Ofatumumab Included in Regulatory Submission to US Authorities from Gilead

Media Release

• Gilead announces submission of a supplemental New Drug Application to use Zydelig® in combination with ofatumumab in previously treated patients with CLL
• Submission based on data presented at American Society of Clinical Oncology Meeting 2015

Copenhagen, Denmark; June 1, 2015 – Genmab A/S (OMX: GEN) announced today that Gilead has published that it has submitted a supplemental New Drug Application (sNDA) with the U.S. Food and Drug Administration to include data from a phase 3 study of Zydelig^® (idelalisib) in combination with ofatumumab in previously-treated patients with chronic lymphocytic leukemia (CLL). As reported the study included 261 patients and the results showed a 73 percent reduction in the risk of disease progression or death for patients in the Zydelig plus ofatumumab arm versus the ofatumumab arm alone.  The safety profile of Zydelig was similar to prior studies in previously-treated patients with CLL. Grade ≥3 adverse events occurring in the Zydelig plus ofatumumab arm included diarrhea/colitis (20.2 percent), pneumonia (12.7 percent) and febrile neutropenia (11.6 percent). The data was presented over the weekend at the American Society of Clinical Oncology Meeting 2015 held in Chicago, USA. Gilead also announced it plans to submit a supplemental filing to the European Medicines Agency later this year.

About Genmab
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 currently has one marketed antibody, Arzerra® (ofatumumab) for the treatment of certain chronic lymphocytic leukemia indications and daratumumab in clinical development for multiple myeloma and non-Hodgkin’s lymphoma, in addition to other clinical programs, and an innovative pre-clinical pipeline.  Genmab's technology base consists of validated and proprietary next generation antibody technologies - the DuoBody® platform for generation of bispecific antibodies, and the HexaBody® platform which creates effector function enhanced antibodies. Genmab's deep antibody expertise is expected to provide a stream of future product candidates.  Partnering of selected 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.

Contact:          
Rachel Curtis Gravesen, Senior Vice President, Investor Relations & Communication
T: +45 33 44 77 20; M: +45 25 12 62 60; E: r.gravesen@genmab.com

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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 trademark of Novartis Pharma AG.

Media Release no. 03
CVR no. 2102 3884

Genmab A/S
Bredgade 34E
1260 Copenhagen K
Denmark

Vedhæftede filer:

i03_MR sNDA zydelig ofa_010615_uk.pdf