June 20 U.S. health regulators informed Pozen
Inc that they have come to a preliminary determination
that the drugmaker's experimental stomach ulcer drug did not
show bioequivalence with 325 mg aspirin, further jeopardizing
the drug's chances to win approval soon.
Pozen's shares were down 19 percent in extended trade, after
closing at $7.45 Wednesday on the Nasdaq.
The stock had plunged by nearly a third in April, when the
U.S. Food and Drug Administration suggested the company also
seek approval for a lower version of the drug, and that it may
limit the drug to a smaller-than-expected patient population.
In a regulatory filing Wednesday, Pozen said the FDA now
advised it that its lower dose drug would also likely need an in
vivo bioequivalence study to win approval.
Pozen had said In April that it did not intend to conduct a
new study for the lower dose and would instead submit existing
data in support of the application. At the time, the company
said it expected its filing for marketing approval to be delayed
by six months.
The oral, once-daily drug is a combination of aspirin and
AstraZeneca's Prilosec, a commonly used gastric
medicine. If approved, the pill would offer a convenient
alternative to patients who would otherwise have to take these
two drugs separately.
Pozen said on Wednesday it planned a follow-up call with the
FDA in the next few weeks to determine the next steps in
satisfying the bioequivalence requirements and any impact on the
approval filing timeline.