Pozen Inc. has signed an exclusive global collaboration agreement with AstraZeneca for the co-development and commercialization of proprietary fixed dose combinations of the proton pump inhibitor (PPI) esomeprazole magnesium, with the non-steroidal anti-inflammatory drug (NSAID) naproxen, in a single tablet. The product will be indicated for the management of pain and inflammation associated with conditions such as osteoarthritis and rheumatoid arthritis in patients who are at risk for developing Nsaid-associated gastric ulcers.
Under the terms of the agreement, AstraZeneca will pay Pozen an upfront fee totalling $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, which ranges from mid-single digits to mid-teens. Pozen will be responsible for the development and filing of the New Drug Application (NDA) in the United States, while AstraZeneca will have full responsibility for development activities outside of the U.S. as well as all aspects of manufacturing, marketing, sales and distribution on a worldwide basis. AstraZeneca will also be responsible for all non-US regulatory filings. The collaboration is subject to clearance under the Hart-Scott-Rodino Antitrust Improvements Act.
Pozen's proprietary PN drug candidates, are being developed for the management of pain and inflammation, associated with conditions such as osteoarthritis, one of the most frequent causes of physical disability among adults, affecting an estimated 20 to 30 million people in the US Estimates from the National Institutes of Health show that by 2030, 20 per cent of Americans, about 70 million people will have passed their 65th birthday and will be at risk to develop osteoarthritis. Pozen received a US patent for the PN technology in 2005 which expires in 2023.
In short-term proof-of-concept studies conducted by Pozen, two other PN drug candidates produced significantly less gastric mucosal injury compared to a similar regimen of enteric coated naproxen. Earlier this year, Pozen announced that, it had reached agreement with the US Food and Drug Administration (FDA) on a New Drug Application program for PN 200, which included a Special Protocol Assessment (SPA) for the pivotal phase 3 trials. Pozen and AstraZeneca expect to meet with the FDA during the next few months to confirm that the core development programme and the SPA already agreed upon will apply to this new product.
"This collaboration is further evidence of the progress we are making in strengthening our pipeline of new products," stated Dr John Patterson, Executive Director, and 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 gastrointestional ulcers and good tolerability."
John R. Plachetka, Ph.D., Pozen's Chairman, President and CEO 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 our 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."