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Biotech / Medical : Pozen: POZN -- Ignore unavailable to you. Want to Upgrade?

To: kenhott who wrote (12)	9/7/2007 8:17:18 AM
From: rkrw	Read Replies (1) \| Respond to of 19

Looks like the deal was adjusted and now more backend loaded then before. Maybe the first deal structure was too good. Still azn could have opted out and $30M is in the bank. POZEN/AstraZeneca Announce Start of the PN 400 Phase III Program Friday September 7, 5:00 am ET AstraZeneca to Pay an Immediate $30 Million Payment Under Revised Licensing Arrangement CHAPEL HILL, N.C.--(BUSINESS WIRE)--POZEN Inc. (NASDAQ: POZN - News), today announced the start of 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 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. 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. The U.S. royalty structure has been revised from the tiered structure previously announced to one low double digit rate for the life of the agreement. The royalty structure outside the U.S. is a slightly revised multi-tiered structure ranging from mid-single digits to high-teens. 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 clinical 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, US. "PN 400 represents an important product development opportunity for AstraZeneca in line with our commitment to bring additional new pain medicines to market that can make a difference in peoples' lives. We are committed to working with POZEN to develop this innovative product and hope to bring it to market as quickly as possible." 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. Osteoarthritis is one of the most frequent causes of physical disability among adults, affecting an estimated 20 to 30 million people in the United States. Estimates from the National Institutes of Health show that by 2030, 20 percent of Americans--about 70 million people--will have passed their 65th birthday and will be at risk to develop osteoarthritis.