results, events or developments expressed or implied by such forward-looking statements. Such factors include, but are not limited to, changing market conditions, the successful and timely completion of clinical studies, the establishment of corporate alliances, the impact of competitive products and pricing, new product development, uncertainties related to the regulatory approval process and other risks detailed from time to time in the Company’s ongoing quarterly and annual reporting. Certain of the assumptions made in preparing forward-looking statements include but are not limited to the following: that nimotuzumab will continue to demonstrate a competitive safety profile in ongoing and future clinical trials; that AeroLEF(R) will continue to generate positive efficacy and safety data in future clinical trials; and that YM and its various partners will complete their respective clinical trials within the timelines communicated in this release. We undertake no obligation to publicly update or revise any forward-looking statements, whether as a result of new information, future events or otherwise.

Thursday, September 17th, 2009 Uncategorized 1 Comment

Origin Agritech Limited (SEED) Subsidiary Reaches Agreement for Novel Glyphosate-Tolerance Gene

Sep. 17, 2009 (Business Wire) — Origin Biotechnology, a wholly-owned subsidiary of Origin Agritech Limited (NASDAQ:SEED) announced it has reached an comprehensive, worldwide agreement with the Institute of Microbiology of the Chinese Academy of Sciences (CAS) and Sichuan Biotech Engineering, Limited. CAS and Sichuan Biotech jointly own the rights to an internally developed gene which is highly tolerant to glyphosate (herbicide). This glyphosate-tolerance gene, demonstrated to be extremely effective in both laboratory and field environments, is entirely new to the consumer markets in that it has never been commercialized, and is protected by patents granted separately by China and USA separately.

For the entire life of the patent, Origin Biotechnology will receive exclusive rights to sell and develop corn, soybean, rice, cotton and canola products that contain these technology traits worldwide, both in the territory within China and outside of China. Origin Biotechnology will also receive exclusive rights to sub-license to any third parties to sell and develop corn, soybean, rice, cotton and canola products that contain these traits and with application of patent technology worldwide in the territory within China and outside of China. Origin Biotech will also receive the rights to improve and further develop this glyphosate-tolerant gene. Additionally, no change of control in the patent will have impact on the validity of this agreement.

As a result of this landmark agreement for Origin, Chairman Gengchen Han reiterated, “Origin continues to demonstrate that it is the leading, technology-focused crop seed company in China. Our goal remains consistent —- to lead the industry by serving farmers with unique enabling technology and services, producing and protecting higher crop yields. Our focus remains in the production of higher quality seed products, whether proprietary or licensed.”

UPDATE OF ORIGIN GM PROGRAM

Phytase

World’s first transgenic phytase corn is expected to be commercially launched as the first genetically modified corn product in China. Phase 5 passage is expected near term pending a final stage approval from the Ministry of Agriculture (MOA). Currently, phytase corn continues to remain the only biotechnology corn product in Phase 5 of development in China. Phytase is currently used as an additive essential for the growth and development of all animals, and limits the amount of phosphorus waste in the environment. Phytase, as an additive for animal feed, is mandatory in Europe, Southeast Asia, South Korea, Japan, and Taiwan for environmental purposes. The worldwide phytase potential market size is US$500 million dollars, including US$200 million for China alone, according to the China Feed Industry Study. The corn seed market in China is estimated at US$1 billion.

Glyphosate (Herbicide) Tolerance

Glyphosate tolerance has passed the intermediate testing phase (Phase 2) and entered the environmental release testing phase (Phase 3). Worldwide, the largest segment of the transgenic crop market has been herbicide tolerant crops. Specifically, glyphosate tolerant crops have been widely accepted in cotton, corn, and canola in North America. Introduced in the US in 1998, the use of glyphosate tolerant corn grew from 950,000 acres in 1998 to 2.3 million acres in 1999 to 41 million acres in 2007, or at a compounded annual growth rate of 51.9%, according to the US Department of Agriculture. The rapid historical adoption rate indicates farmers find this trait to be extremely valuable. The high level of adoption of these crops by farmers has also caused the reduction in value of the remaining herbicide market.

Since their introduction in 1996, over 75 million acres of genetically engineered glyphosate-tolerant crops have been planted, making up 46% of the corn, 80% of soybean acres, and 70% of cotton acres in the US. These genetically engineered crops have been adopted by farmers because they are perceived to offer significant economic benefits over conventional crop and herbicide programs. The adoption of glyphosate-tolerant crops has reduced costs for US farmers an estimated $1.2 billion. On the basis of recent adoption rates by growers around the world, it appears that glyphosate-tolerant crops will continue to grow in number and in hectares planted.

Pest Resistance (Bt Corn)

Pest resistance (Bt Corn) has passed the intermediate testing phase (Phase 2)and entered the environmental release phase (Phase 3). In these phase 2 and 3 trials, these traits continue to perform as the best performing traits for pest resistance throughout China.

Bt crops produce a protein toxic to specific insects used in areas with high levels of infestations of targeted pests. Bt cotton, which controls varieties of the budworm and bollworm, was planted on 59 percent of U.S. cotton acreage and 75 percent of the Chinese cotton acreage in 2007. Introduced in 1996 in the US, acreage of Bt corn has grown from 3.6 million acres in 1999 to 44 million acres in 2007, or at a compounded annual growth rate of 36.7%, according to the US Department of Agriculture. This Bt corn variety was planted on 49 percent of U.S. corn acreage in 2007.

About Origin

Founded in 1997 and headquartered in Beijing, Origin Agritech Limited (Nasdaq: SEED) is one of China’s leading, vertically-integrated agricultural technology company specializing in hybrid seed research, development and production to supply the growing populations of China and Southeast Asia. Origin develops, grows, processes, and markets hybrid seeds to farmers throughout China and parts of Southeast Asia via a network of approximately 3,200 distributors. The hybrid seed industry is estimated at US$2 billion and that is expected to double by 2010. The animal nutrition market is estimated at US$1.6 billion. The Company currently operates facilities in 30 of China’s 32 provinces as well as Beijing. Since Origin launched its first entirely internally developed seed in 2003, the Company has developed and commercialized a proprietary seed portfolio of ten corn hybrids, six rice hybrids and two canola hybrids. For further information, please log on www.originagritech.com.

Forward Looking Statements

This release contains forward-looking statements. All forward-looking statements included in this release are based on information available to us on the date hereof. These statements involve known and unknown risks, uncertainties and other factors, which may cause our actual results to differ materially from those implied by the forward-looking statements. In some cases, you can identify forward-looking statements by terminology such as “may,” “will,” “should,” “could,” “expects,” “plans,” “anticipates,” “believes,” “estimates,” “predicts,” “potential,” “targets,” “goals,” “projects,” “continue,” or variations of such words, similar expressions, or the negative of these terms or other comparable terminology. Although we believe that the expectations reflected in the forward-looking statements are reasonable, we cannot guarantee future results, levels of activity, performance or achievements. Therefore, actual results may differ materially and adversely from those expressed in any forward-looking statements. Neither we nor any other person can assume responsibility for the accuracy and completeness of forward-looking statements. Important factors that may cause actual results to differ from expectations include, but are not limited to, those risk factors discussed in Origin’s filings with the SEC including its transition report on Form 20-F filed with the SEC on February 15, 2007. We undertake no obligation to revise or update publicly any forward-looking statements for any reason.

Thursday, September 17th, 2009 Uncategorized Comments Off on Origin Agritech Limited (SEED) Subsidiary Reaches Agreement for Novel Glyphosate-Tolerance Gene

Positive Phase IIb Results for GSK1838262 (XP13512) Reported for Neuropathic Pain Associated with Post-Herpetic Neuralgia

Sep. 17, 2009 (Business Wire) — GlaxoSmithKline (NYSE:GSK) and XenoPort, Inc. (Nasdaq:XNPT) today announced top-line results from a Phase IIb clinical trial evaluating the safety and efficacy of GSK1838262/XP13512 (gabapentin enacarbil) for neuropathic pain associated with post-herpetic neuralgia (PHN) in adults. In this study, subjects were randomized to receive placebo, 1200, 2400 or 3600 mg/day of GSK1838262 dosed twice a day. All doses of GSK1838262 demonstrated statistically significant improvements over placebo on the primary endpoint, which was the change from baseline to the end of maintenance treatment in the 24-hour average pain intensity score.

This 14-week, double-blind, placebo-controlled study enrolled 376 subjects with PHN who had been experiencing pain for at least three months following healing of the herpes zoster skin rash. The pre-specified statistical analysis included adjustment for comparisons of multiple GSK1838262 doses to placebo. The adjusted p-values for comparison of 1200, 2400 and 3600 mg/day doses to placebo were 0.013, 0.029 and 0.002, respectively.

GSK1838262 was generally well tolerated at all doses in this study. The most common adverse events were dizziness (placebo 15%, 1200 mg/day 17%, 2400 mg/day 26% and 3600 mg/day 30%) and somnolence (8%, 10%, 11% and 14%, respectively). Most of these adverse events were mild or moderate in intensity. Withdrawals due to adverse events were 13%, 6%, 15% and 18%, respectively.

“We are encouraged by the positive results in this study of GSK1838262 in treating neuropathic pain associated with PHN, which is a debilitating condition for affected patients. We look forward to sharing the full results at a future medical meeting,” said Atul Pande, M.D., senior vice president, GlaxoSmithKline Neurosciences Medicines Development Center. “We are currently evaluating the next steps for the development of this compound for the treatment of neuropathic pain.”

Ronald W. Barrett, Ph.D., chief executive officer of XenoPort said, “We are pleased with the efficacy and tolerability results observed across all doses in this study. These results build upon the positive Phase IIa study in PHN patients we previously conducted with this product candidate. We look forward to continuing to work with GSK to advance the development of this compound in neuropathic pain.”

About PHN

Post-herpetic neuralgia is a neuropathic pain syndrome that primarily affects people over fifty and often results in disability. PHN follows an outbreak of herpes zoster, commonly known as shingles. Approximately one million people in the United States develop shingles each year. Of these, nearly 15 percent develop PHN.

Conference Call and Webcast Information

XenoPort will host a conference call at 9:00 a.m. Eastern Time today. To access the conference call via the Internet, go to www.XenoPort.com. To access the live conference call via phone, dial 1-888-275-3514. International callers may access the live call by dialing 1-706-679-1417.

The replay of the conference call may be accessed after 12:00 p.m. Eastern Time today via the Internet, at www.XenoPort.com, or via phone at 1-800-642-1687 for domestic callers or 1-706-645-9291 for international callers. The reference number to enter the call and the replay of the call is 31158623.

GSK1838262 is a new chemical entity that is designed to provide dose proportional and sustained exposure of gabapentin by taking advantage of high-capacity transport mechanisms in the gastrointestinal tract. A New Drug Application for GSK1838262 for the treatment of moderate-to-severe primary restless legs syndrome (RLS) is being reviewed by the U.S. Food and Drug Administration.

GlaxoSmithKline – one of the world’s leading research-based pharmaceutical and healthcare companies – is committed to improving the quality of human life by enabling people to do more, feel better and live longer. For further information please visit www.gsk.com.

XenoPort is a biopharmaceutical company focused on developing a portfolio of internally discovered product candidates that utilize the body’s natural nutrient transport mechanisms to improve the therapeutic benefits of existing drugs. XenoPort is developing its lead product candidate in partnership with Astellas Pharma Inc. and GSK. XenoPort’s product candidates are being studied for the potential treatment of RLS, gastroesophageal reflux disease, migraine headaches, neuropathic pain, spasticity related to spinal cord injury and Parkinson’s disease. To learn more about XenoPort, please visit the Web site at www.XenoPort.com.

Thursday, September 17th, 2009 Uncategorized Comments Off on Positive Phase IIb Results for GSK1838262 (XP13512) Reported for Neuropathic Pain Associated with Post-Herpetic Neuralgia

Zargis Receives FDA Clearance for Signal X6 Telemedicine Device; OK Allows Delivery to US Army

STAMFORD, Conn., Sept. 17 /PRNewswire-FirstCall/ — Zargis Medical Corp., a spin-off from Siemens Corporate Research (NYSE: SI) and a majority-owned subsidiary of Speedus Corp. (Nasdaq: SPDE), announced today it has received U.S. Food and Drug Administration (FDA) clearance to market its new Signal X6(TM) device. Zargis also announced the delivery of seven Signal X6 devices to the U.S. Army for deployment in six Department of Defense medical facilities.

Signal X6 is noninvasive, easy to use and simultaneously records heart and lung sounds from six adhesive sensors. The recordings can be evaluated locally or, for locations where a cardiac specialist is not immediately available for consultation, transmitted through the Internet for remote evaluation. Signal X6 and our recently launched Zargis Cardioscan(TM) device were both designed for user-friendly digital heart sound analysis. The configuration of the Signal X6 provides a unique telemedicine resource in situations where evaluations would benefit from high fidelity multi-channel synchronous recordings.

“As healthcare systems continue to demand improved outcomes with utilization of fewer resources, we believe that Signal X6 will provide cost-effective, high quality cardiac analysis in situations where it’s not practical for a patient to visit a specialist,” said John Kallassy, Zargis’ CEO.

