Archive for October, 2009

MDRNA, Inc. (MRNA) Reports UsiRNA Reduces Tumor Growth In Vivo

BOTHELL, WA–(Marketwire – 10/12/09) – MDRNA, Inc. (NASDAQ:MRNA – News), a leading RNAi-based drug discovery and development company, today presented new in vivo data demonstrating continued progress in the advancement of the Company’s oncology program. J. Michael French, President and CEO, reported that MDRNA’s UsiRNAs, delivered by the Company’s DiLA2 platform, down-regulated a previously “non-druggable” target with subsequent reductions in tumor growth in models of liver and bladder cancer via both systemic and local delivery.

In a presentation to BioPartnering Europe in London today, Mr. French said that MDRNA has demonstrated successful delivery of a UsiRNA targeting survivin, a protein involved in mitotic progression and inhibition of apoptosis, via intravenous administration using its DiLA2 liposome formulation in two liver cancer models. Knockdown ( > 60%) of survivin mRNA in a rodent orthotopic model was noted as early as 24 hours after a second (of six) dose and this was associated with an approximate 65% decrease in tumor weight at study termination; this decrease was comparable to tumor weight reduction with Avastin� (bevacizumab)-treated mice as a positive control. A similar level of survivin mRNA knockdown was noted in subcutaneously implanted liver tumors following intravenous administration of the UsiRNA/DiLA2 liposomes.

Data from an orthotopic bladder cancer model were also presented, in which localized application (intravesical dosing) of the survivin UsiRNA to a bladder tumor was performed using a DiLA2 liposome formulation. Again, the UsiRNA was highly active in providing gene silencing, demonstrating > 90% inhibition of survivin mRNA which was dose-dependent and sustained over at least a three week period. At study termination there was also a dose-dependent decrease in bioluminescence of up to approximately 90% in UsiRNA-treated mice which is a clear indication of reduced tumor growth.

Mr. French said, “We have always maintained that our RNAi discovery engine can generate novel compounds with broad therapeutic applicability. These data are a powerful indicator of the value and strength of that drug discovery platform and represents a significant step in the advancement of our product pipeline. Moreover, we now have evidence illustrating the potential role of RNAi-based therapeutics in down-regulating typically ‘non-druggable’ targets.”

The presentation given by Mr. French is posted on the Company website (www.mdrnainc.com).

About UsiRNAs

A UsiRNA is a duplex siRNA containing at least one Unlocked Nucleobase Analog (UNA). In a UsiRNA, UNAs are non-nucleotide monomers and synthesized much like RNA in the construction of a double-stranded oligonucelotide for use as an RNAi-based therapeutic. In the case of the UsiRNA, UNA is substituted for specific nucleotides in both the guide and passenger strands. UsiRNAs are fully recognized by the cellular RNAi machinery, as demonstrated by their potent activity. MDRNA has also shown that substitution of UNA for specific RNA increases stability to nucleases, substantially reduces cytokine induction, and reduces passenger and guide strand-mediated offtarget effects. The high potency, and improved drug-like properties, associated with UsiRNAs provide the potential to greatly enhance RNAi-based therapeutics.

About the DiLA2 Delivery Platform

The DiLA2 Delivery Platform is MDRNA’s proprietary platform for creating novel liposomal delivery systems based on di-alkylated amino acids (DiLA2). The DiLA2 Platform enables MDRNA to tailor the charge, linker length, and acyl chain characteristics to improve delivery of the liposomes to target tissue of interest. In vivo studies have demonstrated effective delivery in models of metabolic disease, cancer, and other diseases. DiLA2-based liposomes are well tolerated for repeat dose, and systemic and local administration. MDRNA is also utilizing condensing peptides to form peptide-siRNA nanoparticles to further increase the delivery efficiency of its DiLA2 delivery systems. In addition, the platform is designed to permit attachment of peptides and other targeting molecules for delivery to a variety of tissues, and thus provide for a diverse therapeutic portfolio.

About MDRNA, Inc.

MDRNA is a biotechnology company focused on the development and commercialization of therapeutic products based on RNA interference (RNAi). Our goal is to improve human health through the development of RNAi-based compounds and drug delivery technologies that together provide superior therapeutic options for patients. Over the past decade, we have developed substantial capabilities in molecular biology, cellular biology, lipid chemistry, peptide chemistry, pharmacology and bioinformatics, which we are applying to a wide range of RNAi technologies and delivery approaches. These capabilities plus the in-licensing of key RNAi-related intellectual property have rapidly enabled us to become a leading RNAi-based therapeutics company with a pre-clinical pipeline in oncology. Through our capabilities, expertise and know-how, we are incorporating multiple RNAi technologies as well as peptide- and lipid-based delivery approaches into a single integrated drug discovery platform that will be the engine for our clinical pipeline as well as a versatile platform for establishing broad therapeutic partnerships with biotechnology and pharmaceutical companies. We are also investing in new technologies that we expect to lead to safer and more effective RNAi-based therapeutics while aggressively building upon our broad and extensive intellectual property estate. By combining broad expertise in siRNA science with proven delivery platforms and a strong IP position, MDRNA is well positioned as a leading RNAi-based drug discovery and development company. Additional information about MDRNA, Inc. is available at http://www.mdrnainc.com.

MDRNA Forward-Looking Statements

Statements made in this news release may be forward-looking statements within the meaning of Federal Securities laws that are subject to certain risks and uncertainties and involve factors that may cause actual results to differ materially from those projected or suggested. Factors that could cause actual results to differ materially from those in forward-looking statements include, but are not limited to: (i) the ability of MDRNA to obtain additional funding; (ii) the ability of MDRNA to attract and/or maintain manufacturing, research, development and commercialization partners; (iii) the ability of MDRNA and/or a partner to successfully complete product research and development, including preclinical and clinical studies and commercialization; (iv) the ability of MDRNA and/or a partner to obtain required governmental approvals; and (v) the ability of MDRNA and/or a partner to develop and commercialize products that can compete favorably with those of competitors. Additional factors that could cause actual results to differ materially from those projected or suggested in any forward-looking statements are contained in MDRNA’s most recent periodic reports on Form 10-K and Form 10-Q that are filed with the Securities and Exchange Commission. MDRNA assumes no obligation to update and supplement forward-looking statements because of subsequent events.

Monday, October 12th, 2009 Uncategorized Comments Off on MDRNA, Inc. (MRNA) Reports UsiRNA Reduces Tumor Growth In Vivo

Shiner International, Inc. (BEST) Announces Receipt of Multi-Million Chinese Government Subsidy

HAINAN, China, Oct. 12 /PRNewswire-Asia/ — Shiner International, Inc. (Nasdaq: BEST – News; website: http://www.shinerinc.com ), a market leader in the food safe packaging and anti-counterfeiting packaging industries, today announced that the Company’s Packaging Industrial Park Project in Hainan was listed as a “Budgeted Investment Plan” by the Chinese central government and received a subsidy of 29 million RMB or approximately $4.26 million towards its construction.

“We are delighted that our project has been designated as a National Budgeted Investment Plan,” Mr. Jian Fu, Shiner’s CEO commented. “For quite some time, the Chinese domestic market has relied on the importing of high quality packaging films for high-end consumer products at great expense to Chinese manufacturers. In recent years, the central government has begun to realize the importance of domestically developed key technology products that utilize intellectual property that is developed and owned by Chinese companies such as Shiner. Recognizing that our Packaging Industrial Park Project will allow us to manufacture many of our patented products in a state of the art facility, the central government awarded us this subsidy. The funds received from the government will be used for the construction of infrastructures, improvement of capacity and recruitment of senior technical staff for the project. We believe the construction of this project, with the government’s assistance, will enable us to deliver quality products at competitive prices to new and existing customers in the domestic and international markets.”

About Shiner International, Inc.

NASDAQ listed Shiner International ( http://www.shinerinc.com ) is a U.S. corporation that has its primary operations in China. Headquartered in the city of Haikou — China’s “Hawaii” — Shiner’s products include coated packaging film, shrink-wrap film, common packaging film, anti-counterfeit laser holographic film and color-printed packaging materials. Approximately 60 percent of Shiner’s current customers are located in China, with the remainder spanning Southeast Asia, Europe, the Middle East and North America. Shiner holds 14 patents on products and production equipment, and has an additional eight patent applications pending. The Company’s coated films meat the approval of U.S. FDA requirements, as well as those required for food packaging sold in the EU. Shiner’s product manufacturing process is certified under ISO 9001:2000.

Safe Harbor Statement

All statements in this press release that are not historical are forward- looking statements made pursuant to the “safe harbor” provisions of the Private Securities Litigation Reform Act of 1995. You are cautioned not to place undue reliance on any forward-looking statements in this press release as they reflect Shiner International, Inc.’s current expectations with respect to future events and are subject to risks and uncertainties that may cause actual results to differ materially from those contemplated. Potential risks and uncertainties include, but are not limited to, the risks described in Shiner’s filings with the Securities and Exchange Commission.

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Raptor Pharmaceutical (RPTPD) Reports Positive Interim Phase 2a Clinical Data in Non-Alcoholic Steatohepatitis (NASH)

NOVATO, Calif., Oct. 12 /PRNewswire-FirstCall/ — Raptor Pharmaceutical Corp. (“Raptor” or the “Company”) (Nasdaq: RPTPD – News), announced positive findings from the completed treatment phase of its open-label Phase 2a clinical trial of delayed-release cysteamine bitartrate (“DR Cysteamine”) in adolescent patients with non-alcoholic steatohepatitis (“NASH”), a progressive form of liver disease believed to affect 2% to 5% of the U.S. population. At the completion of the initial six-month treatment phase, the study achieved the primary endpoint: mean blood levels of alanine aminotransferase (“ALT”), a common biomarker for NASH, were reduced by over 50%. Additionally, over half of the study participants had achieved normalized ALT levels by the end of the treatment phase.

There are no currently approved drug therapies for NASH, and patients are limited to lifestyle changes such as diet, exercise and weight reduction to manage the disease. DR Cysteamine represents an important potential treatment option for patients with NASH. Although NASH is most common in insulin-resistant obese adults with diabetes and abnormal serum lipid profiles, its prevalence is increasing among juveniles as obesity rates rise within this patient population. Although most patients are asymptomatic and feel healthy, NASH causes decreased liver function and can lead to cirrhosis, liver failure and end-stage liver disease.

Under a collaboration agreement between Raptor and the University of California, San Diego (“UC San Diego”), the open-label Phase 2a trial of a prototype formulation of DR Cysteamine is being conducted at UC San Diego’s General Clinical Research Center and entails six months of treatment followed by a six-month post-treatment monitoring period. Eligible patients with baseline ALT and aspartate aminotransferase (“AST”) measurements at least twice that of normal levels were enrolled to receive twice-daily, escalating oral doses of up to 1,000 mg of DR Cysteamine. The trial currently has enrolled eleven NASH patients between 11-18 years old. No major adverse events were reported during the six-month treatment phase. Trial subjects continue to be monitored during the six-month post-treatment period currently underway. Full results are being submitted for peer review by Raptor and UC San Diego, and are expected to be presented in 2010.

Joel Lavine, M.D., Ph.D., pediatric gastroenterologist at UC San Diego and principal investigator for the NASH study, stated, “We were encouraged by the results of this study. The degree of ALT and AST reductions are indicative of likely improvements in severity of fatty liver damage. The trial results are consistent with ALT and AST reductions normally seen in patients that achieve at least 10% weight loss, even though study participants did not show a significant change in body mass index. DR Cysteamine appears to be a promising candidate for NASH and we look forward to further analyzing these patients during the post-treatment phase.”

Raptor’s chief medical officer, Patrice Rioux, M.D., Ph.D., said, “These interim results have established proof-of-concept and support further clinical development of DR Cysteamine in NASH. This is an area of significant unmet need, especially with growing numbers of obese children diagnosed with the disorder. While the clinical hurdle is usually high for studies in children and adolescents, we are satisfied with the long-term safety demonstrated in this age group by the currently-marketed immediate-release cysteamine bitartrate formulation. This safety track record, coupled with our interim Phase 2a efficacy data, gives us a great sense of encouragement as we advance DR Cysteamine through the clinic.”

