AstraZeneca (AZ) has signed a global agreement with Pozen (NASDAQ: POZN) to co-develop fixed dose combinations of naproxen and esomeprazole for chronic pain, utilising Pozen’s proprietary formulation technology.  The fixed dose combinations have the potential to provide chronic pain sufferers with a new treatment with good efficacy and a low upper GI (gastro-intestinal) side-effect profile.
Under the terms of the agreement, AstraZeneca will pay Pozen an upfront fee totaling $40 million with potential aggregate milestone payments of $160 million for certain development and regulatory milestones; and $175 million of potential sales performance milestones, if certain thresholds are achieved.  Royalties will be paid on net sales on a tiered royalty structure that ranges from mid-single digits to mid-teens. 
The development programme will be co-funded, with Pozen responsible for the US development programme and for regulatory filings in the US.  Phase III clinical development is expected to start in 2007, with a US submission currently targeted for the end of 2008.  AstraZeneca will have full responsibility for all development activities outside of the US as well as all aspects of manufacturing, marketing, sales and distribution on a worldwide basis. AstraZeneca will also be responsible for all non-U.S. regulatory filings. Both parties will contribute scientific, development and regulatory expertise to the collaboration.  The patent expires in 2023 in the United States.
“This collaboration is further evidence of the progress we are making in strengthening our pipeline of new products,” said Dr. John Patterson, Executive Director, Development, for AstraZeneca.  “We believe that the combination of esomeprazole and Pozen’s proprietary PN technology has the potential to address one of the key unmet medical needs for patients with chronic pain; namely, good pain relief coupled to a low risk of gastrointestinal ulcers and good tolerability.”
John R. Plachetka, Pharm.D., Pozen’s Chairman, President and Chief Executive Officer said, “One of our goals in developing our PN technology has been to collaborate with a large pharma company that has the commercial resources necessary to drive products based on PN technology into a leadership position amongst all NSAID products.  AstraZeneca has consistently shown that it is one of the best pharmaceutical companies in the world, and we are especially pleased to be utilizing esomeprazole in this product.”
The collaboration is subject to clearance under the Hart-Scott-Rodino Antitrust Improvements Act. No further financial terms have been disclosed.