Prototypes for Signal X6 were first developed with funding from the Telemedicine and Advanced Technology Research Center (TATRC) through the AAMTI program. The AAMTI program provides funding to AMEDD personnel to demonstrate technology and document the impact on cost, access and quality of care. TATRC (www.tatrc.org) is an element of the United States Army Medical Research and Materiel Command (USAMRMC).

About Zargis Medical Corp.

Zargis Medical Corp. develops advanced diagnostic decision support products and services for primary care physicians, pediatricians, cardiologists and other healthcare professionals. Zargis was formed in 2001 when Siemens Corporate Research, a division of Siemens AG (NYSE: SI), and Speedus Corp. co-invested to develop and market an advanced acoustic technology designed to detect heart abnormalities identified through analysis of heart sounds.

For additional information about Zargis or Speedus Corp., contact Peter Hodge at 888.773.3669 (ext. 23) or phodge@zargis.com or visit the following Web sites: www.zargis.com and www.speedus.com.

Statements contained herein that are not historical facts, including but not limited to statements about the Company’s product, corporate identity and focus, may be forward-looking statements that are subject to a variety of risks and uncertainties. There are a number of important factors that could cause actual results to differ materially from those expressed in any forward-looking statements made by the Company, including, but not limited to, the continuing development of the Company’s sales, marketing and support efforts.

Thursday, September 17th, 2009 Uncategorized Comments Off on Zargis Receives FDA Clearance for Signal X6 Telemedicine Device; OK Allows Delivery to US Army

Adobe to Acquire Omniture, Inc. (OMTR)

Sep. 15, 2009 (Business Wire) — Adobe Systems Incorporated (Nasdaq:ADBE) and Omniture, Inc. (Nasdaq:OMTR) today announced the two companies have entered into a definitive agreement for Adobe to acquire Omniture in a transaction valued at approximately $1.8 billion on a fully diluted equity-value basis. Under the terms of the agreement, Adobe will commence a tender offer to acquire all of the outstanding common stock of Omniture for $21.50 per share in cash.

Adobe’s acquisition of Omniture furthers its mission to revolutionize the way the world engages with ideas and information. By combining Adobe’s content creation tools and ubiquitous clients with Omniture’s Web analytics, measurement and optimization technologies, Adobe will be well positioned to deliver solutions that can transform the future of engaging experiences and e-commerce across all digital content, platforms and devices.

The combination of the two companies will increase the value Adobe delivers to customers. For designers, developers and online marketers, an integrated workflow — with optimization capabilities embedded in the creation tools — will streamline the creation and delivery of relevant content and applications. This optimization will enable advertisers, advertising agencies, publishers and e-tailers to achieve greater ROI from their digital media investments and improve their end users’ experiences.

“Adobe customers are looking to us for solutions to deliver engaging experiences and more effectively monetize their content and applications online,” said Shantanu Narayen, president and chief executive officer of Adobe. “This is a game changer for both Adobe and our customers. We will enable advertisers, media companies and e-tailers to realize the full value of their digital assets.”

“Omniture’s mission has been to enable our customers to optimize every digital interaction,” said Josh James, CEO of Omniture. “By joining forces with Adobe, we will accelerate our ability to deliver on that vision and together bring new innovation to the market that improves content engagement, advertising effectiveness and the overall user experience, which will drive more advertising dollars online.”

Expanded Opportunities for Adobe and Omniture

This acquisition will significantly expand Adobe’s addressable market and growth potential, broadening solutions Adobe provides to the rapidly growing Internet advertising, e-commerce and digital media markets.

The combination will also expand Adobe’s offering of mission-critical solutions to the enterprise customer. Adding the capabilities of Omniture will further enhance Adobe’s offerings and ability to appeal to online marketers, including chief marketing officers.

The acquisition of Omniture will further diversify Adobe’s business, adding a scalable SaaS platform that captures over a trillion transactions per quarter, an expansive partner ecosystem, and a recurring revenue model.

For Omniture, joining Adobe will provide global operational scale and the ability to more quickly penetrate new geographies and markets, thereby accelerating its go-to-market strategy and growth potential.

Integration and Closing Details

As part of the expected integration of the two companies, Omniture will become a new business unit within Adobe. Omniture’s CEO, Josh James, will join Adobe as senior vice president of the new business unit, reporting to Adobe’s president and CEO, Shantanu Narayen.

The completion of the transaction, which is subject to customary government approvals and the satisfaction of other customary conditions, is expected to close in the fourth quarter of Adobe’s 2009 fiscal year.

The proposed offer represents a premium of 45 percent over Omniture’s average closing price for the last 30 trading days through yesterday’s close.

Adobe believes the acquisition will be accretive to Adobe’s non-GAAP earnings in fiscal year 2010.

The companies will make information, including an FAQ and other details about the acquisition, available at http://www.adobe.com/aboutadobe/invrelations/adobeandomniture.html.

Conference Call Scheduled for 2:00 p.m. PDT Today

Adobe will comment on the acquisition of Omniture today during its Q3 FY2009 earnings conference call, which is scheduled to begin at 2:00 p.m. PDT today. Investors, analysts and press can participate in a live Webcast via Adobe Acrobat Connect Pro or access the live conference call using the following access information:

Webcast: Go to http://www.adobe.com/ADBE and click on the Q3 FY09 Earnings Conference Call icon
Live Call: Dial 888-213-3930 and use passcode 3412311
Questions: Contact Adobe Investor Relations at 408-536-4416 or ir@adobe.com

The call and Webcast will last approximately one hour. An archive of the call will be made available in Adobe Acrobat Connect Pro for approximately 45 days. Listening to the live Webcast works best with Adobe Flash Player version 10 or later. Firewalls designed to protect corporate information can prevent listening to the Webcast.

Forward-Looking Statements Disclosure

This press release includes forward-looking statements, within the meaning of the Private Securities Litigation Reform Act of 1995, that are subject to risks, uncertainties and other factors, including the risks to both companies that the acquisition of Omniture will not be consummated, as the transaction is subject to certain closing conditions. All statements other than statements of historical fact are statements that could be deemed forward-looking statements, including statements regarding: the anticipated timing of filings and approvals relating to the transaction; the expected timing of the completion of the transaction; the ability to complete the transaction considering the various closing conditions; any projections of earnings, revenues or other financial items; any statements of the plans, strategies and objectives of management for future operations; any statements of expectation or belief; and any statements of assumptions underlying any of the foregoing. In addition, if and when the transaction is consummated, there will be risks and uncertainties related to Adobe’s ability to successfully integrate the products and employees of Adobe and Omniture, as well as the ability to ensure continued performance or market growth of Omniture’s products. These risks, uncertainties and other factors, and the general risks associated with the respective businesses of Adobe and Omniture described in the reports and other documents filed by each of them with the Securities and Exchange Commission, could cause actual results to differ materially from those referred to in the forward-looking statements. The reader is cautioned not to rely on these forward-looking statements. All forward-looking statements are based on information currently available to Adobe and Omniture and are qualified in their entirety by this cautionary statement. Neither Adobe nor Omniture assumes any obligation to update any such forward-looking statements or other statements included in this press release.

Additional Information and Where to Find It

This press release is for informational purposes only and is not an offer to buy or the solicitation of an offer to sell any securities. The solicitation and the offer to buy shares of Omniture’s common stock will only be made pursuant to a tender offer statement on schedule TO, including an offer to purchase and other related materials that Snowbird Acquisition Corporation, a wholly-owned subsidiary of Adobe Systems Incorporated, intends to file with the Securities and Exchange Commission. In addition, Omniture will file with the Securities and Exchange Commission a Solicitation/Recommendation Statement on Schedule 14D-9 with respect to the tender offer. Once filed, Omniture stockholders will be able to obtain the tender statement on schedule TO, the offer to purchase, the Solicitation/Recommendation Statement on Schedule 14D-9 and related materials with respect to the offer, free of charge at the website of the Securities and Exchange Commission at www.sec.gov, from the information agent and dealer manager named in the tender offer materials or from Snowbird Acquisition Corporation. Omniture’s stockholders are advised to read these documents, any amendments to these documents and any other documents relating to the tender offer that are filed with the SEC carefully and in their entirety prior to making any decisions with respect to the offer because they contain important information, including the terms and conditions of the offer.

About Omniture

Omniture, Inc. is a leading provider of online business optimization software, enabling customers to manage and enhance online, offline and multi-channel business initiatives. Omniture’s software, which it hosts and delivers to its customers as an on-demand subscription service and on-premise solution, enables customers to capture, store and analyze information generated by their Web sites and other sources and to gain critical business insights into the performance and efficiency of marketing and sales initiatives and other business processes. In addition, Omniture offers a range of professional services that complement its online services, including implementation, best practices, consulting, customer support and user training through Omniture Education. Omniture’s more than 5,000 customers include eBay, AOL, Wal-Mart, Gannett, Microsoft, Neiman Marcus, Oracle, Sony and HP. www.omniture.com

About Adobe Systems Incorporated

Adobe revolutionizes how the world engages with ideas and information – anytime, anywhere and through any medium. For more information, visit www.adobe.com.

© 2009 Adobe Systems Incorporated and Omniture, Inc. All rights reserved. Adobe, Flash, and the Adobe Logo are either registered trademarks or trademarks of Adobe Systems Incorporated in the United States and/or other countries. Omniture and the Omniture logo are either registered trademarks or trademarks of Omniture, Inc. in the United States and/or other countries. All other trademarks are the property of their respective owners.

Wednesday, September 16th, 2009 Uncategorized Comments Off on Adobe to Acquire Omniture, Inc. (OMTR)

Keryx Biopharmaceuticals, Inc. (KERX) Receives Orphan-Drug Designation for KRX-0401 (Perifosine) for the Treatment of Multiple Myeloma

NEW YORK, Sept. 16 /PRNewswire/ — Keryx Biopharmaceuticals, Inc. today announced that KRX-0401 (perifosine) has received Orphan-Drug designation from the U.S. Food and Drug Administration (FDA) for the treatment of multiple myeloma. In August, the Company announced that it had reached an agreement with the FDA regarding a Special Protocol Assessment (SPA) on the design of a Phase 3 trial in relapsed/refractory multiple myeloma and that the study is expected to start by year-end.

Ron Bentsur, Chief Executive Officer of Keryx, commented, “The Orphan-Drug designation for perifosine in multiple myeloma is a very important milestone for Keryx, as the market exclusivity protection provided by this designation significantly enhances the commercial opportunity of perifosine in this indication.” Mr. Bentsur continued, “Following our exciting announcement last month that we had reached an agreement with the FDA on an SPA for a Phase 3 trial for perifosine in relapsed/refractory multiple myeloma, it is encouraging to further add to the value of the perifosine program with this Orphan-Drug designation. We look forward to commencing the Phase 3 study by year-end.”

KRX-0401 (perifosine) is in-licensed by Keryx from Aeterna Zentaris, Inc. in the United States, Canada and Mexico.

About Orphan-Drug Designation

Orphan-drug designation is granted by the FDA Office of Orphan Drug Products to novel drugs or biologics that treat a rare disease or condition affecting fewer than 200,000 patients in the U.S. The designation provides the drug developer with a seven-year period of U.S. marketing exclusivity if the drug is the first of its type approved for the specified indication or if it demonstrates superior safety, efficacy, or a major contribution to patient care versus another drug of its type previously granted the designation for the same indication, as well as with tax credits for clinical research costs, the ability to apply for annual grant funding, clinical research trial design assistance and waiver of Prescription Drug User Fee Act (PDUFA) filing fees.

About Special Protocol Assessments

The Special Protocol Assessment (SPA) process is a procedure by which the FDA provides official evaluation and written guidance on the design and size of proposed protocols that are intended to form the basis for a new drug application.

Final marketing approval depends on the results of efficacy, the adverse event profile and an evaluation of the benefit/risk of treatment demonstrated in the Phase 3 trial. The SPA agreement may only be changed through a written agreement between the sponsor and the FDA, or if the FDA becomes aware of a substantial scientific issue essential to product efficacy or safety. For more information on Special Protocol Assessment, please visit: http://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Gui dances/ucm080571.pdf

About Multiple Myeloma

Multiple myeloma, a cancer of the plasma cells, is an incurable but treatable disease. Multiple myeloma is the second most-common hematologic cancer, representing 1% of all cancer diagnoses and 2% of all cancer deaths. According to the American Cancer Society, in 2009 there will be an estimated 20,580 new cases of multiple myeloma and an estimated 10,500 deaths from multiple myeloma in the United States. To date, several FDA approved therapies exist for the treatment of multiple myeloma. Despite this progress, patients continue to relapse, become refractory to prior treatments and eventually die from their disease. Thus, new therapies are needed to treat these patients and extend their survival.

