Copenhagen, Denmark; December 12, 2005 – Genmab A/S (CSE: GEN) announced today preliminary results in the Phase II study using HuMax-CD4™ to treat patients with refractory or relapsed non-cutaneous T-cell lymphoma. At week 6, according to the Cheson criteria, 3 patients achieved objective responses as assessed by CT scan and clinical investigation, including 1 complete response unconfirmed (CRu) and 2 partial responses (PR).  Two of the patients (CRu and PR) had progressive disease at week 12, whereas the third patient had only the week 6 CT scan to date and is still being treated in the study.

In addition to the responses verified by CT scan, study investigators reported significant improvement in another 3 patients. Following treatment with 2 and 3 infusions of HuMax-CD4, most of the lymph nodes in 2 patients returned to normal size lasting for a period of 3 and 6 weeks, respectively, after which both patients were withdrawn from the study due to disease progression. The third patient had received 7 infusions of HuMax-CD4 and described an overall improvement in general condition during the course of treatment, however, CT scan at week 6 demonstrated progressive disease.

A total of 14 patients were enrolled in the study.  The efficacy data represent 11 patients who received at least 1 infusion of HuMax-CD4 and were followed for at least 6 weeks or were withdrawn for safety reasons.  Three of the 11 patients have received all 12 infusions.  The remaining 8 patients received 2 to 7 infusions. One of the 11 patients is still being treated.

Safety

The safety data include all 14 patients. HuMax-CD4 was generally well tolerated in this patient population. Four patients had serious adverse events (SAE) considered treatment related by investigator: 1 patient had 2 grade 1 SAEs, hyperthermia and hypotension; 1 patient had a grade 2 SAE, infusion related reaction, 2 patients had 2 grade 4 SAEs, febrile neutropenia and thrombocytopenia.  The incident of thrombocytopenia was observed the day after the patient’s first infusion.  Eight hours after the first measurement, the thrombocyte count had returned to normal and the patient received 5 additional infusions of HuMax-CD4 without reoccurrence.

“We are encouraged by the responses with this intractable disease where there is currently no approved therapy available, and believe further development of HuMax-CD4 for non-cutaneous T-cell lymphoma is warranted,” said Lisa N. Drakeman, Ph.D., Chief Executive Officer.

The poster was presented today at the 2005 Annual Meeting of the American Society of Hematology and is available at www.genmab.com.

Conference Call

Genmab will hold a conference call about this news, as well as news from the HuMax-CD20 presentation at ASH, today, Monday, December 12, 2005 at

8:45 p.m. CET

7:45 p.m. GMT

2:45 p.m. EST

The dial in numbers are as follows:

+1 800-289-0743 (in the US) and ask for the Genmab conference call

+1 913-981-5546 (outside the US) and ask for the Genmab conference call

The conference call will be held in English.

About CTCL and NCTCL

Cutaneous T-cell lymphomas (CTCL) are a group of lymphomas characterized by abnormal accumulation of malignant T-cells in the skin, resulting in the development of rashes, plaques and tumors. The most common types of CTCL include mycosis fungoides (MF) and Sezary syndrome (SS). CTCL result from transformation of T-lymphocytes into malignant cells. Abnormal, uncontrolled growth and multiplication of malignant T-lymphocytes result in accumulation of these lymphocytes in the skin and may in some cases spread and affect the lymph nodes and other body tissues and organs, resulting in life-threatening complications. 

Non-cutaneous T-cell lymphoma (NCTCL) is defined by highly malignant diseases, which have localized to the lymph nodes even at the earliest stage of presentation, and include angioimmunoblastic T-cell lymphoma, anaplastic large cell lymphoma (ALCL) and unspecified peripheral T-cell lymphoma. This disease entity is characterized by aggressive progression with average survival time of approximately two years.

About HuMax-CD4 (Zanolimumab)

HuMax-CD4 (zanolimumab) is a human monoclonal antibody currently in Phase III development for cutaneous T-cell lymphoma (CTCL) and in Phase II for non-cutaneous T-cell lymphoma. These types of lymphomas express the CD4 receptor, which is the target of HuMax-CD4. In April 2005, Genmab and the United States Food and Drug Administration (FDA) reached an agreement on the design of its pivotal study protocol for HuMax-CD4 to treat CTCL under the Special Protocol Assessment process (SPA).  The pivotal study will include patients with mycosis fungoides (MF) who are refractory to or intolerant of Targretin and one other standard therapy, and will treat a total of 88 patients.

In March 2004, Genmab announced that HuMax-CD4 had been designated a Fast Track Product by the US Food and Drug Administration (FDA). This designation covers patients with CTCL for whom no available therapy exists, i.e. have failed at least two systemic treatment regimens. HuMax-CD4 for the treatment of MF has also been granted Orphan Drug status in the US and Europe.