Drug Maker Pozen Announces Positive Results for Its Aspirin
Drug Maker Pozen Announces Positive Results for Its Aspirin [the News & Observer, Raleigh, N.C.]
From News & Observer (Raleigh, NC) (March 23, 2012)
March 23--Pozen’s efforts to attract a marketing partner for the easier-to-stomach aspirin that it is developing got a boost Thursday when the Chapel Hill company announced positive test results for the drug.
Investors were upbeat, too. Pozen shares rose 42 cents to close at $5.22. Shares rose as much as 19 percent earlier in the day before falling back somewhat.
Pozen reported that two Phase 3 tests of its experimental drug PA32540, which combines aspirin and a gastrointestinal medicine, significantly reduced the incidence of gastric ulcers in patients who took the drug over six months.
The drug is aimed at helping to prevent heart disease and stroke in patients who are susceptible to aspirin-induced ulcers.
"We just don’t know how it could have turned out any better than what we were able to see," said co-founder and CEO John Plachetka.
The results released Thursday didn’t include detailed data, just the report of a statistically significant improvement. Pozen intends to announce the details at a scientific conference later this year.
The two Phase 3 clinical trials involved a total of 1,049 patients who took either PA32540 or 325 milligrams of enteric-coated aspirin once daily.
PA32540 contains aspirin and a modified version of omeprazole, the active ingredient found in Prilosec. The modifications accelerate the release of omeprazole ahead of the aspirin.
"It’s the equivalent of putting on a bullet-proof vest before someone pulls the trigger," Plachetka said.
The trials were especially challenging, Plachetka said, because enteric-coated aspirin, which delays the drug’s release, is widely rated "the safest of all forms of aspirin. So we went against what is considered to be the gold standard."
In addition, participation in the trial was limited to patients who already had been taking aspirin for at least 3 months.
"These are people who themselves thought they were very aspirin-tolerant and also their physicians thought they were aspirin-tolerant," Plachetka said.
The results could accelerate the company’s discussions with potential marketing partners and "may help Pozen secure a partnership on more favorable terms," wrote Wells Fargo Securities analyst Michael Tong in a research note.
Plachetka said he anticipates reaching a partnership deal before the end of the year.
The company expects to submit a filing seeking marketing approval of PA32540 in the third quarter.
Pozen projects PA32540 could achieve peak annual sales of $400 million in the U.S. alone. That projection is based on making it available to patients for about $1 a day.
"We think that’s what the world needs, not just better medicine but medicine that people can afford," Plachetka said.
Drug development is a marathon and many small companies never make it to the ultimate finish line -- having a drug that passes regulatory muster.
But Pozen, which has 32 employees, already has done it twice.
Its two drugs are Treximet, a migraine mediation sold by GlaxoSmithKline, and Vimovo, an arthritis pain reliever sold by AstraZeneca.
Pozen also is developing a higher-dose version of aspirin for pain relief.
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Posted: March 2012