Under a license with UC San Diego, Raptor is developing DR Cysteamine for cystinosis, NASH and other potential therapeutic indications. Cysteamine is known to be a scavenger of reactive oxygen species and potent antioxidant, most likely through its ability to increase intracellular glutathione levels. Cysteamine has also demonstrated potential efficacy in preclinical and clinical studies in Huntington’s Disease, Batten Disease and other indications.

About Raptor Pharmaceutical Corp.

Raptor Pharmaceutical Corp. (Nasdaq: RPTPD – News; “Raptor”) is dedicated to speeding the delivery of new treatment options to patients by working to improve existing therapeutics through the application of highly specialized drug targeting platforms and formulation expertise. Raptor focuses on underserved patient populations where it can have the greatest potential impact. Raptor currently has product candidates in clinical development designed to potentially treat nephropathic cystinosis, non-alcoholic steatohepatitis (“NASH”), Huntington’s Disease (“HD”), aldehyde dehydrogenase (“ALDH2”) deficiency, and a non-opioid solution designed to potentially treat chronic pain and thrombotic disorder.

Raptor’s preclinical programs are based upon bioengineered novel drug candidates and drug-targeting platforms derived from the human receptor-associated protein (“RAP”) and related proteins that are designed to target cancer, neurodegenerative disorders and infectious diseases.

For additional information, please visit www.raptorpharma.com.

FORWARD LOOKING STATEMENTS

This document contains forward-looking statements as that term is defined in the Private Securities Litigation Reform Act of 1995. These statements relate to future events or our future results of operation or future financial performance, including, but not limited to the following statements: Raptor’s and UC San Diego’s ability to complete the clinical trial in NASH patients, DR Cysteamine’s ability to treat NASH, ALT and AST as a biomarker to determine the efficacy of a treatment for NASH, Raptor’s ability to further develop DR Cysteamine in NASH and other indications. These statements are only predictions and involve known and unknown risks, uncertainties and other factors, which may cause the Company’s actual results to be materially different from these forward-looking statements. Factors which may significantly change or prevent the Company’s forward looking statements from fruition include that Raptor may be unsuccessful in developing any products or acquiring products; that Raptor’s technology may not be validated as it progresses further and its methods may not be accepted by the scientific community; that Raptor is unable to retain or attract key employees whose knowledge is essential to the development of its products; that unforeseen scientific difficulties develop with the Company’s process; that Raptor’s patents are not sufficient to protect essential aspects of its technology; that competitors may invent better technology; that Raptor’s products may not work as well as hoped or worse, that the Company’s products may harm recipients; and that Raptor may not be able to raise sufficient funds for development or working capital. As well, Raptor’s products may never develop into useful products and even if they do, they may not be approved for sale to the public. Raptor cautions readers not to place undue reliance on any such forward-looking statements, which speak only as of the date they were made. Certain of these risks, uncertainties, and other factors are described in greater detail in the Company’s filings from time to time with the Securities and Exchange Commission (the “SEC”), which Raptor strongly urges you to read and consider, including the joint proxy statement/prospectus on Form S-4 filed with the SEC on August 19, 2009; Raptor’s annual report on Form 10-K filed with the SEC on March 27, 2009; Raptor’s quarterly report on Form 10-Q filed with the SEC on August 11, 2009; Raptor’s wholly-owned subsidiary’s, Raptor Pharmaceuticals Corp. (“RPC”) Registration Statement on Form S-1, as amended, that was declared effective on August 7, 2008; RPC’s annual report on Form 10-K filed with the SEC on October 30, 2008, as amended by that Form 10-K/A filed with the SEC on December 23, 2008; and RPC’s quarterly report on Form 10-Q filed with the SEC on July 15, 2009, all of which are available free of charge on the SEC’s web site at http://www.sec.gov. Subsequent written and oral forward-looking statements attributable to Raptor or to persons acting on its behalf are expressly qualified in their entirety by the cautionary statements set forth in Raptor’s reports filed with the SEC. Raptor expressly disclaims any intent or obligation to update any forward-looking statements.

Monday, October 12th, 2009 Uncategorized Comments Off on Raptor Pharmaceutical (RPTPD) Reports Positive Interim Phase 2a Clinical Data in Non-Alcoholic Steatohepatitis (NASH)

Sinoenergy Corp. (SNEN) Signs Merger Agreement With Skywide Capital Management Ltd.

Sinoenergy Corporation (Nasdaq: SNEN – News), developer and operator of retail compressed natural gas (CNG) filling stations in the People’s Republic of China and a manufacturer of CNG transport truck trailer, CNG filling station equipment and CNG fuel conversion kits for automobiles, today announced that, on October 12, 2009, the Company entered into an agreement with Skywide Capital Management Limited, pursuant to which the Company will be merged with and into Skywide. Upon the effectiveness of the merger, each issued and outstanding share of the Company’s common stock, other than shares owned by Skywide, will automatically be converted into the right to receive $1.90 per share.

Skywide, which is owned by the Company’s chairman, Mr. Tianzhou Deng, and its president, Mr. Bo Huang, is the Company’s largest shareholder, owning approximately 39.06% of the Company’s outstanding common stock.

The merger agreement provides that the consummation of the merger is subject to the approval of the holders of a majority of the Company’s outstanding common stock and customary closing conditions. As a result of the merger, the Company will cease to exist as a separate corporation, and its common stock will no longer be publicly traded.

The merger was approved by the board of directors, upon the recommendation of a special committee of the board which was comprised solely of independent directors.

Brean Murray, Carret & Co. served as financial advisor to the Company in this transaction and rendered a fairness opinion to the special committee with respect to the transaction. Arent Fox LLP acted as legal advisor to the special committee of the Company’s board. Sichenzia Ross Friedman Ference LLP acted as legal advisor to the Company. Mintz & Fraade P.C. acted as legal advisor to Skywide.

Additional Information and Where to Find It

In connection with the proposed merger, the Company will prepare a proxy statement for the shareholders of the Company to be filed with the SEC. Before making any voting decision, the Company’s shareholders are urged to read the proxy statement regarding the merger carefully in its entirety when it becomes available because it will contain important information about the proposed transaction. The Company’s shareholders and other interested parties will be able to obtain, without charge, a copy of the proxy statement (when available) and other relevant documents filed with the SEC from the SEC’s website at http://www.sec.gov . The Company’s shareholders and other interested parties will also be able to obtain, without charge, a copy of the proxy statement and other relevant documents (when available) by directing a request by mail or telephone to Sinoenergy Corporation, 1603-1604, Tower B Fortune Centre Ao City, Beiyuan Road, Chaoyang District, Beijing, People’s Republic of China 100107, Attention: Investor Relations; and +86-10-84928149, or to Georgeson Inc., the Company’s proxy solicitor, toll-free in the United States, 877-278-4751; Banks and Brokers should call 212-440-9800.

Participants in the Solicitation

The Company and its directors and officers may be deemed to be participants in the solicitation of proxies from the Company’s shareholders with respect to the merger. Information about the interests of the Company’s directors and officers in the transaction, which may differ from other shareholders generally, will be set forth in the proxy statement and other relevant documents regarding the merger when they are filed with the SEC.

About Sinoenergy

Sinoenergy is a developer and operator of retail CNG stations as well as a manufacturer of CNG transport truck trailers, CNG station equipment, and natural gas fuel conversion kits for automobiles, in China. In addition to its CNG related products and services, the Company designs and manufactures a wide variety of customized pressure containers for use in the petroleum and chemical industries. The Company’s website is http://www.sinoenergycorporation.com . Information on the Company’s website or any other website does not constitute a portion of this press release.

Forward-Looking Statements

This release contains certain “forward-looking statements” relating to the business of the Company and its subsidiaries. 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 that may cause actual results to be materially different from those described herein as anticipated, believed, estimated or expected. 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 those discussed in the Company’s periodic reports that are filed with the Securities and Exchange Commission and available on its website ( http://www.sec.gov ). All forward-looking statements attributable to 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.

Monday, October 12th, 2009 Uncategorized 1 Comment

GameTech International, Inc. (GMTC) Receives Approval From the Montana Gambling Control Division for New Multi-game Suite

RENO, Nev., Oct. 8 /PRNewswire-FirstCall/ — GameTech International, Inc. (“GameTech®”) (Nasdaq: GMTC), a leading designer, developer and manufacturer of electronic bingo, gaming equipment, gaming systems, and video lottery terminals, today announced that the Montana Gambling Control Division has approved GameTech International’s latest multi-game release of new titles for the Montana Video Lottery Terminal market.

This multi-game suite includes the highly anticipated release of Gold Works, Cow Abduction and Sweet Success video keno games with state-of-the-art graphics and animation. These games are designed for maximum player interaction and a heightened entertainment experience through innovative bonus rounds, sound packages, and new and exciting game play features.

According to the Montana Gambling Control Division’s quarterly Active Machine Count Report of September 30, 2009, GameTech’s Summit Gaming branded products already hold a dominant position in the Montana market with almost double the number of gaming machines deployed in the state as the next largest gaming machine provider.

“We are very excited about getting our approvals for these new games,” said Tim Minard, Senior Vice President of Sales and Marketing for GameTech International. “We are confident that they will meet and exceed customer and player expectations in this very important market for us. These games, which really focus on the player experience, are strong examples of why we hold the market leader position in Montana and in other major VLT markets”.

GameTech International, Inc. is in the business of designing, manufacturing, and marketing computerized bingo and gaming equipment, systems, and services. Under the GameTech® product brand the company provides electronic bingo systems and equipment, and is an innovator in advanced wireless gaming applications and devices. Under the Summit Gaming (TM) product brand the Company provides video lottery terminal devices, Class III gaming machines, and related software and content. GameTech International, Inc. serves customers in 43 U.S. States, Canada, Japan, Mexico, Norway, Philippines, and the United Kingdom. The company was incorporated in 1994 and is headquartered in Reno, Nevada.

Statements in this press release that are not historical facts are intended to be forward-looking statements subject to the safe harbor provisions of the Private Securities Litigation Reform Act of 1995. GameTech cautions that these statements are qualified by important factors that could cause actual results to differ materially from those reflected by the forward-looking statements contained herein. Such factors include risks associated with doing business in a regulated industry, our ability to retain customers and secure new customers, risks associated with rapid technological change, and those disclosed in documents filed by the Company with the Securities and Exchange Commission, including the Company’s most recently filed Annual Report on Form 10-K and Quarterly Reports on Form 10-Q. GameTech does not intend, and undertakes no obligation, to update our forward-looking statements to reflect future events or circumstances

Thursday, October 8th, 2009 Uncategorized Comments Off on GameTech International, Inc. (GMTC) Receives Approval From the Montana Gambling Control Division for New Multi-game Suite

Ceragon Networks Ltd. (CRNT) to Collaborate With Alvarion(R) for Open Range Communications’ 4G Network Deployment

TEL AVIV, Israel, Oct. 8, 2009 (PRNewswire-FirstCall) — Ceragon Networks Ltd. (NASDAQ and TASE: CRNT), a leading provider of high-capacity wireless backhaul solutions, today announced that it will partner with Alvarion Ltd. (NASDAQ:ALVR) as wireless backhaul equipment provider to deploy a network for Open Range Communications. The new network is planned to be the largest Rural Utilities Service (RUS) funded deployment in the United States, spanning 17 states, 546 rural communities, and reaching up to 6 million people.

Alvarion is a leading provider of WiMAX and wireless broadband solutions. The company was recently selected as the WiMAX solution provider for the Open Range best-of-breed 4G network. Alvarion is also acting as the prime system integrator of the project. Ceragon’s high-capacity platforms will be used for backhauling rich voice and multimedia content over a newly constructed wireless IP network.

“This Open Range network will bring high-speed broadband connectivity to millions of Americans,” said Tzvika Friedman, CEO of Alvarion, Ltd. “The backhaul solution plays a critical role in building such a high capacity network. Ceragon’s wireless IP backhaul solution provides a variety of benefits including high-capacity and advanced networking capabilities while allowing for simple, quick and cost-efficient deployment. Our partnership with Ceragon is another example of our strategy to enable Open WiMAX networks.”

“We are very excited to partner with Alvarion for the Open Range network deployment,” said Ira Palti, President and Chief Executive Officer of Ceragon. “Delivering broadband services to rural communities brings new forms of enterprise, new sources of wealth and new forms of social interaction to millions of new users. Our wireless backhaul solutions help operators around the world to simplify their network deployments while driving down set up and maintenance costs. We look forward to a long and fruitful partnership with Alvarion.

