BioWorld International Correspondent
PARIS - Genentech Inc. agreed to expand the geographical scope of the exclusive license it granted Serono SA last August for developing and marketing Raptiva (efalizumab) to include 15 Asian countries.
The new agreement means Geneva-based Serono will now develop and market Raptiva for all markets except the United States and Japan. The financial terms of the deal were not disclosed.
Raptiva is a recombinant humanized monoclonal antibody that has completed clinical development for the treatment of moderate to severe plaque psoriasis and is in Phase II trials for rheumatoid arthritis. The deal between Genentech and Serono does not restrict the number of pathologies for which they might jointly develop the drug.
Development and marketing rights in the U.S. remain with Genentech and its American partner, XOMA Ltd., while Genentech retains exclusive marketing rights in Japan. Following publication of the results of a final Phase III trial in the U.S. in September, Genentech and XOMA submitted a biologics license application to the FDA in December. And Serono plans to seek regulatory approval for Raptiva this quarter in moderate to severe psoriasis in Europe and most of the 15 countries covered by this latest agreement.
Those countries are China, Hong Kong, South Korea, Taiwan, Singapore, Malaysia, Thailand, the Philippines, Indonesia, Vietnam, Cambodia, Laos, Nepal, Myanmar and Brunei.