About Keryx Biopharmaceuticals

Keryx Biopharmaceuticals is focused on the acquisition, development and commercialization of medically important pharmaceutical products for the treatment of life-threatening diseases, including cancer and renal disease. Keryx is developing KRX-0401 (perifosine), a novel, potentially first-in-class, oral anti-cancer agent that inhibits the phosphoinositide 3-kinase (PI3K)/Akt pathway, a key signaling cascade that has been shown to induce cell growth and cell transformation. KRX-0401 has demonstrated both safety and clinical efficacy in several tumor types, both as a single agent and in combination with novel therapies. KRX-0401 also modulates a number of other key signal transduction pathways, including the JNK and MAPK pathways, which are pathways associated with programmed cell death, cell growth, cell differentiation and cell survival. KRX-0401 is currently in Phase 2 clinical development for multiple tumor types, with a Phase 3 in multiple myeloma, under Special Protocol Assessment (SPA), pending commencement by year-end. Keryx is also developing Zerenex(TM) (ferric citrate), an oral, iron-based compound that has the capacity to bind to phosphate and form non-absorbable complexes. Zerenex has recently completed a Phase 2 clinical program as a treatment for hyperphosphatemia (elevated phosphate levels) in patients with end-stage renal disease, and Keryx is in the process of finalizing the U.S. Phase 3 program for Zerenex in consultation with the FDA. Keryx is headquartered in New York City.

Cautionary Statement

Some of the statements included in this press release, particularly those anticipating future clinical trials and business prospects for KRX-0401 (perifosine), may be forward-looking statements that involve a number of risks and uncertainties. For those statements, we claim the protection of the safe harbor for forward-looking statements contained in the Private Securities Litigation Reform Act of 1995. Among the factors that could cause our actual results to differ materially are the following: our ability to successfully and cost-effectively complete clinical trials for KRX-0401; the risk that the data (both safety and efficacy) from the Phase 3 study of KRX-0401 (perifosine) will not coincide with the data analyses from the Phase 1 / 2 study previously reported by the Company; and other risk factors identified from time to time in our reports filed with the Securities and Exchange Commission. Any forward-looking statements set forth in this press release speak only as of the date of this press release. We do not undertake to update any of these forward-looking statements to reflect events or circumstances that occur after the date hereof. This press release and prior releases are available at http://www.keryx.com. The information found on our website and the FDA website is not incorporated by reference into this press release and is included for reference purposes only.

Wednesday, September 16th, 2009 Uncategorized Comments Off on Keryx Biopharmaceuticals, Inc. (KERX) Receives Orphan-Drug Designation for KRX-0401 (Perifosine) for the Treatment of Multiple Myeloma

Hi-Shear Technology Corp. (HSR) Signs Merger Agreement

Sep. 16, 2009 (Business Wire) — Hi-Shear Technology Corporation (NYSE Amex: HSR) today announced that it has entered into a definitive merger agreement with Chemring Group PLC (LSE: CHR), whereby Chemring will acquire Hi-Shear in an all cash transaction valued at approximately $132.0 million.

The board of directors of Hi-Shear approved the transaction with Chemring, based, in part, upon the recommendation of a special committee of the board that was established to consider strategic alternatives. Under the terms of the merger agreement, upon consummation of the transaction, Hi-Shear stockholders will receive an amount in cash equal to $19.18 per share of Hi-Shear’s outstanding common stock, which represents a premium of 61.4% over Hi-Shear’s closing stock price on September 15, 2009. The transaction is subject to customary closing conditions, including approval of the transaction by Hi-Shear’s stockholders and the expiration or termination of applicable waiting periods under the Hart-Scott Rodino Antitrust Improvement Act of 1976, and is expected to be completed in the fourth quarter of 2009.

“We are extremely pleased to join the Chemring Group. This combination of two well-known and respected companies worldwide will provide enhanced and increased capabilities and resources to better serve our loyal customers. The transaction has a strong strategic basis and supports Hi-Shear’s commitment to both our stockholders and our customers,” stated George Trahan, Hi-Shear’s Chairman and CEO.

In connection with the transaction, Lazard served as financial advisor to the Special Committee of the Board of Directors of Hi-Shear and Gibson, Dunn & Crutcher LLP served as its legal counsel.

About Hi-Shear

Hi-Shear Technology Corporation provides pyrotechnic, mechanical, and electronic products to prime aerospace customers for use in aerospace and defense markets where safety, performance and high reliability are essential. It develops and produces advanced systems and products that are primarily used worldwide in space satellites, launch vehicles, national defense, and government programs.

About Chemring

Chemring, with 2008 revenues of £354.2 million, is a global company that specializes in the manufacture of energetic material products and decoy countermeasures. Chemring provides solutions for highly demanding customer requirements in defense, security and safety markets. Chemring is a world-leading defense company involved in critical defense development programs in the UK, US, Europe and Australia. Chemring’s capabilities to provide solutions to customer requirements are based on its core competencies in: (i) energetic materials, (ii) high reliability and safety and (iii) volume manufacturing. Chemring is built on a hundred-year history of innovation and development and currently employs over 3000 people in the UK, US, France, Germany, Italy, Norway, Spain and Australia. Chemring sells to over 80 countries and its end-users include the military services, security forces and commercial marine operators.

This release contains forward-looking statements that involve risks and uncertainties. The forward-looking statements are made pursuant to the safe harbor provisions of the Private Securities Litigation Reform Act of 1995. Actual results could differ materially from those projected in the forward-looking statements as a result of certain risk factors, including but not limited to: (i) adverse changes in general economic or market conditions; (ii) the satisfaction of closing conditions, including the receipt of Hi-Shear’s stockholder approval and regulatory approvals, in connection with the proposed transaction; (iii) fluctuations in Hi-Shear’s operating results and risks associated with trading of Hi-Shear’s stock; (iv) war or acts of terrorism; (v) the ability to attract and retain highly qualified employees; (vi) changes in government laws and regulations; and (vii) other one-time events and other important factors disclosed previously and from time to time in Hi-Shear’s filings with the U.S. Securities and Exchange Commission (the “SEC”). Except as required by law, Hi-Shear disclaims any obligation to update any such forward-looking statements after the date of this release.

IMPORTANT ADDITIONAL INFORMATION WILL BE FILED WITH THE SEC

In connection with the proposed transaction with Chemring, Hi-Shear intends to file a proxy statement and other relevant documents concerning the transaction with the SEC. STOCKHOLDERS OF HI-SHEAR ARE URGED TO READ THE PROXY STATEMENT AND ANY OTHER RELEVANT DOCUMENTS FILED WITH THE SEC WHEN THEY BECOME AVAILABLE BECAUSE THEY WILL CONTAIN IMPORTANT INFORMATION ABOUT THE TRANSACTION.

Investors and security holders will be able to obtain free copies of the proxy statement and other documents filed with the SEC by Hi-Shear through the web site maintained by the SEC at www.sec.gov. Free copies of the proxy statement, when available, and Hi-Shear’s other filings with the SEC also may be obtained on Hi-Shear’s website at www.hstc.com or by directing a request to Investor Relations at (310) 784-2100.

Hi-Shear, and its directors and executive officers, may be deemed to be participants in the solicitation of proxies from Hi-Shear’s stockholders at Hi-Shear’s upcoming Special Meeting of Stockholders with respect to the transaction with Chemring. Information regarding Hi-Shear’s directors and executive officers is contained in Hi-Shear’s definitive proxy statement filed with the SEC on September 9, 2009 for its 2009 Annual Meeting of Stockholders. As of September 15, 2009, Hi-Shear’s directors and executive officers beneficially owned (as calculated in accordance with SEC Rule 13d-3) in the aggregate approximately 2,489,140 shares, or 36.4%, of Hi-Shear’s common stock. Additional information regarding the interests of such participants will be included in the proxy statement relating to the upcoming Special Meeting of Stockholders that will be filed with the SEC and available free of charge as indicated above. You can obtain free copies of these documents as set forth above.

Wednesday, September 16th, 2009 Uncategorized Comments Off on Hi-Shear Technology Corp. (HSR) Signs Merger Agreement

Lexicon Pharmaceuticals, Inc. (LXRX) Completes Phase 1 Clinical Trial and Initiates Phase 2 Clinical Trial of LX4211

THE WOODLANDS, Texas, Sept. 15 /PRNewswire-FirstCall/ — Lexicon Pharmaceuticals, Inc. (Nasdaq: LXRX), a biopharmaceutical company focused on discovering breakthrough treatments for human disease, obtained favorable results from recently completed Phase 1 studies of LX4211 and announced today that it has initiated a Phase 2 clinical trial of the drug candidate in patients with type 2 diabetes mellitus. LX4211 is an orally-delivered, small molecule drug candidate that inhibits the sodium glucose transporter 2 (SGLT2). LX4211 is Lexicon’s fourth drug candidate currently being tested in Phase 2 clinical trials.

“LX4211 offers an opportunity to treat diabetes by increasing urinary glucose excretion through a mechanism of action that is expected to avoid some of the disadvantages of existing diabetes drugs that result in storage of excess glucose,” said Brian P. Zambrowicz, Ph.D., executive vice president and chief scientific officer at Lexicon. “By contrast, LX4211 through inhibition of SGLT2 has the potential to reduce caloric load and thereby enhance overall glucose homeostasis in patients with type 2 diabetes.”

In the recently completed Phase 1 clinical trial in normal healthy volunteers, LX4211 was well tolerated at all dose levels and produced a dose-dependent increase in urinary glucose excretion. LX4211 also demonstrated a favorable pharmacokinetic profile supporting the potential for once daily dosing. Adverse events were generally mild and were distributed across all dose groups, including the placebo group.

Based on the Phase 1 clinical results, Lexicon has initiated a Phase 2 clinical trial to evaluate the safety and tolerability of two dose levels of LX4211 and its effect on diabetes biomarkers including: fasting blood glucose, urinary glucose excretion and response to oral glucose tolerance testing in patients with type 2 diabetes. The four-week, randomized, double-blind, placebo-controlled study will be conducted in the United States and is expected to enroll 36 patients with type 2 diabetes.

In addition to LX4211, Lexicon has three other drug candidates progressing in Phase 2 clinical trials: LX1031 for irritable bowel syndrome, LX1032 for carcinoid syndrome and LX2931 for rheumatoid arthritis. For more information about Lexicon’s clinical development programs, please visit www.lexpharma.com.

About the Target

LX4211 was developed at Lexicon as a potent inhibitor of the sodium glucose transporter 2 (SGLT2), a transporter responsible for the majority of glucose reabsorption by the kidneys. Lexicon found that mouse knockouts engineered to lack the SGLT2 gene are healthy and require less insulin to manage a glucose challenge. Compounds developed by Lexicon that inhibit SGLT2 may potentially treat diabetes by increasing urinary glucose excretion, thereby lowering blood glucose levels as well as caloric load.

About Diabetes

Diabetes mellitus is a common metabolic disorder associated with abnormally high blood sugar levels. Diabetes is classified as either type 1, which is characterized by severely diminished insulin production, or type 2, which is characterized by moderately diminished insulin production in conjunction with insulin resistance (insensitivity of the tissues of the body to insulin). Insulin is a hormone that regulates blood glucose levels. Diabetes can seriously impair overall quality of life and may lead to multiple complications including heart disease, stroke, and kidney failure. According to the International Diabetes Federation, more than 245 million people have diabetes, with type 2 diabetes being the most prevalent.

About Lexicon

Lexicon is a biopharmaceutical company focused on discovering breakthrough treatments for human disease. Lexicon currently has five drug candidates in development for autoimmune disease, carcinoid syndrome, diabetes, glaucoma and irritable bowel syndrome, all of which were discovered by the company’s research team. The company has used its proprietary gene knockout technology to identify more than 100 promising drug targets. Lexicon has focused drug discovery efforts on these biologically-validated targets to create its extensive pipeline of clinical and preclinical programs. For additional information about Lexicon and its programs, please visit www.lexpharma.com.

Safe Harbor Statement

This press release contains “forward-looking statements,” including statements relating to Lexicon’s clinical development of LX4211 and the potential therapeutic and commercial potential of LX4211. This press release also contains forward-looking statements relating to Lexicon’s growth and future operating results, discovery and development of products, strategic alliances and intellectual property, as well as other matters that are not historical facts or information. All forward-looking statements are based on management’s current assumptions and expectations and involve risks, uncertainties and other important factors, specifically including those relating to Lexicon’s ability to successfully conduct clinical development of LX4211 and preclinical and clinical development of its other potential drug candidates, advance additional candidates into preclinical and clinical development, obtain necessary regulatory approvals, achieve its operational objectives, obtain patent protection for its discoveries and establish strategic alliances, as well as additional factors relating to manufacturing, intellectual property rights, and the therapeutic or commercial value of its drug candidates, that may cause Lexicon’s actual results to be materially different from any future results expressed or implied by such forward-looking statements. Information identifying such important factors is contained under “Factors Affecting Forward-Looking Statements” and “Risk Factors” in Lexicon’s annual report on Form 10-K for the year ended December 31, 2008, as filed with the Securities and Exchange Commission. Lexicon undertakes no obligation to update or revise any such forward-looking statements, whether as a result of new information, future events or otherwise.

Tuesday, September 15th, 2009 Uncategorized Comments Off on Lexicon Pharmaceuticals, Inc. (LXRX) Completes Phase 1 Clinical Trial and Initiates Phase 2 Clinical Trial of LX4211

Hyperdynamics Corp. (HDY) Signs Memorandum of Understanding with Guinea Government

Sep. 14, 2009 (PR Newswire) — SUGAR LAND, Texas, Sept. 14 /PRNewswire-FirstCall/ — Hyperdynamics Corporation (NYSE Amex: HDY) today announced that following a week of negotiations, Ray Leonard, Chief Executive Officer, and Minister of Mines, Energy and Hydraulics of the Republic of Guinea, Mahmoud Thiam, have signed a Memorandum of Understanding (“MOU”). The MOU is a binding agreement reaffirming the validity of Hyperdynamics’ concession.

