Archive for February, 2014

(DRNA) Panel on RNAi Therapeutics At 16th Annual BIO CEO and Investor Conference

Dicerna Pharmaceuticals, Inc. (NASDAQ:DRNA), a leader in the development of RNAi-based therapeutics, today announced its participation in a panel discussion on RNAi therapeutics at the 16th Annual BIO CEO & Investor Conference. Douglas M. Fambrough, PhD, the company’s President and CEO, is scheduled to take part in a Therapeutic Workshop entitled: “Delivering the [RNAi] Goods” to be held on Monday, February 10th, at 10:30 a.m. Eastern Standard Time.

About Dicerna Pharmaceuticals, Inc.

Dicerna is a biopharmaceutical company focused on the discovery and development of innovative treatments for rare inherited diseases involving the liver and for cancers that are genetically defined. Dicerna is using its proprietary RNA interference (RNAi) technology platform to build a broad pipeline in these therapeutic areas and intends to discover, develop and commercialize novel therapeutics either on its own or in collaboration with pharmaceutical partners.

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(MYGN) to Acquire Crescendo Bioscience

Diversifies Myriad’s Product Portfolio Into High Growth Autoimmune Market

SALT LAKE CITY, Feb. 4, 2014  — Myriad Genetics, Inc. (Nasdaq:MYGN) announced today that it has entered into a definitive agreement to acquire Crescendo Bioscience, Inc., a global leader in autoimmune diagnostics, for $270 million in cash which will be reduced by $25 million for the repayment of a loan made to Crescendo and customary adjustments in accordance with the acquisition agreement.

The transaction is expected to close before the end of Myriad’s fiscal year 2014, pending satisfactory completion of customary closing items and regulatory approval. A discussion of the acquisition will be provided during Myriad’s second fiscal quarter earnings call later today at 4:30 pm EST.

“Crescendo Bioscience fits well into our diagnostic portfolio that is focused on saving lives and improving the quality of life of patients across major diseases,” said Peter D. Meldrum, president and CEO of Myriad Genetics. “Crescendo has pioneered protein-based diagnostics for monitoring disease activity in patients with rheumatoid arthritis and this acquisition diversifies our business into a new high growth, multibillion dollar market opportunity. We are pleased to welcome the 130 employees of Crescendo to the Myriad team and look forward to the impact of this innovative and dedicated group on our organization.”

“Crescendo has built a strong and growing position in the rheumatoid arthritis diagnostic market, and I believe Myriad will enable us to move to the next level in terms of scale and growth,” said William Hagstrom, president and CEO of Crescendo Bioscience. “We envision multiple opportunities over the next several years where, as a combined company, we can expand our presence into international markets and provide new innovative products that help improve the lives of patients suffering from autoimmune diseases.”

Crescendo was founded in July 2002 and is a leading molecular diagnostic laboratory in the area of inflammatory and autoimmune diseases. Their core product, Vectra® DA, is a quantitative, protein-based test to routinely assess rheumatoid arthritis disease activity and provide rheumatologists with expanded clinical insights to more effectively treat their patients. In the United States, more than 1.5 million individuals suffer from rheumatoid arthritis (RA) resulting in over $11 billion in healthcare costs. Crescendo is also building a comprehensive understanding of the biology of other autoimmune diseases and has a pipeline of products under development for a wide range of diseases and conditions managed by rheumatologists. Crescendo additionally has created novel software products for physicians, including VectraView which allows a comprehensive overview of all RA patients’ level of disease activity and trends and MyRA® which is a patient tracking and communications tool.

In 2013, Crescendo was ranked the 2nd fastest growing healthcare company in North America on Deloitte’s 2013 Technology Fast 500 list. During the quarter ended December 31, 2013, Crescendo tested 27,000 RA patient samples, an increase of 23 percent over the prior quarter ended September 30, 2013. Crescendo Bioscience, Inc. will retain its name and operate as a wholly owned subsidiary of Myriad Genetics, Inc. based in South San Francisco.

Benefits of the Transaction

  • Facilitates Myriad’s Entry into the High Growth Autoimmune Market: Myriad sees a major growth opportunity for molecular diagnostics to aid patients in the autoimmune market. Beyond rheumatoid arthritis there are several other areas in rheumatology as well as the broader autoimmune market where molecular diagnostics could play a major role in patient risk assessment, diagnosis, prognostic outlook and therapy selection. This complements Myriad’s current disease focus which includes products in oncology, women’s health, urology, and dermatology.
  • Diversifies Myriad’s Product Revenues: A core strategic initiative for Myriad is to continue to diversify its revenue stream into new attractive markets. Vectra DA represents a $3.0 billion global market opportunity, and Myriad believes Crescendo will be a major growth driver for the Company looking forward.
  • Enhances Myriad’s Strength in Protein-Based Diagnostics: Myriad, a world leader in molecular diagnostics, believes that it will further strengthen its leadership position in protein diagnostics with the acquisition of Crescendo. The three major sources of novel biomarkers are DNA, RNA, and proteins and Myriad believes that Crescendo will contribute significantly to Myriad’s industry leading diagnostic product pipeline and complement the protein expertise at Myriad RBM.
  • Creates Opportunities to Leverage Myriad’s Commercial Infrastructure: As one of the largest molecular diagnostic laboratories in the United States, Myriad expects to leverage its operational expertise in customer service, sales and marketing, managed care, and product development to further expand Crescendo’s domestic business. Additionally, Myriad’s expects that its international presence will open up new market opportunities for Crescendo’s products outside of the United States.
  • Offers Long-Term Financial Benefits: Myriad expects Crescendo to generate significant operating profits in the future and to be accretive to earnings beginning in fiscal year 2016. In April 2013, Vectra DA received national coverage for reimbursement by the Centers for Medicare and Medicaid Services (CMS) and is in the process of obtaining private insurance coverage. The typical RA patient may be monitored with a Vectra DA test at least twice per year.

Financing and Approvals

Myriad intends to fund the transaction entirely through cash on hand and anticipates having sufficient cash following the transaction to continue its current $300 million share repurchase program. The transaction is expected to be completed before the end of fiscal year 2014 and is subject to the satisfaction of customary closing conditions and regulatory approvals.

Advisors

JP Morgan Securities LLC is acting as financial advisor to Myriad Genetics and Mintz Levin Cohn Ferris Glovsky and Popeo PC is serving as legal counsel.

Conference Call

The Company will discuss the proposed acquisition during its second fiscal quarter earnings call on Tuesday, February 4, 2014 at 4:30 pm EST. Participating on the call will be Peter Meldrum, president and CEO; William Hagstrom, president of Crescendo Bioscience; Mark Capone, president of Myriad Genetic Laboratories; and James Evans, CFO. The dial-in number for domestic callers is (800) 891-8357. International callers may dial (212) 231-2921. All callers will be asked to enter the reservation number 21703449. An archived replay of the call will be available for seven days by dialing (800) 633-8284 and entering the above reservation number. The conference call also will be available through a live webcast at www.myriad.com.

About Crescendo Biosciences

Crescendo Bioscience, Inc., is a molecular diagnostics company dedicated to developing and commercializing quantitative blood tests for rheumatoid arthritis (RA) and other autoimmune diseases, located in South San Francisco, CA.  Crescendo Bioscience develops quantitative, objective, blood tests to provide rheumatologists with deeper clinical insight to help enable more effective management of patients with autoimmune and inflammatory diseases.  For more information, please visit the company’s website at http://www.CrescendoBio.com.

About Myriad Genetics

Myriad Genetics is a leading molecular diagnostic company dedicated to making a difference in patients’ lives through the discovery and commercialization of transformative tests to assess a person’s risk of developing disease, guide treatment decisions and assess risk of disease progression and recurrence. Myriad’s molecular diagnostic tests are based on an understanding of the role genes play in human disease and were developed with a commitment to improving an individual’s decision making process for monitoring and treating disease. Myriad is focused on strategic directives to introduce new products, including companion diagnostics, as well as expanding internationally. For more information on how Myriad is making a difference, please visit the Company’s website: www.myriad.com. Myriad, the Myriad logo, BART, BRACAnalysis, Colaris, Colaris AP, Melaris, Myriad myPath, Myriad myPlan, Myriad myRisk, TheraGuide, Prezeon, Panexia, and Prolaris are trademarks or registered trademarks of Myriad Genetics, Inc. in the United States and foreign countries. MYGN-F, MYGN-G

Safe Harbor Statement

This press release contains “forward-looking statements” within the meaning of the Private Securities Litigation Reform Act of 1995, including statements relating to the timing of the closing of the proposed acquisition; the fit of Crescendo into the Company’s diagnostic portfolio and diversification of the Company’s business as a result of this acquisition; the expected addition of Crescendo employees to the Myriad team; Crescendo’s position in the rheumatoid arthritis diagnostic market and its ability to move to the next level in terms of scale and growth with the Company’s assistance; Crescendo’s vision of multiple opportunities over the next several years; the anticipated benefits of the acquisition of Crescendo set forth under the caption “Benefits of the Transaction;” the Company’s intent to fund the transaction entirely through cash and marketable securities on hand and the Company’s expectation of having sufficient cash following the transaction to continue its current $300 million share repurchase program; and the Company’s strategic directives under the caption “About Myriad Genetics.” These “forward-looking statements” are management’s present expectations of future events and are subject to a number of risks and uncertainties that could cause actual results to differ materially and adversely from those described in the forward-looking statements. These risks include, but are not limited to: the risk that sales and profit margins of our existing molecular diagnostic tests and companion diagnostic services may decline or will not continue to increase at historical rates; risks related to changes in the governmental or private insurers reimbursement levels for our tests; risks related to increased competition and the development of new competing tests and services; the risk that we may be unable to develop or achieve commercial success for additional molecular diagnostic tests and companion diagnostic services in a timely manner, or at all; the risk that we may not successfully develop new markets for our molecular diagnostic tests and companion diagnostic services, including our ability to successfully generate revenue outside the United States; the risk that licenses to the technology underlying our molecular diagnostic tests and companion diagnostic services tests and any future tests are terminated or cannot be maintained on satisfactory terms; risks related to delays or other problems with operating our laboratory testing facilities; risks related to public concern over our genetic testing in general or our tests in particular; risks related to regulatory requirements or enforcement in the United States and foreign countries and changes in the structure of the healthcare system or healthcare payment systems; risks related to our ability to obtain new corporate collaborations or licenses and acquire new technologies or businesses on satisfactory terms, if at all; risks related to our ability to successfully integrate and derive benefits from any technologies or businesses that we license or acquire; the risk that we or our licensors may be unable to protect or that third parties will infringe the proprietary technologies underlying our tests; the risk of patent-infringement claims or challenges to the validity of our patents or other intellectual property; risks related to changes in intellectual property laws covering our molecular diagnostic tests and companion diagnostic services and patents or enforcement in the United States and foreign countries; risks of new, changing and competitive technologies and regulations in the United States and internationally; and other factors discussed under the heading “Risk Factors” contained in Item 1A of our most recent Annual Report on Form 10-K filed with the Securities and Exchange Commission, as well as any updates to those risk factors filed from time to time in our Quarterly Reports on Form 10-Q or Current Reports on Form 8-K. All information in this press release is as of the date of the release, and Myriad undertakes no duty to update this information unless required by law.

