RxNews Recap for Friday 01-29-10. Mylan (MYL) gets FDA nod. Print E-mail
By Mary Davila   
Friday, 29 January 2010 19:00


Below is a list of the companies that made news in the healthcare sector on Friday, January 29, 2010.

Mylan Inc. (Nasdaq: MYL)On a day that saw most stocks finish in the red, shares of Mylan we up as the company announced that its subsidiary Mylan Pharmaceuticals Inc. received final approval from the U.S. Food and Drug Administration (FDA) for its Abbreviated New Drug Application (ANDA) for Polyethylene Glycol 3350 and Electrolytes for Oral Solution, USP, the generic version of Braintree Laboratories' GoLytely® laxative.

Polyethylene Glycol 3350 and Electrolytes for Oral Solution had U.S. sales of approximately $14 million for the 12 months ending Sept. 30, according to IMS Health. Mylan's version is available for immediate shipment.

Currently, Mylan has 141 ANDAs pending U.S. Food and Drug Administration approval representing $87.9 billionin annual brand sales, according to IMS. Thirty-nine of these pending ANDAs are potential first-to-file opportunities, representing $19.6 billion in annual brand sales, according to IMS.

Mylan Inc. ranks among the leading generic and specialty pharmaceutical companies in the world and provides products to customers in more than 140 countries and territories. The company maintains one of the industry's broadest and highest quality product portfolios supported by a robust product pipeline; operates one of the world's largest active pharmaceutical ingredient manufacturers; and runs a specialty business focused on respiratory, allergy and psychiatric therapies.

In other news on what was a relatively quiet Friday:

American Medical Systems Holdings, Inc.(Nasdaq: AMMD) announced today they have signed an agreement with privately held Tissue Genesis, Inc., an emerging leader in advanced tissue engineering and cell therapy solutions, for the research and development of adipose (fat) derived regenerative cells for use in treating pelvic health disorders. American Medical Systems will pay $1.1 million over the life of the agreement to obtain rights offered by Tissue Genesis, Inc.

"AMS is committed to being at the forefront of innovation to improve the lives of the millions of people worldwide who suffer from pelvic health disorders," said Tony Bihl, President and CEO of American Medical Systems. "We are delighted to partner with Tissue Genesis, a leader in the burgeoning field of regenerative cell technology, to research therapies that may fundamentally improve patient treatment within our markets."

Conceptus, Inc. (NASDAQ:CPTS), developer of the Essure® procedure, today announced that the Company will introduce 2010 guidance and release 2009 fourth quarter financial results on Tuesday, February 23, 2010 after the close of market.

Enzo Biochem, Inc. (NYSE: ENZ) is well positioned to benefit from the results of its transformation involving acquisitions, new managements at each of its major subsidiaries and a heightened focus on new life science, diagnostic and therapeutic products, Barry Weiner, President, told the annual meeting of shareholders today.

Genzyme Corporation (NASDAQ: GENZ) announced today that it has taken steps to strengthen the role of its lead independent director, and appointed new leadership to head the board’s audit committee.

Gilead Sciences, Inc. (Nasdaq:GILD) today announced that the company’s Board of Directors has authorized the repurchase of up to $1.0 billion of the company’s common stock through January 2011.

Keryx Biopharmaceuticals, Inc. (Nasdaq: KERX)(the "Company") today announced that an article entitled "Clinical and Translational Studies of a Phase II Trial of the Novel Oral Akt Inhibitor Perifosine in Relapsed or Relapsed/Refractory Waldenstrom's Macroglobulinemia," reporting Phase 2 data demonstrating the single agent activity of KRX-0401 (Perifosine) for the treatment of advanced Waldenstrom's Macroglobulinemia ("Waldenstrom's"), will appear in the February 1, 2010 issue of Clinical Cancer Research.  

NuVasive, Inc. (Nasdaq: NUVA), a medical device company focused on developing products for minimally disruptive surgical treatments for the spine, today announced preliminary unaudited financial results for the full year ended December 31, 2009.

NuVasive anticipates full year 2009 revenue of approximately $370 million, ahead of previously issued guidance. The Company announced anticipated full year 2009 revenue in advance of its annual global sales meeting, which will take place January 29-30, 2010. The Company expects full year 2009 GAAP earnings per share of $0.14 to $0.15. Excluding intellectual property litigation expenses, acquisition related charges, and the benefit of the reversal of a leasehold termination charge, the Company expects full year 2009 earnings per share of $0.30 to $0.31.

PROLOR Biotech, Inc., (OTC Bulletin Board: PBTH) today noted the European Commission (EC) approval of Merck & Co., Inc.'s ELONVA®, a long-acting CTP-modified version of the fertility drug follicle stimulating hormone (FSH).  With the EC approval, Merck has marketing authorization for ELONVA with unified labeling valid in all European Union Member States.  

QuantRx Biomedical Corporation (OTCBB: QTXB)today announced that it has entered into an agreement to acquire NuRx Pharmaceuticals, Inc. (OTCBB: NUXP).

Quidel Corporation (NASDAQ:QDEL), a leading provider of rapid point-of-care (POC) diagnostic tests, will release fourth quarter and full year 2009 financial results after market close on Thursday, February 11, 2010.

Repligen Corporation (Nasdaq: RGEN)announced today that the Company President and Chief Executive Officer, Walter C. Herlihy, Ph.D., will host a conference call and webcast on Thursday, February 4th, 2010 at 10:00 a.m. EST, to report third quarter fiscal year 2010 financial results and to provide a quarterly update of the Company.

Rosetta Genomics (NASDAQ:ROSG)today announced that the United States Patent and Trademark Office has allowed claims in two patent applications. “Rosetta Genomics owns or has access to intellectual property related to microRNAs that is among the broadest of any commercial entity, and these two notices of allowance further solidify our position,” said Kenneth A. Berlin, president and chief executive officer. “Our patent applications and issued patents cover approximately 51% of publicly registered microRNAs, plus 168 non-public, newly discovered microRNAs. microRNAs are at the forefront of an exciting revolution in personalized medicine and we believe that Rosetta is leading the way in diagnostic uses as we harness this knowledge to advance our deep pipeline of products.”

Senomyx, Inc. (NASDAQ: SNMX),a leading company focused on using proprietary technologies to discover and develop novel flavor ingredients for the food, beverage, and ingredient supply industries, announced today that Firmenich SA, the world's largest privately-owned fragrance and flavor company, has made a decision to proceed with commercial development of S6973, Senomyx’s enhancer of sucrose (table sugar) that has demonstrated the ability to reduce up to 50% of the sugar in a variety of products while maintaining the taste of natural sugar.

Spectrum Pharmaceuticals, Inc. (Nasdaq: SPPI), announced today that it has received $15 million from Nippon Kayaku in connection with the collaboration agreement for apaziquone (EOquin®) announced on November 10, 2009, and $1 million from Handok Pharmaceuticals announced on November 23, 2009.

As required under the indenture covering Apogent Technologies Inc. Floating Rate Convertible Senior Debentures due 2033 (CUSIP No. 03760AAK7), Thermo Fisher Scientific Inc. (NYSE: TMO) is providing public notice to the holders of these bonds that they have the right to receive contingent interest for the current quarterly interest period ending March 15, 2010.

Biotech investors interested in seeing more details about these companies and a full list of their related stories can do so by typing the stock ticker symbol into the Stock Quotes box on the right side of the page.


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