Genmab Announces European Marketing Authorization for the Subcutaneous Formulation of DARZALEX (daratumumab) for the Treatment of Patients with Multiple Myeloma

Company Announcement

• Subcutaneous fixed-dosed formulation of DARZALEX (daratumumab) approved in Europe for the treatment of adult patients with multiple myeloma
• Approval follows positive opinion by European Committee for Medicinal Products for Human Use (CHMP) in April 2020 and applies to all current daratumumab indications in frontline and relapsed/refractory settings
• Approval based on data from Phase III COLUMBA and Phase II PLEIADES studies
• In the studies, the fixed-dose subcutaneous formulation reduced treatment time from hours to minutes and demonstrated similar efficacy and safety with significantly fewer infusion-related reactions compared with the intravenous formulation

Copenhagen, Denmark; June 4, 2020 – Genmab A/S (Nasdaq: GMAB) announced today that the European Commission (EC) has granted marketing authorization for the subcutaneous (SC) formulation of DARZALEX (daratumumab), for the treatment of adult patients with multiple myeloma in all currently approved daratumumab intravenous (IV) formulation indications in frontline and relapsed / refractory settings. The approval follows a Positive Opinion by the CHMP of the European Medicines Agency (EMA) in April 2020. The SC formulation is administered as a fixed-dose over approximately three to five minutes, significantly less time than IV daratumumab, which is given over several hours. Patients currently on daratumumab IV will have the choice to switch to the SC formulation. In August 2012, Genmab granted Janssen Biotech, Inc. (Janssen) an exclusive worldwide license to develop, manufacture and commercialize daratumumab.

“We are extremely pleased that patients in Europe with multiple myeloma will now, like patients in the U.S., have the opportunity for treatment with the subcutaneous formulation of daratumumab. With consistent efficacy, and greater convenience for patients and health care providers with dosing time reduced from hours to just minutes and fewer infusion-related reactions, this formulation provides significant benefits for patients,” said Jan van de Winkel, Ph.D., Chief Executive Officer of Genmab

The approval was based on data from two studies: the Phase III non-inferiority COLUMBA (MMY3012) study, which compared the SC formulation of daratumumab to the IV formulation in patients with relapsed or refractory multiple myeloma, and data from the Phase II PLEIADES (MMY2040) study, which is evaluating SC daratumumab in combination with certain standard multiple myeloma regimens. The topline results from the COLUMBA study were announced in February 2019 and subsequently presented in oral sessions at the 2019 American Society of Clinical Oncology (ASCO) Annual Meeting and the 24^th European Hematology Association (EHA) Annual Congress. Updated data of the COLUMBA and the PLEIADES studies were presented during poster sessions at the 61^st American Society of Hematology (ASH) Annual Meeting in December 2019.