Healthcare Industry News:  fast track designation 

Biopharmaceuticals Oncology

 News Release - June 18, 2007

Genmab Announces Development Plans for Ofatumumab

Summary: Genmab Announces That Further Development Plans for Ofatumumab in Oncology and Autoimmune Disease Will be Described Today at GlaxoSmithKline's Oncology Seminar.

COPENHAGEN, June 18 (HSMN NewsFeed) -- Genmab A/S (CSE: GEN ) announced that development plans for ofatumumab (HuMax-CD20®) will be described at GlaxoSmithKline's (GSK) Oncology Seminar today. Ofatumumab is currently in late stage development for chronic lymphocytic leukemia (CLL), follicular non-Hodgkin's lymphoma (NHL) and in Phase II for rheumatoid arthritis (RA) and is being developed under a worldwide co-development and commercialisation agreement between Genmab and GSK.

A clear demonstration of the efficacy and safety of ofatumuamb in two late stage single-arm trials (CLL and follicular NHL), which are not routinely accepted as registration studies, could provide the initial regulatory applications. Genmab has received a fast track designation for the CLL study. Under these circumstances, ofatumumab could potentially enter the market in 2008 first for the treatment of refractory CLL and subsequently for rituximab-refractory follicular NHL. We furthermore expect to expand the ofatumumab program into new indications with the planned initiation of clinical studies in diffuse large B-cell lymphoma (DLBCL) by the end of 2007 and randomized Phase III studies in CLL and follicular NHL in the first half of 2008.

In the autoimmune disease setting, we expect to initiate Phase III studies of ofatumumab in RA by the end of 2007. We also plan to expand the development program with initiation of a Phase II study in relapsing remitting multiple sclerosis (RRMS) in the first quarter of 2008. There is potential to pursue indications in a wide range of autoimmune disease settings.

About Genmab A/S

Genmab A/S is a biotechnology company that creates and develops human antibodies for the treatment of life-threatening and debilitating diseases. Genmab has numerous products in development to treat cancer, infectious disease, rheumatoid arthritis and other inflammatory conditions, and intends to continue assembling a broad portfolio of new therapeutic products. In addition, Genmab has developed UniBody(TM), a new proprietary technology that creates a stable, smaller antibody format. Genmab has operations in Europe and the US. For more information about Genmab, 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®; the Y-shaped Genmab logo®; HuMax®; HuMax-CD4®; HuMax-CD20®; HuMax-EGFr(TM); HuMax-Inflam(TM); HuMax-TAC(TM); HuMax-HepC(TM); HuMax-CD38(TM); HuMax-ZP3(TM); and UniBody(TM) are all trademarks of Genmab A/S.

Source: Genmab

Issuer of this News Release is solely responsible for its content.
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