Open Range Communications Inc. is a U.S. broadband wireless operator. The operator’s new rural broadband access network will be built with an all-IP architecture leveraging the latest 4G technology. This solution will give millions of rural Americans the ability to enjoy wireless broadband services across the communities where they live and work.

About Ceragon Networks Ltd.

Ceragon Networks Ltd. (NASDAQ and TASE: CRNT) is a leading provider of high capacity wireless backhaul solutions that enable wireless service providers to deliver voice and premium data services, such as Internet browsing, music and video applications. Ceragon’s wireless backhaul solutions use microwave technology to transfer large amounts of network traffic between base stations and the infrastructure at the core of the mobile network. Ceragon designs solutions to provide fiber-like connectivity for circuit-switched, or SONET/SDH, networks, next generation Ethernet/Internet Protocol, or IP-based, networks, and hybrid networks that combine circuit-switched and IP-based networks. Ceragon’s solutions support all wireless access technologies, including GSM, CDMA, EV-DO and WiMAX. These solutions address wireless service providers’ need to cost-effectively build-out and scale their infrastructure to meet the increasing demands placed on their networks by growing numbers of subscribers and the increasing demand for premium data services. Ceragon also provides its solutions to businesses and public institutions that operate their own private communications networks. Ceragon’s solutions are deployed by more than 150 service providers of all sizes, as well as in hundreds of private networks, in nearly 100 countries. More information is available at http://www.ceragon.com

Ceragon Networks(R), CeraView(R), FibeAir(R), the FibeAir(R) design mark and Native2(R) are registered trademarks., and Ceragon(TM), PolyView(TM), ConfigAir(TM), CeraMon(TM), EtherAir(TM), QuickAir(TM), QuickAir Partner Program(TM), QuickAir Partner Certification Program(TM), QuickAir Partner Zone(TM), EncryptAir(TM) and Microwave Fiber(TM) are trademarks of Ceragon Networks Ltd.

This press release may contain statements concerning Ceragon’s future prospects that are “forward-looking statements” under the Private Securities Litigation Reform Act of 1995. These statements are based on current expectations and projections that involve a number of risks and uncertainties. There can be no assurance that future results will be achieved, and actual results could differ materially from forecasts and estimates. These are important factors that could cause actual results to differ materially from forecasts and estimates. These risks and uncertainties, as well as others, are discussed in greater detail in Ceragon’s Annual Report on Form 20-F and Ceragon’s other filings with the Securities and Exchange Commission. Forward-looking statements speak only as of the date on which they are made and Ceragon undertakes no commitment to revise or update any forward-looking statement in order to reflect events or circumstances after the date any such statement is made.

About Alvarion

Alvarion (NASDAQ: ALVR) is the largest WiMAX pure-player with the most extensive WiMAX customer base and over 250 commercial deployments around the globe. Committed to growing the WiMAX market, the company offers solutions for a wide range of frequency bands supporting a variety of business cases. Through its OPEN WiMAX strategy, superior IP and OFDMA know-how, and ability to deploy end-to-end turnkey WiMAX projects, Alvarion is shaping the new wireless broadband experience (http://www.alvarion.com).

Thursday, October 8th, 2009 Uncategorized 2 Comments

Labopharm, Inc. (DDSS) announces that its trazodone API supplier has resolved outstanding manufacturing issues with the FDA

Oct. 7, 2009 (PR Newswire) — LAVAL, QC, Oct. 7 /PRNewswire-FirstCall/ – Labopharm Inc. (TSX: DDS; NASDAQ: DDSS) today announced that it has been informed by Angelini, the manufacturer of the active pharmaceutical ingredient (API) for the Company’s novel trazodone formulation, that it has received a letter from the U.S. Food and Drug Administration (FDA) stating that Angelini has appropriately addressed all deficiencies cited by the FDA following its inspection of the manufacturing facility in June and July of this year. The letter further states that Angelini’s manufacturing facility has been classified as acceptable.

Labopharm received a complete response letter from the FDA on July 17, 2009 indicating the Company’s new drug application (NDA) for its novel trazodone formulation could not be approved in its present form due to the deficiencies at the API supplier’s manufacturing facility. The letter did not raise any efficacy or safety issues.

Labopharm’s novel formulation of trazodone is currently under regulatory review in the U.S. with an action date under the Prescription Drug Users Fee Act (PDUFA) of February 11, 2010.

About Labopharm Inc.

Labopharm is an emerging leader in optimizing the performance of existing small molecule drugs using its proprietary controlled-release technologies. The Company’s lead product, a unique once-daily formulation of tramadol, is now available in 17 countries around the world, including the U.S., Canada, major European markets and Australia. The Company’s second product, a novel formulation of trazodone for the treatment of major depressive disorder, is under regulatory review in the U.S. by the FDA. The Company also has a robust pipeline of follow-on products in both pre-clinical and clinical development. Labopharm’s vision is to become an integrated, international, specialty pharmaceutical company with the capability to internally develop and commercialize its own products. For more information, please visit www.labopharm.com.

This press release contains forward-looking statements, which reflect the Company’s current expectations regarding future events. The forward-looking statements involve risks and uncertainties. Actual events could differ materially from those projected herein and depend on a number of factors, including the uncertainties related to the regulatory process in various countries for the approval of the Company’s products and the successful commercialization of the products throughout the world if they are approved. Investors should consult the Company’s ongoing quarterly filings and annual reports for additional information on risks and uncertainties relating to these forward-looking statements. The reader is cautioned not to rely on these forward-looking statements. Except as required by law, the Company undertakes no obligation and does not intend to update these forward-looking statements.

Wednesday, October 7th, 2009 Uncategorized Comments Off on Labopharm, Inc. (DDSS) announces that its trazodone API supplier has resolved outstanding manufacturing issues with the FDA

Keegan Resources, Inc. (KGN) Continues to Receive Excellent Results From 2009 Drilling at the Esaase Gold Project

VANCOUVER, BRITISH COLUMBIA, Oct. 6, 2009 (Marketwire) — Keegan Resources Inc. (“Keegan”) (TSX:KGN)(NYSE Amex:KGN) is pleased to announce new results from its 2009 drilling program at the Esaase property in southwest Ghana. The results are from drill holes down dip from the existing resource as well as from shallow strike extension drilling to the north of the current resource targeting high grades at shallow depths. The results from the deeper drilling show multiple high grade zones including 9.3 m of 11.1 g/t Au as well as wide intercepts of significant mineralization including 21 meters of 2.04 g/t Au, and 41 m @ 1.1 g/t Au (see Table 1 below for additional results). The results of the shallow holes include seven meters of 7.96 g/t Au and five meters at 3.37 g/t Au; all at less than 100 meters depth Keegan has incorporated the down dip results into its existing model and is planning the next stage of drilling in this area. There are numerous assays still pending from ongoing drilling to the north. Please see www.keeganresources.com for drill hole location maps and cross-sections.

Table 1: Intercepts from the 2009 resource expansion-drilling program at the Esaase property. Only intercepts with grade widths of greater than 10 g/t Au x meter are shown. Intercepts with grade-widths of approximately 40 g/t Au x meter or higher are marked with (i). Distances are in drilled meters and grades reported in g/t Au.

------------------------------------- --------------------------------------
down dip extension drilling           shallow north extension drilling
---------------------------           --------------------------------
------------------------------------- --------------------------------------
Hole_ID       From     To Width Grade Hole_ID     From     To  Width   Grade
------------------------------------- --------------------------------------
KEDD542(i)     321    342    21  2.04 KERC555       58     64      6    2.01
------------------------------------- --------------------------------------
including(i)   334    335     1  28.4 KERC556        4     14     10     1.5
------------------------------------- --------------------------------------
KEDD542(i)     369    410    41   1.1 KERC560(i)     5     10      5    2.84
------------------------------------- --------------------------------------
KEDD552        296    313    17  1.24 KERC560(i)    27     32      5    3.37
------------------------------------- --------------------------------------
KEDD552      371.9    390  18.1  1.21 including     27     28      1      11
------------------------------------- --------------------------------------
KEDD552        399    407     8   4.9 KERC560       53     59      6    2.32
------------------------------------- --------------------------------------
including      404    405     1  30.6 KERC567       74     81      7    7.96
------------------------------------- --------------------------------------
KEDD552(i)     455 464.34  9.34  11.1 including(i)  74     75      1    36.9
------------------------------------- --------------------------------------
including(i)   458    459     1  62.5 and(i)        79     80      1   12.55
------------------------------------- --------------------------------------
including(i)464.04 464.34  0.34   100
------------------------------------- --------------------------------------

President and CEO Dan McCoy states, “These new results provide additional confirmation of Keegan’s potential to add significant ounces to the deposit both at depth as well as along strike. While Keegan proceeds with it’s aggressive exploration program, the engineering and environmental team is also making excellent progress on development-oriented projects such as metallurgical and mine planning studies and comprehensive environmental and community engagement programs.”

Richard Haslinger, P. Eng. is the Qualified Person with respect to NI 43-101 at Esaase. RC samples were taken at one-meter intervals under dry drilling conditions by geologic and resource consultant Coffey Mining Inc. utilizing drilling and sampling techniques widely accepted in resource definition studies of other West African gold deposits. All reverse circulation drill samples are weighed on site. Drill core is HQ diameter and is split, logged and sampled on site. All core and RC samples are assayed using standard 50 gram fire assay with atomic absorption finish by ALS Chemex Labs in Kumasi, Ghana. QA/QC programs using internal and external standard samples, re-assays, and blanks indicate good accuracy and precision in a large majority of standards assayed. Repeatability in duplicate samples is generally within 10% variance. In instances where variance is greater than 10%, the assays from both samples are averaged. Intercepts were calculated to emphasize width rather than grade: a minimum of a 0.2 g/t cut off at beginning and end of the intercept and allowing for no more than six consecutive samples (six meters) of less than 0.2 g/t Au. Mineralization in the A structure strikes approximately 10 to 30 degrees east of north and dips 45 to 90 degrees to the west. Holes are drilled at 110 degrees azimuth and are inclined at 45 to 60 degrees, so true widths are estimated to be over 80% of the drilled widths. The techniques by which drill hole assays have been previously used in resource estimation at Esaase can be found in Keegan’s most recent 43-101 technical report on www.sedar.com.

About Keegan Resources: Keegan is a junior gold company offering investors the opportunity to share ownership in the rapid exploration and development of high quality pure gold assets. The Company is focused on its wholly owned flagship Esaase project (2.025 Moz indicated resources with an average grade of 1.5 g/t Au at a 0.6 g/t Au cutoff and 1.451 million ounces in an inferred category at an average grade of 1.6 g/t Au applying a 0.6 g/t Au cut-off for a total inferred and indicated resource of 3.476 Moz) as well as its Asumura gold project, both of which are located in Ghana, West Africa, a highly favorable and prospective jurisdiction. Managed by highly skilled and successful technical and financial professionals, Keegan is well financed with no debt. Keegan is also strongly committed to the highest standards for environmental management, social responsibility, and health and safety for its employees and neighboring communities. Keegan trades on the TSX and the NYSE AMEX under the symbol KGN. More information about Keegan is available at www.keeganresources.com.

On Behalf of the Board

Dan McCoy, Ph.D., President & CEO

Forward Looking and other Cautionary Information

This release includes certain statements that may be deemed “forward-looking statements”. All statements in this release, other than statements of historical facts, that address estimated resource quantities, grades and contained metals, possible future mining, exploration and development activities, are forward-looking statements. Although the Company believes the expectations expressed in such forward-looking statements are based on reasonable assumptions, such statements should not be in any way construed as guarantees of future performance and actual results or developments may differ materially from those in the forward-looking statements. Factors that could cause actual results to differ materially from those in forward-looking statements include market prices for metals, the conclusions of detailed feasibility and technical analyses, lower than expected grades and quantities of resources, mining rates and recovery rates and the lack of availability of necessary capital, which may not be available to the Company on terms acceptable to it or at all. The Company is subject to the specific risks inherent in the mining business as well as general economic and business conditions. For more information on the Company, Investors should review the Company’s annual Form 20-F filing with the United States Securities Commission and its home jurisdiction filings that are available at www.sedar.com.