CONTACT: Media Contact:
         Ron Rogers
         (801) 584-3065
         rrogers@myriad.com

         Investor Contact:
         Scott Gleason
         (801) 584-1143
         sgleason@myriad.com
Wednesday, February 5th, 2014 Uncategorized Comments Off on (MYGN) to Acquire Crescendo Bioscience

(PTX) Attracts $65 Million Institutional Investment

Pernix Therapeutics Holdings, Inc. (NASDAQ GM: PTX) (“Pernix” or the “Company”), a specialty pharmaceutical company, today announced that it has hired industry veteran Doug Drysdale as Chief Executive Officer. Mr. Drysdale has also been appointed to the Company’s Board of Directors and shall serve as Chairman. Mr. Drysdale’s appointment is supported by a group of institutional investors led by Athyrium Capital Management, who have agreed to purchase $65 million aggregate principal amount of 8.00% Convertible Senior Notes due 2019 (the “Notes”) from Pernix, providing the company with expansion capital for the acquisition of accretive specialty products to be added to the Company’s portfolio, as well as for working capital and general corporate purposes.

Appointment of Doug Drysdale as Chief Executive Officer

Mr. Drysdale most recently served as Chief Executive Officer of Alvogen, Inc., from 2008 to 2013, building the company from inception to become a global leader in pharmaceuticals. Alvogen now operates in thirty countries and has a portfolio of over 200 projects in development and registration. Prior to Alvogen, Mr. Drysdale helped build the multinational pharmaceutical giant Actavis, as head of mergers and acquisitions and a member of the executive board, spearheading specialty acquisitions such as Sindan (oncology) and Abrika (CR formulations). Recognized in 2012 as an Ernst & Young Entrepreneur of the Year, Mr. Drysdale brings a track record of accomplishment earned over the course of a twenty-five year career in the healthcare industry. Prior industry leadership positions also include Vice President of Global Business Development with Alpharma, Inc.; Global Licensing with Forest Laboratories, Inc.; Executive Vice President and Co-Founder of Alkensa, Inc.; and Director Business Development with Elan Corp, plc.

“Doug is a proven value creator for shareholders,” said Mike Pearce, board member and former chief executive officer of Pernix. “Fortified with expansion capital and a stable platform free of legacy issues, I believe he will lead Pernix to unprecedented heights.”

Commenting on his appointment, Mr. Drysdale said, “I am excited to be leading Pernix toward a brighter future. Armed with a strong war chest and with the support of the Pernix board, the Company is well-positioned to acquire specialty pharmaceutical products to add to its portfolio. By focusing less on primary care and more on specialty audiences, Pernix can better leverage its sales and marketing expertise, create cross-selling opportunities, and provide a more cohesive continuum of care to patients and physicians.” Mr. Drysdale added, “I want to thank Mike for doing a great job of steadying the ship during a period of restructuring for Pernix. I look forward to working with Mike and the other members of our board of directors.”

Mike Pearce, who has resigned as chief executive officer, has agreed to remain with the company through a transition period. Further changes to the Company’s board of directors will be announced in due course as the Company looks to add additional industry talent to its board.

Pricing of $65 Million of 8.00% Convertible Senior Notes

The Notes, which mature in 2019 unless earlier converted, carry a coupon of 8% and are convertible into shares of Pernix common stock at an initial conversion price of $3.60 per share, representing a conversion premium of more than 70% over the last reported sale price of Pernix’s common stock on the NASDAQ Global Market on February 4, 2014.

The purchase of the Notes is expected to close as soon as practicable, subject to the satisfaction of customary closing conditions. The Notes will be issued at a price equal to 100% of the principal amount thereof.

The offering of the Notes was limited to institutional accredited investors and qualified institutional buyers pursuant to Section 4(a)(2) of the Securities Act of 1933, as amended (the “Securities Act”) and Regulation D promulgated thereunder. Neither the Notes nor any shares of Pernix’s common stock issuable upon conversion of the Notes have been registered under the Securities Act or under any state securities laws and, unless so registered, may not be offered or sold in the United States or to U.S. persons except pursuant to an exemption from, or in a transaction not subject to, the registration requirements of the Securities Act and applicable state securities laws. This press release does not constitute an offer to sell, or the solicitation of an offer to buy, these securities, nor will there be any sale of these securities in any state or other jurisdiction in which such offer, solicitation or sale is not permitted.

Settlement of Legal Liabilities

Pernix today also announced favorable resolution of pending legal matters.

On January 29, 2014, a Stipulation of Dismissal was filed with the United States District Court for the Southern District of Texas in connection with the settlement of all claims brought against Pernix by the former shareholders of Cypress Pharmaceuticals, Inc. (“Cypress”) and all claims brought against the former shareholders of Cypress by Pernix in connection with the purchase of Cypress by Pernix pursuant to the Securities Purchase Agreement by and among Pernix and the former Cypress shareholders (the “Purchase Agreement”). As part of the settlement, Pernix has agreed to pay $1,330,000 to the former Cypress shareholders on or before February 7, 2014, which Pernix accrued at the time of the Cypress acquisition as a contingent consideration in the Company’s financial statements. In exchange for this payment, both parties released all claims against the other parties, which includes the former Cypress shareholders waiving any rights to the put obligation of Pernix included in the Purchase Agreement. Additionally, the payment repays in full all currently existing obligations by Pernix to fund the escrow account or to pay the holdback amount under the Purchase Agreement. The settlement also modified the language relating to a prospective product milestone payment to the former Cypress shareholders pursuant to the Purchase Agreement with an aim toward greater product development flexibility, but still reflects a one-time payment of $5,000,000, payable in cash or stock, upon the achievement of an NDA acceptance by the FDA of any one of the four pipeline products transferred in the acquisition of Cypress.

In resolution of a separate and unrelated matter, Pernix also reports that it has reached an agreement with the Attorney General of the State of Texas to settle all claims arising from certain actions by Cypress prior to its acquisition by Pernix under the Texas Medicaid Fraud Protection Act in conjunction with a Civil Investigative Demand made on Cypress and referencing a $42 million preliminary claim. In settlement, Pernix has agreed to pay $12,000,000 to the State of Texas, which the Company accrued and charged to expense in the Company’s financial statements at December 31, 2013. An initial payment of $2,000,000, which has already been paid to the Company’s counsel, is due and payable within ten business days of the effective date of the final settlement agreement. Thereafter, Pernix shall make subsequent payments of $2,000,000 on each of the first five anniversaries of the effective date of the settlement agreement.

Conference Call

Management will host a conference call on Wednesday, February 5, 2014 at 4:30 p.m. to discuss these developments. The conference call will feature remarks from Michael Pearce, outgoing Chairman and Chief Executive Officer, and Doug Drysdale, incoming Chairman and Chief Executive Officer. To participate in the live conference call, please dial (877) 312-8783 (domestic) or (408) 940-3874 (international), and provide conference ID code 59083028. A live webcast of the call will also be available on the investor relations section of the Company website, www.pernixtx.com. Please allow extra time prior to the webcast to register and download and install any necessary audio software.

A replay of the call will be available through February 12, 2014. To access the replay, please dial (855) 859-2056 (domestic) and (404) 537-3406 (international), and provide conference ID code 59083028. An online archive of the webcast will be available on the Company’s website for 30 days following the call.

About Athyrium Capital Management

Athyrium Capital Management, LLC is an asset management company formed in 2008 to focus on investment opportunities in the global healthcare sector. Athyrium invests across all healthcare verticals including biopharma, medical devices and products, and healthcare services and partners with management teams to implement creative financing solutions to companies’ capital needs. The Athyrium team has substantial investment experience in the healthcare sector across a wide range of asset classes, including public equity, private equity, fixed income, royalties, and other structured securities. Athyrium has over $600 million under management as of September 30, 2013. The firm’s investors include public and corporate pension funds, charitable endowments, insurance companies, funds-of-funds, family offices, and university endowments. For more information, please visit www.athyrium.com.

About Pernix Therapeutics Holdings, Inc.

Pernix Therapeutics is a specialty pharmaceutical company primarily focused on the sales, marketing, manufacturing and development of branded pharmaceutical products. The Company markets a portfolio of branded products, including: CEDAX®, an antibiotic for middle ear infections; NATROBA™, a topical treatment for head lice; ZUTRIPRO®, for the treatment of cough and cold; OMECLAMOX-PAK®, a 10-day treatment for H. pylori infection and duodenal ulcer disease; and REZYST™, a dietary pro-biotic. The Company also markets SILENOR, a non-narcotic product for the treatment of insomnia. The Company promotes its branded products to physicians through its Pernix sales force and markets its generic portfolio through its wholly owned subsidiaries, Cypress Pharmaceuticals and Macoven Pharmaceuticals. The Company’s wholly owned subsidiary, Pernix Manufacturing, manufactures and packages products for the pharmaceutical industry in a wide range of dosage forms. Founded in 1996, the Company is based in Houston, TX.

