Pozen drug wins FDA approval

Posted April 30, 2010 7:15 p.m. EDT

— Pozen Inc. and AstraZeneca Plc won U.S. clearance Friday to sell an arthritis drug that combines a painkiller with an ulcer medication.

The Food and Drug Administration approved the medicine, called Vimovo, for use in arthritis patients who are at risk of developing gastric ulcers, the agency said today in an e-mail. Pozen’s shares rose 21 percent, or $2.30, to $13.15 in extended trading on the Nasdaq Stock Market before being halted.

The drug, developed with Pozen’s technology, combines the over-the-counter pain reliever naproxen with esomeprazole, the main ingredient in London-based AstraZeneca’s Nexium ulcer medicine. Vimovo may generate $500 million in sales in 2014, Gbola Amusa, an analyst at UBS AG in London, said Thursday in an e-mail.

Patients who took Vimovo in two six-month clinical trials developed fewer ulcers than people who took naproxen alone, Pozen said last fall.

The company, which reported a net loss of $6.9 million last year, received a $10 million payment from AstraZeneca in September after the FDA agreed to review the drug, and is now entitled to another $20 million based on the agency’s approval. Pozen also will earn royalty payments based on sales under the companies’ licensing agreement.

Revenue from Vimovo royalties may reach $1.5 million in 2011 and jump to $10.9 million in 2013, Eun Yang, an analyst with Jefferies & Co. in New York, said yesterday.

“Under this scenario, we estimate Pozen could potentially become profitable in 2012,” Yang said in a note to clients.