COPENHAGEN, Denmark—Genmab announced today it has reached the third milestone in its daratumumab collaboration with Janssen Biotech, Inc. The USD 25 million milestone payment was triggered by progress in the ongoing Phase 3 study of daratumumab in combination with lenalidomide and dexamethasone versus lenalidomide and dexamethasone alone for the treatment of relapsed or refractory multiple myeloma.
"Since our partnership with Janssen began in October 2012, we have made very significant progress with the development of daratumumab, announcing five new clinical studies and reporting data from two ongoing studies in multiple myeloma. Today's milestone marks another important step, as patients are now receiving treatment in the first Phase 3 study of daratumumab in multiple myeloma," said Jan van de Winkel, Ph.D., chief executive officer of Genmab.
The milestone payment is included in Genmab's 2014 financial guidance published on May 1, 2014.
Daratumumab is a human CD38 monoclonal antibody with broad-spectrum killing activity and is in clinical development for multiple myeloma. Daratumumab targets the CD38 molecule which is highly expressed on the surface of multiple myeloma cells. Daratumumab may also have potential in other cancers on which CD38 is expressed, including diffuse large B-cell lymphoma, chronic lymphocytic leukemia, acute lymphoblastic leukemia, plasma cell leukemia, acute myeloid leukemia, follicular lymphoma and mantle cell lymphoma. Daratumumab has been granted Breakthrough Therapy Designation from the U.S. Food and Drug Administration for the treatment of patients with multiple myeloma who have received at least three prior lines of therapy including a proteasome inhibitor (PI) and an immunomodulatory agent (IMiD) or who are double refractory to a PI and an IMiD.
In August 2012, Genmab granted Janssen Biotech, Inc. an exclusive worldwide license to develop and commercialize daratumumab. Under the terms of the agreement, Genmab was to receive an upfront license fee of $55 million (approximately DKK 327 million) and Johnson & Johnson Development Corporation (JJDC) agreed to invest DKK 475 million, (approximately $80 million) to subscribe for 5.4 million new shares of Genmab at a price of DKK 88 per share. Genmab's closing share price on August 29, 2012 was DKK 67.85. Genmab could also be entitled to up to $1 billion in development, regulatory and sales milestones, in addition to tiered double digit royalties. Janssen will be fully responsible for all costs associated with developing and commercializing daratumumab going forward, including the costs of two ongoing Phase 1/2 studies, since completed.
At that time, Genmab’s van de Winkel noted that "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."
Genmab is a publicly traded, international biotechnology company specializing in the creation and development of differentiated human antibody therapeutics for the treatment of cancer. Founded in 1999, the company currently has one marketed antibody, Arzerra® (ofatumumab) for the treatment of certain chronic lymphocytic leukemia indications, a clinical pipeline with both late and early stage programs, and an innovative pre-clinical pipeline. Genmab's technology base consists of validated and proprietary next generation antibody technologies—the DuoBody® platform for generation of bispecific antibodies, and the HexaBody™ platform which creates effector function enhanced antibodies. Genmab's deep antibody expertise is expected to provide a stream of future product candidates. Partnering of selected innovative product candidates and technologies is a key focus of Genmab's strategy and the company has alliances with top tier pharmaceutical and biotechnology companies.