Information Concerning Estimates of Measured, Indicated and Inferred Resources This news release also uses the terms ‘indicated resources’ and ‘inferred resources’. Keegan Resources Inc. advises investors that although these terms are recognized and required by Canadian regulations (under National Instrument 43-101 Standards of Disclosure for Mineral Projects), the U.S. Securities and Exchange Commission does not recognize them. Investors are cautioned not to assume that any part or all of the mineral deposits in these categories will ever be converted into reserves. In addition, ‘inferred resources’ have a great amount of uncertainty as to their existence, and economic and legal feasibility. It cannot be assumed that all or any part of an Inferred Mineral Resource will ever be upgraded to a higher category. Under Canadian rules, estimates of Inferred Mineral Resources may not form the basis of feasibility or pre-feasibility studies, or economic studies except for Preliminary Assessment as defined under 43-101. Investors are cautioned not to assume that part or all of an inferred resource exists, or is economically or legally mineable.

To view the maps accompanying this press release please click on the following link: http://media3.marketwire.com/docs/kgn106m1.pdf

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Nutrisystem, Inc. (NTRI) Announces Distribution at Walmart

HORSHAM, Pa., Oct. 5 /PRNewswire-FirstCall/ — Nutrisystem, Inc. (Nasdaq: NTRI), a leading provider of weight management programs and services, has aligned with Walmart to offer customers the convenience of a Nutrisystem 14-Day Starter Program for the first time in the retail channel.

Hitting shelves at the brink of the holiday rush and leading into the height of the 2010 New Year’s resolution season, the Nutrisystem 14-Day Starter Program will start rolling out nationwide at over 3,200 Walmart locations the first week of October, and will be available on Walmart.com.

“Our alliance with Walmart is an extension of our goal to consistently offer consumers a convenient, affordable and effective weight loss option,” said Will Auchincloss, Senior Vice President of Business Development at Nutrisystem. “Walmart provides us with a new and valuable distribution channel to broaden our customer base and build awareness of our product at the retail level.”

Walmart customers will find the Nutrisystem weight loss Starter Program in the pharmacy area of their local store and online at Walmart.com. The Program may be purchased through a convenient gift card system that starts with buying a card, then activating it online at nutrisystem.com/redeem or by calling 800 873-1925, to begin home delivery and start losing weight. The Nutrisystem Starter Program consists of 14 days of the Nutrisystem favorites menu, free shipping, access to 24/7 weight loss counseling, and free membership in Nutrisystem’s robust online community, for $148.00.

About Nutrisystem, Inc.

Nutrisystem, Inc. (Nasdaq: NTRI) is a leading provider of weight management products and services. Nutrisystem is sold direct to the consumer through nutrisystem.com for convenient home delivery. The company offers proven nutritionally balanced weight loss programs designed for women, men, and seniors, as well as the new clinically tested Nutrisystem D plan, formulated specifically to help people with type 2 diabetes who want to lose weight. The Nutrisystem program is based on 35 years of nutrition research and offers a variety of great tasting, satisfying high-fiber, heart healthy, good carbohydrate meals that are low on the Glycemic Index and contain zero trans fats. Nutrisystem is hundreds of dollars cheaper than other weight loss programs, based on an independent survey by National Business Research Institute (October 2008). The program has no membership fees and provides 24/7 weight management support by trained weight loss coaches and online weight management tools free of charge. In 2009 Nutrisystem was selected as the #1 overall online retailer in the Health and Beauty category and #46 out of the top 500 online retailers overall by Internet Retailer Magazine. For more information or to become a customer visit http://www.nutrisystem.com or call 1-877-681-THIN (8446).

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Avocent Corp. (AVCT) Empowers MindTree With Centralized Data Center IT Management From Any Location in the World

HUNTSVILLE, AL — (Marketwire) — 10/06/09 — Avocent Corporation (NASDAQ: AVCT), a global leader in IT operations management, today announced that MindTree Limited has deployed Avocent’s suite of remote infrastructure management solutions to enable full IT operations control over IP.

With support for a variety of servers, network equipment and other data center devices, Avocent’s physical resource infrastructure management platform has allowed MindTree to successfully optimize its skilled manpower resource and business operations.

MindTree, a global IT solutions company that specializes in IT services, independent testing, infrastructure management and technical support (IMTS), knowledge services and product engineering, is today one of India’s fastest growing IT and R&D services companies. The accelerated expansion of MindTree’s IT services business created an infrastructure management challenge as the company needed to control and troubleshoot a growing footprint of more than 300 mission-critical servers and network devices.

Before the IP-enabled solution, MindTree relied on analog KVM technology to manage its assets and this required engineers to physically enter each data center to carry out management tasks. As the complexity, size and number of MindTree’s data centers increased, so did the cost of manpower and fault resolution times.

MindTree deployed Avocent’s DSR®2000 series of digital KVM switches and its DSView®3 management software as well as its CCM console manager solution to reign in management across its data center campuses. Avocent’s DSR® KVM over IP solution provided MindTree secure control of all its servers over a browser-based IP connection while DSView 3 enabled the centralized management of both physical and virtual server resources. With Avocent’s console manager, MindTree is also able to achieve out-of-band access IP-based access to serially managed devices including Unix/Linux servers, power distribution units, routers, switches, firewalls and load balancers.

“Avocent’s remote infrastructure management has drastically enhanced the efficiency and productivity of our IT team because it provides web/dial-in access to servers and network devices up to BIOS level and console access to network devices, as well as fault identification and rectification from anywhere and at any time,” said Ramesh Kumar, Associate Director of Information Systems at MindTree. “OS and application installation are now a breeze and we can access and manage our datacenter resources without being physically at the location (or site).”

“MindTree is a fast-growing global company and we are happy to provide the technology they require to be able to compete more efficiently and competitively, as they extend their footprint into the global marketplace,” said Ryan Sia, Vice President, Avocent Asia Pacific.

About MindTree Ltd. MindTree Ltd. is a global IT Solutions company specializing in IT Services, Independent Testing, Infrastructure Management and Technical Support (IMTS), Knowledge Services and Product Engineering, which comprises of R&D Services and Software Product Engineering. MindTree partners with its clients to create a transparent, value-based relationship. Our people build innovative solutions in a wide range of technology domains that enable our customers to succeed in their business goals.

MindTree was ranked 45th among the leaders in The 2009 Global Outsourcing 100 by the International Association of Outsourcing Professionals. Widely known for its focus on human capital development, MindTree has been consistently rated among the most admired employers by several industry surveys, including Great Places To Work Institute, Hewitt Associates and Mercer.

MindTree was ranked No. 1 among the Most Admired Knowledge Enterprise (MAKE) India Award winners for the second consecutive year in 2008. MindTree is the winner of the National Award for Excellence in Corporate Governance in India in 2007-08. The Company is publicly listed in India. More information is available at www.mindtree.com.

About Avocent Corporation

Avocent delivers IT operations management solutions that reduce operating costs, simplify management and increase the availability of critical IT environments 24/7 via integrated, centralized software. Additional information is available at www.avocent.com.

Forward-looking Statements

This press release contains statements that are forward-looking statements as defined within the Private Securities Litigation Reform Act of 1995. These forward-looking statements are subject to risks and uncertainties that could cause actual results to differ materially from the statements made, including the risks associated with general economic conditions, risks attributable to future product demand, sales, and expenses, risks associated with acquisitions and acquisition integration, risks associated with product design efforts and the introduction of new products and technologies, and risks associated with obtaining and protecting intellectual property rights. Other factors that could cause operating and financial results to differ are described in the Avocent annual report on Form 10-K filed with the Securities and Exchange Commission on February 27, 2009. Other risks may be detailed from time to time in reports to be filed with the SEC. Avocent does not undertake any obligation to publicly update its forward-looking statements based on events or circumstances after the date hereof.

Copyright © 2009, Avocent Corporation. All rights reserved. Avocent, LANDesk, and their respective logos are registered trademarks or trademarks of Avocent Corporation, its subsidiaries or its affiliated companies in the United States and/or other countries. Other brands and names may be claimed as the property of others.

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Sykes Enterprises, Inc. (SYKE) and ICT Group, Inc. (ICTG) Sign Definitive Merger Agreement

TAMPA, Fla., Oct. 6, 2009 (GLOBE NEWSWIRE) — Sykes Enterprises, Incorporated (“SYKES” or the “Company”) (Nasdaq:SYKE), a global leader in providing outsourced customer contact management solutions and services in the business process outsourcing (BPO) arena, and ICT Group, Inc. (“ICTG”) (Nasdaq:ICTG), a leading global provider of customer management and business process outsourcing (BPO) solutions, announced today that they have entered into a definitive merger agreement under which SYKES agrees to acquire ICTG. SYKES will pay $15.38 for each share of ICTG common stock on a fully diluted basis, for a total purchase price of approximately $263 million. Under the terms of the agreement, each issued and outstanding share of ICTG will be converted into $7.69 in cash and SYKES stock with a value of $7.69, subject to a collar mechanism. The purchase price of $15.38 per share represents a premium of approximately 46% over the closing price of ICTG stock on October 5, 2009. The cash portion of the purchase price is anticipated to be funded through committed credit facilities. The Board of Directors of SYKES and ICTG have each approved the transaction, which is subject to the approval of the ICTG shareholders. John J. Brennan, Donald Brennan and Eileen Brennan Oakley have entered into an agreement with Sykes and ICTG under which they have agreed to vote shares controlled by them, representing approximately 39% of ICTG’s outstanding shares, in favor of the transaction. The transaction is expected to close around the end of 2009, subject to the satisfaction of customary closing conditions, including Hart- Scott-Rodino clearance.

SYKES expects to realize synergies of up to $20 million annually. Giving consideration to realizing a portion of the anticipated synergies in 2010, the acquisition is expected to be neutral to SYKES’ earnings per diluted share in 2010. On an adjusted basis, which excludes expenses related to the amortization of acquisition-related intangible assets, while including the expected synergies, this acquisition is expected to be earnings per diluted share accretive in 2010.

Strategic Benefits of the Transaction The business opportunities are significant as this transaction:

  *  Creates a combined company with more than $1.2 billion in
     revenues, while greatly expanding the portfolio of clients
     with minimal client overlap;
  *  Leverages global scale to pursue client acquisition
     opportunities that are larger and more complex in scope;
  *  Broadens the vertical reach;
  *  Strengthens the domestic delivery footprint;
  *  Expands global delivery footprint to 23 countries;
  *  Builds deeper expertise within the financial services and
     telecom verticals, the two largest market segments in the
     customer contact management industry;
  *  Increases the opportunity for sustainable long-term revenue
     growth and operating margin expansion by leveraging of
     general and administrative expenses over a larger revenue
     base; and
  *  Further diversifies risk while sustaining an already-strong
     financial position.

“A highly regarded player with over two decades in the customer contact management industry, ICTG has built a solid business platform around its portfolio of services across various verticals targeted toward Fortune 500 clients,” said Chuck Sykes, President and Chief Executive Officer of Sykes Enterprises, Inc. “As clients across the industry move increasingly toward outsourcing more processes to fewer vendors, the breadth and depth of service offerings along with a strong delivery footprint are likely to become a driving force in the industry. Against that backdrop, and coupled with the embedded opportunities, the strategic rationale for this transaction is extremely compelling, making it a win-win for our combined clients, employees and shareholders. For our combined clients, the acquisition offers the reach of our global delivery footprint through the addition of new delivery geographies and markets, along with deeper expertise in key verticals. For our employees, given our shared vision and mission, the acquisition allows us to capitalize on each other’s best practices by leveraging the global resources of the combined organization across all functional areas. And for our shareholders, we significantly strengthen our competitive position, sustain our strong balance sheet and drive toward the goal of sustained long-term operating margin expansion as we are able to better leverage our general and administrative expenses across a larger base of revenues. Moreover, with minimal client overlap and lower client concentration resulting from a larger overall client base, we believe that some of the key integration hurdles inherent in shareholders realizing value creation have been somewhat mitigated. Altogether, this transaction represents a significant milestone for all SYKES stakeholders, and we are delighted to add ICTG’s customers and employees to our organization.”