Leonard stated, “I am pleased that the government supports Hyperdynamics’ continuing program to explore for oil and gas offshore Guinea. This agreement clarifies key points such as the relinquishment dates of portions of our acreage and continuing rights, which allows us to move forward on our planned seismic program in the fourth quarter 2009.”

Key terms of the agreement include the following:

    --  The Government of Guinea reaffirms the validity of Hyperdynamics'
concession and the Company's right to choose 36%, being 28,800
square kilometers, (11,160 square miles) of the initial acreage and
carry it through the exploration period.
--  The required relinquishment of 64% of the acreage by the Company, as
stated in the 2006 Hydrocarbon Production Sharing Contract, must take
place by December 31, 2009.
--  The Company must spud its first well no later than calendar year 2011.
--  Hyperdynamics has the right of first refusal on any new concessions
Guinea offers within the 64% relinquished area, granting Hyperdynamics
the right to match the terms offered by another party.

--  The contract in its entirety will be reviewed to assure it is in
conformity with international standards. If this process has not come to
a satisfactory conclusion within six months, any unresolved points will
be submitted to international arbitration.

A joint working team of Hyperdynamics Corporation and the Ministry of Mines, Energy and Hydraulics technical experts will begin joint work in October to identify outstanding points in the contract and begin transference of data to Guinea to allow the Ministry to prepare for the handling of the released acreage.

About Hyperdynamics

Hyperdynamics Corporation is committed to providing energy for the future by exploring internationally for new sources of oil and gas. It holds the exploration license for the offshore area of the West African Republic of Guinea. To find out more about Hyperdynamics, visit its website at http://www.hyperdynamics.com.

Forward Looking Statements

This news release and the Company’s website referenced in this news release contain forward looking statements as defined by the U.S. Securities and Exchange Commission regarding Hyperdynamics Corporation’s future plans and expected performance that are based on assumptions the Company believes to be reasonable. A number of risks and uncertainties could cause actual results to differ materially from these statements, including without limitation, funding and exploration efforts, risks associated with operating in a developing country in Africa, political developments in Guinea, fluctuations in oil and gas prices and other risk factors described from time to time in the Company’s reports filed with the SEC. The Company undertakes no obligation to publicly update these forward-looking statements to reflect events or circumstances that occur after the issuance of this news release or to reflect any change in the Company’s expectations with respect to these forward-looking statements.

Monday, September 14th, 2009 Uncategorized Comments Off on Hyperdynamics Corp. (HDY) Signs Memorandum of Understanding with Guinea Government

eDiets.com, Inc. (DIET) Announces Additional Investment for Growth Opportunities

FORT LAUDERDALE, Fla., Sept. 11 /PRNewswire-FirstCall/ — eDiets.com, Inc. (Nasdaq: DIET), a leading provider of convenient at-home diet, fitness and healthy lifestyle solutions, today announced that it has entered into a $600,000 Private Placement with certain members of management and the Board of Directors. The investment will immediately convert into common stock at $1.06 per share. The Company will use the proceeds to fund future growth opportunities including the expansion of advertising related to fresh meal delivery relaunch.

Kevin McGrath, President and Chief Executive Officer, commented, “We continue to make meaningful progress on improving our overall operating performance and improving our cash flow. I am confident that our strategic plan and promotional initiatives have positioned our business for long-term profitable growth.”

About eDiets

eDiets.com, Inc. is a leading provider of personalized nutrition, fitness and weight-loss programs. eDiets currently features its award-winning, fresh-prepared diet meal delivery service as one of the more than 20 popular diet plans sold directly to members on its flagship site, www.eDiets.com. The company also provides a broad range of customized wellness and weight management solutions for Fortune 500 clients. eDiets.com’s unique infrastructure offers businesses, as well as individuals, an end-to-end solution strategically tailored to meet its customers’ specific goals of achieving a healthy lifestyle. For more information, please call 310-954-1105 or visit www.eDiets.com.

Safe Harbor Statement

Statements which are not historical in nature are forward-looking statements. Forward-looking statements involve known and unknown risks and uncertainties which could cause the actual results, performance or achievements to be materially different from those which may be expressed or implied by such statements. These risks and uncertainties include, among others, that we will not be able to obtain sufficient and/or acceptable outside financing (when and if required);, changes in general economic and business conditions; changes in product acceptance by consumers; a decline in the effectiveness of sales and marketing efforts; loss of market share and pressure on prices resulting from competition; significant investments in our technology platform, marketing plans, and product development to remain competitive with other online providers of healthy living and weight loss plans, many of which may be found to offer superior and more varied features than our plans and may also be offered for free; volatility in the advertising markets; any delay, disruption, or suspension of our supply of prepared meals from our vendor; changes in consumer preferences and discretionary spending; product liability and other risks from the sale of ingested products; regulatory actions affecting our marketing activities; and the outcome of litigation pending against us. For additional information regarding these and other risks and uncertainties associated with eDiets.com’s business, reference is made to our Annual Report on Form 10-K for the year ended December 31, 2008, and other reports filed from time to time with the Securities and Exchange Commission. All forward-looking statements are current only as of the date on which such statements are made. We do not undertake any obligation to publicly update any forward- looking statements.

Monday, September 14th, 2009 Uncategorized Comments Off on eDiets.com, Inc. (DIET) Announces Additional Investment for Growth Opportunities

Salix Pharmaceuticals, Ltd. (SLXP) Announces Statistically Significant Results for Both the Primary and Key Secondary Analyses Of Rifaximin

Sep. 14, 2009 (Business Wire) — Salix Pharmaceuticals, Ltd. (NASDAQ:SLXP) today announced the successful outcome of two Phase 3, randomized, double-blind, placebo-controlled, multicenter trials, TARGET 1 and TARGET 2, designed to evaluate the efficacy and safety of rifaximin 550 mg TID in the treatment of patients with non-constipation irritable bowel syndrome (non-C IBS). In each trial rifaximin versus placebo treated patients demonstrated a statistically significant improvement for the primary endpoint of the adequate relief of IBS symptoms as assessed over one month (weeks 3, 4, 5 and 6) following completion of a 14-day course of therapy (weeks 1 and 2). Consistent with the primary endpoint in each trial, the key secondary endpoint of relief of IBS-related bloating also demonstrated statistical significance of rifaximin versus placebo in each trial. These two large confirmatory trials with 600 patients each were conducted following the previously reported positive results from a Phase 2 trial.

“We are extremely pleased with the outcome of our pivotal Phase 3 trials of rifaximin in the treatment of non-constipation irritable bowel syndrome,” stated Bill Forbes, Pharm.D., Senior Vice President and Chief Development Officer, Salix Pharmaceuticals. “Irritable bowel syndrome, characterized by abdominal pain, bloating and altered bowel habits, is one of the most common chronic medical conditions. Non-constipation IBS comprises the most common forms of IBS by including patients that have either diarrhea-predominant or diarrhea-constipation alternating symptoms. Based on the most current understanding of IBS, TARGET 1 and TARGET 2 were designed to investigate the utility of rifaximin, a broad spectrum, minimally absorbed, gut-selective antibiotic, with minimal side effects, in relieving the symptoms of IBS by altering the bacteria believed to be responsible for creating the symptoms. TARGET 1 and TARGET 2 will serve as the confirmatory trials for the Company’s New Drug Application seeking marketing approval for rifaximin as a treatment option in this condition which is associated with widespread prevalence, incapacitating symptoms and substantial medical costs. The Company is targeting to submit the NDA during the first half of 2010.”

Commenting on the results of TARGET 1 and TARGET 2, Mark Pimentel, MD, FRCP (C), Associate Professor of Medicine, Geffen School of Medicine at UCLA, Director, GI Motility Program, Cedars-Sinai Medical Center, stated: “Over the past decade, scientific discovery has continued to mount evidence for the role of gut bacteria in IBS and the effectiveness of antibiotics in alleviating symptoms of this condition. These two large-scale, multicenter trials affirm the rationale for a gut-selective antibiotic in the treatment of this common, chronic and debilitating condition and may provide pivotal evidence in the effort to deliver a significant therapeutic advancement to these patients.”

About TARGET 1 and TARGET 2

TARGET 1 and TARGET 2 (T-Targeted, non-systemic; A-Antibiotic; R-Rifaximin; G-Gut-selective; E-Evaluation of; T-Treatment for non-C IBS) were designed to assess the clinical efficacy and safety of a 550 mg TID dosing regimen of rifaximin (1650 mg/day) compared with placebo in a broad population comprised of males and females 18 years of age and older who have been diagnosed with non-constipation IBS, e.g., diarrhea-predominant IBS or alternating IBS. The primary efficacy endpoint of TARGET 1 and TARGET 2 is the proportion of subjects who achieve adequate relief of IBS symptoms for at least 2 weeks during the first 4 weeks of the 10-week follow-up phase. The two 600-subject trials were conducted simultaneously in approximately 180 study centers throughout the United States and Canada. Subjects received rifaximin or placebo (1:1 randomization) for 14 days and then were followed for 10 weeks for study duration of 12 weeks.

About Phase 2b Trial

Salix previously announced the successful completion and outcome of its Phase 2b trial to assess the efficacy and safety of rifaximin in the treatment of patients with diarrhea-associated irritable bowel syndrome. As reported in a May 20, 2008 press release, top-line results of the 680-patient study demonstrated that a 14-day course of rifaximin at 550 mg twice-a-day provided a statistically significant improvement in the protocol specified co-primary endpoints for both adequate relief of diarrhea-associated IBS symptoms as well as the adequate relief of IBS related bloating, compared to placebo.

About IBS

Among one of the most common chronic conditions, irritable bowel syndrome (IBS) affects approximately 15% of adults in the United States. IBS includes altered bowel habits with abdominal pain and discomfort. Among other contributors, recent science has shown that alterations in gut flora / bacteria have been identified as a potentially important contributor to the pathophysiology of IBS. Small intestinal bacterial overgrowth, a condition associated with excessive numbers of bacteria in the small intestine, may underlie some of the gastrointestinal symptoms associated with IBS. The Company estimates the U.S. commercial opportunity represented by the non-constipation IBS market to be approximately $2.2 billion.

About XIFAXAN® (rifaximin)

Rifaximin is a gut-selective antibiotic with negligible systemic absorption (<0.4%) and broad-spectrum activity in vitro against both gram-positive and gram-negative pathogens. Rifaximin has a similar tolerability profile to that of placebo.

Rifaximin tablets 200 mg, which Salix markets in the United States under the trade name XIFAXAN® (rifaximin) tablets 200 mg, currently is approved for the treatment of patients, 12 years of age or older, with travelers’ diarrhea caused by non–invasive strains of Escherichia coli. XIFAXAN (rifaximin) is a gut–selective antibiotic with negligible systemic absorption (<0.4%) and broad–spectrum activity in vitro against both gram–positive and gram–negative pathogens. Rifaximin has a similar tolerability profile to that of placebo and has activity against the most common TD pathogens. XIFAXAN should not be used in patients with diarrhea complicated by fever or blood in the stool or diarrhea due to pathogens other than Escherichia coli. XIFAXAN should be discontinued if diarrhea symptoms get worse or persist more than 24–48 hours and alternative antibiotic therapy should be considered. In clinical trials, XIFAXAN was generally well tolerated. The most common side effects (vs. placebo) were flatulence 11.3% (versus 19.7%), headache 9.7% (versus 9.2%), abdominal pain 7.2% (versus 10.1 %) and rectal tenesmus 7.2% (versus 8.8%).

Rifaximin has been used in Italy for 24 years and is approved in 33 countries. Salix acquired rights to market rifaximin in North America from Alfa Wassermann S.p.A. in Bologna, Italy. Alfa Wassermann markets rifaximin in Italy under the trade name Normix®.

About Salix Pharmaceuticals

Salix Pharmaceuticals, Ltd., headquartered in Raleigh, NC, develops and markets prescription pharmaceutical products for the treatment of gastrointestinal diseases. Salix’s strategy is to in-license late-stage or marketed proprietary therapeutic drugs, complete with any required development and regulatory submission of these products, and market them through the Company’s gastroenterology specialty sales and marketing team.

Salix also markets OSMOPREP® (sodium phosphate monobasic monohydrate, USP and sodium phosphate dibasic anhydrous, USP) Tablets, MOVIPREP® (PEG 3350, Sodium Sulfate, Sodium Chloride, Potassium Chloride, Sodium Ascorbate and Ascorbic Acid for Oral Solution), VISICOL® (sodium phosphate monobasic monohydrate, USP, and sodium phosphate dibasic anhydrous, USP) Tablets, APRISO™ (mesalamine) extended-release capsules 0.375 g., METOZOLVTM ODT (metoclopramide HCl), PEPCID® (famotidine) for Oral Suspension, Oral Suspension DIURIL® (Chlorothiazide), AZASAN® Azathioprine Tablets, USP, 75/100 mg, ANUSOL-HC® 2.5% (Hydrocortisone Cream, USP), ANUSOL-HC® 25 mg Suppository (Hydrocortisone Acetate), PROCTOCORT® Cream (Hydrocortisone Cream, USP) 1% and PROCTOCORT® Suppository (Hydrocortisone Acetate Rectal Suppositories) 30 mg. Crofelemer, budesonide foam and rifaximin for additional indications are under development.

