UK Government Funding Granted for Phase III Safety and Effectiveness Trial of PRO 2000
Wednesday April 6, 9:28 am ET
GBP26 Million to be Provided for MRC-coordinated HIV Prevention Trial
LEXINGTON, Mass.--(BUSINESS WIRE)--April 6, 2005--Indevus Pharmaceuticals, Inc. (Nasdaq: IDEV - News) today announced that the UK Government and the Medical Research Council (MRC) of the UK are to provide GBP26 million (approximately $48.6 million) to fund a Phase III clinical trial of PRO 2000, the Company's microbicide under development to prevent sexually acquired HIV infection. The trial will be conducted by the Microbicides Development Programme (MDP), an international partnership funded by the UK Department for International Development (DFID) and the MRC, and coordinated by the MRC Clinical Trials Unit and the Clinical Trials Centre of Imperial College London.
The Phase III trial is designed to test the safety and effectiveness of PRO 2000 vaginal gel for preventing HIV infection and other sexually transmitted infections in women. It is expected to begin within 4 months in four African countries: Uganda, South Africa, Tanzania and Zambia, and to run for 39 months. An estimated 12,000 women will be enrolled.
"The development of microbicides such as PRO 2000 is being made possible through public-private sector partnerships that recognize the significant need to stem the spread of AIDS throughout the world," said Glenn L. Cooper, chairman, president and chief executive officer of Indevus. "We believe a safe, effective microbicide would empower women in both developed and developing countries to help protect themselves against sexually-transmitted pathogens such as HIV."
PRO 2000 is a topical vaginal microbicide under development by Indevus to prevent the sexual transmission of HIV and certain other sexually transmitted disease-causing viruses and bacteria. An NIH-sponsored clinical trial to assess the safety and preliminary effectiveness of PRO 2000 and another candidate microbicide for preventing HIV infection is currently underway in Africa and the U.S.
DFID is the UK Government department responsible for promoting sustainable development and reducing poverty. The MRC is a national organization funded by the UK tax-payer. Its business is medical research aimed at improving human health. The MRC has funded work which has led to some of the most significant discoveries and achievements in medicine in the UK. The MRC Clinical Trials Unit was formed by the amalgamation of the MRC HIV Clinical Trials Centre and MRC Cancer Trials Office and supports trials in a wide range of specialties.
The MDP is a partnership established to develop vaginal microbicides for the prevention of HIV transmission. Funded by DFID through grants to the MRC and Imperial College London, it includes researchers in the UK, South Africa, Uganda, Tanzania, Cameroon and Zambia.
Indevus Pharmaceuticals is a biopharmaceutical company engaged in the acquisition, development and commercialization of products targeting certain medical specialty areas, including urology and infectious diseases. The Company currently markets SANCTURA(TM) for overactive bladder and has multiple compounds in clinical development, including PRO 2000 for the prevention of infection by HIV and other sexually transmitted pathogens, pagoclone for stuttering, aminocandin for systemic fungal infections, and IP 751 for interstitial cystitis.
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(TM) and SANCTURA XR(TM); the early stage of products under development; uncertainties relating to clinical trials, regulatory approval and commercialization of our products, particularly SANCTURA and SANCTURA XR; risks associated with contractual agreements, particularly for the manufacture and co-promotion of SANCTURA and SANCTURA XR; 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.
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Contact:
Indevus Pharmaceuticals
Michael W. Rogers, 781-861-8444
Executive Vice President and CFO
or
Robin L. DeCarlo, 781-402-3405
Sr. Manager, Corp. Comm. |
