Pozen drug wins FDA approval
Chapel Hill-based Pozen and AstraZeneca won U.S. clearance Friday to sell an arthritis drug that combines a painkiller with an ulcer medication.
Posted — UpdatedThe 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.
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