“This transaction gives the combined companies the scale and size needed to effectively compete on a global basis. We have very little client overlap in the vertical markets that we currently serve and will be able to greatly broaden our reach through this transaction. Upon completion of merger, we will have the resources and footprint to address the increasingly complex needs of our Fortune 500 client base,” commented John J. Brennan, Chairman, Chief Executive Officer and President of ICT Group Inc. “At ICTG, we have spent the last 18 months transforming our organization and positioning the Company for profitable growth. We believe this combination will accelerate the opportunity for our shareholders to realize the value that we have created.”

For the six months ended June 30, 2009, ICTG’s revenues were $194.4 million. ICTG ended the second quarter of 2009 with $42.3 million in cash and cash equivalents on its balance sheet. Mr. Brennan has agreed to remain with SYKES for a transition period to assist with the integration of the two businesses.

Mr. Chuck Sykes commented further, “We have been extremely disciplined about our acquisition strategy, avoiding the mergers and acquisitions frenzy at the peak of the last market cycle. Our focus has been on optimizing our business while seeking the right acquisition that would be highly complimentary to our core business. The ICTG transaction represents the fruits of that discipline and is consistent with our focus on driving long-term shareholder value.”

Transaction Terms

Under the terms of the agreement, each issued and outstanding share of ICTG will be converted into $7.69 in cash and SYKES stock with a value of $7.69, subject to a collar mechanism. If SYKES’ volume weighted average stock price for a 10 trading-day period ending on the third trading day before the effective date of the merger is between $19.3306 and $22.4652, the fraction of a share of SYKES common stock to be delivered with the $7.69 in cash for each ICTG share (the “exchange rate”) will be adjusted to deliver SYKES stock valued at $7.69 per ICTG share. If SYKES’ average stock price is at or above $22.4652, the exchange rate will be 0.3423 SYKES share per ICTG share. If SYKES’ average stock price is at or below $19.3306, the exchange rate will be 0.3978 SYKES share per ICTG share. Each outstanding ICTG restricted stock unit will become fully vested at closing and the holder will receive a cash payment of $15.38. Each outstanding ICTG stock option will become fully vested at closing and the holder will receive a cash payment based upon the difference between the exercise price for the stock option and $15.38.

SYKES Third-Quarter 2009 Business Outlook Update

Excluding costs associated with the ICTG acquisition and on a stand-alone basis, SYKES expects to exceed the top-end of its previously discussed third-quarter 2009 earnings per diluted share outlook range of $0.31 to $0.34.

Advisors

Credit Suisse Securities (USA) LLC served as a sole financial advisor to SYKES on the transaction, while Greenhill & Company served as a sole financial adviser to ICTG. Shumaker, Loop & Kendrick, LLP served as SYKES’ legal advisor, while Morgan, Lewis & Bockius LLP served as ICTG’s legal advisor.

Conference Call

SYKES and ICTG will hold a conference call to discuss the acquisition at 10:00 a.m. EDT on Tuesday, October 6, 2009. The conference call will be carried live on the Internet at: http://phx.corporate-ir.net/phoenix.zhtml?p=irol-eventDetails&c=119541&eventID=2469191. Or, interested parties can dial in domestically at 888-396-2384 or internationally at 617-847-8711. For both dial-in numbers, the participant pass code is 45834648. Investors can also access the webcast portion of the conference call through the “Investors” section of ICTG’s website at www.ictgroup.com

Non-GAAP Financial Measure

Adjusted earnings per diluted share is an important indicator of performance as this non-GAAP financial measure assists readers in further understanding the Company’s results of operations and trends from period-to-period exclusive of certain acquisition-related items. Adjusted earnings per diluted share, however, is a supplemental measure of performance that is not required by, or presented in accordance with, U.S. Generally Accepted Accounting Principles (GAAP).

About ICT Group, Inc.

ICT GROUP, headquartered in Newtown, Pa., is a leading global provider of customer management and business process outsourcing solutions. The Company provides a comprehensive mix of customer care/retention, up-selling/cross-selling, technical support and database marketing as well as e-mail management, data entry, collections, claims processing and document management services, using its global network of onshore, near-shore and offshore operations. ICT GROUP also provides interactive voice response (IVR) and advanced speech recognition solutions as well as hosted Customer Relationship Management (CRM) technologies, available for use by clients at their own in-house facility or on a co-sourced basis in conjunction with the Company’s fully integrated contact center operations. To learn more about ICT GROUP, visit the Company’s website: www.ictgroup.com

About Sykes Enterprises, Incorporated

SYKES is a global leader in providing customer contact management solutions and services in the business process outsourcing (BPO) arena. SYKES provides an array of sophisticated customer contact management solutions to Fortune 1000 companies around the world, primarily in the communications, financial services, healthcare, technology and transportation and leisure industries. SYKES specializes in providing flexible, high quality customer support outsourcing solutions with an emphasis on inbound technical support and customer service. Headquartered in Tampa, Florida, with customer contact management centers throughout the world, SYKES provides its services through multiple communication channels encompassing phone, e-mail, web and chat. Utilizing its integrated onshore/offshore global delivery model, SYKES serves its clients through two geographic operating segments: the Americas (United States, Canada, Latin America, India and the Asia Pacific Rim) and EMEA (Europe, Middle East and Africa). SYKES also provides various enterprise support services in the Americas and fulfillment services in EMEA, which include multi-lingual sales order processing, payment processing, inventory control, product delivery and product returns handling. For additional information please visit www.sykes.com.

Forward-Looking Statements

This press release may contain “forward-looking statements,” including SYKES’ estimates of future business outlook, prospects or financial results, statements regarding SYKES’ objectives, expectations, intentions, beliefs or strategies, or statements containing words such as “believe,” “estimate,” “project,” “expect,” “intend,” “may,” “anticipate,” “plans,” “seeks,” or similar expressions. It is important to note that SYKES’ actual results could differ materially from those in such forward-looking statements, and undue reliance should not be placed on such statements. Among the important factors that could cause such actual results to differ materially are (i) the impact of economic recessions in the U.S. and other parts of the world, (ii) fluctuations in global business conditions and the global economy, (iii) SYKES’ ability to continue the growth of its support service revenues through additional technical and customer contact centers, (iv) currency fluctuations, (v) the timing of significant orders for SYKES’ products and services, (vi) loss or addition of significant clients, (vii) the early termination of contracts by clients, (viii) SYKES’ ability to recognize deferred revenue through delivery of products or satisfactory performance of services, (ix) construction delays of new or expansion of existing customer support centers, (x) difficulties or delays in implementing SYKES’ bundled service offerings, (xi) failure to achieve sales, marketing and other objectives, (xii) variations in the terms and the elements of services offered under SYKES’ standardized contract including those for future bundled service offerings, (xiii) changes in applicable accounting principles or interpretations of such principles, (xiv) delays in the Company’s ability to develop new products and services and market acceptance of new products and services, (xv) rapid technological change, (xvi) political and country-specific risks inherent in conducting business abroad, (xvii) SYKES’ ability to attract and retain key management personnel, (xviii) SYKES’ ability to further penetrate into vertically integrated markets, (xix) SYKES’ ability to expand its global presence through strategic alliances and selective acquisitions, (xx) SYKES’ ability to continue to establish a competitive advantage through sophisticated technological capabilities, (xxi) the ultimate outcome of any lawsuits or penalties (regulatory or otherwise), (xxii) SYKES’ dependence on trends toward outsourcing, (xxiii) risk of interruption of technical and customer contact management center operations due to such factors as fire, earthquakes, inclement weather and other disasters, power failures, telecommunications failures, unauthorized intrusions, computer viruses and other emergencies, (xxiv) the existence of substantial competition, (xxv) the ability to obtain and maintain grants and other incentives, including tax holidays or otherwise, (xxvi) regulatory proceedings that affect the ability to complete the ICTG acquisition as contemplated, (xxvii) the potential of cost savings/synergies associated with the acquisition not being realized, or will not be realized within the anticipated time period, (xxviii) the potential loss of key clients related to the acquisition, (xxix) risks related to the integration of the acquisition, (xxx) the possibility that the acquisition does not close, including but not limited to, due to the failure to satisfy the closing conditions, and (xxxi) other risk factors listed from time to time in SYKES’ registration statements and reports as filed with the Securities and Exchange Commission. All forward-looking statements included in this press release are made as of the date hereof, and SYKES undertakes no obligation to update any such forward-looking statements, whether as a result of new information, future events, or otherwise.

Additional Information

In connection with the proposed merger, SYKES will file with the SEC a Registration Statement on Form S-4 that will include a proxy statement of ICTG that also constitutes a prospectus of SYKES. ICTG will mail the proxy statement/prospectus to its shareholders. SYKES and ICTG urge investors and security holders to read the proxy statement/prospectus regarding the proposed merger when it becomes available because it will contain important information. You may obtain copies of all documents filed with the Securities and Exchange Commission regarding this transaction, free of charge, at the SEC’s website (www.sec.gov). You may also obtain these documents free from Sykes at http://investor.sykes.com/phoenix.zhtml?c=119541&p=irol-sec, or by contacting SYKES’ Investor Relations Department at 1-813-233-7143, or by contacting MBS Value Partners at 1-212-750-5800. You may also obtain these documents, free of charge from ICTG at www.ictgroup.com.

SYKES, ICTG and their respective directors, executive officers and certain other members of management and employees may be soliciting proxies from ICTG shareholders in favor of the merger. Information regarding the persons who may, under the rules of the SEC, be deemed participants in the solicitation of the ICTG shareholders in connection with the proposed merger will be set forth in the proxy statement/prospectus when it is filed with the SEC. You can find information about SYKES’ executive officers and directors in the proxy statement for SYKES’s 2009 annual meeting of shareholders, filed with the SEC on April 15, 2009. You can find information about ICTG’s executive officers and directors in the proxy statement for ICTG’s 2009 annual meeting of shareholders, filed with the SEC on April 29, 2009. Free copies of these documents may be obtained from SYKES and ICTG as described above.

Tuesday, October 6th, 2009 Uncategorized Comments Off on Sykes Enterprises, Inc. (SYKE) and ICT Group, Inc. (ICTG) Sign Definitive Merger Agreement

FONAR Corp. (FONR) Reports Fiscal 2009 Year-End Financial Results

MELVILLE, NY — (Marketwire) — 10/05/09 — FONAR Corporation (NASDAQ: FONR), The Inventor of MR Scanning(TM), today announced its financial results for the fiscal year ending June 30, 2009. Total net income for the fiscal year ended June 30, 2009 was $1.1 million, as compared to a net loss of $13.5 million for fiscal 2008. The net income per share (basic and diluted) for the fiscal year ended June 30, 2009 was $0.21, as compared to a net loss per share (basic and diluted) of $2.76 during fiscal 2008.

Raymond V. Damadian, Chairman and President of Fonar Corporation, said, “We are very pleased to see the Company return to profitability. We have now made a profit for three quarters straight and are hopeful to continue this trend of profitability. A very sound reason is that the FONAR UPRIGHT® Multi-Position(TM) MRI technology (Dynamic MRI) is the only participant in this unique market. The impact of FONAR’s patented technology on net income growth can be seen in Fig. 1.”

Total revenues increased by 12% to $39.7 million for the fiscal year ended June 30, 2009 as compared to $35.6 million for fiscal 2008.

Total costs and expenses related to operations decreased 23%, from $52.5 million in the fiscal year ended June 30, 2008, to $40.4 million in the fiscal year ended June 30, 2009. The loss from operations decreased 96% from a loss of $16.9 million in the fiscal year ended June 30, 2008, to a loss of $0.7 million in the fiscal year ended June 30, 2009. Dr. Damadian continued, “The Company has done well controlling costs while continuing to produce the FONAR UPRIGHT® Multi-Position(TM) MRI scanner. This is the result of a cost cutting program that we initiated over a year ago.”

Revenues from product sales of the FONAR UPRIGHT® Multi-Position(TM) MRI scanners increased 48% from $11.2 million in the fiscal year ended June 30, 2008 to $16.6 million one year later at fiscal 2009. At June 30, 2009 there were 137 FONAR UPRIGHT® Multi-Position(TM) MRI scanners installed in the United States and around the world. Included in net income for the year ended June 30, 2009 is a pre-tax gain on the sale of a subsidiary of $1.4 million.

