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Millennium Initiates Phase I Clinical Trial of MLN3897

First product candidate to enter clinical trials from Aventis collaboration

December 22, 2003
Source: Millennium Pharmaceuticals, Inc.
Cambridge, Mass.

Millennium Pharmaceuticals, Inc. today announced the initiation of a phase I clinical trial of MLN3897, the first compound to enter clinical trials from its inflammation collaboration with Aventis Pharmaceuticals, Inc.  MLN3897 (Aventis' compound code: AVE-9897), an orally-administered small molecule, is designed to block CCR1, a chemokine receptor found on the surface of various cells in the immune system which is believed to play a role in a number of inflammatory conditions, including rheumatoid arthritis, multiple sclerosis and psoriasis.  The primary objectives of this double-blind, placebo- controlled, single dose-escalation study are to evaluate the safety, tolerability, pharmacokinetic and to obtain preliminary information on receptor binding properties of the compound.

"Advancing MLN3897 into the clinic represents real progress from the Millennium-Aventis collaboration and we believe it is a precursor to further success," said Robert I. Tepper, M.D., president of research and development at Millennium.  "We believe that our expertise and knowledge of this critical cell trafficking pathway is going to enable us to develop breakthrough medicines for areas of significant unmet medical need, such as these chronic inflammatory conditions."

CCR1 is believed to play an important role in the MIP-1a/RANTES/CCR1 chemokine pathway.  This receptor signals monocytes and T cells to travel to sites of injury, such as arthritic joints, as part of the inflammatory process.  It is also believed that an antagonism of CCR1 could potentially offer new therapeutic approaches in a variety of inflammatory and autoimmune indications.

For more information about this and other clinical trials, patients and physicians can contact the Millennium Medical Product Information Department at (800) 589-9005.

The Millennium-Aventis Collaboration

Millennium and Aventis Pharmaceuticals, Inc. formed an alliance in June 2000 focused on identifying drug targets and developing new therapies for inflammatory diseases.  Scientists are collaborating on discovery, development and commercialization of small molecule drugs for the treatment of inflammation-based conditions such as rheumatoid arthritis, asthma and multiple sclerosis.  The companies are sharing inflammation discovery pipeline assets, jointly developing new technologies and sharing costs equally.

About Millennium

Millennium Pharmaceuticals, Inc., a leading biopharmaceutical company based in Cambridge, Mass., markets VELCADE(TM) (bortezomib) for Injection, a novel cancer product, co-promotes INTEGRILIN(R) (eptifibatide) Injection, a market-leading cardiovascular product, and has a robust clinical development pipeline of product candidates.  The Company's research, development and commercialization activities are focused in three therapeutic areas: oncology, cardiovascular, and inflammation.  By applying its knowledge of the human genome, its understanding of disease mechanisms, and its industrialized drug discovery platform, Millennium is seeking to develop breakthrough products.

This press release contains "forward-looking statements," including statements about our growth and future operating results, discovery and development of products, potential acquisitions, strategic alliances and intellectual property.  Various important risks may cause the Company's actual results to differ materially from the results indicated by these forward- looking statements, including: adverse results in our drug discovery and clinical development programs; failure to obtain patent protection for our discoveries; commercial limitations imposed by patents owned or controlled by third parties; our dependence upon strategic alliance partners to develop and commercialize products and services based on our work; difficulties or delays in obtaining regulatory approvals to market products and services resulting from our development efforts; the commercial success of INTEGRILIN(R) (eptifibatide) Injection and VELCADE(TM) (bortezomib) for Injection; and the requirement for substantial funding to conduct research and development and to expand commercialization activities.  For a further list and description of the risks and uncertainties we face, see the reports we have filed with the Securities and Exchange Commission.  We disclaim any intention or obligation to update or revise any forward-looking statements, whether as a result of new information, future events or otherwise.

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