Serono and Genmab sign commercialisation agreement

Genmab, a biotechnology company that creates and develops human antibodies for the treatment of life-threatening and debilitating diseases, has signed an agreement to grant Serono exclusive worldwide rights to develop and commercialise its HuMax-CD4, a fully human monoclonal antibody in development for the treatment of cutaneous and non-cutaneous T-cell lymphomas (CTCL and NCTCL).

Currently being evaluated in a pivotal Phase III clinical trial for CTCL under US FDA special protocol assessment process, HuMax-CD4 is directed against the CD4 antigen and causes depletion of certain T-cells through antibody-dependent cellular cytotoxicity.

Under the terms of the agreement, Genmab will receive a license fee of US$20m, and Serono will make a US$50m investment in Genmab common stock at a premium to the market price. Genmab may receive up to US$215m in total payments, including the initial license fee and equity purchase; milestone payments for regulatory submissions and approvals in the US, Europe and Japan; and payments based on the achievement of certain sales milestones, as well as royalties on global sales. Serono will be responsible for all future development costs and for future manufacturing of the product, while Genmab will continue to conduct the ongoing clinical trials as described above.

CTCL are characterised by abnormal accumulation of malignant T-cells in the skin, which can result in the development of rashes, plaques and tumors. Common types include mycosis fungoides and Sezary syndrome. NCTCL are defined by highly malignant disease localised to the lymph nodes, and include angioimmunoblastic T-cell lymphoma, anaplastic large cell lymphoma and unspecified peripheral T-cell lymphoma. Aggressively progressive, average survival time is approximately two years.