At June 30, 2009, total assets were $28.4 million, total current assets were $18.3 million, total current liabilities were $29.1 million, and total long-term liabilities were $2.1 million. The backlog for MRI product was $25.7 million. Total cash and marketable securities were $1.2 million.

Dr. Damadian said, “FONAR’s prospects have much improved since the country’s financial difficulties last year and our customers’ uncertainties regarding the Deficit Reduction Act (DRA) have eased. Over the past few years, the medical evidence continues to grow indicating that the FONAR UPRIGHT® Multi-Position(TM) MRI is the best MRI for diagnosing spine problems. So as pent-up demand for MRI scanners surfaces, we can expect rising sales.”

“Unfortunately, the outcomes of spinal surgery are less than optimal, a fact underscored by the recent book titled ‘The Failed Spine,’ published by Lippincott, Williams & Wilkins, (M. Szpalski and R. Gunzburg, Editors, 2005). The high failure rate has resulted in the acronym, FBSS, which stands for Failed Back Surgery Syndrome. The authors report that the ‘major identifiable causes of FBSS’ include ‘failure to identify the structural source(s) of pain correctly,'” stated Dr. Damadian.

“Sadly, the distinguished Swedish spine surgeon, Alf Nachemson, MD, characterizes these unsatisfactory patient outcomes as the ‘high number of multiply operated surgical cripples,’ (Nachemson, A., The lumbar spine: An orthopaedic challenge. Spine, 1976:1, 59-71.).

“Since the FONAR UPRIGHT® Multi-Position(TM) MRI can place the patient in the exact position that generates his or her symptoms, the MRI picture can be taken in that position. This unique capability assures that the degenerative spinal change responsible for the patient’s pain is correctly identified and operated on, instead of surgery being performed on another spinal change that is not responsible for the patient’s symptoms. Unfortunately, surgery on the wrong spinal segment can generate additional symptoms post-operatively, while the patient continues to suffer with the symptoms not addressed by surgery on the wrong segment,” remarked Dr. Damadian.

“FONAR’s position in medical imaging is immeasurably enhanced by the fact that FONAR is the leader in UPRIGHT® Multi-Position(TM) MRI technology,” concluded Dr. Damadian.

RECENT HIGHLIGHTS AND ACCOMPLISHMENTS

On November 17, 2008, The Company held its annual shareholder meeting for the combined fiscal years ending June 30, 2009 and 2008. All proposals before the shareholders passed.

In February 2009, Dr. Damadian was the recipient of the 2009 AIMBE Honorary Fellow Award (American Institute for Medical and Biological Engineering) for his discovery of MRI. Dr. Damadian is the originator of the concept of magnetic resonance (MR) scanning of the human body (1969). The AIMBE Award was presented at the annual meeting of AIMBE, held February 11-13 in Washington, D.C.

The award says: “In 1970, Raymond Damadian, M.D., made the discovery that is the basis for magnetic resonance (MR) scanning that there is a marked difference in relaxation times between normal and abnormal tissues of the same type, as well as between different types of normal tissues. This seminal discovery, which remains the basis for the making of every MRI image ever produced, is the foundation of the MRI industry. Dr. Damadian published his discovery in his milestone 1971 paper in the journal Science (Science 171:1151, 1971) and filed the pioneer patent for the practical use of his discovery in 1972.” (www.fonar.com/news/022409.htm).

During the past fiscal year, FONAR also expanded its global reach with a sale in Libya, marking the first sale of an UPRIGHT® MRI in Africa and additional sales in the Middle East.

On February 18, 2009 the Company made an earnings announcement titled: FONAR Reports Profit and 2nd Quarter Fiscal 2009 Financial Results; FONAR’s Innovative ‘Made In America’ UPRIGHT MRI Adds Product Revenues. Within the release, Dr. Damadian said, “In this era of jobs being exported to other countries, 82% of the components that create The FONAR UPRIGHT® Multi-Position(TM) MRI are purchased from 26 American States. So FONAR can truly say, ‘Made in America.'”

This past June, Dr. Damadian attended grand openings for three UPRIGHT® Multi-Position(TM) MRI customers who spanned the world. First he attended a grand opening in Kamloops, Canada, for the installation of the first UPRIGHT® Multi-Position(TM) MRI in Canada. Then he participated in a grand opening in South Dakota. Finally, Dr. Damadian attended a grand opening in Munich, Germany. All of these ceremonies featured Dr. Damadian as the inventor of the MRI.

For investor and other information visit: www.fonar.com.

UPRIGHT® and STAND-UP® are registered trademarks and The Inventor of MR Scanning(TM), Full Range of Motion(TM), pMRI(TM), Dynamic(TM), Multi-Position(TM), True Flow(TM), The Proof is in the Picture(TM), Spondylography(TM) Spondylometry(TM) and Upright Radiology(TM) are trademarks of FONAR Corporation.

This release may include forward-looking statements from the company that may or may not materialize. Additional information on factors that could potentially affect the company’s financial results may be found in the company’s filings with the Securities and Exchange Commission.

                 FONAR CORPORATION AND SUBSIDIARIES
                    CONSOLIDATED BALANCE SHEETS

                             ASSETS
                                                          June 30,
                                                  ------------------------
                                                      2009         2008
                                                  -----------  -----------
Current Assets:
  Cash and cash equivalents                       $ 1,225,619  $ 1,325,512
  Marketable securities                                22,652    1,068,168
  Accounts receivable - net of allowances for
   doubtful accounts of $2,393,326 and $2,020,208
   at June 30, 2009 and 2008, respectively          5,391,822    5,157,594
  Medical receivables - net of allowances for
   doubtful accounts of $1,343,500 and $769,000
   at June 30, 2009 and 2008, respectively            374,225    1,227,858
  Management fee receivable - net of allowances for
   doubtful accounts of $5,093,345 and $3,958,733
   at June 30, 2009 and 2008, respectively          3,273,756    5,040,523
  Management fee receivable - related medical
   practices - net of allowances for doubtful
   accounts of $1,094,818 and $2,413,483 at
   June 30, 2009 and 2008, respectively             2,196,580    1,372,261
  Costs and estimated earnings in excess of
   billings on uncompleted contracts                1,475,706        6,285
  Inventories                                       3,172,397    3,255,915
  Current portion of advances and notes to related
   medical practices                                  164,611      155,423
  Current portion of note receivable                  517,934    2,508,306
  Prepaid expenses and other current assets           472,397      869,353
                                                  -----------  -----------
      Total Current Assets                         18,287,699   21,987,198

Property and Equipment - Net                        2,892,380    3,932,533

Advances and Notes to Related Medical Practices -
 net of allowances for doubtful accounts of
 $264,791 at June 30, 2009 and at June 30, 2008        89,032      263,363

Notes Receivable - net of allowance for doubtful
 accounts of $65,000 at June 30, 2009 and at
 June 30, 2008                                      1,778,626    2,296,560

Other Intangible Assets - Net                       4,920,241    4,809,564

Other Assets                                          391,237    1,936,415
                                                  -----------  -----------
      Total Assets                                $28,359,215  $35,225,633
                                                  ===========  ===========

                 FONAR CORPORATION AND SUBSIDIARIES
                    CONSOLIDATED BALANCE SHEETS

                            LIABILITIES
                                                           June 30,
                                                   -----------------------
                                                       2009        2008
                                                   ----------  -----------
Current Liabilities:
  Current portion of long-term debt and capital
   Leases                                          $  277,494  $   372,722
  Current portion of long-term debt - related
   party                                               79,509            -
  Accounts payable                                  3,518,609    4,019,993
  Other current liabilities                         8,460,042    8,316,263
  Unearned revenue on service contracts             5,526,006    5,193,645
  Customer advances                                 9,237,921   14,276,311
  Billings in excess of costs and estimated
   earnings on uncompleted contracts                2,026,441    5,773,286
                                                  -----------  -----------
      Total Current Liabilities                    29,126,022   37,952,220
                                                  -----------  -----------
Long-Term Liabilities:
  Accounts payable                                    184,168            -
  Due to related medical practices                    643,135       97,663
  Long-term debt and capital leases, less
   current portion                                    759,211      756,976
  Long-term debt, less current
   portion - related party                            160,176            -
  Other liabilities                                   363,550      496,837
                                                  -----------  -----------
      Total Long-Term Liabilities                   2,110,240    1,351,476
                                                  -----------  -----------
      Total Liabilities                            31,236,262   39,303,696
                                                  -----------  -----------
Commitments, Contingencies and Other Matters

                 FONAR CORPORATION AND SUBSIDIARIES
                    CONSOLIDATED BALANCE SHEETS

                     STOCKHOLDERS' DEFICIENCY
                                                         June 30,
                                                 -------------------------
                                                     2009          2008
                                                 -----------   -----------
Minority Interest                                $    63,815   $   166,966

Stockholders' Deficiency:
  Class A non-voting preferred stock - $.0001
   par value; authorized - 1,600,000 shares;
   issued and outstanding - 313,451 shares
   at June 30, 2009 and 2008                              31            31
  Preferred stock - $.001 par value;
   authorized - 2,000,000 shares; issued
   and outstanding - none                                  -             -
  Common stock - $.0001 par value; authorized -
   30,000,000 shares at
   June 30, 2009 and 2008, respectively;
   issued - 4,917,918 and 4,915,918 shares
   at June 30, 2009 and 2008, respectively;
   outstanding - 4,906,275 and 4,904,275
   shares at June 30, 2009 and 2008, respectively        491           490
  Class B common stock (10 votes per share) -
   $.0001 par value; authorized - 800,000
   shares; issued and outstanding - 158
   shares at June 30, 2009 and 2008                        -             -
  Class C common stock (25 votes per share) -
   $.0001 par value; authorized - 2,000,000
   shares; issued and outstanding - 382,513
   shares at June 30, 2009 and 2008
  Paid-in capital in excess of par value
  Accumulated other comprehensive loss                    38            38
  Accumulated deficit                            172,280,600   172,276,540
  Notes receivable from employee stockholders        (20,995)      (72,723)
  Treasury stock, at cost - 11,643 shares       (174,258,607) (175,379,874)
   of common stock at June 30, 2009 and 2008        (267,030)     (394,141)

      Total Stockholders' Deficiency                (675,390)     (675,390)
                                                ------------  ------------
      Total Liabilities and Stockholders'
       Deficiency                                 (2,940,862)   (4,245,029)
                                                ------------  ------------

                                                $ 28,359,215  $ 35,225,633
                                                ============  ============

                 FONAR CORPORATION AND SUBSIDIARIES
               CONSOLIDATED STATEMENTS OF OPERATIONS

                                              For the Years Ended June 30,
                                              ----------------------------
                                                  2009            2008
Revenues                                      -------------  -------------
  Product sales - net                         $  17,175,417  $  11,326,388
  Service and repair fees - net                  10,345,091     10,930,331
  Service and repair fees - related
   parties - net                                    192,500        110,000
  Management and other fees                       7,342,614      8,337,000
  Management and other fees - related
   medical practices - net                        2,911,318      3,706,636
  License fees and royalties                      1,755,493      1,158,478
                                               ------------   ------------
      Total Revenues - Net                       39,722,433     35,568,833
                                               ------------   ------------
Costs and Expenses
  Costs related to product sales                 10,758,201     11,143,826
  Costs related to service and repair fees        3,992,557      5,107,802
  Costs related to service and repair fees
    - related parties                                74,293         51,404
  Costs related to management and other fees      4,507,587      5,548,605
  Costs related to management and other fees
    - related medical practices                   2,790,745      3,041,828
  Research and development                        3,593,470      5,006,591
  Selling, general and administrative, inclusive
   of compensatory element of stock issuances of
   $4,061 and $360 for the years ended June 30,
   2009 and 2008, respectively                   13,423,066     20,386,748
  Provision for bad debts                         1,286,451      2,208,820
                                              -------------  -------------
      Total Costs and Expenses                   40,426,370     52,495,624
                                              -------------  -------------
      Loss from Operations                         (703,937)   (16,926,791)
Other Income and (Expenses):
  Interest expense                                 (333,229)      (535,322)
  Investment income                                 325,688        694,910
  Interest income - related parties                  20,818         33,801
  Other income - net                                410,657        129,368
  Minority interests in income of partnerships      (10,995)      (219,058)
  Gain on sale of investment                              -        571,161
  Gain on sale of consolidated subsidiary         1,448,196      3,394,975
  Loss on note receivable                                 -       (658,351)
                                              -------------  -------------
      Income (Loss) Before Provision For
       (Benefit From) Income Taxes                1,157,198    (13,515,307)

