Pozen’s stock fell 18 percent on Thursday after the Chapel Hill company announced that federal regulators may delay approval of its experimental cardiovascular drug PA32540.
The company said Wednesday that federal regulators have preliminarily decided the drug did not meet an approval milestone and have recommended further study.
Pozen is seeking approval to market the drug as a replacement for aspirin in the prevention of heart disease and stroke in patients at high risk for developing ulcers from aspirin use.
PA32540, which is now in the final stages of clinical trials, is an experimental combination of aspirin and a modified version of omeprazole (Prilosec).
The FDA also told Pozen that PA32540 approval will also probably require an in vivo study of the bioequivalence of the lower-dose version of the drug, which could add money and time to the approval process.
Pozen said it will follow up with a call to the FDA in the next few weeks to discuss the agency’s concerns and determine the next steps.
Pozen previously estimated that the market for PA32540 could reach $400 million annually in the United States, charging patients $1 per day for the drug. So far, the company has spent millions of dollars on clinical trials for the drug.
The drug is aimed at patients who currently take aspirin and Prilosec as separate pills.
Pozen has had success bringing two drugs to the market: Treximet, used to treat migraines and sold by GlaxoSmithKline, and Vimovo, an arthritis pain reliever sold by AstraZeneca. Most of the company’s revenue comes from royalties from the sales of these two drugs.
The company is seeking a strategic partner for PA32540 and has another experimental migraine drug in the pipeline, MT 400.
Pozen shares closed down $1.355 at $6.095 on Thursday. The stock is up 55 percent this year.
Staff writer Gloria Lloyd