Additional information about Pernix is available on the Company’s website located at www.pernixtx.com.

Cautionary Notice Regarding Forward-Looking Statements

This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. Statements including words such as “estimate,” “plan,” “project,” “forecast,” “intend,” “expect,” “anticipate,” “believe,” “seek,” “target” or similar expressions are forward-looking statements. Because these statements reflect the Company’s current views, expectations and beliefs concerning future events, these forward-looking statements involve risks and uncertainties. Investors should note that many factors, as more fully described under the caption “Risk Factors” in our Form 10-K, Form 10-Q and Form 8-K filings with the Securities and Exchange Commission and as otherwise enumerated herein or therein, could affect the Company’s future financial results and could cause actual results to differ materially from those expressed in forward-looking statements contained in the Company’s Annual Report on Form 10-K. The forward-looking statements in this press release are qualified by these risk factors. These are factors that, individually or in the aggregate, could cause our actual results to differ materially from expected and historical results. The Company assumes no obligation to publicly update any forward-looking statements, whether as a result of new information, future developments or otherwise.

Wednesday, February 5th, 2014 Uncategorized Comments Off on (PTX) Attracts $65 Million Institutional Investment

(CYTR) Announces Closing of Public Offering of Common Stock

CytRx Announces Closing of Public Offering of Common Stock, Including Full Exercise of Underwriters’ Option to Purchase Additional Shares

CytRx Corporation (Nasdaq: CYTR), a biopharmaceutical research and development company specializing in oncology, today announced the closing of its previously announced underwritten public offering. The gross proceeds to CytRx from its sale of 13,225,000 shares of common stock at a price to the public of $6.50 per share, which include the proceeds from the exercise of the underwriters’ option to purchase an additional 1,725,000 shares, were approximately $86.0 million, prior to deducting underwriting discounts and commissions and other offering expenses payable by CytRx.

CytRx intends to use the net proceeds of the offering to fund clinical trials of its drug candidate aldoxorubicin and for general corporate purposes, which may include working capital, capital expenditures, research and development and other commercial expenditures.

Jefferies LLC acted as the sole book-running manager for the offering. Oppenheimer & Co. Inc., Aegis Capital Corp. and H.C. Wainwright & Co., LLC acted as co-lead managers for the offering.

The shares described above were sold pursuant to a shelf registration statement on Form S-3, including a base prospectus, previously filed with and declared effective by the Securities and Exchange Commission (SEC). The final prospectus supplement related to the offering also has been filed with the SEC. Copies of the final prospectus supplement and the accompanying prospectus may be obtained from Jefferies LLC, Equity Syndicate Prospectus Department, 520 Madison Avenue, 12th Floor, New York, NY 10022, by email at Prospectus_Department@Jefferies.com or by phone at 877-547-6340 or by accessing the SEC’s website at http://www.sec.gov.

About CytRx Corporation

CytRx Corporation is a biopharmaceutical research and development company specializing in oncology. CytRx currently is focused on the clinical development of aldoxorubicin (formerly known as INNO-206), its improved version of the widely used chemotherapeutic agent doxorubicin.

Forward-Looking Statements

This press release contains statements relating to the offering that are forward-looking statements within the meaning of Section 21E of the Securities Exchange Act of 1934, as amended. Such statements involve risks and uncertainties. All forward-looking statements are based upon information available to CytRx on the date the statements are first published. CytRx undertakes no obligation to publicly update or revise any forward-looking statements, whether as a result of new information, future events or otherwise.

Wednesday, February 5th, 2014 Uncategorized Comments Off on (CYTR) Announces Closing of Public Offering of Common Stock

(ATNM) to Present at the 16th Annual BIO CEO & Investor Conference

Company Looks Forward to Communicating its Exciting Prospects and Meeting with Conference Attendees

Actinium Pharmaceuticals, Inc. (OTCQB:ATNM.OB) (“Actinium” or “the Company”), a biopharmaceutical Company developing innovative targeted payload immunotherapeutics for the treatment of advanced cancers, announced today that Dr. Kaushik J. Dave, President and CEO, will present at the 16th Annual BIO CEO & Investor Conference from February 10th to 11th, 2014. Dr. Dave will present an overview of the company on Tuesday, February 11, 2014 at 1:30 pm ET.

Presentation Information:
Date: Tuesday, February 11, 2014
Time: 1:30 pm ET
Location: The Waldorf-Astoria Hotel: Conrad Room, New York, NY
Webcast: http://www.veracast.com/webcasts/bio/ceoinvestor2014/68234189.cfm

About Actinium Pharmaceuticals

Actinium Pharmaceuticals, Inc. (ATNM.OB) is a New York-based biopharmaceutical company developing innovative targeted payload immunotherapeutics for the treatment of advanced cancers. Actinium’s targeted radiotherapy is based on its proprietary delivery platform for the therapeutic utilization of alpha-emitting actinium-225 and bismuth-213 and certain beta emitting radiopharmaceuticals in conjunction with monoclonal antibodies. The Company’s lead radiopharmaceutical Iomab™-B will be used in preparing patients for hematopoietic stem cell transplant, commonly referred to as bone marrow transplant. The Company is conducting a single, pivotal, multicenter Phase 3 clinical study of Iomab™-B in refractory and relapsed Acute Myeloid Leukemia (AML) patients over the age of 55 with a primary endpoint of durable complete remission. The company’s second program, Actimab-A, is continuing its clinical development in a Phase 1/2 trial for newly diagnosed AML patients over the age of 60 in a single-arm multicenter trial. For more information, please visit www.actiniumpharmaceuticals.com.

For more information:

Visit our web site www.actiniumpharmaceuticals.com

Forward-Looking Statement for Actinium Pharmaceuticals, Inc.

This news release contains “forward-looking statements” as defined in the Private Securities Litigation Reform Act of 1995. These statements are based on management’s current expectations and involve risks and uncertainties, which may cause actual results to differ materially from those set forth in the statements. The forward-looking statements may include statements regarding product development, product potential, or financial performance. No forward-looking statement can be guaranteed and actual results may differ materially from those projected. Actinium Pharmaceuticals undertakes no obligation to publicly update any forward-looking statement, whether as a result of new information, future events, or otherwise.

 

Wednesday, February 5th, 2014 Uncategorized Comments Off on (ATNM) to Present at the 16th Annual BIO CEO & Investor Conference

(OHRP) to Present at the 16th Annual BIO CEO & Investor Conference

NEW YORK, NYvia eTeligisOhr Pharmaceutical (NASDAQ: OHRP), a pharmaceutical company focused on the development of novel therapeutics for large unmet medical needs, today announced that Irach Taraporewala, Ph.D., Chief Executive Officer, will present a corporate overview and business update at the 16th Annual BIO CEO & Investor Conference, being held at The Waldorf Astoria in New York City on February 10-11, 2014.

 

Details of the presentation are as follows:
Date: Tuesday, February 11, 2014
Time: 9:00am Eastern Time
Webcast: http://www.veracast.com/webcasts/bio/ceoinvestor2014/66223481077.cfm
Location: Waldorf Astoria, Basildon Room

 

About Ohr Pharmaceutical Inc.

 

Ohr Pharmaceutical Inc. (OHRP) is a pharmaceutical company dedicated to the clinical development of new drugs for underserved therapeutic needs in large and growing markets. The Company is focused on advancing its pipeline products currently in phase II clinical development: Squalamine Eye Drops for the treatment of the wet form of age-related macular degeneration, and OHR/AVR118 for the treatment of cancer cachexia. Additional information on the company can be found at www.ohrpharmaceutical.com.

 

Safe Harbor Statement under the Private Securities Litigation Reform Act of 1995: This news release contains forward-looking statements within the meaning of the “safe harbor” provisions of the Private Securities Litigation Reform Act of 1995. These forward-looking statements are made only as the date thereof, and Ohr Pharmaceutical undertakes no obligation to update or revise the forward-looking statement whether as a result of new information, future events or otherwise. Our actual results may differ materially and adversely from those expressed in any forward-looking statements as a result of various factors and uncertainties, including the future success of our scientific studies, our ability to successfully develop products, rapid technological change in our markets, changes in demand for our future products, legislative, regulatory and competitive developments, the financial resources available to us, and general economic conditions. Shareholders and prospective investors are cautioned that no assurance of the efficacy of pharmaceutical products can be claimed or assured until final testing; and no assurance or warranty can be made that the FDA or Health Canada will approve final testing or marketing of any pharmaceutical product. Ohr’s most recent Annual Report and subsequent Quarterly Reports discuss some of the important risk factors that may affect our business, results of operations and financial condition. We disclaim any intent to revise or update publicly any forward-looking statements for any reason.

 

Contact:
Ohr Pharmaceutical Inc.
Investor Relations
(877) 215-4813
ir@ohrpharmaceutical.com

LifeSci Advisors, LLC
Michael Rice
646-597-6987
mrice@lifesciadvisors.com

Tuesday, February 4th, 2014 Uncategorized Comments Off on (OHRP) to Present at the 16th Annual BIO CEO & Investor Conference

(OVAS) Appoints Fertility Pioneer Jamie Grifo M.D., Ph.D., to Clinical Advisory Board

OvaScienceSM, (NASDAQ: OVAS), a life sciences company focused on the discovery, development and commercialization of female fertility treatments, announced today the appointment of Jamie Grifo, M.D., Ph.D., of the New York University (NYU) Fertility Center and the Division of Reproductive Endocrinology at the NYU School of Medicine, to its Clinical Advisory Board.

“Throughout his career, Dr. Grifo has been at the forefront of bringing the latest innovations in fertility to patients, such as pre-implantation genetic diagnosis,” said Michelle Dipp, Chief Executive Officer, OvaScience. “His research continues to drive major advances in the field and we look forward to his contributions to OvaScience.”

“As more women delay childbearing, which can result in decreased egg quality, there are a growing number of patients seeking fertility treatments that could benefit from new innovations in the field,” said Dr. Grifo. “OvaScience’s EggPCSM technology is unique in that it has the potential to improve egg quality and offer new possibilities for helping women build their own families.”

