Copenhagen, Denmark; March 26, 2014 – Genmab A/S (OMX: GEN) announced today it has reached the second milestone in its daratumumab collaboration with Janssen Biotech, Inc. (“Janssen”). The $22 million milestone payment was triggered by progress in the ongoing Phase II study of daratumumab in multiple myeloma patients who have received at least three different lines of therapy, including both a proteasome inhibitor (PI) and an immunomodulatory agent (IMiD), or who are double refractory to a PI and an IMiD. This is the same indication for which daratumumab was granted Breakthrough Therapy Designation from the FDA in May 2013.
“The daratumumab development program continues to move forward successfully under our productive collaboration with Janssen and we are pleased to reach this second milestone in the agreement,” said Jan van de Winkel, Ph.D., Chief Executive Officer of Genmab.
The milestone payment is included in Genmab's 2014 financial guidance published on March 4, 2014.
Daratumumab is a human CD38 monoclonal antibody with broad-spectrum killing activity. Daratumumab is in clinical development for multiple myeloma (MM). Daratumumab targets the CD38 molecule which is highly expressed on the surface of multiple myeloma cells. Daratumumab may 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. Daratumumab has been granted Breakthrough Therapy Designation from the US FDA. In August 2012, Genmab granted Janssen Biotech, Inc. an exclusive worldwide license to develop, manufacture and commercialize daratumumab.
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
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Genmab A/S and its subsidiaries own the following trademarks: Genmab®; the Y-shaped Genmab logo®; Genmab in combination with the Y-shaped Genmab logo™; the DuoBody logo™; the HexaBody logo™; HuMax®; HuMax-CD20®; DuoBody®; HexaBody™ and UniBody®. Arzerra® is a registered trademark of the GSK group of companies.
Company Announcement no. 15
CVR no. 2102 3884
1260 Copenhagen K