Provision for (Benefit from) Income Taxes            35,931         (6,940)
                                               ------------  -------------
       Net Income (Loss)                       $  1,121,267  $ (13,508,367)
                                               ============  =============

                 FONAR CORPORATION AND SUBSIDIARIES
               CONSOLIDATED STATEMENTS OF OPERATIONS

                                              For the Years Ended June 30,
                                              ----------------------------
                                                   2009          2008
                                              -------------  -------------
Net Income (Loss) Available to Common and
 Class C Common Stockholders                  $   1,053,898  $ (13,508,367)
                                              =============  =============
Basic and Diluted Net Income (Loss) Per Common
 Share Available to Common Stockholders       $        0.21  $       (2.76)
                                              =============  =============
Basic Net Income Per Share - Common C         $        0.06            N/A
                                              =============  =============
Tuesday, October 6th, 2009 Uncategorized Comments Off on FONAR Corp. (FONR) Reports Fiscal 2009 Year-End Financial Results

Oncolytics Biotech(R) Inc. (ONCY) Reaches Special Protocol Assessment Agreement with the FDA on Design of Phase 3 Trial for REOLYSIN(R) in Head and Neck Cancers

CALGARY, Oct. 2 /PRNewswire-FirstCall/ – Oncolytics Biotech Inc. (“Oncolytics”) (TSX:ONC, NASDAQ:ONCY) today announced that it has reached an agreement with the U.S. Food and Drug Administration (FDA) under the Special Protocol Assessment (SPA) process for the design of a Phase 3 trial examining REOLYSIN in combination with paclitaxel and carboplatin in patients with platinum-refractory head and neck cancers. The SPA is an agreement between Oncolytics and the FDA that the design and planned analyses of the Phase 3 study is adequately designed to provide the necessary data, that depending upon outcome, could support a license application submission for REOLYSIN.

“Oncolytics is the first company to reach an agreement with the FDA on a Phase 3 trial design for an intravenously-administered oncolytic virus under the SPA process,” said Dr. Brad Thompson, President and CEO of Oncolytics. “This is an exciting step forward for our clinical program for REOLYSIN, which has become a first-in-class agent. A Phase 3 trial in patients with platinum-refractory head and neck cancers is a logical choice for our first pivotal trial with REOLYSIN. In Phase 1/2 trials, the treatment combination has increased the response rate by several-fold compared to historical outcomes.”

As specified in the SPA, the randomized, two-arm, double-blind, multicentre, two-stage, adaptive Phase 3 trial will assess the intravenous administration of REOLYSIN with the chemotherapy combination of paclitaxel and carboplatin versus the chemotherapy alone in patients with metastatic or recurrent squamous cell carcinoma of the head and neck, or squamous cell cancer of the nasopharynx, who have progressed on or after prior platinum-based chemotherapy. All patients will receive treatment every three weeks (21 day cycles) with paclitaxel and carboplatin and will also receive, on a blinded basis, either intravenous placebo or intravenous REOLYSIN. All dosing takes place in the first five days of each cycle with all patients receiving standard intravenous doses of paclitaxel and carboplatin on day one only, and on days one through five, either intravenous placebo or intravenous REOLYSIN at a dose of 3×10(10) TCID(50). Patients may continue to receive the trial combination therapy for up to eight, 21-day cycles and, thereafter, blinded placebo or blinded REOLYSIN until the patient has progressive disease or meets other criteria for removal from the trial.

The primary endpoint for the trial is overall survival (OS); secondary endpoints include progression free survival (PFS), objective response rate (complete response (CR) + partial response (PR)) and duration of response, and safety and tolerability of REOLYSIN when administered in combination with paclitaxel and carboplatin. The first stage of the trial is non-adaptive, and is designed to enroll 80 patients. The second stage is adaptive, and is designed to enroll between 100 and 400 patients with the most probable statistical enrolment being 195 patients in this stage. This adaptive trial design allows frequent data evaluation to determine if the probability of reaching a statistically significant endpoint has been achieved.

The decision to pursue a Phase 3 trial in head and neck cancers was predicated on positive results seen in the Company’s U.K. Phase 1 and Phase 2 combination REOLYSIN and paclitaxel/carboplatin clinical trials, as well as significant preclinical work demonstrating synergy in combination with taxane or platinum-based drugs. Interim results of the U.K. Phase 1/2 trial reported in March 2009 demonstrated an overall response rate (PR and CR) of 42% and a total clinical benefit rate (PR + CR + stable disease) of 75%. Enrolment in the Phase 2 portion of the trial was concluded in July 2009, and updated results are expected to be presented in the fourth quarter of 2009.

Conference Call Details

Dr. Brad Thompson, President and CEO of Oncolytics, will host a conference call and webcast today, October 2, 2009 at 6:30 a.m. MT (8:30 a.m. ET) to update investors on the Phase 3 program for REOLYSIN. To access the conference call by telephone, dial 1-416-644-3426 or 1-800-732-1073. A live audio webcast will also be available at the following link: http://www.newswire.ca/en/webcast/viewEvent.cgi?eventID=2828320 or through the Company’s website at www.oncolyticsbiotech.com. Please connect at least 15 minutes prior to the webcast to ensure adequate time for any software download that may be needed. A replay of the webcast will be available at www.oncolyticsbiotech.com and will also be available by telephone through October 9, 2009. To access the telephone replay, dial 1-416-640-1917 or 1-877-289-8525 and enter reservation number 4169017 followed by the number sign.

About the Special Protocol Assessment Process

Upon the request of a study sponsor, the FDA will evaluate certain protocols and issues relating to the protocols to assess whether they are adequate to meet scientific and regulatory requirements; this includes clinical protocols for Phase 3 trials whose data will form the primary basis for an efficacy claim that will be part of an original Biologics License Application. For more information about the SPA process, please go to:

http://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/ucm080571.pdf

About REOLYSIN

REOLYSIN is a proprietary formulation of the human reovirus that acts primarily as a direct cytotoxic agent. Reovirus is naturally occurring (not genetically engineered) and has been demonstrated to replicate specifically in tumour cells bearing an activated Ras pathway, leaving healthy normal cells intact. At least two thirds of carcinomas and more than 90% of metastatic disease has Ras involvement.

About Oncolytics Biotech Inc.

Oncolytics is a Calgary-based biotechnology company focused on the development of oncolytic viruses as potential cancer therapeutics. Oncolytics’ clinical program includes a variety of human trials including a Phase III trial in head and neck cancers using REOLYSIN, its proprietary formulation of the human reovirus. For further information about Oncolytics, please visit: www.oncolyticsbiotech.com.

This press release contains forward-looking statements, within the meaning of Section 21E of the Securities Exchange Act of 1934, as amended. Forward-looking statements, including the Company’s expectations related to the SPA agreement on a Phase 3 combination REOLYSIN and paclitaxel/carboplatin trial for patients with platinum-refractory head and neck cancers, the planned timing and implementation of the Phase 3 trial, and the Company’s belief as to the potential of REOLYSIN as a cancer therapeutic, involve known and unknown risks and uncertainties, which could cause the Company’s actual results to differ materially from those in the forward-looking statements. Such risks and uncertainties include, among others, the availability of funds and resources to pursue research and development projects, the efficacy of REOLYSIN as a cancer treatment, the tolerability of REOLYSIN outside a controlled test, the success and timely completion of clinical studies and trials, the Company’s ability to successfully commercialize REOLYSIN, uncertainties related to the research and development of pharmaceuticals and uncertainties related to the regulatory process. Investors should consult the Company’s quarterly and annual filings with the Canadian and U.S. securities commissions for additional information on risks and uncertainties relating to the forward looking statements. Investors are cautioned against placing undue reliance on forward-looking statements. The Company does not undertake to update these forward-looking statements, except as required by applicable laws.

Friday, October 2nd, 2009 Uncategorized Comments Off on Oncolytics Biotech(R) Inc. (ONCY) Reaches Special Protocol Assessment Agreement with the FDA on Design of Phase 3 Trial for REOLYSIN(R) in Head and Neck Cancers

Arigene Co., Ltd. to Acquire Trimeris, Inc. (TRMS)

Oct. 2, 2009 (Business Wire) — Trimeris, Inc. (“Trimeris”) (NASDAQ:TRMS) today announced that it has entered into a merger agreement with Arigene Co., Ltd., a Korean corporation traded on the Korean Securities Dealers Association Quotation System (“Arigene”) (KOSDAQ: 067850) pursuant to which Arigene has agreed to acquire Trimeris for approximately $81 million through a cash tender offer of $3.60 per share, followed by a merger to acquire all remaining outstanding Trimeris shares at the same price per share paid in the tender offer. The tender offer price represents an approximately 55% premium to Trimeris’ average stock price over the last three month period ending on October 1, 2009 and an approximately 40% premium to the closing price of Trimeris’ common stock on October 1, 2009.

Stockholders of Trimeris representing approximately 36% of shares outstanding have executed voting agreements in support of the transaction. The transaction has been approved by the boards of directors of Trimeris and Arigene. The parties expect the tender offer and merger to be completed in the fourth quarter of 2009.

The tender offer will expire at midnight Eastern Time on the 20th business day following and including the tender offer commencement date, unless extended in accordance with the terms of the merger agreement and the applicable rules and regulations of the U.S. Securities and Exchange Commission. Following the tender offer, if successful, RTM Acquisition Company, a wholly owned subsidiary of Arigene, will be merged with and into Trimeris, with Trimeris continuing as the surviving corporation. As a result of the merger, Trimeris will become a wholly-owned subsidiary of Arigene.

The consummation of the tender offer is subject to the satisfaction or waiver of certain conditions, including, among others: (i) a majority of outstanding Trimeris shares having been tendered in response to the offer, (ii) the absence of any injunction or act by any governmental agency prohibiting the transaction, (iii) there not having been a material adverse change with respect to Trimeris, and (iv) other customary conditions. The tender offer is not subject to a financing condition.

Advisors

Wilmer Cutler Pickering Hale and Dorr LLP is acting as legal advisor to Trimeris for this transaction. HCube Advisors, Inc. acted as financial advisor and K&L Gates, LLP is acting as legal advisor to Arigene.

About Trimeris, Inc.

Trimeris, Inc. (Nasdaq: TRMS) is a biopharmaceutical company engaged in the commercialization of therapeutic agents for the treatment of viral disease. The core technology platform of fusion inhibition is based on blocking viral entry into host cells. FUZEON®, approved in the U.S., Canada and European Union, is the first in a new class of anti-HIV drugs called fusion inhibitors. For more information about Trimeris, please visit the Company’s website at http://www.trimeris.com.

About Arigene Co., Ltd.

Arigene Co., Ltd. (KOSDAQ: 067850) is a developer, manufacturer and marketer of Ubiquitous Healthcare Systems (U-Healthcare) and related medical equipment in Korea. With its planned acquisition of Trimeris, Inc., Arigene is expanding its business to the broader biotechnology industry.

Cautionary Note regarding Forward Looking Statements

This document and any attachments may contain forward-looking information about the proposed transaction between Trimeris and Arigene, the expected timetable for completing the transaction, future financial and operating results, benefits and synergies of the transaction, future opportunities for the combined company, new product development, including obtaining regulatory approvals, and any other statements about Trimeris’ managements’ future expectations, beliefs, goals, plans or prospects constitute forward looking statements. Any statements that are not statements of historical fact (including statements containing the words “believes,” “plans,” “anticipates,” “expects,” “estimates” and similar expressions) should also be considered to be forward looking statements. These forward looking statements involve known and unknown risks and uncertainties that may cause Trimeris’ actual results, levels of activity, performance or achievements to be materially different from those expressed or implied by these forward looking statements. Important factors that may cause or contribute to such differences include uncertainties as to the timing of the tender offer and merger; uncertainties as to how many of Trimeris’ stockholders will tender their stock in the offer; the risk that competing offers will be made; the possibility that various closing conditions for the transaction may not be satisfied or waived; the effects of disruption from the transaction making it more difficult to maintain relationships with employees, licensees, other business partners or governmental entities; transaction costs; whether results obtained in clinical studies or in preclinical studies will be indicative of results obtained in future clinical trials; whether Trimeris will be able to obtain regulatory approvals and such other factors as are set forth in the risk factors detailed from time to time in Trimeris’ periodic reports and registration statements filed with the Securities and Exchange Commission including, without limitation, the risk factors detailed in Trimeris’ Form 10-K filed with the Securities and Exchange Commission on March 13, 2009, which are incorporated herein by reference. The forward looking statements are made only as of the date of publication. Except as otherwise required by law, the Company specifically disclaims any obligation to update any of these forward looking statements.

