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Biotech / Medical : Millennium Pharmaceuticals, Inc. (MLNM) -- Ignore unavailable to you. Want to Upgrade?

To: scaram(o)uche who wrote (685)	4/6/2001 8:25:26 AM
From: wgh613	Respond to of 3044

M&I Partners' Response Concerning CAMPATH Accepted by FDA SAN ANTONIO, Apr 6, 2001 (BUSINESS WIRE) -- ILEX(tm) Oncology Inc. (Nasdaq: ILXO chart, msgs) today announced the receipt of a letter from the U.S. Food and Drug Administration (FDA) to Millennium & ILEX Partners, L.P. (M&I Partners) stating that the agency intends to take action by May 19, 2001 on the partnership's Biologics License Application (BLA) for CAMPATH(R) (alemtuzumab). In its letter, the FDA stated that it accepted the partnership's response to the agency's Feb. 20, 2001 action letter on March 19, 2001, and considers it "a complete, Class 1 response." The letter further stated that the FDA's Center for Biologics Evaluation and Research (CBER) "intends to review this submission and take action on it by May 19, 2001." The CAMPATH(R) investigational humanized monoclonal antibody received "fast track" designation from the FDA and has been undergoing priority review under the Prescription Drug User Fee Act (PDUFA). Since receiving the FDA's action letter on Feb. 20, 2001, M&I Partners has been working with the FDA to finalize package labeling and design of a post-marketing clinical study of CAMPATH(R). CAMPATH(R) is jointly owned by Millennium Pharmaceuticals Inc. (Nasdaq: MLNM chart, msgs) and ILEX in the joint venture known as Millennium & ILEX Partners L.P. Worldwide marketing and distribution rights, outside of East Asia and Japan, have been granted to Schering AG, Germany, (NYSE: SHR chart, msgs). Berlex Laboratories Inc. of Montville, N.J., the U.S. affiliate of Schering AG, Germany will be marketing Campath in the United States. 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 most experienced in-house development organizations for oncology drugs, with locations in San Antonio, Annapolis, Md., and the United Kingdom. ILEX also conducts drug discovery research in angiogenesis inhibition, medicinal chemistry and nuclear receptor biology from its laboratories in Boston and Geneva, Switzerland. Further information about ILEX can be found on the company's Web site at www.ilexonc.com. Certain statements contained herein are "forward-looking" statements (as such term is defined in the Private Securities Litigation Reform Act of 1995). Because such statements include risks and uncertainties, actual results may differ materially from those expressed or implied by such forward-looking statements. Factors that could cause actual results to differ materially from those expressed or implied by such forward-looking statements include, but are not limited to, failure to successfully complete clinical trials; failure to receive market clearance from regulatory agencies; and those risks described in ILEX's Form S-3 filed March 8, 2000 (Commission file No. 333-32000), and ILEX's Annual Report on Form 10-K for the year ended December 31, 1999, and in other filings made by ILEX with the SEC. ILEX disclaims any obligation to update these forward-looking statements