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Friday, 04/27/2012 2:50:16 PM

Friday, April 27, 2012 2:50:16 PM

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Pozen tumbles on delay for cardiovascular drug
Pozen falls after saying cardiovascular drug filing will be delayed; approval could be limited
Associated PressAssociated Press – 20 minutes ago
Companies:

POZEN Inc.
AstraZeneca PLC
AstraZeneca PLC

RELATED QUOTES
Symbol Price Change
POZN 6.26 -1.47
AZN.L 2,680.50 14.00
ZEG.DE 32.62 0.00
AZN 43.64 0.28
Fantasy Finance

NEW YORK (AP) -- Shares of Pozen Inc. dropped Friday after the company said approval for an experimental cardiovascular drug may be delayed, and it is possible the product's marketing approval will be limited.

THE SPARK: The drug, code-named PA32540, is intended as an alternative to aspirin as a secondary treatment for the prevention of cardiovascular disease. Many people take aspirin to prevent heart problems, but long-term use of aspirin can cause ulcers. PA32540 contains aspirin and omeprazole, the active ingredient in heartburn drugs like Prilosec. The omeprazole is released as soon as the drug is taken and the aspirin is released over time.

Pozen said Friday that the Food and Drug Administration has suggested it seek approval of a lower-dose version of PA32540 — one that contains 81 milligrams of aspirin instead of 325 milligrams. Pozen said the FDA might only be willing to approve the 325-milligram version for use in patients who have just had heart bypass surgery, and it may recommend that patients take the drug for only one year.

The Chapel Hill, N.C., company said it is gathering on the FDA's proposed version of the drug. It does not plan to conduct a late-stage clinical trial. Pozen had planned to seek marketing approval of PA32540 in the third quarter of 2012, but it said the process of collecting data might delay that filing for up to six months.

THE BIG PICTURE: Pozen gets most of its revenue from sales of the arthritis treatment Vimovo, which contains a combination of naproxen, a common painkiller, and esomeprazole magnesium, the active ingredient in the heartburn drug Nexium. That reduces patients' risk of developing ulcers, a common side effect of treatment with some arthritis drugs.

Pozen developed Vimovo through a partnership with British drugmaker AstraZeneca PLC. It reported about $34 million in Vimovo sales in 2011, with $21 million in the U.S. and $13 million from the 27 other markets where the drug is approved. Early this year Pozen said prescriptions in the U.S. have been flat "for a number of months."

AstraZeneca is continuing to pursue approvals in other countries, and Pozen said growth in other markets is solid.

SHARE ACTION: Shares of Pozen sank $1.44, or 18.6 percent, to $6.29 in afternoon trading. The shares have more than tripled in value since Nov. 23, and closed at $7.73 Thursday.