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Indevus Announces Selection of PRO 2000 by Microbicide Development Programme as Sole Agent for Full-Scale, International Anti-HIV Trials
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LEXINGTON, Mass.--(BUSINESS WIRE)--09/22/2004--Indevus Pharmaceuticals, Inc. (Nasdaq:IDEV) today announced that the Microbicide Development Programme (MDP) has selected PRO 2000, the Company's microbicide under development to prevent sexual infection by HIV, as the sole agent to be tested in full-scale clinical trials due to start next year in a number of African countries. These trials represent the largest single medical research project that has ever been funded by the United Kingdom's Department for International Development.
In announcing their selection of PRO 2000, the MDP stated that PRO 2000 has been shown in laboratory studies to be substantially more effective in blocking HIV infection than another microbicide known as Emmelle. Rather than include another microbicide in the trial, the MDP will now compare two doses of PRO 2000 (0.5 percent and 2 percent). As stated by the MDP, this range of doses to be tested may provide information about the relationship between dose and protection which could be of significant value for microbicide development. In addition, if the low dose of PRO 2000 is shown to be as effective as higher doses, it may help reduce the cost of manufacture and speed access to an effective product.
"We are excited that the MDP has selected PRO 2000 as the sole product candidate for these critical international trials," said Glenn L. Cooper, M.D., chairman, president and chief executive officer of Indevus. "The majority of new adult HIV infections worldwide are acquired through heterosexual intercourse, and the scope of the AIDS epidemic is expected to increase in both developed areas of the world and areas where resources and medical awareness are more limited. Because a safe and effective topical microbicide would increase the opportunities for sexually active women to be more proactive in the prevention of the sexual transmission of HIV, we see microbicide development as a potentially important new worldwide HIV prevention strategy."
At least 12,000 women will be recruited and supported for nine months or longer in connection with these trials. Trial organizers hope to begin enrollment around April 2005.
The MDP is funded by a grant from the Department for International Development of GBP 16 million, or approximately $28.6 million. The MDP is a partnership set up to develop vaginal microbicides for the prevention of HIV transmission, funded by the U.K. Department for International Development through the U.K. Medical Research Council (MRC) and administered by the MRC Clinical Trials Unit and Imperial College in London.
Indevus Pharmaceuticals is a biopharmaceutical company engaged in the development and commercialization of a diversified portfolio of pharmaceutical product candidates, including multiple compounds in development: SANCTURA, pagoclone for panic and generalized anxiety disorders, IP 751 for pain and inflammatory disorders, PRO 2000 for the prevention of infection by HIV and other sexually transmitted pathogens and aminocandin for systemic fungal infections.
Except for the descriptions of historical facts contained herein, this press release contains forward-looking statements that involve risks and uncertainties that could cause the Company's actual results and financial condition to differ materially from those anticipated by the forward-looking statements. These risks and uncertainties are set forth in the Company's filings under the Securities Act of 1933 and the Securities Exchange Act of 1934 under "Risk Factors" and elsewhere, and include, but are not limited to: dependence on the success of SANCTURA; the early stage of products under development; uncertainties relating to clinical trials, regulatory approval and commercialization of our products, particularly SANCTURA; risks associated with contractual agreements, particularly for the manufacture and co-promotion of SANCTURA; dependence on third parties for manufacturing and marketing; competition; need for additional funds and corporate partners, including for the development of our products; failure to acquire and develop additional product candidates; history of operating losses and expectation of future losses; product liability and insurance uncertainties; risks relating to the Redux-related litigation; limited patent and proprietary rights; dependence on market exclusivity; valuation of our Common Stock; risks related to repayment of debts; risks related to increased leverage; and other risks.
CONTACT:Indevus Pharmaceuticals, Inc. Michael W. Rogers, 781-861-8444 or William B. Boni, 781-402-3410
SOURCE: Indevus Pharmaceuticals, Inc.
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