|RxNews Recap for Friday 01-29-10. Mylan (MYL) gets FDA nod.|
|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.
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.
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.
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.