Additional Information

This press release is neither an offer to purchase nor a solicitation of an offer to sell shares of Trimeris. Arigene and RTM Acquisition Company, a wholly owned subsidiary of Arigene, have not commenced the tender offer for the shares of Trimeris stock described in this press release. Upon commencement of the tender offer, Arigene and RTM Acquisition Company 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, Trimeris will file with the SEC a tender offer solicitation/recommendation statement on Schedule 14D-9. These documents will contain important information about Arigene, Trimeris, the transaction and other related matters. Investors and security holders are urged to read each of these documents carefully when they are available. These materials will be sent free of charge to all stockholders of Trimeris. Investors and security holders will also 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 Arigene and Trimeris through the web site maintained by the SEC at www.sec.gov.

Friday, October 2nd, 2009 Uncategorized 2 Comments

Additional Analysis Confirms Significant Symptomatic Benefit of Droxidopa in Treatment of Neurogenic Orthostatic Hypotension

CHARLOTTE, N.C., Oct. 1, 2009 (GLOBE NEWSWIRE) — Chelsea Therapeutics International, Ltd. (Nasdaq:CHTP) announced that continued analysis of previously reported results from Study 302, the first of two pivotal Phase III trials in Chelsea’s registration program of Droxidopa for the treatment of symptomatic, neurogenic orthostatic hypotension (NOH), confirm statistically significant benefits across five clinically relevant assessment criteria that reflect symptomatic improvements and corroborate other supportive symptom data. The collective dataset also supports the exceptional safety and tolerability of Droxidopa.

“We are encouraged by the breadth and depth of findings from Study 302 that demonstrate a symptomatic benefit and provide validation of the safety and tolerability of Droxidopa for the treatment of neurogenic orthostatic hypotension — a serious condition with an urgent need for improved treatments,” said Dr. Simon Pedder, president and CEO of Chelsea Therapeutics. “In looking ahead, we believe these results will be evident in the results of Study 301 expected this quarter. Further, we believe the outcome of Study 301 may be enhanced by the washout period included in that study. This belief is supported by open-label data from Study 301 that demonstrate a marked return of symptoms prior to randomization. The increase in average dizziness score from 1.0 following dose titration to 5.4 after a 7-day washout period in Study 301 suggests a reduction in the carry-over effect that appeared to follow sustained drug treatment prior to randomized withdrawal in Study 302.”

Statistically Significant Symptomatic Benefit on Multiple Endpoints

Patients randomized into this double-blind, placebo controlled study were evaluated for functional and symptomatic improvement through multiple secondary endpoints including a clinician-recorded and patient-recorded clinical global impressions-severity (CGI-S) scale and the orthostatic hypotension questionnaire (OHQ), a two part questionnaire consisting of the six-item orthostatic hypotension symptom assessment scale (OHSA) and the four-item orthostatic hypotension daily activities scale (OHDAS).

With the exception of vision, Droxidopa demonstrated a marked improvement over placebo for each of the five other symptoms measured by the OHSA (dizziness, weakness, fatigue, concentration, and head/neck pain) with the overall composite OHSA score supporting the benefit of Droxidopa over placebo. Despite indicating an improvement over placebo, Item 1 on the OHSA (dizziness), the primary endpoint in the study, did not achieve statistical significance.

On the OHDAS, a measure of patient function which asks patients to evaluate the average impact of orthostatic hypotension on their daily lives over the prior week period using an 11-point scale, Droxidopa demonstrated a statistically significant improvement in activities that require standing for a short time (p=0.043), standing for a long time (p=0.023) as well as a statistically significant improvement in the composite OHDAS score (p=0.029) which includes evaluation of standing and walking for both short and long times.

Notably, in addition to symptomatic and functional benefits registered on the OHQ, Droxidopa demonstrated statistically significant improvement on both the clinician-recorded (p=0.045) and patient-recorded (p=0.008) CGI-severity scale, a widely accepted scale that asks clinicians and patients to rate the severity of a patient’s symptoms at the time of assessment.

“No other drug treatment has successfully demonstrated a statistically significant symptomatic and/or functional benefit in treating orthostatic hypotension,” commented Dr. Art Hewitt, Vice President of Drug Development at Chelsea Therapeutics. “By achieving statistical significance on five secondary endpoints that reflect both a functional and symptomatic benefit, three of which were specifically developed for this indication, Droxidopa has clearly demonstrated its unique ability to meaningfully treat symptomatic neurogenic orthostatic hypotension. We look forward to discussing these results with the FDA, as we believe that results from Study 302 provide meaningful data supporting Droxidopa’s efficacy and want to ensure we are taking all appropriate and actionable steps to ensure a successful NDA filing.”

Proven Safety and Tolerability

As previously reported, Droxidopa proved to be safe and well tolerated at all dose levels, with no significant adverse events or treatment related withdrawals in the Droxidopa arm.

Of the 101 patients evaluated in Study 302 (50 Droxidopa/51 Placebo), an equal number of patients on Droxidopa and placebo, 13 (26%), experienced at least one instance of supine systolic blood pressure (SBP) >160 mmHg; six (12%) of Droxidopa patients experienced supine SBP >180 mmHg vs. four (8%) on placebo. No patients treated with Droxidopa experienced supine hypertension >200 mmHg compared to one (2%) patient on placebo. These findings, in light of the inherent prevalence of supine hypertension in patients with primary autonomic failure, demonstrate that treatment with Droxidopa does not meaningfully alter the incidence of supine hypertension in the patient group. In the product labeling for Midodrine, the only approved compound for the treatment of orthostatic hypotension, supine hypertension (> 200 mmHg) is reported at 13.4%.

In addition, treatment with Droxidopa demonstrates a dramatic improvement in the incidence of falls associated with orthostatic hypotension. In Study 302, six (12%) patients on placebo reported falling at least once during the 14-day treatment period compared to one (2%) patient in the Droxidopa arm. This marked reduction in falls, while recorded under adverse events for the study, further supports the significant symptomatic benefit experienced by patients treated with Droxidopa.

NOH Impacts Quality of Life, Increases Health Care Costs

Neurogenic orthostatic hypotension is a neurogenic disorder resulting from a deficient release of norepinephrine, the neurotransmitter used by sympathetic autonomic nerves to send signals to the blood vessels and the heart. This deficiency results in decreased blood pressure when a person assumes a standing position and is characterized by lightheadedness, dizziness, blurred vision and syncope.

An estimated 300,000 patients suffer from chronic symptomatic NOH in the U.S. and the EU. Symptoms of chronic NOH can be incapacitating — not only putting patients at high risk for falls and associated injuries — but also severely impacting the quality of life of patients and their loved ones, and generating significant health care costs. The only current FDA-approved treatment for orthostatic hypotension has not been shown to be effective in alleviating the symptoms of the condition and is limited in its use by a pronounced side-effect profile.

About Droxidopa and the Droxidopa Registration Trial in NOH

Currently available in Japan and with 15 years of safety and efficacy data, Droxidopa is the first drug to demonstrate symptomatic improvement of NOH. As an orally active synthetic precursor of norepinephrine, Droxidopa increases the supply of norepinephrine available for delivery to its receptors, effectively targeting the root cause of NOH to improve orthostatic blood pressure and alleviate symptoms of orthostatic hypotension.

The Droxidopa Phase III registration program in NOH includes two double-blind, placebo-controlled studies: Study 301 and Study 302. Study 301was reviewed by the U.S. Food and Drug Administration (FDA) and awarded a Special Protocol Assessment (SPA). An SPA provides a binding agreement that the study design, including trial size, clinical endpoints and/or data analyses is acceptable to support regulatory approval. In addition to the SPA, the FDA has awarded Chelsea Fast Track designation for its pivotal program in NOH. Fast Track designation is designed to facilitate the review of products that address serious or potentially life-threatening conditions for which there is an unmet medical need and provides the option to file a New Drug Application (NDA) on a rolling basis. This permits the FDA to review the filing as it is received, expediting the review process.

About Chelsea Therapeutics

Chelsea Therapeutics is a biopharmaceutical development company that acquires and develops innovative products for the treatment of a variety of human diseases. Chelsea’s most advanced drug candidate, Droxidopa, is an orally active synthetic precursor of norepinephrine initially being developed for the treatment of neurogenic orthostatic hypotension. In addition to Droxidopa, Chelsea is also developing a portfolio of metabolically inert oral antifolate molecules engineered to have potent anti-inflammatory and anti-tumor activity to treat a range of immunological disorders, including two clinical stage product candidates: CH-1504 and CH-4051. Preclinical and clinical data suggest superior safety and tolerability, as well as increased potency versus methotrexate (MTX), currently the leading antifolate treatment and standard of care for a broad range of abnormal cell proliferation diseases including RA.

This press release contains forward-looking statements regarding future events. These 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 our need to raise operating capital, our history of losses, risks and costs of drug development, risk of regulatory approvals, our reliance on our lead drug candidates Droxidopa and CH-1504, reliance on collaborations and licenses, intellectual property risks, competition, market acceptance for our products if any are approved for marketing and reliance on key personnel including specifically Dr. Pedder.

Thursday, October 1st, 2009 Uncategorized Comments Off on Additional Analysis Confirms Significant Symptomatic Benefit of Droxidopa in Treatment of Neurogenic Orthostatic Hypotension

RAM Energy Resources (RAME) Announces Regained Compliance With Nasdaq Listing Rules

TULSA, Okla., Sept. 30, 2009 (GLOBE NEWSWIRE) — RAM Energy Resources, Inc. (Nasdaq:RAME) reported today that the company had received a letter from The Nasdaq Stock Market advising that RAM had regained compliance with Nasdaq’s minimum bid price listing requirements.

Previously, RAM received a notice of deficiency on September 15, 2009 from Nasdaq notifying the company that for the 30 consecutive business days preceding the date of the letter, the bid price of the company’s common stock had closed below the $1.00 per share minimum bid price required for continued listing on The Nasdaq Capital Market, and that RAM had 180 days to regain compliance by meeting or exceeding the minimum bid price for a period of at least 10 consecutive trading days.

The letter received from Nasdaq today states, because the company’s common stock closed above the $1.00 minimum bid price for at least 10 consecutive trading days following September 15, 2009, the company had regained compliance and the matter is now closed. Shares of RAM common stock closed Tuesday at $1.23 per share.

Forward-Looking Statements

This release includes certain statements that may be deemed to be “forward-looking statements” within the meaning of the Private Securities Litigation Reform Act of 1995. All statements in this release, other than statements of historical facts, that address RAM’s interpretation of Nasdaq Marketplace Rule 5801C (3)(A) as well as potential outcomes evolving from the compliance process, are forward-looking statements. Although RAM believes the expectations expressed in such forward-looking statements are based on reasonable assumptions, such statements are not guarantees of future performance and actual results or developments may differ materially from those in the forward-looking statements. Factors that could cause actual results to differ materially from those in forward-looking statements include oil and gas prices, developmental, exploitation and exploration successes, actions taken and to be taken by governments as a result of political and economic conditions or other factors, inflation rates, continued availability of capital and financing, and general economic, market or business conditions as well as other risk factors described from time to time in the company’s filings with the SEC. The company assumes no obligation to update publicly such forward-looking statements, whether as a result of new information, future events or otherwise.

RAM is an independent energy company engaged in the acquisition, development, exploitation and exploration of oil and gas properties and the marketing of natural gas and crude oil. Company headquarters are in Tulsa, Oklahoma, and its common shares are traded on the Nasdaq Exchange under the symbol RAME. For additional information, visit the company website at www.ramenergy.com.

Thursday, October 1st, 2009 Uncategorized 2 Comments
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