Chapel Hill drugmaker Pozen said this week its application for a new heart attack and stroke-prevention pill will be delayed by three months and will require a new clinical trial.
Pozen’s application at the U.S. Food and Drug Administration will be held up by additional tests of the drug on as many as 30 patients, at an estimated cost of $750,000, the company said. Pozen said FDA officials want to determine that each of the drugs two versions have equal amounts of omeprazole, which reduces the body’s production of stomach acid.
Pozen had previously announced a Jan. 24 date for anticipated FDA approval. On Monday, Pozen postponed the drug’s approval date to April 25.
“It’s a minor delay,” said Bill Hodges, Pozen’s chief financial officer. “It’s an amendment to the NDA” (New Drug Application).
The company is seeking approval for its drug as an alternative to aspirin for treating heart-disease and stroke patients; Pozen has estimated the drug’s potential market at $400 million annually in the United States. The small company, which reported revenue of $5.3 million in 2012, has spent nearly $70 million dollars developing the drug since 2007.
Pozen in September announced that it signed a deal with French pharmaceutical firm Sanofi to commercialize and market the drug, with Pozen to receive between 12.5 percent and 22.5 percent of sale proceeds, Hodges said.
The as-yet unnamed drug comes in two formulations – PA8140 and PA32540 – and is designed to reduce aspirin-induced gastric ulcers and associated internal bleeding. The medication combines coated aspirin and omeprazole.
PA32540 has four times the amount of aspirin as PA8140.
Pozen has said that clinical trials on hundreds of patients demonstrated that patients experienced fewer ulcers after taking its treatment.
The company, which employs 16 people, was founded in 1996 and became publicly traded in 2000.
It has developed two other drugs – Treximet for migraine headaches and Vimovo for arthritis pain relief – that are on the market.