HuMax-CD4(TM) Continues to Show Long Lasting Responses in T-Cell Lymphoma Patients

02/18/05 -- Genmab A/S (CSE: GEN) announced today additional encouraging duration of response data from one of its HuMax-CD4 (zanolimumab) Phase II studies treating patients with mycosis fungoides (MF) a type of cutaneous T-cell lymphoma (CTCL). Data from all patients in the study showed a median response duration of more than 45 weeks (10.5 months). Furthermore, analysis of the time to response showed that 85% of the responding patients (11/13) obtained clinical response within 8 weeks.

Dose Response

Additionally, previously released data was analyzed to assess the relation between dose and the serum concentration of HuMax-CD4 measured immediately before the next treatment (trough values). Increasing doses of HuMax-CD4 resulted in increased trough values. Furthermore, a 55% response rate was achieved in patients reaching lesser than or equal to 10 mu g/ml serum concentration compared to only 6% (1/16) in patients not reaching this serum level. In the 280 mg dose group, 25% (5/20) were above 10 mu g/ml and a 15% response rate (3/20 patients) was achieved. In the 560 mg dose group, 93% (13/14) were above 10 mu g/ml and a 50% response rate (7/14) was obtained. In the 980 mg group 100% (4/4) were above 10 mu g/ml and a 75% response rate (3/4) was obtained.

These data are being presented today by Dr. Y. H. Kim, Professor of Dermatology and Director, Multidisciplinary Cutaneous Lymphoma Clinic, Stanford University at the 63rd Annual Meeting of the American Academy of Dermatology in New Orleans, Louisiana, USA. The poster will subsequently be available on http://www.genmab.com .

"This latest set of duration of response data is very encouraging and indicates that HuMax-CD4 may be effective in treating CTCL patients with mycosis fungoides, especially at higher doses," said Lisa N. Drakeman, Ph.D., Chief Executive Officer of Genmab.

About HuMax-CD4

HuMax-CD4 is a high affinity human antibody that targets the CD4 receptor on T-lymphocytes. Genmab has run two Phase II studies using HuMax-CD4 to treat CTCL, one in early stage patients and the other for patients with advanced disease, both of which achieved positive results. Thirty-eight CTCL patients with MF, the most common form of CTCL, were treated in these studies. Genmab has US Orphan Drug designation for HuMax-CD4 to treat MF patients and is making plans for a pivotal study with HuMax-CD4 under an FDA Fast Track designation for patients who have failed available therapies.

International Non-proprietary Name (INN)

Zanolimumab has reached the status of recommended INN which is the international non-proprietary name (generic name) for HuMax-CD4, as adopted by WHO.

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. At present, Genmab has multiple partnerships to gain access to disease targets and develop novel human antibodies including agreements with Roche and Amgen. A broad alliance provides Genmab with access to Medarex, Inc.'s array of proprietary technologies, including the UltiMAb(TM) platform for the rapid creation and development of human antibodies to virtually any disease target. Genmab is headquartered in Copenhagen, Denmark, and has operations in Utrecht, The Netherlands, and Princeton, New Jersey in the US. For more information about Genmab, visit http://www.genmab.com.

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.

Source: Genmab A/S