FDA approves new treatment, Campath , humanized monoclonal antibody, for patients with B-cell chronic lymphocytic leukemia

Berlex Laboratories to market a new option for patients with refractory, or hard-to-treat, B-CLL

MONTVILLE, N.J., May 8, 2001 The U.S. Food and Drug Administration (FDA) late yesterday cleared Campath (alemtuzumab) humanized monoclonal antibody for marketing as a treatment for patients with B-cell chronic lymphocytic leukemia (B-CLL) who have been treated with alkylating agents and have failed fludarabine therapy. With this decision, Berlex Laboratories, Inc., the U.S. affiliate of Schering AG, Germany (NYSE: SHR), will provide patients with refractory B-CLL a new treatment option. Campath therapy for B-CLL was developed by M&I Partners, a 50-50 joint venture of Millennium Pharmaceuticals, Inc., (NASDAQ: MLNM) and ILEX Oncology, Inc., (NASDAQ: ILXO). Campath will be marketed and distributed in the United States by Berlex Laboratories, Inc., of Montville, N.J.

This approval is good news for patients with refractory B-CLL. Campath provides a new option for refractory patients who have no other approved therapeutic options available, said Kanti Rai, M.D., chief of the division of hematology and oncology, Long Island Jewish Medical Center and a principal investigator in the Campath clinical trials.

Chronic lymphocytic leukemia is the most prevalent form of adult leukemia, affecting approximately 120,000 patients in the U.S. and Europe. B-CLL is characterized by an accumulation of leukemic (malignant) lymphocytes that often bear the CD52+ antigen, in the bone marrow, blood, and other tissues. As a result of the accumulation of malignant lymphocytes, bone marrow dysfunction and enlargement of the lymph nodes, liver, and spleen may occur. Patients with B-CLL may suffer from disease-related symptoms such as fatigue, bone pain, night sweats, and decreased appetite and weight loss.

Campath appears to work by targeting the CD52+ antigen on the malignant lymphocytes. Campath binds to CD52+, an antigen

Contact: Richard Salem
Porter Novelli

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