Janssen's Daratumumab SNDA In Japan Triggers $2 Mln Milestone Payment To Genmab

(RTTNews) - Danish biotechnology company Genmab A/S announced Thursday that Janssen Pharmaceutical K.K. has submitted a supplemental new drug application or sNDA in Japan for Daratumumab to use in front line Multiple Myeloma. The submission of the application triggers a milestone payment of $2 million to Genmab from Janssen.

Daratumumab is being developed by Janssen Biotech, Inc. under an exclusive worldwide license to develop, manufacture and commercialize daratumumab from Genmab.

The sNDA application was submitted to the Ministry of Health, Labor and Welfare or MHLW in Japan, for the use of daratumumab (DARZALEX) in combination with bortezomib, melphalan and prednisone for the treatment of patients with newly diagnosed multiple myeloma who are ineligible for autologous stem cell transplant or ASCT.

The application will receive a priority review. The submission was based on data from the Phase III ALCYONE study that showed a reduction of the risk of disease progression or death by 50 percent in newly diagnosed ASCT ineligible multiple myeloma patients when daratumumab is combined with bortezomib, melphalan and prednisone.

This data was presented as a Late-Breaking Abstract at the 2017 American Society of Hematology (ASH) Annual Meeting and published in The New England Journal of Medicine in December, 2017.

In February 2018, the MHLW granted Orphan Drug Designation to DARZALEX for patients with newly diagnosed multiple myeloma. In August 2012, Genmab granted Janssen an exclusive worldwide license to develop, manufacture and commercialize daratumumab.