Indevus Pharmaceuticals Review Recommends Close of High-Dose Arm in HIV Study
LEXINGTON, Mass., Feb. 15 -- Indevus Pharmaceuticals, Inc. announced today that they have been advised by the United Kingdom's Medical Research Council (MRC) that after review of data from the Phase III clinical trial of PRO 2000, the Company's candidate vaginal microbicide for HIV prevention, the Independent Data Monitoring Committee (IDMC) has recommended that the low-dose arm (0.5%) continue to be tested for safety and effectiveness in the trial. The IDMC, a group of independent experts providing oversight to the MDP 301 trial, also recommended the high-dose arm (2.0%) be closed as there is no more than a small chance of the high dose showing protection against HIV infection compared to placebo gel. The trial is sponsored by the MRC and conducted by the Microbicides Development Programme (MDP), an international partnership of researchers established to develop microbicides for the prevention of HIV transmission. The 0.5% dose of PRO 2000 is also being tested for safety and effectiveness in Protocol HPTN 035 sponsored by the National Institute of Allergy and Infectious Diseases (NIAID), part of the National Institutes of Health (NIH).
"We are encouraged that the MRC has decided to continue testing the 0.5% dose of PRO 2000 at this advanced stage of the MDP 301 trial," stated Glenn L. Cooper, M.D., chairman and chief executive officer of Indevus. "Additionally, the NIAID trial, which has completed enrollment, continues to test the 0.5% dose of PRO 2000. We are hopeful that this dose will prove to be a safe and effective treatment for the prevention of the sexual transmission of HIV."
Dr. Cooper continued, "We are grateful for the generous government support of the program, both in terms of funding and access to scientific expertise. The development of an effective microbicide is critical to the fight against HIV."
MDP 301 is a multi-national, randomized, double-blind, placebo-controlled Phase III trial designed to examine the safety and effectiveness of PRO 2000 in preventing HIV infection in women. The MDP selected two PRO 2000 strengths (0.5% and 2.0%) for testing against placebo. Participants also receive a standard HIV prevention package. The trial opened in October 2005, and is currently underway at clinical centers in South Africa, Tanzania, Uganda and Zambia. Approximately 7,730 women have been enrolled in the trial to date and enrollment is expected to be completed later this year. The IDMC will continue to monitor the trial carefully until its planned completion in late 2009.
HPTN 035 is a multi-national, randomized, placebo-controlled trial designed to examine the safety and effectiveness of PRO 2000 and another candidate vaginal microbicide (BufferGel, Reprotect, Inc.) in preventing HIV infection in women. One PRO 2000 strength, 0.5%, is being tested in comparison with a placebo and no treatment. The trial involves seven clinical centers in South Africa, Malawi, Zimbabwe, Zambia, and the United States. The trial opened in February 2005, and 3,100 healthy women were enrolled before planned recruitment ended in July 2007. An NIAID Data and Safety Monitoring Board (DSMB) reviewed the unblinded data from the trial on six separate occasions, most recently in November 2007, and each time has found no safety concerns and recommended proceeding as planned. Completion of the HPTN 035 trial is expected this summer.
Indevus Pharmaceuticals, Inc. is a specialty pharmaceutical company engaged in the acquisition, development and commercialization of products to treat conditions in urology and endocrinology. The Company's approved products include SANCTURA XR(TM) and SANCTURA(R) for overactive bladder, VANTAS(R) for advanced prostate cancer, SUPPRELIN(R) LA for central precocious puberty, and DELATESTRYL(R) to treat male hypogonadism. The Indevus development pipeline contains multiple compounds within the Company's core therapeutic areas in addition to several partnered or partnerable programs. The most advanced compounds in development include, VALSTAR(TM) for bladder cancer, NEBIDO(R) for male hypogonadism, PRO 2000 for the prevention of infection by HIV and other sexually-transmitted pathogens, octreotide for acromegaly, and pagoclone for stuttering.
PRO 2000 (naphthalene sulfonate polymer) is a topical vaginal microbicide under development to prevent the sexual transmission of HIV and other sexually transmitted diseases.
Forward Looking Statements
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, SANCTURA XR, NEBIDO, VANTAS and SUPPRELIN LA; effectiveness of our sales force; competition and its effect on pricing, spending, third-party relationships and revenues; dependence on third parties for supplies, particularly for histrelin, manufacturing, marketing, and clinical trials; risks associated with being a manufacturer of some of our products; risks associated with contractual agreements, particularly for the manufacture and co-promotion of SANCTURA and SANCTURA XR and the manufacture of NEBIDO, VANTAS, SUPPRELIN LA and VALSTAR; reliance on intellectual property and having limited patents and proprietary rights; dependence on market exclusivity, changes in reimbursement policies and/or rates for SANCTURA, SANCTURA XR, VANTAS, SUPPRELIN LA, DELATESTRYL and any future products; acceptance by the healthcare community of our approved products and product candidates; uncertainties relating to clinical trials, regulatory approval and commercialization of our products, particularly SANCTURA XR, NEBIDO, and VALSTAR; product liability and insurance uncertainties; risks relating to the Redux-related litigation; need for additional funds and corporate partners, including for the development of our products; history of operating losses and expectation of future losses; uncertainties relating to controls over financial reporting; difficulties in managing our growth; valuation of our Common Stock; risks related to repayment of debts; risks related to increased leverage; general worldwide economic conditions and related uncertainties; and other risks. Indevus undertakes no obligation to publicly update any forward- looking statement, whether as a result of new information, future events or otherwise.