AstraZeneca announced today that it will start a Phase III programme for PN400, a new pain product under co-development with POZEN, Inc. The Phase III programme is scheduled to begin in 3Q 2007, with a US submission currently targeted for 1H 2009. POZEN and AstraZeneca entered into an agreement in August 2006 to co-develop a new pain product that combines naproxen and esomeprazole in a single tablet using POZENâs proprietary formulation technology.
PN400 is an investigational product for patients who require chronic NSAID (non-steroidal anti-inflammation drug) treatment for arthritis pain and are at risk for NSAID associated gastric ulcers.
By mutual agreement, POZEN and AstraZeneca have 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 totalled $160 million, of which, $20 million was to be paid upon the successful completion of the proof of concept studies, and sales performance milestones totalled $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.
The development programme is co-funded, with POZEN responsible for the US development programme and for regulatory filings in the US. AstraZeneca has responsibility for all development activities and regulatory filings outside of the US. AstraZeneca has responsibility for all aspects of manufacturing, marketing, sales and distribution on a worldwide basis. Both parties will contribute scientific, development and regulatory expertise to the collaboration. The patent for PN400 expires in 2023 in the United States.
"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. "PN400, 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."
More than 60 million patients in the US and Europe (US/ France, Germany, UK, Spain and Italy) currently suffer from osteo and rheumatoid arthritis and it is a leading cause of disability in the US. Fifty nine percent of all people over 65 in the US suffer from arthritis.
About AstraZeneca
AstraZeneca is a major international healthcare business engaged in research, development, manufacturing and marketing of prescription pharmaceuticals and supplier for healthcare services. AstraZeneca is one of the world's leading pharmaceutical companies with healthcare sales of US $26.47billion and is a leader in gastrointestinal, cardiovascular, neuroscience, respiratory, oncology and infection product sales. AstraZeneca is listed in the Dow Jones Sustainability Index (Global) as well as the FTSE4Good Index. For more info visit www.astrazeneca.com
About Pozen Inc
POZEN is a pharmaceutical company committed to developing therapeutic advancements for diseases with unmet medical needs where it can improve efficacy, safety, and/or patient convenience. POZENâs efforts are focused primarily on the development of pharmaceutical products for the treatment of acute and chronic pain and other pain-related conditions. POZEN has a development and commercialization alliance with AstraZeneca for the proposed product candidate PN 400, for conditions such as osteoarthritis and rheumatoid arthritis in patients who are at risk for developing NSAID-associated gastric ulcers. The company's common stock is traded on The Nasdaq Stock Market under the symbol "POZN". For detailed company information, including copies of this and other press releases, see POZEN's website: www.pozen.com