Dr. Grifo is renowned in reproductive medicine for his technical innovation and leadership. His team pioneered the first successful use of pre-implantation genetic diagnosis (PGD) in the U.S., a technique which has been used in the assisted reproduction of thousands of children worldwide. Dr. Grifo’s research also produced the NYU Vitrification Method, a standard of care at NYU Fertility Center since 2004. Additional research focuses on egg freezing and stem cells.

Dr. Grifo is the Program Director of the New York University (NYU) Fertility Center. Since 1995 he has been the Director of the Division of Reproductive Endocrinology at the NYU School of Medicine where he also holds the faculty appointment of Professor of Obstetrics and Gynecology. He received his M.D. and Ph.D. degrees at Case Western Reserve School of Medicine. A member of the American Society for Reproductive Medicine since 1989, Dr. Grifo has served on the Ethics Committee and is past president of the Society for Assisted Reproductive Technologies.

About OvaScience

OvaScience (NASDAQ: OVAS) is a life sciences company focused on the discovery, development and commercialization of new fertility treatments. The Company’s patented technology is based on the discovery of egg precursor cells (EggPCSM), which are found in the ovaries. By applying proprietary technology to identify and purify EggPCs, OvaScience is developing potential next generation in vitro fertilization (IVF) treatments. The Company currently has three fertility treatments in development: AUGMENTSM, which aims to improve egg quality and increase the success of IVF; OvaPrimeSM, designed to boost a woman’s egg reserve using her own EggPCs; and OvaTureSM, which seeks to create mature fertilizable eggs from a woman’s own EggPCs without the need for hormone injections. OvaScience’s team of scientists, physicians and advisers includes recognized leaders in the field of reproductive medicine. For more information, please visit www.ovascience.com and connect with us on Twitter and Facebook.

Forward-Looking Statements

This press release includes forward-looking statements about the prospects for the Company’s technology in addressing female infertility, the Company’s strategy, future plans and prospects, and the development and commercialization of the Company’s product candidates. Any statements in this release about our strategy, plans, prospects and future expectations, financial position and operations, and other statements containing the words “anticipate,” “believe,” “estimate,” “expect,” “intend,” “may,” “plan,” “predict,” “project,” “target,” ”aim,” “potential,” “will,” “would,” “could,” “should,” “continue,” and similar expressions, constitute forward-looking statements for the purposes of the safe harbor provisions under The Private Securities Litigation Reform Act of 1995. Actual results may differ materially from those indicated by these forward-looking statements as a result of various important factors, including risks related to: our expectations regarding the regulatory approvals required for AUGMENT outside of the United States and our expectation that AUGMENT meets the requirements of a class of products exempt from premarket review and approval under applicable regulations in those countries where we plan to introduce AUGMENT in ACE clinics; the science underlying our product candidates (including AUGMENT, OvaPrime and OvaTure), which is unproven; our ability to obtain, maintain and protect intellectual property utilized by our products; our ability to obtain additional funding to support our activities; our dependence on third parties, including our dependence on Intrexon Corporation; the successful development of, and ability to obtain regulatory approval for, our product candidates; our ability to develop our product candidates, including AUGMENT, OvaPrime and OvaTure, on the timelines we expect, if at all; our ability to commercialize our product candidates, including AUGMENT and OvaPrime, on the timelines we expect, if at all; competition from others; and our short operating history; as well as those risks more fully discussed in the “Risk Factors” section of our most recently filed Quarterly Report on Form 10-Q or Annual Report on Form 10-K. The forward-looking statements contained in this press release reflect our current views with respect to future events. We anticipate that subsequent events and developments will cause our views to change. However, while we may elect to update these forward-looking statements in the future, we specifically disclaim any obligation to do so. These forward-looking statements should not be relied upon as representing our view as of any date subsequent to the date hereof.

Tuesday, February 4th, 2014 Uncategorized Comments Off on (OVAS) Appoints Fertility Pioneer Jamie Grifo M.D., Ph.D., to Clinical Advisory Board

(ATMI) Entegris to Acquire ATMI

Transaction Combines Two Preeminent Suppliers of Critical Technology to the Semiconductor Industry

ATMI Shareholders to Receive $34.00 per Share in Cash

Expected to be Immediately Accretive to non-GAAP EPS

BILLERICA, Mass. and DANBURY, Conn., Feb. 4, 2014 — Entegris, Inc. (Nasdaq:ENTG) and ATMI (Nasdaq:ATMI) today announced that the Boards of Directors of both companies have unanimously approved a definitive merger agreement under which Entegris will acquire ATMI for a total equity value of approximately $1.15 billion on a fully-diluted basis, or approximately $850 million net of cash acquired, including the net cash proceeds from the sale of ATMI’s LifeSciences business of $170 million.

Under the terms of the merger agreement, ATMI shareholders will receive $34.00 in cash, without interest or dividends, for each share of ATMI common stock they hold at the time of closing. The companies anticipate closing the transaction in the second quarter of 2014. The price represents a premium of 26.3 percent to ATMI’s closing price of $26.93 on February 3, 2014. The transaction is expected to yield approximately $30 million in annualized cost synergies. Entegris expects to fund the all-cash transaction with a combination of existing cash balances and additional committed debt financing, and expects it to be immediately accretive to non-GAAP earnings per share (EPS).

The combination brings together two key suppliers in the semiconductor industry to create a technology leader in advanced process materials, contamination control and wafer handling. By leveraging ATMI’s market-leading critical products, global infrastructure and expertise in key processes, Entegris will have an even stronger platform to serve the demanding technology needs of the world’s largest semiconductor makers and other electronics companies. The transaction will also provide a broader set of growth opportunities, and the company will sustain its investments in R&D, infrastructure and metrology to support that growth.

Bertrand Loy, President and Chief Executive Officer of Entegris said, “ATMI’s microelectronics business is an excellent fit with Entegris and provides us with a premium portfolio of products that will enable us to create enhanced value. ATMI and Entegris share a long and successful history of solving some of the most difficult yield challenges facing the industry. Together, we will be uniquely positioned with innovative yield-enhancing solutions to address the increasing complexity and cost of new semiconductor processes. Upon closing, approximately 80% of our product sales will be unit-driven and focused on the most rapidly growing and critical areas of the semiconductor fab. We are excited about the opportunities ahead and look forward to quickly realizing the significant benefits of this transaction for our shareholders, customers and employees.”

Doug Neugold, President and Chief Executive Officer of ATMI, said, “Throughout this process, our goal has been to enter into a transaction that not only maximizes shareholder value, but also places our business with the right partner for our valued customers and employees. We are pleased to merge our microelectronics business into Entegris. Entegris’ global platform and complementary products represents a great opportunity for ATMI stakeholders, including our shareholders, who will receive an immediate premium for their investment.”

Financial Benefits

The combination is expected to generate annualized cost synergies of approximately $30 million, achieved through identified operational efficiencies and overhead consolidation. The combined company will have an efficient balance sheet, benefitting from the deployment of excess cash and the addition of attractive debt financing. The transaction is expected to be immediately accretive to non-GAAP EPS with the potential for significant earnings leverage as the combined company’s cash flow generation enables the repayment of debt.

Closing Conditions

The transaction is subject to regulatory approvals of both U.S. and international regulators, including expiration or termination of the applicable waiting period under the Hart-Scott-Rodino Antitrust Act, as well as other customary closing conditions. The transaction is also subject to approval by ATMI shareholders.

The transaction is also conditioned on the closing of ATMI’s previously announced sale of its LifeSciences business, which is expected in the first quarter of 2014.

Entegris and ATMI Fourth Quarter 2013 Earnings Results

In separate press releases issued today, both Entegris and ATMI announced their financial results for the fourth quarter and full year 2013.

Advisors

Goldman, Sachs & Co. is serving as the exclusive financial advisor and Ropes & Gray LLP is serving as legal counsel to Entegris. Barclays Capital is serving as the financial advisor and Weil, Gotshal & Manges LLP is serving as legal counsel to ATMI. Goldman Sachs Bank USA has been appointed to act as the lead arranger and bookrunner for the committed financing that has been obtained by Entegris in connection with the merger and the related transactions.

Conference Call and Webcast Details

Entegris and ATMI will host a joint conference call and online webcast today, February 4, 2014, at 8:30 a.m. Eastern Time to discuss the transaction announcement. It will be streamed live over Entegris’ website at http://investor.entegris.com/events.cfm and over ATMI’s website at http://www.atmi.com/. Interested participants can access the call by dialing toll-free (866) 610-1072 or (973) 935-2840 for international callers and referencing confirmation code #59322873. Participants are asked to dial in 5 to 10 minutes prior to the start of the call. A replay of the call will be available starting February 4, 2013 at 11:30 a.m. Eastern Time and can be accessed telephonically by dialing (800) 585-8367 or (404) 537-3406 and using the passcode #59322873, or by accessing http://investor.entegris.com/events.cfm.

About Entegris

Entegris provides a wide range of products for purifying, protecting and transporting critical materials used in processing and manufacturing in semiconductor and other high-tech industries. Entegris is ISO 9001 certified and has manufacturing, customer service or research facilities in the United States, China, France, Germany, Israel, Japan, Malaysia, Singapore, South Korea and Taiwan. Additional information can be found at www.entegris.com.

About ATMI

ATMI, Inc. is a global provider of specialty semiconductor materials, and safe, high-purity materials handling and delivery solutions designed to increase process efficiencies for the microelectronics, life sciences, and other industries. For more information, please visit http://www.atmi.com.

Important Notice and Additional Information

This communication may be deemed to be solicitation material in respect of the proposed acquisition of ATMI by ENTEGRIS. In connection with the proposed transaction, ATMI intends to file a proxy statement and other related documents with the Securities and Exchange Commission (the “SEC”). INVESTORS AND STOCKHOLDERS OF ATMI ARE ADVISED TO READ THE PROXY STATEMENT AND THESE OTHER MATERIALS WHEN THEY BECOME AVAILABLE BECAUSE THEY WILL CONTAIN IMPORTANT INFORMATION ABOUT ATMI AND THE PROPOSED TRANSACTION. Investors and stockholders may obtain a free copy of the proxy statement (when available) and other documents filed by ATMI with the SEC at the SEC web site at www.sec.gov. Copies of the proxy statement (when available) and other filings made by ATMI with the SEC can also be obtained, free of charge, by directing a request to Troy Dewar, VP investor Relations and Corporate Communications, ATMI, Inc., 7 Commerce Drive, Danbury, CT 06810. The proxy statement (when available) and such other documents are also available for free on ATMI’s web site at www.atmi.com as soon as reasonably practicable after ATMI electronically files such material with, or furnish it to, the SEC.

