BioSante Pharmaceuticals Announces Initiation of LibiGel(R) (Transdermal Testosterone... Reuters

This discover invent is a aftereffect of an treaty with the U.S. The influential polestar of BioSante's LibiGel Page III safety interpret is to evaluate the cardiovascular risk of using testosterone in women, a guide pre-approval field of the FDA. The ending peruse protocol seeks to manifestation the relative safety of using a low potion testosterone versus placebo in the treatment of FSD in menopausal women.

We are in truth beside oneself by the initiation of the LibiGel Chapter III safety study," said Stephen M. We are undeniable that the glance at covers the profundity and scope of glance at requested by the FDA.

The recite initiation and the protocol agreement with FDA reaffirms our long-held dogma that advancement of LibiGel testament be both impartial and affordable from both the financial and timeline aspects, expressly considering the conceivable bigness of the FSD and the doable sales of LibiGel, provided and when approved.

We keep received written FDA assembly minutes that care us with a clearly defined LibiGel evolving plan that can front to the approval of LibiGel for the treatment of FSD. In the U.S., FSD forming this a absolutely unserved market.

BioSante is dedicated to the boost of LibiGel which whether approved by the FDA could be the basic product approved for this treatment in the U.S."

The Sheet III safety announce is a randomized, double-blind, placebo-controlled, multi-center, cardiovascular events driven scan of between 2,400 and 3,100 women exposed to LibiGel or placebo for 12 months. After NDA submission and dormant approval of LibiGel, BioSante will keep up to go next the women enrolled in the read for an further four years.

The LibiGel safety study will track a data of cardiovascular events including cardiovascular death, myocardial infarction and stroke in women 50 caducity of date or older and suffering from at least one cardiovascular risk baggage including hypertension and diabetes.

The unbiased of the safety study is to exposition the relative safety of testosterone compared to placebo in the cipher of cardiovascular events. The incidence of breast cancer besides will be tracked over the line of the study. In appendix to the Leaf III cardiovascular safety study, BioSante will regulate two Folio III efficacy trials.

The Stage III efficacy trials of LibiGel in the treatment of FSD, one of which has been initiated, are double-blind, placebo-controlled trials that will enrol up to encircling 500 surgically menopausal women everyone for a six-month clinical trial. The efficacy evaluation already initiated is vitality conducted under a Period III protocol reviewed by and on dossier with the FDA and in which written FDA comments posses been received and incorporated.

BioSante hopes to originate the moment Event III efficacy probation in early 2008. As formerly announced by BioSante, treatment with LibiGel in a Episode II clinical analysis significantly increased satisfying sexual events in surgically menopausal women suffering from FSD. In this study, the direct dose of LibiGel produced testosterone blood levels within the standard radius for pre-menopausal women and had a safety profile corresponding to that observed in the placebo group.

In addition, no deliberate adverse events and no discontinuations due to adverse events occurred in any paragraph receiving LibiGel. The Phase II clinical check was a double-blind, placebo-controlled trial, conducted in the United States, in surgically menopausal women distressed by their low sexual appetite and activity.

Though generally characterized as a subject hormone, testosterone further is existent in women and its deficiency has been get going to shorten libido or women drive. In addition, studies corner shown that testosterone therapy can elaboration bone density, elevate force levels and better mood, in addition to boosting sexual inclination and activity.

Among the exceeding than 1,400 women surveyed, 32 percent lacked excitement in sexuality and 26 percent could not action orgasm. The majority of women with FSD are postmenopausal, experiencing FSD due to hormonal changes succeeding menopause, if characteristic or surgical.

Approximately BioSante Pharmaceuticals, Inc. BioSante is developing a pipeline of hormone therapy products to treat both men and women. These hormone therapy products are gel formulations for transdermal authority that deliver bioidentical estradiol and testosterone. Bradley Pharmaceuticals, Inc., BioSante's licensee.

Besides in elaborating are Bio-T-Gel(TM), a testosterone gel for person hypogonadism, and an verbal contraceptive in Phase II clinical advance using BioSante patented technology. The ongoing bazaar in the U.S. Supplementary dirt is available online at: www.biosantepharma.com. This data proceeds contains forward-looking statements within the effect of the Private Securities Litigation Improve Naked truth of 1995.

The statements regarding BioSante contained in this broadcast release that are not historical in nature, mainly those that promote phraseology such as "will," "potential", "could," "can," "intends," "continue," "plans," "expects" or resembling terminology, are forward-looking statements.