NicOx S.A. has signed an exclusive license and agreement with AstraZeneca for rights to develop and commercialise AZD3582 and certain other CINODs (COX-Inhibiting Nitric Oxide-Donators) in Japan in the treatment of pain and inflammation. The license for Japan is an extension of the 1998 agreement between NicOx and AstraZeneca, which granted AstraZeneca an exclusive worldwide license (semi-exclusive in Japan) to develop, manufacture and sell products containing certain CINODs. CINODs are a new class of analgesic and anti-inflammatory drugs designed to treat acute and chronic pain.
Under the terms of this new agreement, AstraZeneca will make milestone payments to NicOx totalling up to 22 million euros, including a 5 million euro upfront payment. In addition, NicOx will receive a royalty of 12% of Japanese net sales for the duration of the patent protection.
Japan is the second largest pharmaceutical market in the world after the United States. The pain and inflammation market in Japan is estimated at more than US$2 billion (IMS) with over 12 million people annually diagnosed with musculoskeletal pain (Decision Resources, February 2002). The global pain and inflammation market is expected to grow from US$10 billion in 2002 to US$14 billion in 2005 (Scrip Reports, April 2002).
AZD3582, the first compound selected for development by AstraZeneca from the new CINOD class, is a new chemical entity with a novel, multi-pathway mechanism of action of controlled nitric oxide donation and balanced COX inhibition. AZD3582 is currently in Phase II clinical trials. Proof of concept in man for AZD3582 was announced in May 2002, showing a significant reduction in gastrointestinal tract toxicity compared to naproxen, the current standard of care.
Elisabeth Robinson, NicOx'' Executive Vice-President, Corporate Development, commented: "The granting of exclusivity in Japan will allow AstraZeneca to implement a truly global development and marketing plan for the new CINOD class and potentially bring AZD3582 to the Japanese market in the shortest possible time. This agreement also confirms the commitment of AstraZeneca to the new CINOD class and its enormous therapeutic potential."