Participants in the Solicitation

ATMI and its directors and officers and other persons may be deemed to be participants in the solicitation of proxies from ATMI’s stockholders in connection with the proposed acquisition transaction. Information regarding the directors and executive officers of ATMI is set forth in the proxy statement for ATMI’s 2013 Annual Meeting of Stockholders, which was filed with the SEC on April 11, 2013, and in ATMI’s Annual Report on Form 10-K for the fiscal year ended December 31, 2012, which was filed with the SEC on February 22, 2013. Other information regarding the participants in the proxy solicitation and a description of their direct and indirect interests, by security holdings or otherwise, will be contained in the proxy statement and other relevant materials to be filed with the SEC when they become available. Investors should read the proxy statement carefully when it becomes available before making any voting or investment decisions.

Cautionary Statement Regarding Forward-Looking Statements

Statements about the expected timing, completion and effects of the proposed merger, and all other statements made in this news release that are not historical facts are forward-looking statements and are made pursuant to the safe harbor provisions of the Private Securities Litigation Reform Act of 1995. In some cases, these forward-looking statements may be identified by the use of words such as “may,” “will,” “should,” “expect,” “plan,” “anticipate,” “believe” or “project,” or the negative of those words or other comparable words. Any forward-looking statements included in this news release are made as of the date hereof only, based on information available to Entegris and ATMI as of the date hereof, and, subject to any applicable law to the contrary, Entegris and ATMI undertake no obligation to update or revise any forward-looking statements, whether as a result of new information, future events or otherwise. Such forward-looking statements are subject to a number of risks, assumptions and uncertainties that could cause actual results to differ materially from those projected in such forward-looking statements. Such risks and uncertainties include: any conditions imposed on the parties in connection with consummation of the transaction described herein; approval of the merger by ATMI’s stockholders; the ability to obtain regulatory approvals of the transactions contemplated by the merger agreement on the proposed terms and schedule; the failure of ATMI’s stockholders to approve the transactions contemplated by the merger agreement; ATMI’s ability to maintain relationships with customers, employees or suppliers following the announcement of the merger agreement; the ability of third parties to fulfill their obligations relating to the proposed transactions, including providing financing under current financial market conditions; the ability of the parties to satisfy the conditions to closing of the transactions contemplated by the merger agreement; the risk that the transactions contemplated by the merger agreement may not be completed in the time frame expected by the parties or at all; and the risks that are described from time to time in Entegris and ATMI’S reports filed with the SEC, including Entegris’s Annual Report on Form 10-K for the fiscal year ended December 31, 2012, filed with the SEC on February 22, 2013, ATMI’s Annual Report on Form 10-K for the fiscal year ended December 31, 2012, filed with the SEC on February 22, 2013, and in other of Entegris and ATMI’s filings with the SEC from time to time, including Quarterly Reports on Form 10-Q and Current Reports on Form 8-K, and on general industry and economic conditions.  Entegris and ATMI caution investors not to place substantial reliance on the forward-looking statements contained in this press release. These statements speak only as of the date of this press release and Entegris and ATMI do not undertake and expressly disclaim any obligation to update or revise them except as otherwise required by law.

CONTACT: Steven Cantor
         VP of Corporate Relations
         T +1 978 436 6750
         irelations@entegris.com
Tuesday, February 4th, 2014 Uncategorized Comments Off on (ATMI) Entegris to Acquire ATMI

(FURX) Positive Top-Line Results Pivotal Phase III In IBS-d

Studies Meet FDA and EMA Primary Endpoints Conference Call and Webcast Scheduled for 8:30 a.m. ET Today

Furiex Pharmaceuticals, Inc. (NASDAQ: FURX) today announced top-line results indicating the company’s two pivotal Phase III clinical trials evaluating the efficacy and safety of eluxadoline in the treatment of diarrhea-predominant irritable bowel syndrome (IBS-d) met both the U.S. Food and Drug Administration (FDA) and the European Medicines Agency (EMA) formally agreed-upon primary endpoints of composite response based on simultaneous improvements in stool consistency and abdominal pain. These endpoints are aligned with both the current FDA guidance and the 2013 EMA draft guidance for clinical trial evaluation of new medicines for irritable bowel syndrome.

“I am very pleased with the strength of the data, and proud of our team for its hard work and excellent development of eluxadoline,” said Fred Eshelman, founding chairman of Furiex. “In just under four years, working closely with regulatory authorities, the team has completed nine Phase I studies, a Phase II dose-ranging trial in approximately 800 patients, and these two large Phase III trials. Additionally, we have completed all toxicology studies and believe we are on schedule, including chemistry and manufacturing work, for an NDA submission by the end of the second quarter of 2014.”

The studies, known as 3001 and 3002, were randomized, double-blind, placebo-controlled studies in which patients received eluxadoline, 75 mg twice-daily (BID), eluxadoline 100 mg BID or placebo BID. A total of 2,428 subjects were enrolled across the two studies. The primary efficacy endpoint was a composite response evaluated over the initial 12 weeks of double-blind treatment for FDA evaluation, and over the 26 weeks of double-blind treatment for EMA evaluation. Response rates were compared based on patients who met the daily composite response criteria (improvement in pain and stool consistency) for at least 50% of the days from weeks 1 to 12 and weeks 1 to 26. A patient must have met both of the following criteria on any given day to be a daily responder:

  • Daily stool consistency response: Bristol stool score <5, or the absence of a bowel movement; and
  • Daily pain response: worst abdominal pain scores in the past 24 hours improved by ≥30% compared to baseline (average of week prior to randomization).

“We are pleased with these top-line results, which put us one step closer to filling an unmet medical need in men and women with IBS-d,” said June Almenoff, M.D., Ph.D., president and chief medical officer of Furiex. “In addition to showing both rapid onset and durable efficacy of the primary endpoints, both pivotal studies demonstrated robust efficacy for the secondary endpoint of adequate relief of IBS symptoms. We look forward to further analyzing the data and plan to present details at an upcoming medical conference.”

Eluxadoline has been granted Fast Track status by the FDA, a process designed to facilitate development and expedite the review of drugs to treat diseases with significant unmet medical need.

Key Findings from Study 3002 (intention-to-treat analysis):

Patients receiving eluxadoline demonstrated statistically significantly higher responder rates for the following composite primary endpoints:

  • For the FDA composite endpoint (response over weeks 1-12), the responder rates were 29.5% for eluxadoline 100 mg, 28.9% for eluxadoline 75 mg and 16.2% for placebo (p <0.001 both doses); and
  • For the EMA composite endpoint (response over weeks 1-26), the responder rates were 32.6% for 100 mg, 30.4% for 75 mg and 20.2% for placebo (p ≤0.001 both doses).

With respect to the individual secondary components of the FDA composite endpoint, eluxadoline-treated patients demonstrated significantly higher rates of stool consistency response over weeks 1-12, namely 100 mg=35.5%, 75 mg=37.0% and placebo=20.9% (p <0.001 both doses), and numerical improvement in pain response rates at 100 mg over weeks 1-12, although this difference did not reach statistical significance (100 mg=50.9% vs. placebo=45.3%, p =0.12).

Key Findings from Study 3001 (intention-to-treat analysis)

Patients receiving eluxadoline demonstrated statistically significantly higher response rates for the following primary composite endpoints:

  • For the FDA composite endpoint (response over weeks 1-12), the responder rates were 25.1% for eluxadoline 100 mg (p =0.004), 23.9% for eluxadoline 75 mg (p =0.014) and 17.1% for placebo; and
  • For the EMA composite endpoint (response over weeks 1-26), the responder rates were 29.3% for 100 mg (p <0.001), 23.4% for 75 mg (p =0.11) and 19.0% for placebo.

With respect to the individual secondary components of the FDA composite endpoint, eluxadoline-treated patients demonstrated significantly higher response rates of stool consistency over weeks 1-12, namely 100 mg=34.3%, 75 mg=30.0% and placebo=22.0% (p <0.009 both doses) and, numerical improvement in pain response rates at 100 mg over weeks 1-12, although this difference did not reach statistical significance (100 mg=43.2% vs. placebo=39.6%, p =0.28).

Data pooled from studies 3001 and 3002 for the composite endpoint from the two studies demonstrated a differential effect between active and placebo. For the FDA endpoint, the differential effects were 9.5% and 10.3% for 75 and 100 mg respectively. Similarly, for the EMA 26 week endpoint, the differential effects were 7.2% and 11.5% for the 75 and 100 mg respectively. All p values were <0.001.

Eluxadoline had a favorable tolerability and safety profile in the trials. The most commonly reported side effects across the two studies were constipation (8.3% for 100 mg eluxadoline, 7.4% for 75 mg eluxadoline vs. 2.4% for placebo) and nausea (7.3% for 100 mg eluxadoline, 7.8% for 75 mg eluxadoline vs. 4.8% placebo). Sporadic elevations of liver enzymes (>3XULN) were seen in both the active and placebo arms, with a difference between active and placebo <0.5%, all of which resolved. There were infrequent adjudicated events of mild pancreatitis involving five patients who received eluxadoline (0.3% of those treated with the compound). Three of these subjects reported heavy alcohol consumption, one patient was noted to have biliary sludge, a known risk factor for pancreatitis, and one subject experienced transient sphincter of Oddi spasm, which is a known opiate class effect associated with pancreatitis.

About the Eluxadoline Clinical Trial Program

More than 2,500 subjects have received eluxadoline across the Phase I, II and III programs.

