Pozen, Inc. and AstraZeneca began the Phase III program for PN 400, a fixed dose combination of the proton pump inhibitor (PPI), esomeprazole magnesium, with the non-steroidal anti-inflammatory drug (NSAID) naproxen, in a single tablet. An NDA is targeted for 1H2009. The two companies have also amended terms of their August 2006 collaboration and license agreement.
Under the terms of the amended agreement, AZ will pay Pozen as much as $345 million for the achievement of development, regulatory, and sales milestones. Pozen will receive an immediate $30 million payment for successful proof of concept, $55 million upon achievement of certain development and regulatory milestones, and $260 million as sales performance milestones 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 R. Plachetka, Pozen's chairman, president and chief executive officer 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."
"AstraZeneca is pleased to announce that we are progressing PN 400 into Phase III development in collaboration with Pozen. Millions of people worldwide suffer from arthritis and we are excited about the prospect of developing and bringing an important new therapy to these patients," said Mr. Tony P. Zook, president and chief executive officer, AstraZeneca LP, U.S. "We are committed to working with Pozen to develop this innovative product and hope to bring it to market as quickly as possible."
Interim results of PN 200-301, a recent 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.