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.


About Indevus

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

PRO 2000 (naphthalene sulfonate polymer) is a topical vaginal microbicide under development to prevent the sexual transmission of HIV and other sexually transmitted diseases.