On November 19, 2015 Genmab A/S (OMX: GEN) reported it has achieved a USD 45 million milestone in its DARZALEX (daratumumab) collaboration with Janssen Biotech, Inc. (Janssen) (Press release, Genmab, NOV 19, 2015, View Source [SID:1234508294]). The milestone payment was triggered by the first commercial sale of DARZALEX in the United States. Schedule your 30 min Free 1stOncology Demo! "Today marks a significant moment in the history of Genmab — the day DARZALEX, our second approved antibody therapeutic, is commercially available. We are very pleased to have brought two differentiated antibody products to the market since our inception in 1999," said Jan van de Winkel, Ph.D., Chief Executive Officer of Genmab.
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This milestone was included in the updated financial guidance for 2015, which was published on November 16, 2015.
About DARZALEX (daratumumab)
DARZALEX (daratumumab) injection for intravenous infusion is indicated in the United States 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, or who are double-refractory to a PI and an immunomodulatory agent.1 DARZALEX is the first monoclonal antibody (mAb) to receive U.S. Food and Drug Administration (FDA) approval to treat multiple myeloma. For more information, visit www.DARZALEX.com.
Daratumumab is a human IgG1k monoclonal antibody (mAb) that binds with high affinity to the CD38 molecule, which is highly expressed on the surface of multiple myeloma cells. It is believed to induce rapid tumor cell death through programmed cell death, or apoptosis,1,2 and multiple immune-mediated mechanisms, including complement-dependent cytotoxicity,1,2 antibody-dependent cellular phagocytosis3,4 and antibody-dependent cellular cytotoxicity.1,2
Daratumumab is being developed by Janssen Biotech, Inc. under an exclusive worldwide license to develop, manufacture and commercialize daratumumab from Genmab. Five Phase III clinical studies with daratumumab in relapsed and frontline settings are currently ongoing, and additional studies are ongoing or planned to assess its potential in other malignant and pre-malignant diseases on which CD38 is expressed, such as smoldering myeloma and non-Hodgkin’s lymphoma.