CancerVax Corporation and Serono announced a worldwide collaboration for the development and commercialization of Canvaxin, an investigational specific active immunotherapy product being developed for the treatment of advanced-stage melanoma, a deadly form of skin cancer. Canvaxin 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 for melanoma, as well as other indications. The companies will share equally the costs of developing Canvaxin and seeking regulatory approvals for Canvaxin.
Canvaxin, one of a new class of products being developed in the area of specific active immunotherapy (SAI) or therapeutic cancer vaccines, is based on a proprietary technology that may potentially be applied to treat a number of cancers. Canvaxin is currently being evaluated in two international, randomized, double-blind, placebo-controlled trials designed to evaluate the ability of Canvaxin to extend the survival of patients with Stage III and Stage IV melanoma following surgical resection of their tumors. In September 2004, CancerVax completed the planned enrolment of 1,118 patients into its Phase 3 clinical trial of Canvaxin for the treatment of patients with Stage III melanoma. CancerVax continues to make progress with the enrolment of patients in the Stage IV clinical trial and is evaluating the potential for Canvaxin in the treatment of other types of cancer.
CancerVax and Serono will co-promote Canvaxin in the US and share certain expenses and profits on a 50/50 basis. Outside the US, Serono will have the exclusive right to commercialize Canvaxin and will pay royalties to CancerVax based on its sales of the product. Initially, CancerVax will manufacture Canvaxin for supply throughout the world. Serono may eventually establish a second manufacturing site for Canvaxin, to supply primarily markets outside the US.
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 solely in Stage III and Stage IV melanoma in the US and the EU could amount to $100 million.
"We are very enthusiastic about establishing this collaboration with Serono to potentially bring Canvaxin 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.
"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."