For full prescribing information on Salix products, please visit www.salix.com.

Salix trades on the NASDAQ Global Select Market under the ticker symbol “SLXP.”

For more information, please visit our Web site at www.salix.com or contact the Company at 919-862-1000. Information on our Web site is not incorporated into our SEC filings.

Please Note: The materials provided herein contain projections and other forward-looking statements regarding future events. Such statements are just predictions and are subject to risks and uncertainties that could cause the actual events or results to differ materially. These risks and uncertainties include, among others: the unpredictable nature of the duration and results of regulatory review of new drug applications; market acceptance for approved products; generic and other competition; the possible impairment of, or inability to obtain, intellectual property rights and the costs of obtaining such rights from third parties; our need to return to profitability; and the need to acquire new products. The reader is referred to the documents that the Company files from time to time with the Securities and Exchange Commission.

Monday, September 14th, 2009 Uncategorized Comments Off on Salix Pharmaceuticals, Ltd. (SLXP) Announces Statistically Significant Results for Both the Primary and Key Secondary Analyses Of Rifaximin

Zoom Technologies, Inc. (ZOOM) Reports Q2 2009 Financial Results of Recently Approved Acquisition

BOSTON, MA — (Marketwire) — 09/14/09 — Zoom Technologies, Inc. (NASDAQ: ZOOM)

Highlights:

--  Recently approved Zoom acquisition expected to close by end of
    September
--  Gold Lion Q2 2009 revenue increased 354% to $53.1 million, versus
    $11.7 million in Q2 2008
--  Gold Lion Q2 2009 net income grew to $1.7 million, versus net
    loss of $0.1 million in Q2 2008
--  Gold Lion management's full year 2009 net revenue guidance in the
    range of $145 million to $155 million, versus $81 million in 2008
--  Gold Lion management's full year 2009 net income guidance in the
    range of $5.9 million to $6.1 million, versus $2.8 million in 2008

Zoom Technologies, Inc. (NASDAQ: ZOOM) today announced second quarter financial results of Gold Lion Holdings. Zoom shareholders approved the acquisition of Gold Lion, one of the top ten Chinese mobile phone manufacturers, on Tuesday, September 8, 2009. The acquisition is expected to close this month.

Gold Lion reported Q2 2009 revenues of $53.1 million, up 354% over $11.7 million for Q2 2008, and up 84% sequentially from $28.8 million for Q1 2009. Revenue growth was partially due to a significant order from one of Gold Lion’s existing customers, a major mobile communications original equipment manufacturer.

Gross profit for Q2 2009 rose 147% to $3.2 million, compared to $1.3 million for Q2 2008. Gross profit as a percentage of revenue for the second quarter of 2009 was 5.95%, compared to 10.95% for the same period of the prior year. The decline in gross margins is primarily due to low gross margin for the order mentioned above.

Total operating expenses for Q2 2009 were $0.4 million, compared to $0.6 million in Q2 2008. The decrease in expenses despite a jump in revenues was due primarily to management’s continued emphasis on cost control and production efficiencies.

Net income for Q2 2009 was $1.7 million. This compared to net loss of $0.1 million for the second quarter of 2008 and net income of $0.9 million in the first quarter of 2009.

Mr. Lei Gu, Chairman and Chief Executive Officer of Gold Lion, said, “We are most pleased to report these outstanding quarterly results following the recently announced and shareholder approved transaction with Zoom Technologies. We believe these results reflect the burgeoning mobile telecommunications business in China and our ability to drive revenues and profit in this market. The exceptional quarter includes revenue from an order placed by one of our top customers, which is also the top domestic mobile handset brand.”

Looking ahead, Mr. Gu commented, “For full year 2009, we expect total revenues to be between $145 million and $155 million and net income to be in the range of $5.9 million and $6.1 million.”

Mr. Frank Manning, the President, CEO, and Chairman of Zoom, said: “These results further demonstrate the value of the transaction we expect to close in September. The mobile phone market in China is growing rapidly, and we believe Gold Lion is well-positioned to benefit from this growth.”

About Gold Lion Holding Ltd.

Gold Lion is a holding company with subsidiaries that engage in the manufacturing, research and development, and sales of electronic and telecommunication products for 3rd generation mobile phones, wireless communication circuitry, and related software products. Gold Lion’s subsidiary, Jiangsu Leimone, owns a majority stake of TCB Digital which offers highly customized and high quality Electronic Manufacturing Service (EMS) for Original Equipment Manufacturer (OEM) customers and also designs and manufactures its own brand of mobile phones under the “Leimone” brand.

About Zoom Technologies, Inc.

Zoom Technologies, Inc. designs, produces, markets, and supports communication products under the Zoom, Hayes®, and Global Village® brands. Zoom is headquartered in Boston, and its European sales and support center is in the UK. Zoom markets its products in over forty countries, and provides multi-lingual support from its offices in Boston and the UK. For more information about Zoom and its products, please see www.zoom.com.

Forward-Looking Statements

This release contains forward-looking statements that involve substantial risks and uncertainties. All statements, other than statements of historical facts, included in this release regarding Gold Lion, TCB Digital, JS Leimone and Profit Harvest (collectively, “Gold Lion”), the value or likelihood of the merger, or Gold Lion’s future results are forward-looking statements. The words “anticipate,” “believe,” “estimate,” “expect,” “intend,” “may,” “plan,” “predict,” “project,” “will,” “would” and similar expressions are intended to identify forward-looking statements, although not all forward-looking statements contain these identifying words. The parties may not actually achieve the plans, intentions or expectations disclosed in the forward-looking statements, and readers/investors should not place undue reliance on the forward-looking statements. Important factors that could cause actual results or events to differ materially from the forward-looking statements, include among others: the ability of Zoom and Gold Lion to satisfy the conditions to closing of the proposed acquisition; the ability of Gold Lion to achieve its expected revenues and net income for 2009, which is dependent on a variety of factors; changing principles of generally accepted accounting principles; outcomes of government reviews, inquiries, investigations and related litigation; continued compliance with government regulations; legislation or regulatory environments; requirements or changes adversely affecting the business in which Zoom or Gold Lion is engaged; fluctuations in customer demand; management of rapid growth; intensity of competition; the time to develop and market new products; general economic conditions; geopolitical events and regulatory changes. Further, the forward-looking statements do not reflect the potential impact of any future acquisitions, mergers, dispositions, joint ventures, collaborations or investments made by the combined company. These forward-looking statements inherently involve certain risks and uncertainties, some of which are detailed in Zoom’s proxy statement, its Annual Report on Form 10-K and other filings with the Securities and Exchange Commission. Neither Zoom nor Gold Lion assumes any obligation to update any forward-looking statements.

Monday, September 14th, 2009 Uncategorized Comments Off on Zoom Technologies, Inc. (ZOOM) Reports Q2 2009 Financial Results of Recently Approved Acquisition

NIVS IntelliMedia (NIV) Granted Mobile Phone License

HUIZHOU, China, Sept. 11 /PRNewswire-Asia-FirstCall/ — NIVS IntelliMedia Technology Group, Inc., (“NIVS” or the “Company”) (NYSE: NIV), a consumer electronics company that designs, manufactures and sells intelligent audio and visual products, today announced that the Company has been granted the license to manufacture mobile phones by the Ministry of Industry and Information Technology. The Company will be allowed to operate its mobile phone business in mainland China under NIVS’s own brand name.

NIVS currently has the R&D capabilities and intellectual property rights to manufacture 3G mobile phones and has already introduced a dual-mode EVDO/GSM 3G handset to the market. The license will allow the Company to speed up the market entry for such handsets under the NIVS brand name.

Mr. Tianfu Li, CEO and Chairman of NIVS, commented, “We are very excited to be entering the huge market of 3G telecommunications in China. The three giant telecom operators, China Mobile, China Telecom and China Unicom, are projected to invest a total of RMB 400 billion (US$58.6 billion) in 3G infrastructure over the next three years, which we believe will create a lot of revenue opportunities for NIVS. Because building strong relationships with network operators is so important in the 3G era, we have been actively working closely with these top three operators in China. On August 24, we were invited to participate in China Telecom’s sales conference for their 3G brand, Tianyi, as well as in their smart phone conference in early September. We are pleased to be working closely with such a big operator and are hopeful to become an OEM supplier for China Telecom. Aside from providing 3G terminal products such as the mobile handset, we also aim to be involved in telecom operators’ operational business so as to enhance our sustainable profitability in the 3G industry.”

About NIVS IntelliMedia Technology Group, Inc.

NIVS IntelliMedia Technology Group is an integrated consumer electronics company that designs, manufactures, markets and sells intelligent audio and video products in China, Greater Asia, Europe, and North America. The NIVS brand has received “Most Popular Brand” distinction in China’s acoustic industry for three consecutive years, among numerous other awards. Ranked 43rd on Forbes’ Top 100 Chinese Research and Development Companies, NIVS has developed leading Chinese speech interactive technology, which forms a foundation for the Company’s intelligent audio and visual systems, including digital audio, LCD televisions, digital video broadcasting (“DVB”) set-top boxes, peripherals and more.

Safe Harbor Statement

This release contains certain “forward-looking statements” relating to the business of the Company and its subsidiary companies. These forward looking statements are often identified by the use of forward-looking terminology such as “believes, expects” or similar expressions. Such forward looking statements involve known and unknown risks and uncertainties, including, but not limited to the Company’s reliance on its major customers for a large portion of its net sales; the Company’s ability to develop and market new products; the Company’s ability to continue to borrow and raise additional capital to fund its operations; the Company’s ability to collect aging trade receivables and the effect of a growing doubtful account allowance; the Company’s ability to accurately forecast amounts of supplies needed to meet customer demand; exposure to market risk through sales in international markets; the market acceptance of the Company’s products; exposure to product liability and defect claims; fluctuations in the availability of raw materials and components needed for the Company’s products; protection of the Company’s intellectual property rights; changes in the laws of the PRC that affect the Company’s operations; development of a public trading market for the Company’s securities; and the cost of complying with current and future governmental regulations and the impact of any changes in the regulations on the Company’s operations. Investors should not place undue reliance on these forward-looking statements, which speak only as of the date of this press release. The Company’s actual results could differ materially from those anticipated in these forward-looking statements as a result of a variety of factors, including the discussed above and in the Company’s periodic reports that are filed with the Securities and Exchange Commission and available on its website (www.sec.gov). All forward-looking statements attributable the Company or to persons acting on its behalf are expressly qualified in their entirety by these factors other than as required under the securities laws. The Company does not assume a duty to update these forward-looking statements.

Friday, September 11th, 2009 Uncategorized Comments Off on NIVS IntelliMedia (NIV) Granted Mobile Phone License

Speedus Corp. (SPDE) Subsidiary Develops Distribution; Signs International Rep Agreement

GERMANTOWN, Md., Sept. 11 /PRNewswire/ — Density Dynamics, a majority owned subsidiary of Speedus Corp. (Nasdaq: SPDE), announced today it has signed an International Representation agreement covering India with Graphay, Inc.

“We are excited to establish a sales and distribution channel for the cutting-edge DRAM-based SSD’s built for high speed data enterprise users. My experience at Wachovia in the data center environment led me to witness the Jet.io SSD. Its power and performance capabilities are highly anticipated in the Indian market and together with Graphay’s technologies, will address pressing needs of our Enterprise customers. We look forward to a long and fruitful relationship,” said Ashish Majmundar, CEO and founder of Graphay.

About Density Dynamics

Density Dynamics, a majority owned subsidiary of Speedus Corp., is a pioneer in the solid-state storage and I/O acceleration technology. Its high performance RamFlash solid-state storage and computing devices are designed to reduce I/O bottlenecks while also reducing power, cooling, and rack space requirements. Density Dynamics can be found on the web at www.densitydynamics.com.

About Graphay

Graphay, headquartered in Matthews, NC, is an Enterprise IT Solutions Provider to customers in India & Israel. Graphay offers end-to-end architecture design, desktop and data center virtualization, along with best-in-breed products from its Global technology partners. Graphay can be found on the web at www.graphay.com.

About Speedus Corp.

Additional information on Speedus Corp. may be obtained at www.speedus.com or by contacting Peter Hodge at 888-773-3669 (ext. 23) or phodge@speedus.com.

Statements contained herein that are not historical facts, including but not limited to statements about the Company’s product, corporate identity and focus, may be forward-looking statements that are subject to a variety of risks and uncertainties. There are a number of important factors that could cause actual results to differ materially from those expressed in any forward-looking statements made by the Company, including, but not limited to, the continuing development of the Company’s sales, marketing and support efforts.

