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Approval for Genmab’s DARZALEX in Japan

Jan van de Winkel

The Ministry of Health, Labor and Welfare (MHLW) in Japan has approved the use of DARZALEX (daratumumab) in combination with lenalidomide and dexamethasone or bortezomib and dexamethasone for the treatment of adults with relapsed or refractory multiple myeloma. D

ARZALEX 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.  Genmab will earn milestone payments of USD 25 million from Janssen upon the first commercial sale of DARZALEX in Japan in the coming months.  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.

“Multiple myeloma is one of the most common forms of blood cancer in Japan and we are very pleased that DARZALEX will soon also become available for Japanese multiple myeloma patients who have failed other  treatments,” said Jan van de Winkel, Ph.D., Chief Executive Officer of Genmab.

The approval is 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.