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Indevus Pharmaceuticals Announces Completion of Enrollment in Phase III Trial of PRO 2000
Date:8/22/2008

cluding a New Drug Application with the U.S. Food and Drug Administration, in 2010."

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 trial will also assess effects on other sexually transmitted infections including herpes, chlamydia and gonorrhea. All participants receive condoms and risk-reduction counseling. The trial opened in October 2005, and is currently underway at clinical centers in South Africa, Tanzania, Uganda and Zambia. Completion of the trial is expected in the summer of 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 in preventing HIV infection in women. This trial will also assess effects on other sexually transmitted infections including herpes, chlamydia and gonorrhea. The 0.5% dose of PRO 2000 is being tested in comparison with a placebo and no treatment. All participants receive condoms and risk-reduction counseling. 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. Completion of the HPTN 035 trial is expected later this year. Results from the trial are expected by early 2009.

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(R) and SANCTURA XR(TM) 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
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SOURCE Indevus Pharmaceuticals, Inc.
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