The tablet combines proton pump inhibitor esomeprazole magnesium with non-steroidal anti-inflammatory drug naproxen, in a single tablet.
An new drug application is targeted for the first half of 2009, subject to the pace of enrollment in the pivotal trials. By mutual agreement, Pozen and AstraZeneca have also amended certain terms of their August 2006 collaboration and license agreement for the drug.
Under the terms of the amended agreement, AstraZeneca will pay Pozen up to $345 million, in the aggregate, for the achievement of development, regulatory, and sales milestones.
Pozen will receive an immediate $30 million payment, which includes recognition of successful proof of concept, $55 million will be paid upon achievement of certain development and regulatory milestones, and $260 million will be paid as sales performance milestones if certain aggregate sales thresholds are achieved.
Under the original agreement, development and regulatory milestones totaled $160 million, of which $20 million was to be paid upon the successful completion of the proof of concept studies, and sales performance milestones totaled $175 million.
Dr John Plachetka, Pozen's chairman, president and CEO, said: “We are pleased that PN 400 studies conducted to date have met expectations at both companies, that the interim results of the PN 200-301 study were positive, and that AstraZeneca has agreed to move forward with this program. Our goal now is to move as quickly as possible to deliver the development program agreed with the FDA under the special protocol assessment procedure, and file the NDA on schedule.”
In July, Pozen announced that the interim results of PN 200-301, a pilot study for the PN 400 program, demonstrated a significant reduction in gastric ulcers relative to naproxen, and the anti-secretory profile of PN 400 met expectations for the target product profile.