Genmab's HuMax-CD4 to Treat Lymphoma Awarded Fast Track Status From FDA COPENHAGEN, Denmark, March 23 /PRNewswire/ -- Genmab A/S (CSE: GEN) announced today that HuMax-CD4 has been designated a Fast Track Product by the US Food and Drug Administration (FDA). This designation covers patients with cutaneous T-cell lymphoma (CTCL) who have failed currently available therapy. This patient group includes those who are refractory as well as those who cannot tolerate currently available treatment. HuMax-CD4 is currently in two Phase II studies to treat CTCL. Under the FDA Modernisation Act of 1997, designation as a Fast Track Product means that the FDA will facilitate the development and expedite the review of a drug if it is intendedfor the treatment of a serious or life- threatening condition, and it demonstrates the potential to address unmet medical needs for such a condition. This fast track designation gives Genmab the opportunity to submit a Biologics License Application (BLA) in sequential sections, and have these sections reviewed as they are submitted, thus saving development time. A BLA is the biologic products' equivalent to a New Drug Application and is the final stage before a drug is approved for the market by the FDA. Fast track status also opens the possibility for receiving a priority review of the BLA where the review time would be halved to just 6 months. "Fast Track status confirms there is a major unmet medical need for treatment of CTCL patients," said Lisa N. Drakeman, Ph.D., Chief Executive Officer of Genmab. "We are encouraged by the results of the clinical trials to date and are looking forward to continued development." About HuMax-CD4 HuMax-CD4 is a high affinity human antibody that targets the CD4 receptor on T-lymphocytes. Genmab is running two Phase II studies concurrently using HuMax-CD4 to treat cutaneous T-cell lymphoma (CTCL), one in early stage patients and the other for patients with advanced disease. In February, the company announced that results will be presented at the 65TH Annual Meeting of the Society for Investigative Dermatology (SID) in April. At the time the conference abstract was prepared, data was available from 36 patients enrolled in the two ongoing HuMax-CD4 clinical trials using the Composite Assessment of Index Lesion Disease Activity (CA) score. These patients were treated at one of three dose levels as follows: 280 mg (11 early stage and 10 advanced stage), 560 mg (9 early stage) or 980 mg (6 advanced stage). Efficacy Following 280 mg, 33% of 21 patients obtained a 50% or better CA score reduction. Following 560 mg, 67% (six of nine early stage patients) obtained a CA score reductionof 50% or better, including two who obtained a 100% reduction. Three other early stage patients had stable disease. Following 980 mg, 50% (three of six) advanced stage patients obtained a CA score reduction of more than 50% and three patients had stable disease. Safety Following 280 mg dosing, 6 grade 3 adverse events were reported by 4 patients. 5 were unrelated to HuMax-CD4. Following 560 and 980 mg, 1 unrelated grade 3 adverse event was reported. No grade 4 events were reported. HuMax-CD4 has been found to be safe and well tolerated by patients with CTCL in clinical studies to date. Society for Investigative Dermatology Presentation At the time of the SID abstract, 15 early stage patients were enrolled in the 560 mg treatment group and 10 late stage patients were enrolled in the 980 mg treatment group. At the time of the presentation on April 30, 2004, more complete data covering more of these patients for a longer period of time is expected to beavailable. Disease prevalence T-cell lymphomas positive for the CD4 receptor constitute around 5% of Non Hodgkin's Lymphomas. There are about 1,000 new cases of CTCL per year in the US and the prevalence of the disease is estimated at16,000 to 20, 000. CTCL patients tend to have a lifespan of 10 to 30 years and therefore could be treated several times during the disease progression. In addition to CTCL, approximately half of the non-cutaneous T-cell lymphomas express the CD4 receptor on their cell surface and Genmab has also treated a non-cutaneous T-cell lymphoma patient on a compassionate use basis with a good clinical effect. Considering this and the encouraging data from the CTCL study, Genmab is now making plansto initiate a study in non- cutaneous T-cell lymphoma patients in the second half of 2004, especially since these patients also have a dramatic need for new and less toxic therapies. Non-cutaneous T-cell lymphomas that are positive for the CD4 receptor are predominantly of the nodal subtype. This includes peripheral and angioimmunoblastic T-cell lymphomas of which 75% are CD4 positive and anaplastic large cell lymphomas of which 20% are. The combined incidence of these lymphomas is approximately 2,770 in the US and Canada and 3,280 in industrialised Europe. Their prevalence in Europe is approximately 10,000 and in US and Canada it ranges from 8,000 to 10,000. The Composite Assessment (CA) The recognised compositeassessment of index lesion disease activity (CA) is the primary endpoint for assessing clinical efficacy in the treatment of CTCL in the two ongoing clinical trials. When calculating the CA score, a maximum of five index lesions are assessed with regards to the following components; erythema, scaling, plaque elevation, hypo- or hyperpigmentation, and area. For the first four components values between 0 and 8 can be ascribed, whereas for the area of the index lesion values between 0 and 18 can be ascribed. The CA score is the sum of the assessments of erythema, scaling, plaque elevation, hypo- or hyperpigmentation, and area at a specific visit. Conference Call Genmab's Management will hold a conference call to discuss the news today, Tuesday, March 23, at 3:00 pm CET 2:00 pm GMT 9:00 am US Eastern Time The dial in numbers are as follows: +1-800-915-4836 (in the US) and ask for the Genmab conference call +973-317-5319 (outside the US) and ask for the Genmab conference call The conference call will be held in English. 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 www.genmab.com. Except for the historical information presented herein, matters discussed in this press release are forward-looking statements that are subject to certain risks and uncertainties that couldcause actual results to differ materially from any future results, performance or achievements expressed or implied by such statements, e.g. unforeseen exchange rate and interest rate fluctuations, delayed or unsuccessful development projects. Statements that are not historical facts, including statements preceded by, followed by, or that include the words "believes"; "anticipates"; " plans"; "expects"; "estimates"; or similar statements are forward-looking statements. 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. Web site: http://www.genmab.com DATASOURCE: Genmab A/S CONTACT: Sisse P. Hansen, Investor & Public Relations of Genmab A/S, +45-33-44-77-76, mobile: +45-25-27-47-27, sha@genmab.com FCMN Contact: sha@genmab.com

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