AstraZeneca and Pozen collaborate on fixed dose painkiller
AstraZeneca and US-based Pozen are to co-develop fixed dose combinations of non-steroidal anti-inflammatory drug (NSAID) naproxen and proton pump inhibitor esomeprazole in a single tablet, using Pozen's proprietary formulation technology
AstraZeneca and US-based Pozen are to co-develop fixed dose combinations of non-steroidal anti-inflammatory drug (NSAID) naproxen and proton pump inhibitor esomeprazole in a single tablet, using 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 gastro-intestinal side-effect profile.
There are approximately 16,500 deaths and 100,000 hospitalisations yearly resulting from gastro-intestinal complications attributed to the use of NSAIDs. Pozen's PN tablet is designed to contain an immediate release acid inhibitor with a delayed release NSAID in a single dosage form.
AstraZeneca will pay Pozen an upfront fee of US$40m with devlopment and regulatory milestone payments of $160m and sales performance mile-stones of US$175m, if certain thresholds are achieved. The deal also includes royalty payments.
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. It will also be responsible for all non-US regulatory filings. Both parties will contribute scientific, development and regulatory expertise to the collaboration. The current patent expires in 2023 in the US.
Dr John Patterson, executive director, development, for AstraZeneca said: "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."
The collaboration is subject to clearance under the Hart-Scott-Rodino Antitrust Improvements Act.