Friday, September 11th, 2009 Uncategorized Comments Off on Speedus Corp. (SPDE) Subsidiary Develops Distribution; Signs International Rep Agreement

Comarco, Inc. (CMRO) Reports Positive Gross Profit and 100% Increase in Year-Over-Year Second Quarter Revenue

LAKE FOREST, Calif., Sept. 10 /PRNewswire-FirstCall/ — Comarco, Inc. (Nasdaq: CMRO), a leading provider of innovative mobile power solutions through its ChargeSource(R) line of multi-function universal mobile power products, today announced its financial results for the second quarter of fiscal 2010 ended July 31, 2009.

Revenue for the second quarter of fiscal 2010 was $7.6 million compared with $3.2 million for the second quarter of fiscal 2009. Sequentially, revenue for the second quarter increased $5.6 million from $2.0 million in the first quarter of fiscal 2010. The gross profit in the second quarter of fiscal 2010 was $1.9 million compared with a gross loss of $179,000 in the second quarter of fiscal 2009, and a gross loss of $314,000 in the first quarter of fiscal 2010. The Company reported a net loss of $0.7 million, or $(0.09) per share, for the second quarter of fiscal 2010 compared with a net loss of $1.6 million, or $(0.23) per share, for the second quarter of the prior fiscal year. The Company’s net loss decreased $2.1 million on a sequential basis from $2.8 million, or $(0.39) per share, during the first quarter of fiscal 2010.

“Our second quarter results were largely driven by sales from initial shipments of our ChargeSource(R) power adapters to Targus,” said Sam Inman, President and Chief Executive Officer of Comarco. “We are especially pleased with the significant improvement in our gross profit to $1.9 million compared with gross losses in the comparable period a year ago and in the first quarter of fiscal 2010. We are optimistic that the second quarter represents the beginning of our sales momentum as we anticipate that we will begin shipping our next-generation, ‘slim and light’ power adapters to both Lenovo and Targus over the next few quarters. In addition, we have begun development efforts on the 90 watt DC adapter for Dell, which we previously announced, and currently anticipate getting this new product to the marketplace early next year.”

“With anticipated continued enhancements to the gross profit from the cost-optimized ‘slim and light’ design and an expense structure that can support additional growth, we believe Comarco is positioned to produce improved bottom-line results,” concluded Mr. Inman.

The Company had $11.5 million in cash at July 31, 2009 and had borrowings against its credit facility of $1.0 million.

For the six months ended July 31, 2009, revenue totaled $9.6 million compared with $7.0 million for the same period of the prior fiscal year. The gross profit was $1.6 million for the first six months of fiscal 2010 compared with a gross loss of $187,000 in the comparable period a year ago. The net loss for the six months ended July 31, 2009 was $3.5 million, or $(0.48) per share, compared with a net loss of $3.3 million, or $(0.45) per share, in the comparable period for the prior year.

Forward-Looking Information

This news release includes “forward-looking statements” that are subject to risks, uncertainties, and other factors that could cause actual results or outcomes to differ materially from those contemplated by the forward-looking statements, including, but not limited to, statements regarding the expected introduction of new products, anticipated future shipments of products, anticipated enhancements to gross profit, anticipated future expense levels, and anticipated revenue growth. Forward-looking statements in this release are generally identified by words such as “believes,” “anticipates,” “plans,” “expects,” “will,” “would,” and similar expressions that are intended to identify forward-looking statements. Many important factors may cause the Company’s results to differ materially from those discussed in any such forward-looking statements, including, among others: the fact that the Company has a history of losses and may continue to incur losses in the future; the fact that the Company did not generate a positive gross profit on the sale of ChargeSource(R) products until the second quarter of fiscal 2010 and many factors, including factors outside the Company’s control, will influence the Company’s ability to generate positive gross margins in the future; demand for the Company’s products and the difficulty of accurately estimating demand; quarterly and seasonal fluctuations in revenue and other operating results; the Company’s reliance on a limited number of customers for a significant portion of its revenue; the Company’s reliance on a limited number of contract manufacturers and suppliers and the fact that any delays or disruptions in their production of the Company’s products or in their ability to meet the required specifications for the Company’s products would adversely impact the Company’s results and financial condition; increased competition; the Company’s ability to develop and introduce new products timely and successfully; the risk of third parties infringing the Company’s intellectual property; the impact of general economic, political, and market conditions; any failure to accurately forecast customer demand and the risk that customers may cancel their orders, change production quantities or delay production; the fact that the Company’s products are complex and have short life cycles and the average selling prices of the products will likely decrease over their sales cycles; and the costs and expenses that the Company may incur as a result of arbitration, litigation or other adverse proceedings. Further information on potential factors that could affect financial results are included in risks detailed from time to time in the Company’s Securities and Exchange Commission filings, including without limitation, the annual report on Form 10-K for the fiscal year ended January 31, 2009 and in any subsequently filed quarterly report on Form 10-Q.

Although the Company believes that the assumptions underlying the forward-looking statements are reasonable, any of the assumptions could prove inaccurate and, therefore, it cannot guarantee any anticipated future results, levels of activity, performance, or achievements will be realized in the timeframes anticipated or at all. Moreover, neither any other person nor the Company assumes responsibility for the accuracy and completeness of the forward-looking statements. The Company undertakes no obligation to revise or update publicly any forward-looking statements for any reason.

Earnings Conference Call

Comarco will host a conference call to discuss the financial results for the fiscal second quarter ended July 31, 2009 and current corporate developments at 4:30 p.m. Eastern Time (1:30 p.m. Pacific Time) today, September 10, 2009. The dial-in number to access the conference call is (866) 225-8754 for domestic callers or (480) 629-9692 for international callers. A live Webcast will also be made available at www.comarco.com. A replay will be available approximately one hour after the call for 7 days following the call’s conclusion. To access the replay, dial (800) 406-7325 for domestic callers or (303) 590-3030 for international callers, both using passcode 4150015#. A Web archive will be made available at www.comarco.com for 90 days following the call’s conclusion.

About Comarco

Based in Lake Forest, Calif., Comarco is a leading provider of universal mobile power products used to power and charge notebook computers, mobile phones, and many other rechargeable mobile devices. The Company’s Web sites can be found at www.comarco.com and www.chargesource.com.

Friday, September 11th, 2009 Uncategorized Comments Off on Comarco, Inc. (CMRO) Reports Positive Gross Profit and 100% Increase in Year-Over-Year Second Quarter Revenue

Xyratex Ltd. (XRTX) Provides Preliminary Revenue Results for the Third Quarter Fiscal Year 2009

HAVANT, England, Sept. 10 /PRNewswire-FirstCall/ — Xyratex Ltd. (Nasdaq: XRTX), a leading provider of enterprise class data storage subsystems and storage process technology, said today that it expects Revenue for its fiscal 2009 third quarter ended August 31, 2009 to be approximately $247 million.

“The third quarter benefitted from better than expected sales across our product and customer portfolio, indicating improvements in the overall economy and the relative strength of the storage industry,” said Steve Barber, CEO of Xyratex. “Additionally, I was pleased with our execution in reducing costs while at the same time meeting the demand requirements of our customers.”

The company will report final fiscal third quarter results on Wednesday, September 30, 2009 and will host a conference call to discuss the results at 2:00 p.m. PT/5:00 p.m. ET on that day.

Conference Call Information

    The conference call can be accessed online via the company's website
www.xyratex.com/investors, or by telephone as follows:
United States                  (866) 362-4820
Outside the United States      (617) 597-5345
Passcode                        20291919

A replay will be available via the company's website
www.xyratex.com/investors, or can be accessed by telephone through
October 7, 2009 as follows:
United States                  (888) 286-8010
Outside the United States      (617) 801-6888
Passcode                        82870347

Safe Harbor Statement

This press release contains forward-looking statements. These statements relate to future events or our future financial performance. These statements are only predictions and involve known and unknown risks, uncertainties and other factors that may cause our actual results, levels of activity, performance or achievements to differ materially from any future results, levels of activity, performance or achievements expressed or implied by these forward-looking statements. Factors that might cause such a difference include our inability to compete successfully in the competitive and rapidly changing marketplace in which we operate, failure to retain key employees, changes in our customers volume requirements, cancellation or delay of projects and adverse general economic conditions in the United States and internationally. These risks and other factors include those listed under “Risk Factors” and elsewhere in our Annual Report on Form 20-F as filed with the Securities and Exchange Commission (File No. 000-50799). In some cases, you can identify forward-looking statements by terminology such as “may,” “will,” “should,” “expects,” “intends,” “plans,” “anticipates,” “believes,” “estimates,” “predicts,” “potential,” “continue,” or the negative of these terms or other comparable terminology. Although we believe that the expectations reflected in the forward-looking statements are reasonable, we cannot guarantee future results, levels of activity, performance or achievements.

About Xyratex

Xyratex is a leading provider of enterprise data storage subsystems and storage process technology. The company designs and manufactures enabling technology that provides OEM and disk drive manufacturer customers with data storage products to support high-performance storage and data communication networks. Xyratex has over 25 years of experience in research and development relating to disk drives, storage systems and high-speed communication protocols.

Founded in 1994 in an MBO from IBM, and with headquarters in the UK, Xyratex has an established global base with R&D and operational facilities in Europe, the United States and South East Asia.

Thursday, September 10th, 2009 Uncategorized Comments Off on Xyratex Ltd. (XRTX) Provides Preliminary Revenue Results for the Third Quarter Fiscal Year 2009

Dynavax Technologies Corp. (DVAX) Reports FDA Removes Clinical Hold on HEPLISAVTM Phase 3 Hepatitis B Vaccine

Sep. 10, 2009 (Business Wire) — Dynavax Technologies Corporation (Nasdaq:DVAX) today announced that the U.S. Food and Drug Administration (FDA) has removed the clinical hold for the HEPLISAVTM Investigational New Drug (IND) application in individuals with chronic kidney disease. HEPLISAV is a Phase 3 investigational adult hepatitis B vaccine designed to provide increased, rapid protection with fewer doses than current licensed vaccines.

As a result of the FDA’s decision, Dynavax expects to initiate a Phase 3 trial in chronic kidney disease patients in the near-term. Dynavax also plans to initiate a Phase 3 lot-to-lot consistency trial in adults over 40 years of age in early 2010.

“The success of our scientific approach to resolving the clinical hold on HEPLISAV allows us to resume development of our enhanced hepatitis B vaccine,” commented Dino Dina, M.D., President and Chief Executive Officer of Dynavax. “After achieving strong efficacy data in our prior Phase 3 pivotal trial, we are fully prepared to initiate the final registration trials for HEPLISAV.”

Dynavax’s global strategy as previously discussed with the FDA and the European Medicines Evaluation Agency (EMEA) is to develop HEPLISAV for populations that are less responsive to current licensed vaccines, including adults over 40 years of age, individuals with chronic kidney disease, and others.

About HEPLISAV

HEPLISAV is a Phase 3 investigational adult hepatitis B vaccine designed to provide increased, rapid protection with fewer doses than current licensed vaccines. Over 2,500 individuals have been vaccinated with HEPLISAV to date.

Phase 3 data from Dynavax’s PHAST clinical trial demonstrate subjects over 40 years of age receiving 2 doses of HEPLISAV over a 1 month period achieved a seroprotection rate of 92%, compared to 75% of subjects receiving 3 doses of a licensed vaccine over a 6 month period. For individuals with chronic kidney disease, clinical data from a small Phase 1 and partially completed Phase 2 trial will be reported at an upcoming medical conference.

Dynavax has worldwide commercial rights to HEPLISAV, which combines hepatitis B surface antigen (HBsAg) with a proprietary Toll-like Receptor 9 agonist to enhance the immune response.

About Hepatitis B Vaccines

The total worldwide market for adult hepatitis B vaccines is estimated at over $500 million annually. Current vaccines leave unmet needs for more rapid and increased protection, particularly for less responsive, underserved populations.

Chronic Kidney Disease Market – A high-value segment, the chronic kidney disease market is large, growing rapidly, and is widely recommended for vaccination. There are approximately 750,000 end-stage renal disease (ESRD) patients in the United States and the 5 major European markets and approximately 150,000 new patients annually. Approximately 35% of these immunocompromised ESRD patients do not respond to vaccination and 20% require boosters. As vaccination for these patients occurs regularly at dialysis centers, this is a highly concentrated, renewable market that can be served by cost-effective, targeted sales distribution networks.

Other Markets – Other populations such as individuals infected with HIV or diagnosed with chronic liver disease are also less responsive to current hepatitis B vaccines and represent a large, poorly served market opportunity.

About Dynavax

Dynavax Technologies Corporation, a clinical-stage biopharmaceutical company, discovers and develops novel products to prevent and treat infectious diseases. The Company’s lead product candidate is HEPLISAV, a Phase 3 investigational adult hepatitis B vaccine designed to provide more rapid and increased protection with fewer doses than current licensed vaccines. For more information visit www.dynavax.com.

Forward Looking Statements

This press release contains “forward-looking statements,” that are subject to a number of risks and uncertainties, including statements related to the nature and timing of potential clinical trials of HEPLISAV. Actual results may differ materially from those set forth in this press release due to the risks and uncertainties inherent in our business, including whether successful clinical and regulatory development and approval of HEPLISAV can occur in a timely manner or without significant additional studies or difficulties or delays in development, the Company’s ability to obtain additional financing to support the development and commercialization of HEPLISAV and its other operations, possible claims against the Company based on the patent rights of others; and other risks detailed in the “Risk Factors” section of our current periodic reports with the SEC. We undertake no obligation to revise or update information herein to reflect events or circumstances in the future, even if new information becomes available.

