Daratumumab Granted Fast Track Designation From U.S. Food and Drug Administration

Company Announcement

  • Daratumumab receives Fast Track designation in double refractory multiple myeloma
  • Potential for expedited development

COPENHAGEN, Denmark, April 2, 2013 (GLOBE NEWSWIRE) -- Genmab A/S (Copenhagen:GEN) announced today that the US Food and Drug Administration (FDA) has granted Fast Track designation for daratumumab. This designation covers 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 are double refractory to a PI and an IMiD.

"Fast Track designation for daratumumab means that the FDA recognizes the potential of daratumumab to fill an unmet medical need in multiple myeloma, and that we may be able to reduce the development time and expedite review of the product," said Jan van de Winkel, Ph.D., Chief Executive Officer of Genmab.

In August 2012, Genmab granted Janssen Biotech, Inc. an exclusive worldwide license to develop and commercialize daratumumab.

About Fast Track designation

Fast Track designation is intended to facilitate the development and expedite the review of drugs intended for the treatment of serious conditions and fill an unmet medical need. This designation will enable more frequent interactions with the FDA during drug development. In addition, portions of marketing applications for drugs with Fast Track designation can be submitted before a complete application is submitted, known as rolling review.

About daratumumab

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(r)), 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.

This Company Announcement contains forward looking statements. The words "believe", "expect", "anticipate", "intend" and "plan" and similar expressions identify forward looking statements. Actual results or performance may differ materially from any future results or performance expressed or implied by such statements. The important factors that could cause our actual results or performance to differ materially include, among others, risks associated with pre-clinical and clinical development of products, uncertainties related to the outcome and conduct of clinical trials including unforeseen safety issues, uncertainties related to product manufacturing, the lack of market acceptance of our products, our inability to manage growth, the competitive environment in relation to our business area and markets, our inability to attract and retain suitably qualified personnel, the unenforceability or lack of protection of our patents and proprietary rights, our relationships with affiliated entities, changes and developments in technology which may render our products obsolete, and other factors. For a further discussion of these risks, please refer to the risk management sections in Genmab's most recent financial reports, which are available on www.genmab.com. Genmab does not undertake any obligation to update or revise forward looking statements in this Company Announcement nor to confirm such statements in relation to actual results, unless required by law.

Genmab A/S and its subsidiaries own the following trademarks: Genmab(r); the Y-shaped Genmab logo(r); HuMax(r); HuMax-CD20(r); DuoBody(r), HexaBodyTM and UniBody(r). Arzerra(r) is a trademark of GlaxoSmithKline.

Company Announcement no. 12
CVR no. 2102 3884

Genmab A/S
Bredgade 34E
1260 Copenhagen K

Contact: Rachel Curtis Gravesen Senior Vice President Investor Relations & Communications T: +45 33 44 77 20 M: +45 25 12 62 60 E: r.gravesen@genmab.comSource:Genmab A/S