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Genmab Initiates Ofatumumab Phase II Study in Diffuse Large B-Cell Lymphoma

Summary: Genmab has Initiated a Phase II Study of Ofatumumab in Relapsed

Diffuse Large B-Cell Lymphoma

COPENHAGEN, Denmark, December 13 /PRNewswire-FirstCall/ -- Genmab A/S (OMX: GEN) announced today that study centers have been initiated and are ready to enroll patients in a Phase II study of ofatumumab (HuMax-CD20(R)) to evaluate treatment of relapsed Diffuse Large B-Cell Lymphoma (DLBCL) in patients ineligible for or relapsed following a stem cell transplant. Approximately 75 patients will be enrolled in the study which is being conducted under Genmab's collaboration with GlaxoSmithKline (GSK). Genmab will receive a milestone payment of approximately DKK 87.2 million from GSK upon treatment of the first patient in the study, expected in the near future.

Ofatumumab is an investigational, fully human, next generation monoclonal antibody that targets a unique epitope of the CD20 receptor on the surface of B-cells. Other anti-CD20 antibodies currently available or in development bind to a different epitope on the CD20 receptor. Ofatumumab is being developed under a co-development and commercialization agreement between Genmab and GlaxoSmithKline.

"We have now expanded the ofatumumab clinical development program into a fourth disease area," said Lisa N. Drakeman, Ph.D., Chief Executive Officer of Genmab. "We hope ofatumumab will offer a new and effective treatment option for patients suffering from DLBCL."

About the trial

In this open label trial, each patient will receive 8 weekly infusions of ofatumumab. The first infusion will be 300 mg and the 7 subsequent infusions will be 1000 mg of ofatumumab. Disease status will be assessed 4 weeks after the last infusion and then every 3 months for a total of 24 months after treatment start according to the "Revised response criteria for malignant lymphoma." After 24 months, patients will be followed until initiation of alternative DLBCL treatment or month 60. The objective of the study is to determine the efficacy of ofatumumab in patients with relapsed DLBCL ineligible for transplant or relapsed after transplant. The primary endpoint of the study is objective response over a 6 month period from start of treatment.

About Diffuse Large B-Cell Lymphoma

Diffuse Large B-Cell Lymphoma is a cancer of the B-lymphocytes and represents 30% of non-Hodgkin's lymphomas in adults and is the most common lymphoid malignancy in the western world. There are an estimated 63,000 new cases of DLBCL diagnosed in the US per year. The median age at diagnosis is about 65 years.

About Genmab A/S

Genmab is a leading international biotechnology company focused on developing fully human antibody therapeutics for unmet medical needs. Using unique, cutting-edge antibody technology, Genmab's world class discovery and development teams have created and developed an extensive pipeline of products for potential treatment of a variety of diseases including cancer and autoimmune disorders. As Genmab advances towards a commercial future, we remain committed to our primary goal of improving the lives of patients who are in urgent need of new treatment options. For more information on Genmab's products and technology, visit

This press release 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 product discovery and development, 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. Genmab is not under an obligation to up-date statements regarding the future following the publication of this release; nor to confirm such statements in relation to actual results, unless this is required by law.

Genmab(R); the Y-shaped Genmab logo(R); HuMax(R); HuMax-CD4(R); HuMax-CD20(R); HuMax-EGFr(TM); HuMax-IL8(TM); HuMax-TAC(TM); HuMax-HepC(TM); HuMax-CD38(TM); and UniBody(R) are all trademarks of Genmab A/S.

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