Thursday, September 10th, 2009 Uncategorized Comments Off on Dynavax Technologies Corp. (DVAX) Reports FDA Removes Clinical Hold on HEPLISAVTM Phase 3 Hepatitis B Vaccine

Syneron Medical Ltd. (ELOS) and Candela Corporation (CLZR) to Merge Creating a Leading Global Aesthetic Device Company

Sep. 9, 2009 (Business Wire) — Syneron Medical Ltd. (NASDAQ:ELOS) and Candela Corporation (NASDAQ:CLZR) announced today that they have entered into a definitive agreement to combine the companies in an all stock transaction. This strategic combination, unanimously approved by the Boards of Directors of both companies, will create a global leader in medical aesthetic devices. The transaction is expected to be completed by year-end 2009.

Under the terms of the merger agreement, Candela shareholders will receive 0.2911 ordinary shares of Syneron for each share of Candela common stock they own. Based upon the closing stock price of Syneron common stock on September 8, 2009, this represents $2.84 per share of consideration to be received by Candela shareholders, or a total consideration of approximately $65 million. The consideration represents a premium of approximately 51% to the closing stock price of Candela common stock on September 8, 2009. It is anticipated that the transaction will be tax free to Candela shareholders. Syneron shareholders will retain their shares.

“The combination of Syneron and Candela brings together two well-respected industry leaders in aesthetic medical devices,” said Louis P. Scafuri, Chief Executive Officer of Syneron. “The product portfolio and commercial infrastructure of Syneron and Candela are highly complementary. The combined company will be extremely well positioned to benefit from an improving macroeconomic climate. We are going to take our time to build the right customer-focused organization for long-term growth and market leadership. At this initial stage, we are less concerned with driving immediate synergies that might risk disruption and compromise our ability to take advantage of the opportunities ahead.”

Scafuri continued, “Candela has been a pioneer in our industry for nearly 40 years. We highly respect the achievements of Candela’s leadership team and look forward to welcoming Candela’s world-class sales force and product development organizations to Syneron where they will play a crucial role in our future success. We are committed to maintaining the integrity of the Candela brand and its long standing reputation for quality, efficacy and unparalleled customer support. I would like to recognize the Syneron team for enabling us to be in a position to take this important step in the development of our company.”

“This transaction is a positive outcome for our shareholders, employees and customers,” said Gerard E. Puorro, President and CEO of Candela. “This combination creates an industry global leader with the critical mass, product portfolio, culture of innovation and financial strength required to succeed in the current market environment. The transaction provides our shareholders with attractive value today, as well as an opportunity to participate in the long-term prospects of the combined company.”

The new company will have proforma annualized revenue totaling over $180 million, based on the quarter ended June 30, 2009, ranking it among the leading medical aesthetic device companies in the industry. The combined company will have a global presence, with approximately 62% of revenue generated from outside the United States, as well as a balanced customer mix between “core physicians” (dermatologists and plastic surgeons) and “non-core physicians” with an approximate split of 55% core and 45% non-core. The company expects to generate a meaningful amount of recurring revenue in the future, with Candela’s service revenue complementing Syneron’s recently announced initiative to shift toward a consumables-oriented business model. The combined company will have significant financial strength, with more than $240 million in cash and no debt on a proforma basis as of June 30, 2009.

Fabian Tenenbaum, Syneron’s Chief Financial Officer, noted, “In the challenging recent economic environment, both companies have dramatically reduced operating expenses, which positions the combined company, post integration, to be profitable and the transaction to be accretive to our earnings as market conditions normalize.”

Transaction Terms

Under the terms of the merger agreement, Candela shareholders will receive 0.2911 shares of Syneron ordinary share for each share of Candela common stock they own. Syneron will issue 6.7 million shares to acquire Candela. Upon completion of the transaction, Syneron shareholders will own approximately 80 percent of the combined company and Candela shareholders will own approximately 20 percent.

Syneron will maintain its corporate headquarters in Israel and North American office in Irvine, CA. Candela will operate as a wholly-owned subsidiary of Syneron and maintain their offices in Wayland, MA, as well as subsidiary operations in Australia, France, Germany, Italy, Japan, Portugal, Spain and the United Kingdom.

Following the close of the transaction, Louis P. Scafuri will remain Chief Executive Officer of the combined company and Dr. Shimon Eckhouse will remain Chairman of the Board of Directors. Gerard E. Puorro will join Syneron’s Board of Directors. The management team for the combined company will be comprised of executives from each organization.

The transaction is subject to approval of Candela’s shareholders as well as customary closing conditions and necessary anti-trust approvals. The transaction is expected to close by year-end 2009.

Advisors

In connection with the transaction, Leerink Swann LLC is acting as exclusive financial advisor to Syneron, with Gross, Kleinhendler, Hodak, Halevy, Greenberg & Co. and Morrison & Foerster LLP serving as its legal counsel. Houlihan Lokey is acting as exclusive financial advisor to Candela, and Goodwin Procter LLP is legal counsel.

Conference Call and Webcast

Syneron and Candela management will host a conference call and a live webcast today, Wednesday, September 9 at 8:30 a.m. (ET) to discuss the transaction. Interested participants may participate in the conference call on the following dial-in numbers:

US (toll free): 866-835-8906

International: 703-639-1413

Investors and other interested parties can also access a live webcast of the conference call through the Investor Overview page on Syneron’s website at www.syneron.com or Candela’s website at www.candelalaser.com under Investor Relations. Please log in at least 10 minutes prior to the conference call in order to download the applicable audio software. Following the conclusion of the call, a replay of the webcast will be available within 24 hours on both websites.

About Syneron Medical Ltd.

Syneron Medical Ltd. (NASDAQ: ELOS) manufactures and distributes medical aesthetic devices that are powered by the proprietary, patented elos combined-energy technology of Bi-Polar Radio Frequency and Light. The Company’s innovative elos technology provides the foundation for highly effective, safe and cost-effective systems that enable physicians to provide advanced solutions for a broad range of medical-aesthetic applications including hair removal, wrinkle reduction, rejuvenating the skin’s appearance through the treatment of superficial benign vascular and pigmented lesions, and the treatment of acne, leg veins and cellulite. Founded in 2000, the corporate, R&D, and manufacturing headquarters for Syneron Medical Ltd. are located in Israel. Syneron has offices and distributors throughout the world, including North American headquarters in Irvine, CA, and Asia-Pacific headquarters in Hong Kong, which provide sales, service and support. Additional information can be found at www.syneron.com.

About Candela Corporation

Candela Corporation manufactures, and distributes innovative clinical solutions that enable physicians, surgeons, and personal care practitioners to treat selected cosmetic and medical conditions using lasers, aesthetic laser systems, and other advanced technologies. Founded near Boston in 1970, the company markets and services its products in 86 countries from offices and distributors in the United States, Europe, Japan, China and other Asian locations. Candela established the aesthetic laser market 20 years ago, and currently has an installed base of over 14,000 systems worldwide. Visit Candela on the Web at http://www.candelalaser.com.

IMPORTANT ADDITIONAL INFORMATION WILL BE FILED WITH THE SEC

In connection with the combination of Syneron Medical Ltd. and Candela Corporation pursuant to an Agreement and Plan of Merger (the “Merger”), Syneron Medical Ltd. will file with the Securities and Exchange Commission (the “SEC”) a registration statement on Form F-4, which will include a proxy statement of Candela Corporation and a prospectus of Syneron Medical Ltd. and other relevant materials in connection with the proposed transactions. Candela Corporation will file the same proxy statement/prospectus with the SEC as well as mail it to Candela Corporation stockholders. Investors and security holders are urged to read the proxy statement/prospectus and the other relevant material when they become available because these materials will contain important information about Candela Corporation, Syneron Medical Ltd. and the proposed transaction. The proxy statement/prospectus and other relevant materials (when they become available), and any and all documents filed with the SEC, may be obtained free of charge at the SEC’s web site at www.sec.gov. In addition, free copies of the documents filed with the SEC by Candela Corporation will be available on the investor relations portion of Candela Corporation’s website at www.candelalaser.com. Free copies of the documents filed with the SEC by Syneron Medical Ltd. will be available on the investor relations portion of Syneron Medical Ltd.’s website at www.syneron.com. INVESTORS AND SECURITY HOLDERS ARE URGED TO READ THE PROXY STATEMENT/PROSPECTUS AND THE OTHER RELEVANT MATERIALS WHEN THEY BECOME AVAILABLE BEFORE MAKING ANY VOTING OR INVESTMENT DECISION WITH RESPECT TO THE PROPOSED TRANSACTIONS.

Candela Corporation, Syneron Acquisition Sub, Inc., Syneron Medical Ltd. and their respective executive officers and directors may be deemed to be participants in the solicitation of proxies from the security holders of Candela Corporation in connection with the Merger. Information about those executive officers and directors of Candela Corporation and their ownership of Candela Corporation common stock is set forth in Candela Corporation’s proxy statement, which was filed with the SEC on November 12, 2008 and is supplemented by other public filings made, and to be made, with the SEC. Information about those executive officers and directors of Syneron Medical Ltd. is set forth in Syneron Medical Ltd.’s Annual Report on Form 20-F for the year ended December 31, 2008, which was filed with the Securities and Exchange Commission on March 24, 2009 and is supplemented by other public filings made, and to be made, with the SEC. Investors and security holders may obtain additional information regarding the direct and indirect interests of Candela Corporation, Syneron Acquisition Sub, Inc. Syneron Medical Ltd. and their respective executive officers and directors in the Merger by reading the proxy statement/prospectus and the other filings and documents referred to above.

SAFE HARBOR FOR FORWARD-LOOKING STATEMENTS

Statements in this document regarding the proposed transaction between Candela Corporation and Syneron Medical Ltd., including, without limitation, the expected timetable for completing the transaction, statements related to the anticipated consummation of the proposed combination of Candela Corporation and Syneron Medical Ltd., management of the combined company, the benefits of the proposed combination, the future financial performance of Syneron Medical Ltd. after the proposed combination, and any other statements regarding future expectations, beliefs, goals, plans or prospects constitute forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. Any statements that are not statements of historical fact (including statements containing “believes,” “anticipates,” “plans,” “expects,” “may,” “will,” “would,” “intends,” “estimates” and similar expressions) should also be considered to be forward-looking statements. There are a number of important factors that could cause actual results or events to differ materially from those indicated by such forward-looking statements, including: the ability of each of Candela Corporation and Syneron Medical Ltd. to satisfy the closing conditions and consummate the transaction, including obtaining the approval of the transaction by Candela Corporation’s stockholders; the risk that the businesses may not be integrated successfully; the risk that the transaction may involve unexpected costs or unexpected liabilities; the risk that synergies from the transaction may not be fully realized or may take longer to realize than expected; the risk that disruptions from the transaction make it more difficult to maintain relationships with customers, employees, or suppliers; and the other risks set forth in Candela Corporation and Syneron Medical Ltd.’s most recent Annual Report on Form 10-K and Form 20-F, respectively, as well as the other factors described in the filings that Candela Corporation and Syneron Medical Ltd. make with the SEC from time to time. If one or more of these factors materialize, or if any underlying assumptions prove incorrect, Candela Corporation and Syneron Medical Ltd.’s actual results, performance or achievements may vary materially from any future results, performance or achievements expressed or implied by these forward-looking statements.

In addition, the statements in this document reflect the expectations and beliefs of Candela Corporation and/or Syneron Medical Ltd. as of the date of this document. Candela Corporation and Syneron Medical Ltd. anticipate that subsequent events and developments will cause their expectations and beliefs to change. However, while Candela Corporation and Syneron Medical Ltd. may elect to update these forward-looking statements publicly in the future, they specifically disclaim any obligation to do so. The forward-looking statements of Candela Corporation and/or Syneron Medical Ltd. do not reflect the potential impact of any future dispositions or strategic transactions, including the Merger that may be undertaken. These forward-looking statements should not be relied upon as representing Candela Corporation or Syneron Medical Ltd.’s views as of any date after the date of this document.

Wednesday, September 9th, 2009 Uncategorized Comments Off on Syneron Medical Ltd. (ELOS) and Candela Corporation (CLZR) to Merge Creating a Leading Global Aesthetic Device Company

VIVUS, Inc. (VVUS) Announces Positive Results From Two Phase 3 Studies

Sep. 9, 2009 (PR Newswire) — MOUNTAIN VIEW, Calif., Sept. 9 /PRNewswire-FirstCall/ — VIVUS, Inc. (Nasdaq: VVUS) today announced positive results from two final, phase 3 pivotal 56-week studies, EQUIP (OB-302) and CONQUER (OB-303), evaluating the safety and efficacy of Qnexa(TM), an investigational drug, in more than 3,750 patients across 93 sites. The EQUIP and CONQUER studies met all primary endpoints by demonstrating statistically significant weight loss with all three doses of Qnexa, as compared to placebo. Patients taking Qnexa also achieved significant improvements in cardiovascular and metabolic risk factors including blood pressure, lipid levels, and type 2 diabetes.

