Serono and CancerVax Corporation to collaborate for the development and commercializatian of a new cancer drug for malanoma

20-Dec-2004

Serono and CancerVax Corporation announced a worldwide collaboration for the development and commercialization of Canvaxin(TM) , an investigational specific active immunotherapy product being developed for the treatment of advanced-stage melanoma, a deadly form of skin cancer. Canvaxin(TM) is currently being evaluated in two international, multi-center Phase 3 clinical trials for the treatment of Stage III and Stage IV melanoma.

Under the Agreement, CancerVax and Serono will jointly develop Canvaxin(TM) for melanoma, as well as other indications. The companies will share equally the costs of developing Canvaxin(TM) and seeking regulatory approvals for Canvaxin(TM).

CancerVax and Serono will co-promote Canvaxin(TM) in the U.S. and share certain expenses and profits on a 50/50 basis. Outside the U.S., Serono will have the exclusive right to commercialize Canvaxin(TM) and will pay royalties to CancerVax based on its sales of the product. Initially, CancerVax will manufacture Canvaxin(TM) for supply throughout the world. Serono may eventually establish a second manufacturing site for Canvaxin(TM) , to supply primarily markets outside the U.S.

CancerVax will receive an initial cash payment of $37 million, comprised of $25 million in upfront signing fees and $12 million for the purchase of 1 million shares of CancerVax common stock. CancerVax could receive up to $253 million in additional payments linked to the achievement of development, regulatory and commercial milestones. The element of these milestone payments relating to the receipt of regulatory approvals through to marketing Canvaxin(TM) solely in Stage III and Stage IV melanoma in the U.S. and the EU could amount to $100 million.

"This collaboration with CancerVax is a major milestone in Serono's establishment of a significant presence in the field of oncology, and further demonstrates Serono's commitment to expanding our portfolio of innovative clinical-stage projects which address significant, unmet medical needs," Ernesto Bertarelli, CEO of Serono, said. "Dermatologists have a significant role in the diagnosis and treatment of melanoma in Europe and many other countries around the world. The dermatology presence which Serono has established through the recent launch of Raptiva for the treatment of moderate-to-severe psoriasis will provide us with a significant operational asset on which to build for the commercialization of Canvaxin(TM)."

"We are very enthusiastic about establishing this collaboration with Serono to potentially bring Canvaxin(TM) to patients with advanced-stage melanoma around the world," said David F. Hale, President & CEO of CancerVax Corporation. "By partnering with Serono, a leading biotechnology company with significant expertise in the development and commercialization of biological products, CancerVax has taken a major step forward in achieving its goal of becoming a world leader in new therapies for the treatment of cancer," said Hale.

Consistent with guidance given in its third quarter results release, Serono considers the signing of this collaboration with CancerVax to be a significant further business development deal, and accordingly, the impact on net income of $27.1m is considered exceptional.

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