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Genmab announces European Regulatory Submission

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Genmab announced yesterday that Janssen Pharmaceutica has submitted a variation to the Marketing Authorization to the European Medicines Agency (EMA) seeking to broaden the existing marketing authorization for daratumumab (DARZALEX) to include treatment of adult patients with multiple myeloma who have received at least one prior therapy.

The submission of the application triggers milestone payments totaling USD 10 million to Genmab from Janssen. The milestone payments were included in Genmab’s financial guidance for 2016 that was published on August 9, 2016. In August 2012, Genmab granted Janssen Biotech, an exclusive worldwide license to develop, manufacture and commercialize daratumumab.

“Daratumumab represents a new hope for people suffering from multiple myeloma, a disease which is presently incurable. We look forward to working together with Janssen and the EMA to making daratumumab available to a far wider group of patients,” said Jan van de Winkel, Ph.D., Chief Executive Officer of Genmab.

The submission includes data from two Phase III studies: the CASTOR study of daratumumab in combination with bortezomib and dexamethasone versus bortezomib and dexamethasone in patients with relapsed or refractory multiple myeloma, and the POLLUX study of daratumumab in combination with lenalidomide and dexamethasone versus lenalidomide and dexamethasone in patients with relapsed or refractory multiple myeloma.  The submission also included data from the Phase I study of daratumumab in combination with pomalidomide and dexamethasone in relapsed or refractory multiple myeloma.

Janssen submitted a supplemental Biologics License Application for daratumumab in combination with lenalidomide and dexamethasone, or bortezomib and dexamethasone, for treatment of patients with multiple myeloma who received at least one prior therapy to the U.S. Food and Drug Administration in August 2016.

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