Furiex’s Phase III program of eluxadoline consisted of two similar studies – 3001 and 3002. Both were randomized, double-blind, placebo-controlled trials to evaluate the efficacy and safety of eluxadoline in the treatment of patients with diarrhea-predominant irritable bowel syndrome. The studies involved a pre-treatment phase (consisting of a pre-screening period of up to one week, and a screening period of up to three weeks), and double-blind treatment periods of 52 weeks for study 3001 and 26 weeks for study 3002. Additionally, study 3001 had a two-week post-treatment follow-up period while study 3002 had a four-week, single-blind placebo withdrawal period.

Efficacy assessments for the determination of clinical response were conducted through the first 26 weeks for study 3001, and through 30 weeks for study 3002. The continuation of double-blind treatment through Week 52 for study 3001 allowed for continued observation of the long-term safety of eluxadoline. There were 1,282 and 1,146 patients enrolled into studies 3001 and 3002, respectively; randomization was 1:1:1 eluxadoline 75 mg, eluxadoline 100 mg or placebo.

Company to Host Conference Call

Furiex will conduct a live conference call and webcast Tuesday, February 4, 2014 at 8:30 a.m. ET to discuss the top-line results. A Q&A session will follow. All interested parties can access the webcast through the Presentations and Events link in the Investors section of the Furiex website at www.furiex.com. The webcast will be archived shortly after the call for on-demand replay. The conference call will be broadcast live over the Internet and will also be available using the following direct dial numbers:

Participant dial-in: + 1 877 677 9122 (U.S./Canada)
+ 1 708 290 1401 (International)
Conference ID: 59157670

About IBS-d

IBS-d is a functional bowel disorder characterized by chronic abdominal pain and frequent diarrhea, which affects approximately 28 million patients in the U.S. and the major markets in Europe. Although the exact cause of IBS-d is not known, symptoms are thought to result from a disturbance in the way the gut and nervous system interact. IBS-d can be extremely debilitating and there are limited therapeutic options for managing the chronic symptoms. IBS-d is associated with economic burden in direct medical costs and indirect social costs such as absenteeism and lost productivity, along with decreased quality of life.

About Eluxadoline

Eluxadoline is a novel, orally active investigational agent with combined mu opioid receptor agonist and delta opioid receptor antagonist activity which acts locally in the gut and has very low oral bioavailability. This dual opioid activity is designed to treat diarrhea and pain symptoms of IBS-d, without causing the constipating side effects that can occur with unopposed mu opioid agonists. Eluxadoline has been granted Fast Track status by the FDA, a process designed to facilitate development and expedite the review of drugs to treat diseases with significant unmet medical need.

About Furiex

Furiex Pharmaceuticals is a drug development collaboration company that uses innovative clinical development design to accelerate and increase value of drug development programs by advancing them through the drug discovery and development process in a cost-efficient manner. Our drug development programs are designed and driven by a core team with extensive drug development experience. The Company collaborates with pharmaceutical and biotechnology companies and has a diversified product portfolio and pipeline with multiple therapeutic candidates, including one Phase III-ready asset, two compounds in Phase III development, one of which is with a partner, and four products on the market. The Company’s mission is to develop innovative medicines faster and at a lower cost, thereby improving profitability and accelerating time to market while providing life-improving therapies for patients. For more information, visit www.furiex.com.

Except for historical information, all of the statements, expectations and assumptions contained in this news release are forward-looking statements that involve a number of risks and uncertainties. Although Furiex attempts to be accurate in making these forward-looking statements, it is possible that future circumstances might differ from the assumptions on which such statements are based. In addition, other important factors which could cause actual results to differ materially include the following: progress of compounds in clinical trials and regulatory approvals; potential changes to regulatory guidance by regulatory agencies such as the U.S. Food and Drug Administration and the European Medicines Agency; the risk of finding a collaborator for our late-stage compounds, or risks involved in our attempting to commercialize compounds ourselves; continuing losses and our potential need for additional financing; the risks and expense of continuing the research and development activities of our existing compounds; inability of collaborators to effectively market approved products for which we receive royalty and sales-based milestone payments; changes in the safety and efficacy profile of our existing compounds as they progress through research and development; new collaborative agreements that we might enter into in the future; the costs of defending any patent opposition or litigation necessary to protect our proprietary technologies; and the other risk factors set forth from time to time in the SEC filings for Furiex, copies of which can be found on our website.

Tuesday, February 4th, 2014 Uncategorized Comments Off on (FURX) Positive Top-Line Results Pivotal Phase III In IBS-d

(IPCI) Receives $3.1 Million From Par Pharmaceuticals, Inc.

First Profit-Share Payment on 15 and 30 mg Generic Focalin XR® Sales

TORONTO, Feb. 3, 2014  — Intellipharmaceutics International Inc. (Nasdaq:IPCI) (TSX:I), a pharmaceutical company specializing in the research, development and manufacture of novel and generic controlled-release and targeted-release oral solid dosage drugs, today announced the receipt of approximately $3.1 million as its first payment relating to commercial sales of dexmethylphenidate hydrochloride extended-release capsules by its licensee Par Pharmaceutical, Inc. (“Par”). This represents the Company’s share of profits for the 15 and 30 mg strengths of the drug product for the period commencing with the first commercial sales of those strengths on November 19, 2013 and ending December 31, 2013 under its License and Commercialization Agreement with Par. Future profit-share payments are expected on a quarterly basis, although the amounts of any such payments cannot now be determined and may vary significantly from time-to-time. All dollar amounts referenced herein are in United States dollars unless otherwise noted.

As the first-filer for the drug product in the 15 mg strength, the Company currently has 180 days of exclusivity of generic sales for that strength from the November 19, 2013 date of launch in the United States by Par. In addition, Intellipharmaceutics has the potential to receive its share of the profits on the 5, 10, 20 and 40 mg strengths which were also tentatively approved by the United States Food and Drug Administration (“FDA”), subject to the right of another party or parties to 180 days of generic exclusivity from the date of first launch of such strengths of the drug product by such parties. The Company currently believes Par intends to launch these strengths immediately upon the expiry of those exclusivity periods and upon the anticipated final approvals from the FDA at those times, but there can be no assurance as to if or when any such approvals or launches will occur.

At the present time, publicly available records of the FDA show that only four entities, including the Company, have received approvals or tentative approvals to market one or more generic strengths of this drug product. Further, the Company believes that only three of those entities, including the Company, have commenced sales of one or more generic strengths of the drug product. Dr. Isa Odidi, CEO and co-founder of the Company, stated, “We believe that the number of competitors tentatively approved or in the market at this time is an indication that our drug delivery technologies and competence are robust and well-adapted to the formulation of difficult-to-replicate generic drug products.”

Intellipharmaceutics disclaims any intention and has no obligation or responsibility, except as required by law, to make, update or revise any statements regarding any future profit-share payments under its agreement with Par.

About Intellipharmaceutics

Intellipharmaceutics International Inc. is a pharmaceutical company specializing in the research, development and manufacture of novel and generic controlled-release and targeted-release oral solid dosage drugs. The Company’s patented Hypermatrix™ technology is a multidimensional controlled-release drug delivery platform that can be applied to the efficient development of a wide range of existing and new pharmaceuticals. Based on this technology platform, Intellipharmaceutics has developed several drug delivery systems and has recently been granted final FDA approval for its dexmethylphenidate hydrochloride extended-release capsules for the 15 and 30 mg strengths. In addition, Intellipharmaceutics has a pipeline of product candidates in various stages of development, including Abbreviated New Drug Applications (“ANDAs”) filed with the FDA in therapeutic areas that include neurology, cardiovascular, gastrointestinal tract, diabetes and pain.

Intellipharmaceutics also has New Drug Application 505(b)(2) product candidates in its development pipeline. These include Rexista™ oxycodone, an abuse-deterrent oxycodone, based on its proprietary nPODDDS™ novel Point Of Divergence Drug Delivery System and Regabatin™ XR pregabalin extended-release capsules.

Certain statements in this document constitute “forward-looking statements” within the meaning of the United States Private Securities Litigation Reform Act of 1995 and/or “forward-looking information” under the Securities Act (Ontario). These statements include, without limitation, statements expressed or implied regarding our plans, goals and milestones, status of developments or expenditures relating to our business, plans to fund our current activities, statements concerning our partnering activities, health regulatory submissions, strategy, future operations, future financial position, future sales, revenues and profitability, projected costs, and market penetration. In some cases, you can identify forward-looking statements by terminology such as “may,” “will,” “should,” “expects,” “plans,” “anticipates,” “believes,” “estimates,” “predicts,” “potential,” “continue,” “intends,” “could,” or the negative of such terms or other comparable terminology. We made a number of assumptions in the preparation of our forward-looking statements. You should not place undue reliance on our forward-looking statements, which are subject to a multitude of known and unknown risks and uncertainties that could cause actual results, future circumstances or events to differ materially from those stated in or implied by the forward-looking statements. Risks, uncertainties and other factors that could affect our actual results include, but are not limited to, the effects of general economic conditions, securing and maintaining corporate alliances, our estimates regarding our capital requirements, and the effect of capital market conditions and other factors, including the current status of our product development programs, on capital availability, the potential dilutive effects of any future financing, our programs regarding research, development and commercialization of our product candidates, the timing of such programs, the timing, costs and uncertainties regarding obtaining regulatory approvals to market our product candidates, and the timing and amount of any available investment tax credits, the actual or perceived benefits to users of our drug delivery technologies and products and product candidates as compared to others, our ability to establish and maintain valid and enforceable intellectual property rights in our drug delivery technologies, products and product candidates, the actual size of the potential markets for any of our products and product candidates compared to our market estimates, our selection and licensing of products and product candidates, our ability to attract distributors and collaborators with the ability to fund patent litigation and with acceptable development, regulatory and commercialization expertise and the benefits to be derived from such collaborative efforts, sources of revenues and anticipated revenues, including contributions from distributors and collaborators, product sales, license agreements and other collaborative efforts for the development and commercialization of product candidates, our ability to create an effective direct sales and marketing infrastructure for products we elect to market and sell directly, the rate and degree of market acceptance of our products, the difficulty of predicting the impact of competitive products and pricing, the timing and success of product launches, the timing and amount of insurance reimbursement for our products, changes in the laws and regulations, including Medicare and Medicaid, affecting among other things, pricing and reimbursement of pharmaceutical products, the success and pricing of other competing therapies that may become available, our ability to retain and hire qualified employees, the availability and pricing of third party sourced products and materials, difficulties or delays in manufacturing, the manufacturing capacity of third-party manufacturers that we may use for our products, and the successful compliance with FDA and other governmental regulations applicable to the Company and its third party manufacturers’ facilities, products and/or businesses. Additional risks and uncertainties relating to the Company and our business can be found in the “Risk Factors” section of our latest annual information form, our latest Form 20-F, as amended, and our latest Form F-3 (including any documents forming a part thereof or incorporated by reference therein), as well as in our reports, public disclosure documents and other filings with the securities commissions and other regulatory bodies in Canada and the U.S. The forward-looking statements are made as of the date of this document, and we disclaim any intention and have no obligation or responsibility, except as required by law, to update or revise any forward-looking statements, whether as a result of new information, future events or otherwise.

