CancerVax and Serono agree cancer programme

The CancerVax Corporation and Serono are to collaborate in the development and commercialisation 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-centre Phase III 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 it and seeking regulatory approvals.

CancerVax and Serono will co-promote the therapy in the US and share certain expenses and profits on a 50/50 basis. Outside the US, Serono will have the exclusive right to commercialise the product 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 to supply primarily markets outside the US.

CancerVax will receive an initial cash payment of $37m, comprised of $25m in upfront signing fees and $12m for the purchase of one million shares of CancerVax common stock. CancerVax could receive up to $253m 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 $100m.

'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 Hale, president and ceo of CancerVax Corporation. 'By partnering with Serono, a leading biotechnology company with significant expertise in the development and commercialisation 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,' continued 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 commercialisation of Canvaxin.'

About Melanoma

According to the American Cancer Society, melanoma is the deadliest type of skin cancer and is the sixth most commonly diagnosed cancer in the United States. As reported by the World Health Organisation, the worldwide incidence, or number of newly diagnosed cases, of melanoma in 2000 was 132,600, with 37,000 people dying of the disease. Furthermore, according to the National Cancer Institute, since 1997 the incidence of new melanoma cases in the United States has increased at an average rate of more than 5% per year, one of the highest growth rates for any type of cancer. In 2000, over 510,000 patients in the United States were living with melanoma. "Melanoma is one of the fastest growing types of cancers. According to the American Cancer Society, an estimated 55,000 new cases will be diagnosed in the United States in 2004, double the number from 30 years ago and 7,900 will die as a result of the disease," said Mary Loh, executive director of the American Melanoma Foundation. "Prevention and early detection are the best defences against early-stage melanoma, but we desperately need new treatment options for patients suffering with advanced stages of this disease."

About 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. It is currently being evaluated in two international, randomised, 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 tumours. In September 2004, CancerVax completed the planned enrollment of 1,118 patients into its Phase III clinical trial of Canvaxin for the treatment of patients with Stage III melanoma. CancerVax continues to make progress with the enrollment of patients in the Stage IV clinical trial and is evaluating the potential for Canvaxin in the treatment of other types of cancer.