Daratumumab Receives Breakthrough Therapy Designation from US Food and Drug Administration
Daratumumab receives Breakthrough Therapy Designation in double refractory multiple myeloma
Potential for expedited development
Copenhagen, Denmark; May 1, 2013 – Genmab A/S (OMX: GEN) announced today that the US Food and Drug Administration (FDA) has granted Breakthrough Therapy Designation for daratumumab for the treatment of patients with multiple myeloma who have received at least three prior lines of therapy including a proteasome inhibitor (PI) and an immunomodulatory agent (IMiD) or who are double refractory to a PI and IMiD. Breakthrough Therapy Designation is a program intended to expedite the development and review of drugs to treat serious or life-threatening diseases in cases where preliminary clinical evidence shows that the drug may provide substantial improvements over available therapy. In August 2012, Genmab granted Janssen Biotech, Inc. an exclusive worldwide license to develop and commercialize daratumumab.
"Breakthrough designation allows us to work together with our strategic partner Janssen and the FDA to expedite the development of daratumumab in multiple myeloma, so patients suffering from this devastating type of blood cancer could potentially receive access to this medicine much sooner," said Jan van de Winkel, Ph.D., Chief Executive Officer of Genmab.
About Breakthrough Therapy Designation
The Breakthrough therapy Designation was enacted as part of the 2012 FDA Safety and Innovation Act (FDASIA) and is intended to expedite development of drugs to treat serious and life-threatening medical conditions when preliminary clinical evidence demonstrates that the drug may have substantial improvement on at least one clinically significant endpoint over available therapies. Breakthrough Therapy Designation includes all the features of the Fast Track Designation, as well as more intensive guidance from the FDA on a drug's clinical development program.
Daratumumab is a human CD38 monoclonal antibody with broad-spectrum killing activity. Daratumumab is in Phase I/II clinical development for multiple myeloma (MM). Daratumumab targets the CD38 molecule which is highly expressed on the surface of multiple myeloma cells. Daratumumab could also have potential in other cancers on which CD38 is expressed, including diffuse large B-cell lymphoma, chronic lymphocytic leukemia, acute lymphoblastic leukemia, plasma cell leukemia, acute myeloid leukemia, follicular lymphoma and mantle cell lymphoma.
About Multiple Myeloma
Multiple myeloma is a cancer of plasma cells and accounts for approximately 1% of all cancers and is the most prevalent blood cancer in the US and second in Europe. According to American Society of Cancer estimates, approximately 21,700 new cases of multiple myeloma will be diagnosed and approximately 10,710 deaths will occur in the US in 2012. At present, no cure is available. The 5-year relative survival rate for multiple myeloma is around 40%. New treatment modalities might improve the survival.
About Genmab A/S
Genmab is a publicly traded, international biotechnology company specializing in the creation and development of differentiated human antibody therapeutics for the treatment of cancer. Founded in 1999, the company's first marketed antibody, ofatumumab (Arzerra®), was approved to treat chronic lymphocytic leukemia in patients who are refractory to fludarabine and alemtuzumab after less than eight years in development. Genmab's validated and next generation antibody technologies are expected to provide a steady stream of future product candidates. Partnering of innovative product candidates and technologies is a key focus of Genmab's strategy and the company has alliances with top tier pharmaceutical and biotechnology companies. For more information visit www.genmab.com.
Rachel Curtis Gravesen, Senior Vice President, Investor Relations & Communications
T: +45 33 44 77 20; M: +45 25 12 62 60; E: [email protected]
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