CONTACT: Company Contact:
         Intellipharmaceutics International Inc.
         Shameze Rampertab
         Vice President Finance & CFO
         416-798-3001
         investors@intellipharmaceutics.com

         Investor Contact:
         ProActive Capital
         Kirin Smith
         646-863-6519
         ksmith@proactivecapital.com
Monday, February 3rd, 2014 Uncategorized Comments Off on (IPCI) Receives $3.1 Million From Par Pharmaceuticals, Inc.

(IFON) Broadens Product Line with Launch of the verykool® T742 KolorPad™ Tablet

SAN DIEGO, Feb. 3, 2014  — InfoSonics Corporation (NASDAQ: IFON) today announced the launch of its new verykool® T742 tablet with Wi-Fi and 3G capabilities.

The T742, nicknamed the KolorPadTM, is a 7-inch tablet powered by a 1.3 GHz dual core processor and the Android 4.2 operating system. This full-featured tablet is being offered at a suggested retail price of $149.

“We are thrilled to release our T742 KolorPadTM tablet, which will unlock a multitude of possibilities for users at an incredibly affordable price,” said Joseph Ram, the company’s president and chief executive officer.  “The T742 is a compact tablet featuring a 7-inch capacitive LCD touchscreen, up to 32 GBs of external storage, USB tethering and Bluetooth 4.0. Whether you primarily use your tablet for reading eBooks and browsing the internet, or playing games and checking e-mail, the T742 has the capacity to accommodate most every need. The tablet also supports HID (Human Interface Device) of the Bluetooth profile, so it can connect to a keyboard, mouse and even game joysticks through a USB on-the-go interface.  As an added value, each tablet is packaged with a stereo headset, data cable, travel adapter, USB on-the-go cable and case.”

Additional details on the T742 are as follows:

  • 3G HSDPA (21Mbps, HSUPA 5.76Mbps) Dual band (850/1900) and 2G GSM Quad band (850/900/1800/1900)
  • WAP, SMS and MMS e-mail (POP3, IMAP), plus push e-mail
  • GPS, gravity sensor, and turn by turn navigation
  • 3 megapixel rear camera plus front facing VGA camera
  • Built-in FM radio and MP3 music player
  • 2,500 mAh Li-ion battery
  • USB port, 3.5mm audio jack, and loudspeaker

The verykool® T742 KolorPadTM Tablet is available now.  To learn more about the device, visit our verykool® website at http://www.verykool.net/Products/T742

About InfoSonics Corporation
InfoSonics is a San Diego-based designer, manufacturer and provider of wireless handsets and related products to OEMs, carriers, distributors and consumers in the United States, Latin America, Europe, Africa and Asia Pacific. The company is committed to delivering quality products with innovative industrial designs that appeal to consumers and offer exceptional value. InfoSonics sells and supports its own line of products under the verykool®and other private label brands. Additional information can be found on our corporate website at www.infosonics.com and www.verykool.net.

Except for the factual statements made herein, the information contained in this news release consists of forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995 that involve risks, uncertainties and assumptions that are difficult to predict.  Words and expressions reflecting optimism, satisfaction or disappointment with current prospects, as well as words such as “believes,” “hopes,” “intends,” “estimates,” “expects,” “projects,” “plans,” “anticipates” and variations thereof, or the use of future tense, identify forward-looking statements, but their absence does not mean that a statement is not forward-looking. Such forward-looking statements are not guarantees of performance and our actual results could differ materially from those contained in such statements. Factors that could cause or contribute to such differences include, without limitation: (1) customer acceptance of the new T742 tablet; (2) our ability to continue to differentiate our products, including the T742, from the competition; (3) significant changes in supplier terms and relationships or shortages in component or product supply; (4) extended general economic downturn in world markets; (5) inability to secure adequate supply of competitive products on a timely basis and on commercially reasonable terms; (6) inability to attract new sources of profitable business from expansion of products or services or risks associated with entry into new markets, including geographies, products and services; and (7) rapid product improvement and technological changes leading to changes in consumer demand for multimedia wireless handset products and features.  Reference is also made to other factors detailed from time to time in our periodic reports filed with the Securities and Exchange Commission. These forward-looking statements speak only as of the date of this release and we undertake no obligation to publicly update any forward-looking statements to reflect new information, events or circumstances after the date of this release.

Note:  All trademarks and copyrights other than InfoSonics and verykool are property of their respective owners.

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(GIG) Offers Its Custom Structured ASIC Solutions for Rapid Productization of Cryptocurrency

GigOptix, Inc. (NYSE MKT: GIG), a leading supplier of advanced high speed semiconductor components and Structured ASIC chips for use in various areas such as Cloud connectivity, data centers, consumer electronics links and interactive applications, through optical and wireless communications networks, today announced that its Custom Structured ASIC applications are establishing GigOptix as one the foremost providers of ASICs for the fast growing cryptocurrency bit mining market.

Based on recent product releases, the combination of GigOptix’s leading Structured ASIC and Standard Cell technology have proven the customizable CMOS platform to be a cost effective, high-performance structured ASIC solution with a dramatically reduced product turnaround time compared to traditional ASIC sources. This makes it an excellent offering to address the recently emerging computationally intensive cryptocurrency applications like Bitcoin (BTC), Litecoin (LTC), Dogecoin (DOGE), Ripple (XRP), Peercoin (PPC), Mastercoin (MSC), and Namecoin (NMC).

“GigOptix Structured ASICs provide a quickly deployed, low cost alternative in high-speed systems where FPGAs have been traditionally employed. We are pleased to see a strong interest in cryptocurrency applications where high speed is paramount and low power is becoming more important,” said Anil Chaudhry, Vice President and General Manager of the ASIC Product Line at GigOptix. “Many cryptocurrencies have increasing computational complexity with rapid design cycles, which GigOptix Structured ASICs know-how and Intellectual Property (IP) address efficiently through advanced CMOS processes and fast turnaround times. We take care of the productized silicon so that our customers – from recreational hobbyists to the most advanced commercial digital drilling operations – can focus on their algorithms and system interaction.”

GigOptix’s Custom Structured ASIC technology requires customization of only the metal interconnect layers, making the development cost a fraction of the upfront Non-Recurring Engineering (NRE) investment normally required by other suppliers for a fully custom Standard Cell ASIC. GigOptix technology enables the bit mining system developers to access the necessary technology for building ASICs at an affordable upfront cost instead of using high powered, high cost FPGA’s or high NRE fully custom Standard Cell ASICs. The reduced manufacturing turnaround times associated with GigOptix Custom Structured ASICs are a further advantage to the bit mining community, where fast time to market is critical to the successful deployment of new systems.

GigOptix is actively engaged as a partner for silicon manufacturing for the bit mining community’s newest ASIC designs, with a wide range of applications from the smallest silicon geometries to larger process nodes. This enables a variety of project scales and related budgets, thus minimizing the upfront development costs normally associated with this type of ASIC development. By leveraging robust customization, developers will benefit from lower development costs while delivering a faster time to market.

GigOptix ASIC Applications

For ASIC applications, GigOptix provides the broadest offering of value-added ASIC solutions, including Standard Cell, Structured ASIC and Custom Structured ASIC technologies. GigOptix has completed more than 2000 ASIC designs over its history. A rich portfolio of analog and digital IP’s particularly for optical applications and complimentary technical skills in analog and digital design, enables GigOptix to develop new products and expand its offering for various applications for established and emerging technologies.

About GigOptix, Inc.

GigOptix is a leading fabless supplier of high speed semiconductor components that enable end-to-end information streaming over optical and wireless networks. The products address long haul and metro telecom applications as well as emerging high-growth opportunities for Cloud and data centers connectivity, and interactive applications for consumer electronics. GigOptix offers a unique broad portfolio of Drivers and TIAs for 40Gbps, 100Gbps and 400Gbps fiber-optic telecommunications and data-communications networks, and high performance MMIC solutions that enable next generation wireless microwave systems up to 90GHz. GigOptix also offers a wide range of digital and mixed-signal ASIC solutions and enables product lifetime extension through its GigOptix Sunset Rescue Program.

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(BEAT) Announces Significant Patent Litigation Victory

MALVERN, Pa., Feb. 3, 2014  — BioTelemetry, Inc. (Nasdaq:BEAT), the leading wireless medical technology company focused on the delivery of health information to improve quality of life and reduce cost of care, announced today a significant victory in the patent infringement case against Mednet Healthcare Technologies, Inc. and its subsidiaries, Heart-Care Corporation of America, Universal Medical Inc., and Universal Medical Laboratory, Inc. (“Mednet”), as well as other named defendants. Mednet entered into a consent judgment, declaring that the Mednet entities infringed on five patents owned by BioTelemetry and its subsidiary, Braemar Manufacturing, and that all five patents are valid.

The lawsuit, which was filed in the U.S. District Court for the Eastern District of Pennsylvania in May 2012, centered on patented technology used in BioTelemetry’s Mobile Cardiac Outpatient Telemetry (MCOTTM). A litigation team from Ropes & Gray represented BioTelemetry in the case.

