Regeneron jumps 8% on analyst upgrade; ISTA Announces U.S. Patent Allowance for PROLENSA(TM) Print E-mail
By Staff and Wire Reports   
Friday, 06 January 2012 19:54
Below is a look at some of the headlines for companies that made news in the healthcare sector on January 4, 2012. Shares of biotech group Regeneron Inc. (NASDAQ:REGN) jumped on Friday following an upgrade by Jefferies & Co.

The analysts raised their rating of the stock to buy from hold, and their price target to $75 from $66, citing greater-than-expected market appeal for Regeneron's newly approved ophthalmology drug Eylea. Regeneron shares have been on a roll since the company announced earlier this week that it settled a patent dispute with Roche's RHHBY +0.77% Genentech unit over Eylea.

Also boosting shares was an announcement that leading pharmacy-benefits provider Express Scripts ESRX +0.77% has signed on as a distributor for Eylea. The product was approved by the U.S. Food and Drug Administration on Nov. 18 for the treatment of wet age-related macular degeneration, a leading cause of blindness in the elderly

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STA Pharmaceuticals, Inc. (NASDAQ: ISTA), announced its partner Senju Pharmaceuticals Co. Ltd. has received a Notice of Allowance from the United States Patent and Trademark Office for Application Serial No 10/525,006 titled, "Aqueous Liquid Preparation Containing 2-Amino-3-(4-Bromobenzoyl) Phenylacetic Acid" with claims that cover an optimized formulation of bromfenac. In October, ISTA reported statistically significant Phase 3 results for its product candidate, PROLENSA" (bromfenac ophthalmic solution), which incorporates this proprietary formulation of bromfenac.

The Notice of Allowance concludes the substantive examination of this patent application and is expected to result in the issuance of a U.S. patent following completion of administrative processes. The patent is anticipated to issue in the first half of 2012 and expire in 2024.

"This notice of allowance is important to further broaden the intellectual property position for one of our key franchises," said Vicente Anido, Jr., Ph.D., President and Chief Executive Officer of ISTA. "The bromfenac franchise has multiple barriers to entry -- existing Hatch-Waxman exclusivity for BROMDAY" and Hatch-Waxman exclusivity upon potential approval of PROLENSA, this new allowed patent and additional patents pending. It is a critical step to our continued leadership in the $367 million ophthalmic nonsteroidal anti-inflammatory drug (NSAID) market in the U.S. Once issued, we believe that this patent will provide protection for not only PROLENSA, but also a potential bromfenac adjunct therapy for age-related macular degeneration (AMD)."

Dr. Anido continued, "We anticipate filing a New Drug Application (NDA) with the FDA for PROLENSA in the first half of 2012, with a commercial launch following approval planned in early 2013. Because PROLENSA has a lower-concentration of the active ingredient with high efficacy and safety, we plan to discontinue our current once-daily product, BROMDAY, sometime after the successful launch of PROLENSA. This is the same commercial strategy we successfully implemented in early 2011 for conversion of our twice-daily XIBROM" prescriptions to once-daily BROMDAY."



Also Friday:



AdCare Health Systems, Inc. (NYSE Amex: ADK), a leading nursing home and assisted living company, has signed a definitive purchase agreement for three skilled nursing facilities in Arkansas for $27.3 million.

Advaxis, Inc., (OTCBB: ADXS), a leader in developing the next generation of immunotherapies for cancer and infectious diseases, announced today that Tom Moore, Chairman & CEO of Advaxis, will present a corporate overview at the 5th Annual OneMedForum San Francisco 2012 conference at 2.15pm PST on Tuesday, January 10, 2012.

Alnylam Pharmaceuticals, Inc. (Nasdaq: ALNY), a leading RNAi therapeutics company, announced today that it has filed a Clinical Trial Application (CTA) with the U.K. Medicines and Healthcare products Regulatory Agency (MHRA) to initiate a Phase I clinical trial with ALN-TTR02, an RNAi therapeutic targeting transthyretin (TTR) for the treatment of TTR-mediated amyloidosis (ATTR).

A.P. Pharma, Inc. (OTCBB: APPA), a specialty pharmaceutical company, today announced that the Company will present at the OneMedForum San Francisco 2012 Finance Conference on January 11, 2012 at 10:45 a.m. PST.

Arizona-based algae producer Health Enhancement Products (OTCBB: HEPI) recently named its product development & marketing consultant Andrew Dahl as its President and Chief Executive Officer.

Callidus Software Inc. (NASDAQ: CALD), the leader in sales effectiveness and cloud computing, announced today that a global leader in biotechnology has selected the CallidusCloud™ Monaco SPM suite to drive the performance of its sales organization.

Endo Pharmaceuticals (Nasdaq: ENDP) announced today it has signed a worldwide license and development agreement with U.S.-based BioDelivery Sciences International (Nasdaq: BDSI) for BEMA Buprenorphine.

Lightlake Therapeutics Inc. (OTCBB: LLTP), an early stage biopharmaceutical company developing modern addiction treatments based on its expertise using opioid antagonists, announced today that it intends to develop a treatment for premenstrual syndrome (PMS) overeating using its patented technology involving opioid antagonists.

Neurocrine Biosciences, Inc. (Nasdaq: NBIX) announced today that Kevin Gorman, President and Chief Executive Officer of Neurocrine Biosciences, will be presenting at the 30th Annual J. P. Morgan Healthcare Conference at the Westin St. Francis Hotel in San Francisco, California.

Nyxio Technologies Corporation(OTCBB: NYXO) ("Nyxio" or the "Company"), a leading provider of cutting edge "Smart TV" and consumer electronics devices, looks forward to welcoming attendees to the 2012 International Consumer Electronics Show (CES) January 10 - 13 in Las Vegas.

Pacific Biosciences of California, Inc. (NASDAQ:PACB), provider of Single Molecule Real Time (SMRT®) sequencing products, today announced the appointment of Michael W. Hunkapiller, Ph.D., as President and Chief Executive Officer effective immediately.

Radient Pharmaceuticals Corporation (OTCQX:RXPC) (OTCPK:RXPC), a developer and marketer of In Vitro Diagnostic (IVD) cancer tests, today announced that its new advertising campaign about the effectiveness of Onko-Sure® will be launched with a print ad that will periodically run in four major oncology publications throughout 2012.

SANUWAVE Health, Inc. (OTCBB: SNWV), an emerging medical technology company focused on the development and commercialization of noninvasive, biological response activating devices in regenerative medicine, today announced that the U.S. Patent and Trademark Office (USPTO) has issued the Company patent number 8,088,073, titled “Device for the Application of Acoustic Shock Waves.”

Synta Pharmaceuticals Corp. (NASDAQ: SNTA) announced today that it has priced an underwritten public offering of 7,000,000 shares of its common stock at a price to the public of $4.40 per share.

Transgenomic, Inc. (OTCBB: TBIO) today announced that it has entered into a Convertible Promissory Note Purchase Agreement (the “Purchase Agreement”) in the aggregate amount of $3.0 million with entities (the “Investors”) associated with Third Security, LLC, a leading life sciences investment firm.

Thermo Fisher Scientific Inc. (NYSE: TMO), the world leader in serving science, today introduced Unity™ Lab Services, a new offering that combines product and laboratory support services to create a single solution for customers to optimize productivity and reduce their total cost of laboratory operations.



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