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Back To Vidyya FDA Advisory Committee Recommends Accelerated Approval Of Campath®

Drug To Be Used For Patients With Chronic Lymphocytic Leukemia

The Oncologic Drug Advisory Committee (ODAC) to the U.S. Food & Drug Administration (FDA) voted on Friday, 14-to-1 to recommend accelerated approval of Campath®.

Campath® (Alemtuzumab) is an investigational humanized monoclonal antibody for patients with chronic lymphocytic leukemia (CLL) who have been treated with alkylating agents and have failed fludarabine therapy. CLL is the most prevalent form of adult leukemia, affecting approximately 120,000 patients in the U.S. and Europe.

Accelerated approval requires that M&I Partners further study the compound to verify and describe its clinical benefit. A post-approval clinical trial to examine Campath®'s safety and efficacy in CLL patients is being planned and is expected to begin in 2001.

BTG PLC licensed Campath® to LeukoSite, Inc. in 1997, which in turn sub-licensed the antibody to a 50-50 joint venture with ILEX Products Inc., a subsidiary of ILEX Oncology Inc. This joint venture became M&I Partners following the 1999 acquisition of LeukoSite by Millennium Pharmaceuticals. Campath® will be marketed and distributed in the U.S. by Berlex Laboratories, Inc., a subsidiary of Schering AG, Germany. Under the terms of the licensing arrangement, BTG receives royalties on sales of the product.

The Advisory Committee's recommendation is not binding, but it will be taken into consideration by the FDA upon completing review of the Campath® Biologics License Application, which was submitted to the FDA on 23 December 1999. The FDA has granted Campath® "fast track" and orphan drug designations. In addition, M&I Partners submitted a Marketing Authorization Application for Campath® to the European Agency for the Evaluation of Medicinal Products (EMEA) for evaluation in March 2000, which is currently under review.

The ODAC reviewed efficacy data from a pivotal Phase II clinical trial, as well as two earlier supporting studies, involving a total of 149 patients with CLL. Of the 149, 147 had received at least one regimen containing an alkylating agent, 128 patients had been previously treated with fludarabine and 126 patients received both types of chemotherapy. The pivotal study results showed 33 percent of the patients involved achieved a response to Campath®, which exceeded the protocol specified target response rate of 20 percent.

CLL is characterized by an accumulation of leukemic cells in the bone marrow, blood and other tissues, causing bone marrow dysfunction and enlargement of the lymph nodes, liver and spleen. Investigators believe Campath® works by targeting the CD52 antigen, which is prevalent on cancerous B-lymphocytes, to clear the blood and bone marrow of cancer cells.

"The panel's announcement today is a welcome step forward for patients suffering from CLL," said Ian Harvey, CEO of BTG plc. "This is good news for BTG and our shareholders. If ultimately approved and launched, royalties from Campath® would represent a significant stream of revenues to BTG."

Campath® is a registered trademark of Millennium Pharmaceuticals, Inc.

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Editor: Susan K. Boyer, RN
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