Key Data

Highlights from the EQUIP and CONQUER studies include:

    --  Average weight loss of 14.7% (37 lbs) was achieved by patients treated
with Qnexa for 56 weeks in the EQUIP study;
--  Significant improvements in cardiovascular, metabolic and inflammatory
risk factors among patients treated with Qnexa;
--  FDA efficacy benchmarks for weight loss agents exceeded at all three
doses of Qnexa tested in the clinical program;
--  Completion rates up to 69% were significantly higher than placebo at all
three doses of Qnexa, indicating favorable tolerability; and

--  Favorable benefit/risk safety profile for Qnexa.

“The outstanding results from the EQUIP and CONQUER studies, in addition to the results from EQUATE that were reported late last year, confirm the positive effect of Qnexa and underscore the important role this therapy may play in the lives of patients battling obesity and related co-morbidities, if approved by the FDA,” stated Leland Wilson, president and chief executive officer of VIVUS. “The results of the phase 3 program, designed and executed after Special Protocol Assessments were completed by the FDA, exceed the FDA benchmarks for clinically significant weight loss. The results support the company’s plan to file a New Drug Application with the FDA by the end of 2009 and submit the results from the studies for publication in peer-reviewed journals. We believe these results may provide a compelling opportunity for global pharmaceutical companies, and we intend to initiate partnering discussions now that we have the full data set in hand.”

Wilson added, “We are proud of the results of our Qnexa phase 3 program, and I would like to thank Dr. Thomas Najarian, the inventor of Qnexa, the entire development team at VIVUS, Dr. David Orloff and his staff at Medpace, the clinical research organization that managed these studies, and the clinical investigators and patients who participated in the Qnexa clinical trials.”

Qnexa is a proprietary formulation and unique dosing regimen that combines two well known pharmaceutical therapies – phentermine and topiramate – to create a novel, patented therapy. The phase 3 program evaluated three doses of Qnexa (numbers reflect milligrams of phentermine and controlled release topiramate, respectively):

    --  Qnexa 15/92 (full dose)
--  Qnexa 7.5/46 (mid dose)

--  Qnexa 3.75/23 (low dose)

“The weight loss observed with Qnexa in these two one-year, double-blind, randomized trials far exceeds the weight loss observed for other agents reported in literature,” said Kishore Gadde, MD, director of obesity clinical trials at Duke University and a lead investigator. “The efficacy and safety results confirm the earlier findings of our phase 2 study, which showed a very good efficacy and benefit/risk profile. Importantly, the medical benefits of this treatment in reducing the risk of weight-related co-morbidities such as hypertension, diabetes, and dyslipidemia could establish Qnexa as a major advancement in the management of obesity.”

EQUIP (OB-302) Results

The EQUIP study included 1,267 morbidly obese patients (1,050 females and 217 males) across 93 centers in the United States. The average baseline BMI of the study population was 42.1 kg/m(2) and baseline weight was 256 pounds. Patients had a 4-week dose titration period followed by 52 weeks of treatment. The study was a randomized, double-blind, placebo-controlled, 3-arm, prospective trial with patients randomized to receive once-a-day treatment with low-dose Qnexa, full-dose Qnexa or placebo. Patients were asked to follow a hypocaloric diet representing a 500-calorie/day deficit and advised to implement a simple lifestyle modification program. Results from the study are as follows:

                              ITT-LOCF                      Completers
----------------------------  ----------------------------
Qnexa      Qnexa              Qnexa      Qnexa
EQUIP (OB-302)  Placebo  Low Dose  Full Dose  Placebo  Low Dose  Full Dose
56 Weeks        (n=498)  (n=234)    (n=498)   (n=241)  (n=138)   (n=301)
--------------  -------  --------  ---------  -------  --------  ---------
Mean Weight
Loss (%)         1.6%     5.1%*     11.0%*     2.5%    7.0%*      14.7%*
Greater than
or equal to
5% weight
loss rate         17%      45%*       67%*      26%     59%*        84%*

ITT-LOCF: Intent-to-treat with last observation carried forward

*p<0.0001 vs. placebo

    --  Average weight loss for Qnexa patients completing the EQUIP study was 37
pounds and 18 pounds with full-dose Qnexa and low-dose Qnexa,
respectively, as compared to 6 pounds in the placebo group;
--  60% of the full-dose Qnexa patients who completed the study lost at
least 10% of their baseline weight;
--  43% of the full-dose Qnexa  patients who completed the study lost at
least 15% of their baseline weight;
--  Completion rate for EQUIP was 47%, 57%, 59% for patients taking placebo,
low-dose Qnexa and full-dose Qnexa, respectively; and

--  Patients treated with full-dose Qnexa had significant improvements in
blood pressure, triglycerides and cholesterol.

CONQUER (OB-303) Results

The CONQUER study included 2,487 overweight and obese patients (1,737 females and 750 males) with high blood pressure, high cholesterol or type 2 diabetes across 93 centers in the United States. The average baseline BMI of the study population was 36.6 kg/ m2 and baseline weight was 227 pounds. Patients had a 4-week dose titration period followed by 52 weeks of treatment. The study was a randomized, double-blind, placebo-controlled, 3-arm, prospective trial with patients randomized to receive once-a-day treatment with mid-dose Qnexa, full-dose Qnexa or placebo. Patients were asked to follow a hypocaloric diet representing a 500-calorie/day deficit and advised to implement a simple lifestyle modification program. Results from the study are as follows:

                            ITT-LOCF                      Completers
----------------------------  ----------------------------
Qnexa      Qnexa              Qnexa      Qnexa
CONQUER (OB-303) Placebo Mid Dose  Full Dose  Placebo  Mid Dose  Full Dose
56 Weeks        (n=979)  (n=488)    (n=981)   (n=564)  (n=344)    (n=634)
-------- --------  ---------  -------  --------  ---------
Mean Weight
Loss (%)         1.8%     8.4%*     10.4%*     2.4%*  10.5%*      13.2%*
Greater than
or equal to
5% weight
loss rate         21%      62%*       70%*      26%     75%*        85%*

*p<0.0001 vs. placebo

    --  Average weight loss for Qnexa patients who completed the CONQUER study
was 30 pounds and 24 pounds with full-dose Qnexa and mid-dose Qnexa,
respectively, as compared to 6 pounds in the placebo group.
--  In the CONQUER study subset analysis, higher risk patients, defined as
those in the upper 25th percentile of a specific co-morbidity, who were
treated with full-dose Qnexa for 56 weeks achieved the following changes
in cardiovascular risk factors:
--  Reduction in systolic blood pressure of 20 mmHg from 147 mmHg at
baseline, as compared to a reduction of 14 mmHg in the placebo group
(p<0.0001).   This improvement occurred in the presence of a
significant reduction in blood pressure medications in Qnexa-treated
patients as compared to placebo;
--  Reduction in triglyceride levels of  98 mg/dL from 268 mg/dL at
baseline, as compared to a decrease of 42 mg/dL from 262 mg/dL at
baseline in the placebo group (p<0.0001);
--  Reduction in hemoglobin A1c levels of 0.6% from 7.3% at baseline as
compared to a reduction of 0.1% from 7.4% at baseline for the
placebo patients (p<0.0001).  These improvements occurred in the
presence of a significant reduction in antidiabetic medications in
Qnexa-treated patients compared with placebo.  All patients were
treated to standard of care for type 2 diabetes. 64% of the
full-dose Qnexa patients who completed the study lost at least 10%
of their baseline weight;
--  39% of the full-dose Qnexa patients who completed the study lost at
least 15% of their baseline weight; and

--  Completion rates for CONQUER were 57%, 69%, 64% for patients taking
placebo, mid-dose Qnexa, and full-dose Qnexa, respectively.

Across both 56-week studies comprised of more than 3,750 patients, the most commonly reported side effects were dry mouth, tingling, constipation, altered taste and insomnia. Monthly assessments using prospective psychometric instruments in accordance with FDA’s guidance showed no signal for suicidality risk. There were no suicide attempts or suicidal behaviors, and there was no signal for suicidal ideation across all treatment groups including placebo. Depression or depressed mood adverse events of a moderate to severe nature were less than 2% and were similar among patients in the Qnexa and placebo groups. Overall, depression scores, quality of life including self esteem and general health significantly improved for patients on Qnexa.

“I have seen dramatic and sustained weight loss with Qnexa as well as notable improvements in cardiovascular risk factors, diabetes, emotional well being and quality of life in my patients,” commented Michelle Look, M.D., FAAFP, of the San Diego Sports Medicine and Family Health Center and a lead investigator in the studies. “What is so striking for me is how many of my patients were able to achieve weight loss with Qnexa for the first time after many years of battling weight problems without success. The excellent tolerability of Qnexa allowed patients to stay on therapy for a year, as evidenced by the strong completer rates.”

Other Safety Studies

VIVUS completed a thorough QT prolongation (TQT) study evaluating subjects taking Qnexa. The study was completed with no signal for QT prolongation. Subjects taking Qnexa also underwent complex and extensive cognitive and psychomotor testing using validated, FDA accepted testing methodologies. There was no clinically significant change in overall cognitive function or effect on psychomotor skills seen in patients taking Qnexa.

“These data are significant, and when coupled with my own experience treating patients with Qnexa, clearly demonstrate that it is one of the promising pharmaceutical therapies in development to assist patients in achieving significant weight loss,” stated Louis Aronne, MD, Clinical Professor of Medicine and Director of the Comprehensive Weight Control Program at New York-Presbyterian Hospital/Weill Cornell Medical Center and one of the investigators involved in the clinical trials. “People with weight problems have a truly biologic disease, and we are in desperate need of more options and effective tools to help our patients combat this disease and the other serious medical conditions that arise as a result of weight gain. I am encouraged by the efficacy and safety seen in these late stage Qnexa trials.”

Note to Investors

As previously announced, VIVUS will hold a conference call to discuss these results today, September 9, 2009, beginning at 8:00 a.m. Eastern Time. You can listen to this call by dialing toll free 1-800-967-7185, or 1-719-325-2352. A 30-day archive of the call can be accessed at http://ir.vivus.com/.

To access the webcast of this event, please visit: VIVUS’ Investors site at http://ir.vivus.com/events.cfm. Replay will also be available on demand from the website at the conclusion of the program.

About Qnexa

Qnexa (Q-NEX-uh) is a once-a-day, proprietary, oral, controlled-release formulation of low dose phentermine and topiramate, which is believed to address both appetite and satiety – the two main mechanisms that impact eating behavior – in one capsule. Qnexa, an investigational drug, is being developed to address weight loss. In phase 2 and 3 clinical data to date, Qnexa has demonstrated significant weight loss, glycemic control, and improvement in cardiovascular risk factors.

About Obesity

More than 300 million people worldwide and approximately 30 percent of American adults (more than 60 million people) are obese, a chronic condition defined by having excess body fat. As the second leading cause of preventable death, obesity directly contributes to numerous life-threatening conditions including diabetes, cardiovascular disease, hypertension and stroke. Experts agree that even a modest weight loss of five percent of weight, maintained over time, can bring significant health benefits by lowering blood pressure and reducing the risk of diabetes and heart disease.

About VIVUS

VIVUS is a biopharmaceutical company developing innovative, next-generation therapies to address unmet needs in obesity, diabetes and sexual health. The company’s lead product in clinical development, Qnexa(TM), has recently completed phase 3 clinical trials for the treatment of obesity. Qnexa is also in phase 2 clinical development for the treatment of type 2 diabetes. In the area of sexual health, VIVUS is in phase 3 development with avanafil, a potentially best-in-class PDE5 inhibitor, and in phase 2 development of Luramist(TM) for the treatment of hypoactive sexual desire disorder (HSDD) in women. MUSE(R) (alprostadil), a first generation therapy for the treatment of ED, is already on the market and generating revenue for VIVUS. For more information about the company, please visit www.vivus.com.

Certain statements in this press release are forward-looking within the meaning of the Private Securities Litigation Reform Act of 1995. These statements may be identified by the use of forward-looking words such as “anticipate,” “believe,” “forecast,” “estimated” and “intend,” among others. These forward-looking statements are based on VIVUS’ current expectations and actual results could differ materially. There are a number of factors that could cause actual events to differ materially from those indicated by such forward-looking statements. These factors include, but are not limited to, substantial competition; uncertainties of patent protection and litigation; uncertainties of government or third party payer reimbursement; reliance on sole source suppliers; limited sales and marketing efforts and dependence upon third parties; risks related to the development of innovative products; and risks related to failure to obtain FDA clearances or approvals and noncompliance with FDA regulations. As with any pharmaceutical under development, there are significant risks in the development, regulatory approval and commercialization of new products. There are no guarantees that future clinical studies discussed in this press release will be completed or successful or that any product will receive regulatory approval for any indication or prove to be commercially successful. VIVUS does not undertake an obligation to update or revise any forward-looking statement. Investors should read the risk factors set forth in VIVUS’ Form 10-K for the year ended December 31, 2008 and periodic reports filed with the Securities and Exchange Commission.

Wednesday, September 9th, 2009 Uncategorized Comments Off on VIVUS, Inc. (VVUS) Announces Positive Results From Two Phase 3 Studies
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