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To: Smart_Money who wrote (28496)	6/26/2000 10:22:00 AM
From: Rande Is	Read Replies (3) \| Respond to of 57584

MLNM & ILXO News. . . FDA COMPLETES INITIAL REVIEW OF MILLENNIUM & ILEX PARTNERS' BLA SUBMISSION FOR CAMPATH HEALTH/MEDICAL WRITERS CAMBRIDGE, Mass. and SAN ANTONIO, Texas--(BW HealthWire)--June 26, 2000 -- Millennium & ILEX Partners, L.P., a joint venture of Millennium Pharmaceuticals, Inc. (Nasdaq: MLNM.O) and ILEX(TM)Oncology, Inc. (Nasdaq: ILXO.O), today announced the receipt of a complete response letter from the Food and Drug Administration (FDA) related to the partnership's Biologics License Application (BLA) for Campath(R)(alemtuzumab), an investigational humanized monoclonal antibody. In the complete response letter, the FDA delineated the deficiencies noted after complete review of the licensing application, the resolution of which is necessary to continue the review of the application for consideration for marketing approval. The complete review of the Campath(R) application satisfied FDA's performance goal for priority review under the Prescription Drug User Fee Act (PDUFA). The partnership intends to respond rapidly to the FDA letter, and the agency is expected to reinitiate its review upon receipt of the partnership's complete response. The partnership submitted a BLA for the monoclonal antibody Campath(R) with 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 a six-month priority review under PDUFA. The FDA also granted orphan drug designation to Campath(R). In Europe, the partnership submitted a Marketing Authorization Application in March 2000, which is being reviewed under the European Agency for the Evaluation of Medicinal Products' centralized procedure, required for biotechnology products. Millennium, a biopharmaceutical company, applies its comprehensive and integrated science and technology platform for the discovery and development of therapeutic products. 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, Massachusetts, Millennium and its affiliates currently employ more than 1,000 people. ILEX Oncology, Inc. is a drug development company focused predominantly on the accelerated development of drugs for the treatment and prevention of diseases. The company does this in two ways: by advancing a diversified portfolio of therapeutic drugs through its ILEX Products subsidiary, and, by offering drug development services on a contract basis to pharmaceutical and biotech companies through its ILEX Oncology Services subsidiary. These complementary businesses draw from the company's core relationships with international oncology experts, strategic alliances providing access to patient recruitment for clinical trials, and simultaneous European and US drug development and approval capabilities. ILEX: Certain statements contained herein, including the company's intention to respond rapidly to regulatory requests and the company's expectation of the reinitiation of regulatory review, 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, the company's failure to respond rapidly to regulatory requests; the failure of regulators to reinitiate review of company regulatory applications; the early stage of ILEX's compounds under development; risks in technology and product development; failure to successfully complete clinical trials; failure to receive market clearance from regulatory agencies; dependence on third parties and partners and those risks described in ILEX's Form S-3 filed March 8, 2000 (Commission file #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. Millennium: This press release contains "forward-looking statements." These statements include descriptions of Millennium's operational plans, expectations about future earnings and other results of operations, views of future industry or market conditions, and other statement that include words like "may," "expects," believes," and "intends," and that describe opinions about future events. Known and unknown risks may cause Millennium's actual results and performances to be materially different from those expressed or implied by these statements. Some of these risks are: uncertainties relating to unanticipated difficulties and delays relating to gene identification, drug discovery and clinical development processes; changes in relationships with strategic partners and dependence upon strategic partners for the performance of critical activities under collaborative agreements; the impact of competitive products and technological changes; uncertainties relating to patent protection and regulatory approval; and uncertainties relating to the ability of Millennium and its affiliates to obtain substantial additional funds required for progress in drug discovery and development. These and other factors are identified and more fully explained under the heading "Risk Factors That May Affect Results" in the annual report on Form 10-K filed by Millennium with the Securities and Exchange Commission on February 25, 2000. Editor's Note: This release is available on Millennium's website at: mlnm.com and on the ILEX website at: ilexoncology.com. CONTACT: Millennium Pharmaceuticals Inc.