Following the entry of the consent judgment, BioTelemetry acquired all outstanding shares of Mednet for an aggregate purchase price of approximately $16.0 million, consisting of $5.5 million of cash, $0.8 million of BioTelemetry common stock and the assumption of $9.7 million of debt. Mednet’s core competencies include outpatient cardiac monitoring and contract manufacturing of cardiac monitoring devices.

Joseph H. Capper, President and Chief Executive Officer of BioTelemetry, commented, “I believe the acquisition of Mednet is the best possible outcome for all involved. While an unorthodox path to such a combination, the company will benefit from Mednet’s more than $25 million in annual revenue and its reputation for world class customer service. We expect the acquisition to be accretive, adding $4.0 to $5.0 million of EBITDA post-integration. We are pleased to add the Mednet employees to the BioTelemetry team and look forward to continuing to provide superior service to their many loyal customers.”

Christopher Keane, President of Mednet, commented, “This merger is the perfect fit for the Mednet family. It will allow Mednet to continue to provide unparalleled service while allowing us to offer Biotelemetry’s industry leading technology to our customers.”

About BioTelemetry

BioTelemetry, Inc., formerly known as CardioNet, Inc., is the leading wireless medical technology company focused on the delivery of health information to improve quality of life and reduce cost of care. The Company currently provides cardiac monitoring services, original equipment manufacturing with a primary focus on cardiac monitoring devices and centralized cardiac core laboratory services. More information can be found at www.biotelinc.com.

Cautionary Statement Regarding Forward-Looking Statements

This document includes certain forward-looking statements within the meaning of the “Safe Harbor” provisions of the Private Securities Litigation Reform Act of 1995 regarding, among other things, the impact of the Mednet acquisition on our operations and our ability to successfully integrate their operations, the prospects for our products and our confidence in the Company’s future, as well as our expectations regarding the effect the United contract will have on the company’s operating results.  These statements may be identified by words such as “expect,” “anticipate,” “estimate,” “intend,” “plan,” “believe,” “promises” and other words and terms of similar meaning.  Such forward-looking statements are based on current expectations and involve inherent risks and uncertainties, including important factors that could delay, divert, or change any of these expectations, and could cause actual outcomes and results to differ materially from current expectations.  These factors include, among other things, effects of changes in health care legislation, effectiveness of our cost savings initiatives, relationships with our government and commercial payors, changes to insurance coverage and reimbursement levels for our products, the success of our sales and marketing initiatives, our ability to attract and retain talented executive management and sales personnel, our ability to identify acquisition candidates, acquire them on attractive terms and integrate their operations into our business, the commercialization of new products, market factors, internal research and development initiatives, partnered research and development initiatives, competitive product development, changes in governmental regulations and legislation, the continued consolidation of payors, acceptance of our new products and services, patent protection, adverse regulatory action, and litigation success, our ability to successfully create a new holding company structure and to anticipate the benefits of such structure.  For further details and a discussion of these and other risks and uncertainties, please see our public filings with the Securities and Exchange Commission, including our latest periodic reports on Form 10-K and 10-Q.  We undertake no obligation to publicly update any forward-looking statement, whether as a result of new information, future events, or otherwise.

CONTACT: BioTelemetry, Inc.
         Heather C. Getz
         Investor Relations
         800-908-7103
         investorrelations@cardionet.com
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(HOTR) Completes Acquisition of Hooters Pacific Northwest Franchise

Company Also Completes Acquisition of Spoon Bar & Kitchen

CHARLOTTE, NC–(February 03, 2014) – Chanticleer Holdings, Inc. (NASDAQ: HOTR) (Chanticleer Holdings or the “Company”), a minority holder in the privately held parent company of the Hooters® brand Hooters Of America, and a franchisee of international Hooters restaurants, has announced that it has completed the acquisition of Hooters’ U.S. Pacific Northwest franchise rights and two existing restaurants in Oregon and Washington.

Chanticleer has acquired 100% of the shares of Tacoma Wings, LLC and Hooters of Oregon Partners, LLC, owners and operators of the two locations in Portland, OR and Tacoma, WA. All leasehold and current franchise rights to the Hooters locations in Oregon and Washington have been transferred to the Company and Management is evaluating locations around the Portland and Seattle areas for future restaurant openings.

In addition, Chanticleer also completed its acquisition of Chef John Tesar’s fine dining seafood restaurant, Spoon Bar & Kitchen, located in Dallas, TX, acquiring 100% of the shares of Dallas Spoon, LLC and Dallas Spoon Beverage, LLC. The Company intends to expand the Spoon brand taking its healthier seafood menu into a new, fast-casual dining concept.

Mike Pruitt, Chairman and Chief Executive Officer, commented, “We are starting off the new year successfully completing both of these acquisitions and more importantly adding three operating restaurants to our portfolio. The Pacific Northwest provides strategic opportunities to expand the footprint of our brands.”

For more information on the transactions, please refer to Chanticleer Holdings’ filings at www.sec.gov.

About Chanticleer Holdings, Inc
Headquartered in a Charlotte, NC, Chanticleer Holdings (HOTR), together with its subsidiaries, owns and operates restaurant brands in the United States and internationally. The Company is a franchisee owner of Hooters® restaurants in international markets including England, South Africa, Hungary, and Brazil and has joint ventured with the current Hooters franchisee in Australia and domestically in Oregon and Washington. Chanticleer is evaluating several additional international opportunities. The Company also owns and operates American Roadside Burgers and owns a majority interest in Just Fresh restaurants in the U.S.

For further information, please visit www.chanticleerholdings.com
Facebook: www.Facebook.com/ChanticleerHOTR
Twitter: http://Twitter.com/ChanticleerHOTR
Google+: https://plus.google.com/u/1/b/118048474114244335161/118048474114244335161/posts

Forward-Looking Statements:
Any statements that are not historical facts contained in this release are “forward-looking statements” as that term is defined under the Private Securities Litigation Reform Act of 1995 (PSLRA), which statements may be identified by words such as “expects,” “plans,” “projects,” “will,” “may,” “anticipates,” “believes,” “should,” “intends,” “estimates,” and other words of similar meaning. Such forward-looking statements are based on current expectations, involve known and unknown risks, a reliance on third parties for information, transactions or orders that may be cancelled, and other factors that may cause our actual results, performance or achievements, or developments in our industry, to differ materially from the anticipated results, performance or achievements expressed or implied by such forward-looking statements. Factors that could cause actual results to differ materially from anticipated results include risks and uncertainties related to the fluctuation of global economic conditions, the performance of management and our employees, our ability to obtain financing or required licenses, competition, general economic conditions and other factors that are detailed in our periodic reports and on documents we file from time to time with the Securities and Exchange Commission. The forward-looking statements contained in this press release speak only as of the date the statements were made, and the companies do not undertake any obligation to update forward-looking statements. We intend that all forward-looking statements be subject to the safe-harbor provisions of the PSLRA.

Press Information:
Chanticleer Holdings, Inc.
Investor Relations
Phone: 704.366.5122
ir@chanticleerholdings.com

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(CYTR) to Present at the 16th Annual BIO CEO & Investor Conference on Feb 10

CytRx Corporation (NASDAQ:CYTR), a biopharmaceutical research and development company specializing in oncology, today announced that President and CEO Steven A. Kriegsman and Vice President of Business Development David Haen will present at the 16th Annual BIO CEO & Investor Conference on Monday, February 10, 2014, at 2:30 p.m. Eastern time (11:30 a.m. Pacific time). The conference is being held February 10-11 at the Waldorf Astoria Hotel in New York City.

A live and archived webcast of the presentation will be available on the Company’s website at www.cytrx.com/investors/presentations.

About CytRx Corporation

CytRx Corporation is a biopharmaceutical research and development company specializing in oncology. CytRx currently is focused on the clinical development of aldoxorubicin (formerly known as INNO-206), its improved version of the widely used chemotherapeutic agent doxorubicin. CytRx has completed a global Phase 2b clinical trial with aldoxorubicin as a first-line therapy for soft tissue sarcomas, a Phase 1b/2 clinical trial primarily in the same indication, a Phase 1b study of aldoxorubicin in combination with doxorubicin in patients with advanced solid tumors and a Phase 1b pharmacokinetics clinical trial in patients with metastatic solid tumors. CytRx plans to initiate under a special protocol assessment a pivotal Phase 3 global trial with aldoxorubicin as a therapy for patients with soft tissue sarcomas whose tumors have progressed following treatment with chemotherapy, and recently announced that it has received approval from the FDA to continue dosing patients with aldoxorubicin until disease progression in that clinical trial. CytRx has initiated a Phase 2 clinical trial with aldoxorubicin in patients with late-stage glioblastoma (brain cancer), and a Phase 2 clinical trial in HIV-related Kaposi’s sarcoma. CytRx plans to expand its pipeline of oncology candidates based on a linker platform technology that can be utilized with multiple chemotherapeutic agents and may allow for greater concentration of drug at tumor sites. CytRx also has rights to two additional drug candidates, tamibarotene and bafetinib. CytRx completed its evaluation of bafetinib in the ENABLE Phase 2 clinical trial in high-risk B-cell chronic lymphocytic leukemia (B-CLL), and plans to seek a partner for further development of bafetinib. For more information about CytRx Corporation, visit www.cytrx.com.

About the BIO CEO & Investor Conference

Now in its sixteenth year, the BIO CEO & Investor Conference is the largest investor conference focused on established and emerging publicly traded and select private biotech companies. Each year the BIO CEO & Investor Conference provides a neutral forum where institutional investors, industry analysts, and senior biotechnology executives have the opportunity to shape the future investment landscape of the biotechnology industry. The conference features issue-oriented plenary sessions, educational sessions focused on hot therapeutic areas and key business issues, company presentations, one-on-one meetings, and networking opportunities.

Forward-Looking Statements

This press release contains forward-looking statements within the meaning of Section 21E of the Securities Exchange Act of 1934, as amended. Such statements involve risks and uncertainties that could cause actual events or results to differ materially from the events or results described in the forward-looking statements. All forward-looking statements are based upon information available to CytRx on the date the statements are first published. CytRx undertakes no obligation to publicly update or revise any forward-looking statements, whether as a result of new information, future events or otherwise.

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