Agreement for Daratumumab Receives Antitrust Clearance


Company Announcement

  • Daratumumab license agreement with Janssen Biotech, Inc., one of the Janssen Pharmaceutical Companies of Johnson & Johnson, receives antitrust clearance
  • License agreement has now become effective
  • Issue of new Genmab shares to Johnson & Johnson Development Corporation pursuant to a subscription agreement is subject to formal approval of a private placement prospectus

Copenhagen, Denmark; September 21, 2012 – Genmab A/S (OMX: GEN) announced today that the worldwide license agreement for daratumumab with Janssen Biotech, Inc., one of the Janssen Pharmaceutical Companies of Johnson & Johnson, has received antitrust clearance from the Federal Trade Commission and the Antitrust Division of the Department of Justice under the Hart-Scott-Rodino Act. This means that the license agreement has now become effective. A private placement prospectus containing details of the issue of new Genmab shares to Johnson & Johnson Development Corporation in connection with the agreement has been prepared in accordance with the applicable rules and regulations and filed with the Danish Financial Supervisory Authority. Upon the agency's approval, the new Genmab shares will be registered with the Danish Business Authority by way of a capital increase in Genmab and subsequently admitted to official listing and trading on the NASDAQ OMX Copenhagen A/S, after which the subscription agreement will be considered effective. The license agreement with Janssen Biotech, Inc. was first announced on August 30, 2012 (Company Announcements 20 and 21).

About daratumumab
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 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 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.

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.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®; the Y-shaped Genmab logo®; HuMax®; HuMax-CD20®; HuMax®-EGFr; HuMax®-IL8; HuMax®-TAC; HuMax®-CD38; HuMax®-TF; HuMax®-TF-ADC; HuMax®-Her2; HuMax®-cMet, HuMax®-CD74, DuoBody™ and UniBody® are all trademarks of Genmab A/S. Arzerra® is a trademark of GlaxoSmithKline.

Company Announcement no. 22
CVR no. 2102 3884

Genmab A/S
Bredgade 34
1260 Copenhagen K
Denmark


Attachments

22_daratumumab_antitrust_clearance_210912_uk.pdf