FDA accepts new drug application from Pozen for arthritis drug

Shares in pharmaceutical firm Pozen (Nasdaq: POZN) climbed 7 percent Monday after the company disclosed that the U.S. Food and Drug Administration had accepted its new drug application for Vimovo.

The drug targets arthritis and includes the heartburn product “purple pill” Nexium from AstraZeneca. AstraZeneca is partnering with Pozen in development of Vimovo.

Shares traded at $6.93, up 46 cents, in late-morning trading. By early afternoon, the rally cooled to a 4.5 percent gain of 29 cents. Pozen closed at $6.73, up 4 percent for the day or 26 cents.

The FDA acceptance of the application triggered a $10 million milestone payment from AstraZeneca. Pozen filed the application in June.

Tthe drug formerly known as PN 400 combines Nexium with the anti-inflammatory drug naproxen. It is designed to help patients who face the risk of developing ulcers related to pain relievers.

Vimovo has been tested in clinical trials as a treatment for osteoarthritis, rheumatoid arthritis and a condition known as ankylosing spondylitis.

In September 2007, Pozen and AstraZeneca announced the launch of a Phase III clinical trial. Under a revised partnership agreement. Pozen could earn as much as $345 million from AstraZeneca.

Pozen has proprietary technology that enables the combination of drugs into one compound. It brought a migraine headache pain reliever to market in partnership with GlaxoSmithKline.

"Millions of people worldwide suffer from arthritis and we are excited about the prospect of developing and bringing an important new therapy to these patients," said Tony Zook, president and chief executive officer at AstraZeneca, at the time of the PN 400 partnership announcement.

Source : localtechwire.com

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