Friday, August 31, 2012

Janssen Biotech Announces Global License and Development Agreement for Investigational Anti-Cancer Agent Daratumumab


HORSHAM, Pa.- Janssen Biotech, Inc. ("Janssen"), one of the Janssen Pharmaceutical Companies of Johnson & Johnson, announced today that it has executed a global license and development agreement with the Danish company Genmab A/S for the anti-cancer compound, daratumumab.  Daratumumab (HuMax-CD38) is a human CD38 monoclonal antibody currently in Phase I/II studies in relapsed, refractory multiple myeloma. 

"Janssen was one of the first companies to recognize the power and promise of monoclonal antibodies and today is a world leader in biologics.  We look forward to applying that same expertise to daratumumab to help meet the needs of patients with multiple myeloma," said William N. Hait, M.D., Ph.D., head of Janssen Research & Development, LLC.  "Daratumumab is an exciting, innovative compound, and we are delighted to add it to our portfolio."

Under terms of the agreement, Genmab will grant Janssen an exclusive worldwide license to develop and commercialize daratumumab as well as a back-up CD38 human antibody.  Janssen has made an upfront payment and will make additional payments based upon the achievement of certain development, regulatory and sales milestones.  Genmab will be responsible for completing the GEN501 and GEN503 Phase I/II trials.  Janssen will be responsible for all other development, clinical and regulatory filing activities.  In addition, as part of the agreement, Johnson & Johnson Development Corporation, an affiliate of Janssen, will make an equity investment in Genmab.

The transaction is subject to customary closing conditions, including approval by the Danish Financial Supervisory Authority and clearance by the U.S. antitrust authorities.