New drug promises relief from aspirin-related ulcers
(Reuters) - Millions of aspirin users may soon be able to pop the wonder pill without worrying about stomach ulcers, a nasty side-effect that could come with regular use of the drug.
Pozen Inc, a U.S. pharmaceutical company, on Thursday said its experimental therapy helped significantly reduce stomach ulcers in long-term aspirin users, like those with heart problems.
In use for more than two centuries now, aspirin has become synonymous with pain relief. It is also used to reduce the risk of heart attacks, strokes and some other potentially fatal ailments.
The drug, however, has many side-effects such as gastric or stomach ulcers, a painful condition that often causes heartburn and indigestion.
"About 20-25 percent of aspirin users are at risk to develop gastric ulcers ... so it's an enormous market opportunity for Pozen," Zacks analyst Jason Napodano told Reuters.
According to Pozen's website, about 50 million Americans use aspirin regularly for cardiovascular disease prevention.
The company's oral, once-daily drug is a combination of aspirin and AstraZeneca's Prilosec, a commonly used gastric medicine. If approved, Pozen's treatment, PA32540, would offer a convenient alternative to patients who would otherwise have to take these two drugs separately.
However, analyst Napodano said the company would have to price it competitively to win a bigger slice of the market.
Pozen previously outlined plans to price the drug at about $1 a day, making it more expensive than the combination of aspirin, which sells for about $5 a month and Prilosec, available for $10-$15 monthly, Napodano said.
The Chapel Hill, North Carolina-based company said it plans to file for marketing approval for the drug with the U.S. Food and Drug administration in the third quarter of 2012.
The drug showed significant reduction in the cumulative incidence of gastric ulcers compared with 325 mg delayed-release aspirin in two late-stage studies.
Pozen, which has been on the lookout for a partner for the drug, has not specified when it plans to present complete results from the studies.
Wells Fargo analyst Michael Tong, who kept his "outperform" rating on the stock, said positive top-line data from the studies would help Pozen draw partners.
Analyst Napodano reckons there is an excellent chance of U.S. regulatory approval for the drug, which could garner as much as $200 million in annual sales.
The late-stage studies were conducted on 1,049 patients, who had been taking aspirin for at least three months to prevent cardiovascular problems and were at risk of developing stomach ulcers.
Pozen's shares were up 5 percent at $5.03 on Thursday afternoon on the Nasdaq, after rising to a six-month high of $5.73 earlier in the morning.
(Reporting by Zeba Siddiqui in Bangalore, additional reporting by Bill Berkrot in New York; Editing by Roshni Menon, Viraj Nair)
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