CMLSupport: FDA Extends Approval Period For Campath

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FDA Extends Approval Period For Campath

CAMBRIDGE, Mass. and SAN ANTONIO, Texas, Feb. 21, 2001 — Millennium & ILEX Partners, L.P., a joint venture of Millennium Pharmaceuticals Inc. (Nasdaq: MLNM) and ILEX(TM) Oncology Inc. (Nasdaq: ILXO), today announced the receipt of a Class 1 complete response letter from the Food and Drug Administration (FDA). The letter concerns the partnership's Biologics License Application (BLA) for the CAMPATH(R) (alemtuzumab) investigational humanized monoclonal antibody. The drug received a recommendation for accelerated approval for patients with chronic lymphocytic leukemia who have been treated with alkylating agents and have failed fludarabine therapy from the FDA's Oncologic Drugs Advisory Committee (ODAC) on Dec. 14, 2000.

A Class 1 complete response letter is issued when additional information is required. Issuance of this letter satisfied the FDA's performance goal for priority review under the Prescription Drug User Fee Act (PDUFA). The FDA has indicated that the timeframe for accelerated approval has been extended for a 60-day period. Millennium & ILEX Partners and the FDA will complete ongoing discussions on final package labeling and design of a post-marketing confirmatory study for CAMPATH(R) during this time.

"The drug received a recommendation for accelerated approval for patients with chronic lymphocytic leukemia who have been treated with alkylating agents and have failed fludarabine therapy."

The partnership submitted a BLA for CAMPATH(R) to the FDA in December 1999. The FDA accepted the application for filing in February 2000. CAMPATH(R) received "fast track" designation from the FDA and has been undergoing priority review under PDUFA. The FDA also granted orphan drug designation to CAMPATH(R). On Dec. 14, 2000, ODAC voted 14-1 to recommend accelerated approval of CAMPATH(R).

Millennium, a leading biopharmaceutical company, applies its comprehensive and integrated science and technology platform for the discovery and development of breakthrough therapeutic and predictive medicine products, with a goal of delivering personalized medicine. Through the industrialization of this gene-to-patient platform, Millennium is also striving to accelerate the process of drug discovery and development. Headquartered in Cambridge, Mass., Millennium currently employs more than 1,200 people.

Founded in 1994 as an oncology drug development company, ILEX Oncology Inc. is strategically positioned to become a leading oncology-focused pharmaceutical company. Based in San Antonio, Texas, ILEX is advancing a deep pipeline of compounds focused on the treatment of both advanced and early disease. The pipeline comprises multiple technologies at all stages of clinical development, including a monoclonal antibody, apoptosis-inducing agents, cytotoxic compounds with novel mechanisms of action, angiogenesis inhibitors and chemoprevention agents. ILEX maintains one of the biopharmaceutical industry's largest in-house development organizations for oncology drugs, with locations in San Antonio, Annapolis, Md., and the United Kingdom. ILEX also conducts translational research in angiogenesis inhibition, medicinal chemistry and nuclear receptor biology from its laboratories in Boston and Geneva, Switzerland.

Source: ILEX Oncology

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