AstraZeneca will be responsible for global manufacturing, marketing, sales and distribution of a fixed-dose combination of naproxen and an acid inhibitor to ease arthritis pain for patients at risk for NSAID-associated ulcers, under an agreement with Pozen announced Aug. 2. AstraZeneca will also oversee development outside the U.S.

The developmental product combines the proton pump inhibitor esomeprazole magnesium with the non-steroidal anti-inflammatory drug naproxen in a single tablet using Pozen's proprietary technology.

Under the agreement, AstraZeneca will pay Pozen $40 mil. up-front, with potential aggregate milestone payments of $160 mil., as well as $175 mil. in potential sales performance milestones. Royalties will be paid on net sales on a tiered structure that ranges from mid-single digits to mid-teens, the company said.

The two companies will meet with FDA in the next few months to determine whether they may apply to the new product a special protocol assessment for pivotal Phase III trials of PN 200 - a product candidate for rheumatoid arthritis and ankylosing spondylitis patients at risk for NSAID-associated ulcers. Pozen expects to begin the PN 200 trials by year-end.

Pozen's PN designation applies to a suite of product candidates that combine an acid inhibitor with an NSAID in a single tablet to provide pain management with fewer gastrointestinal side effects.

The company announced July 31 that it would submit a full response - including additional safety information - to FDA by year-end to an "approvable" letter it received for the sumatriptan/naproxen combo Trexima for migraine (¹ Also see "Trexima Approvable Letter Another Headache For Pozen" - Pink Sheet, 9 June, 2006.).

Pozen and Trexima co-developer GlaxoSmithKline recently met with FDA to "reach agreement on the proposed plan for responding to the letter," the company said. FDA will have up to six months to review the additional information.

-Shirley Haley

AstraZeneca, Pozen To Partner On Fixed-Dose Naproxen/Esomeprazole

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