Genmab bags €25m milestone upon market approval of daratumumab

The market approval triggered a US$25m milestone payment from Genmab’s commercialisation partner Janssen Biotech Inc. for first commercial sale in Japan. Daratumumab was approved for second- and third-line treatment in combination with lenalidomide and dexamethasone or bortezomib and dexamethasone in adult patients.

DARZALEX is being developed under an August 2012 agreement in which Genmab granted Janssen Biotech, Inc. an exclusive worldwide license to develop, manufacture and commercialize the product.  As the first commercial sale could take place in either late 2017 or early 2018, Genmab is not updating its financial guidance for 2017. If the first commercial sale is achieved prior to year end, Genmab expects to update its financial guidance at that time. 

The approval was based on two pivotal studies: the Phase III CASTOR study (MMY3004), published in The New England Journal of Medicine in August 2016; the Phase III POLLUX study (MMY3003), published in The New England Journal of Medicine in October 2016; and supported by several other studies, including two safety studies (MMY1002 and MMY1005) in Japanese patients with relapsed or refractory multiple myeloma.

DARZALEX is the first monoclonal antibody (mAb) to receive U.S. Food and Drug Administration (FDA) approval to treat multiple myeloma. DARZALEX is indicated in Europe for use in combination with lenalidomide and dexamethasone, or bortezomib and dexamethasone, for the treatment of adult patients with multiple myeloma who have received at least one prior therapy and as monotherapy for the treatment of adult patients with relapsed and refractory multiple myeloma, whose prior therapy included a PI and an immunomodulatory agent and who have demonstrated disease progression on the last therapy.  In Japan, DARZALEX is approved in combination with lenalidomide and dexamethasone, or bortezomib and dexamethasone, for treatment of adults with relapsed or refractory multiple myeloma.