Serono S.A. announced that Genentech Inc. has extended Serono's exclusive license to develop and market Raptiva (efalizumab) to include an additional 15 Asian countries. This expands the scope of the Genentech-Serono collaboration for Raptiva, which was first established in August 2002.
“The extension of our territory under this important license agreement highlights Serono's considerable presence in Asia and will enable us to bring an innovative new therapy to patients with psoriasis in a region with great growth potential,” said Ernesto Bertarelli, chief executive officer of Serono.
The 15 countries included in the extended agreement are China, S. Korea, Taiwan, Hong Kong, Singapore, Malaysia, Thailand, the Philippines, Indonesia, Vietnam, Cambodia, Laos, Nepal, Myanmar and Brunei.
As a result of the new agreement, Serono will now develop and market Raptiva worldwide outside of the United States and Japan. Development and marketing rights in the United States remain with Genentech and its U.S. partner Xoma. Genentech retains exclusive marketing rights in Japan.
Serono plans to file for approval of Raptiva for moderate to severe psoriasis in Europe in the first quarter of this year and in most of the countries included in this new agreement in the first half of 2004. Genentech and Xoma announced submission of a Biologics License application for Raptiva to the U.S. Food and Drug Administration (FDA) on December 23, 2002.
Financial terms of the agreement were not disclosed. Raptiva is a recombinant humanized monoclonal antibody under evaluation for the treatment of moderate-to-severe plaque psoriasis and is in phase 2 trials for rheumatoid.