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HuMax-CD4, Treatment for Lymphoma, Awarded Fast Track Status From FDA

COPENHAGEN, Denmark, March 23 /PRNewswire-FirstCall/ -- Genmab A/S 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 Modernization 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 intended for 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 reduction of 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 be available.

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 at 16,000 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 plans to 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 industrialized 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 recognized composite assessment 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.

Source: Genmab A/S

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