Janssen Biotech, Genmab sign potential $1 billion deal
by Kelsey Kaustinen  |  Email the author


HORSHAM, Pa.óJanssen Biotech, Inc., one of the Janssen Pharmaceutical Companies of Johnson & Johnson, has announced the execution of a global license and development agreement with Genmab A/S for Genmab's anti-cancer compound daratumumab. The compound is a human CD38 monoclonal antibody, and is currently being studied in Phase I/II studies in patients with 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," William N. Hait, M.D., Ph.D., head of Janssen Research & Development, LLC, said in a press release. "Daratumumab is an exciting, innovative compound, and we are delighted to add it to our portfolio."  
Per the terms of the agreement, Janssen will pay Genmab an upfront license fee of $55 million, for which it will receive an exclusive worldwide license to develop and commercialize daratumumab in addition to a backup CD38 human antibody. In addition, Johnson & Johnson Development Corporation, an affiliate of Janssen, will make an $80 investment to subscribe for 5.4 million new shares of Genmab. Genmab currently has 44,907,142 shares outstanding, and after this private placement, that number will increase to 50,307,142. Following the issuance of the new shares, Johnson & Johnson Development Corporation will own 10.73 percent of Genmab's share capital.
If all development, regulatory and sales milestones are met, Genmab could be eligible for up to $1 billion in milestone payments, and is also eligible for tiered double-digit royalties. Genmab will be responsible for completing the ongoing GEN501 and GEN503 Phase I/II trials, the costs of which will be Janssen's responsibility. Janssen will be responsible for all costs associated with the development and commercialization of daratumumab moving forward, as well as all clinical and regulatory activities.  
Daratumumab is a human monoclonal antibody that displays broad-spectrum cytotoxic activity. The compound targets the CD38 molecule, which is highly expressed on the surface of multiple myeloma cells. In preclinical studies, daratumumab was shown to kill multiple myeloma cells and also enhance the potency of other multiple myeloma treatments. The antibody is also thought to have potential in additional hematological tumors that express CD38, such as diffuse large B-cell lymphoma, chromic lymphocytic leukemia, acute lymphoblastic leukemia, acute myeloid leukemia, follicular lymphoma and mantle cell lymphoma.   
"We are very pleased to partner with Janssen on another Genmab innovation, and look forward to working with them to accelerate the development of daratumumab and to maximize the value of this product," Jan van de Winkel, Ph.D., CEO of Genmab, said in a press release about the deal. "This agreement significantly strengthens our financial position, ensuring that Genmab can continue to develop much-needed differentiated antibody therapeutics to help cancer patients in the future."
The transaction is subject to customary closing conditions, including approval by the Danish Financial Supervisory Authority and clearance from U.S. antitrust authorities under the Hart-Scott-Rodino Act.
Code: E08301201

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