Serono and Genmab annouce global development and commercialization agreement for HuMax-CD4
Serono and Genmab A/S announced an agreement under which Genmab has granted Serono exclusive worldwide rights to develop and commercialize Genmab's HuMax-CD4. HuMax-CD4 is a fully human monoclonal antibody in development for the treatment of cutaneous and non-cutaneous T-cell lymphomas. It is currently being evaluated in a pivotal Phase III clinical trial for cutaneous T-cell lymphoma (CTCL) under the US food and Drug Administration's Special Protocol Assessment process and has Fast Track designation from the FDA. HuMax-CD4 is also being studied in a Phase II trial for non-cutaneous T-cell lymphoma (NCTCL). 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 licence fee of USD 20 million, and Serono will make a USD 50 million investment in Genmab common stock, at a premium to the market price. Genmab may receive up to USD 215 million in total payments, including the initial licence fee and equity purchase, milestone payments for regulatory submissions and approvals of HuMax-CD4 in CTCL and NCTCL in the US, Europe and Japan, and payments based on the achievement of certain sales milestones. Genmab will be entitled to receive royalties on global sales of HuMax-CD4. Serono will be responsible for all future development costs for HuMax-CD4 and for future manufacturing of the product. Genmab will continue to conduct the ongoing clinical trials as described above.
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