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Testosterone Effective In Female Sexual Dysfunction
 
according to new study

 Nov. 13, 2008. BioSante Pharmaceuticals, Inc. (NASDAQ: BPAX), a specialty
 pharmaceutical company focused on developing products for female sexual health,  menopause, contraception, and male hypogonadism, commented today on a new
 publication reporting on the efficacy of testosterone in the treatment of Female Sexual
 Dysfunction (FSD), specifically hypoactive sexual desire disorder (HSDD) in menopausal
 women. In a paper titled, "Testosterone for Low Libido in Postmenopausal Women Not
 Taking Estrogen," the authors state that testosterone therapy provides modest but
 meaningful benefit in the treatment of HSDD in postmenopausal women and that as
 reported in previous blinded studies, 85 percent of those women reporting a benefit wish to
 continue treatment. The authors also state that, "Additional data are needed to assess the
 long-term safety of testosterone in women with estrogen depletion." The paper appeared in
 the November 6, 2008, issue of the New England Journal of Medicine.
 
 BioSante currently has two Phase III clinical trials in progress covered by an SPA (Special
 Protocol Assessment) with the FDA, to demonstrate the safety and efficacy of LibiGel
 (testosterone gel), in the treatment of HSDD. In addition to the two LibiGel Phase III safety
 and efficacy trials, BioSante is enrolling women in a Phase III cardiovascular and breast
 cancer safety study of LibiGel. Pursuant to a written agreement with the FDA, this one
 safety study will serve as the basis of safety for both surgically and naturally menopausal
 women. The safety study is a randomized, double- blind, placebo-controlled, multi-center,
 cardiovascular events driven study of between 2,400 and 3,100 women exposed to LibiGel
 or placebo for twelve months. At the end of the twelve months, BioSante intends to submit
 a LibiGel New Drug Application (NDA) for review and possible approval by the FDA.
 BioSante will continue to follow the women enrolled in the safety study for an additional
 four years after the NDA submission and possible approval of LibiGel.

 BioSante holds two SPAs for LibiGel for the treatment of FSD; one for "surgically" and one
 for "naturally" menopausal women. "BioSante's SPAs confirm the FDA's position that FSD
 and HSDD are true diagnosable conditions that women experience, with measurable
 endpoints that can be evaluated and which deserve therapeutic options. Regarding LibiGel
 specifically, we are pleased that the SPAs affirm that our clinical trial design, endpoints,
 sample size, planned conduct and statistical analyses are acceptable to support regulatory
 approval," said Stephen M. Simes, BioSante's president & CEO. "We have a clearly
 defined, reasonable and feasible LibiGel development path that can lead to the approval of
 LibiGel to provide potential benefit for a broad population of menopausal women."

 "No pharmaceutical product is approved for the treatment of FSD or HSDD in the U.S.
 LibiGel, if approved by the FDA, will address a truly unserved medical need. BioSante
 today is the only company actively in development of a product for the treatment of FSD in
 menopausal women and is the only company that has initiated a long-term safety study to
 determine the safety of testosterone in this indication. BioSante is committed to the
 development of LibiGel, which ultimately could be the first prescription pharmaceutical
 product approved by the FDA for this treatment in the U.S." Although Procter & Gamble
 has conducted several clinical trials of its Intrinsa testosterone patch, P & G has not initiated
 a long-term safety study which is a critical FDA requirement for possible approval of a
 testosterone product for the treatment of FSD.

 As previously announced by BioSante, treatment with LibiGel in a Phase II clinical trial
 significantly increased satisfying sexual events in surgically menopausal women suffering
 from FSD. The Phase II trial results showed LibiGel significantly increased the number of
 satisfying sexual events by 238 percent versus baseline (p<0.0001); this increase also was
 significant versus placebo (p<0.05). In this study, the effective dose of LibiGel produced
 testosterone blood levels within the normal range for pre- menopausal women and had a
 safety profile similar to that observed in the placebo group. In addition, no serious adverse
 events and no discontinuations due to adverse events occurred in any subject receiving
 LibiGel. The Phase II clinical trial was a double-blind, placebo-controlled trial, conducted
 in the United States, in surgically menopausal women distressed by their low sexual desire
 and activity.
 
 About LibiGel®

 LibiGel is a gel formulation of testosterone designed to be quickly absorbed through the
 skin after application of a pea-sized dose of gel on the upper arm, delivering testosterone to
 the bloodstream evenly over time and in a non-invasive and painless manner. Though
 generally characterized as a male hormone, testosterone also is present in women and its
 deficiency has been found to decrease libido or sex drive. In addition, studies have shown
 that testosterone therapy can increase bone density, raise energy levels and improve mood,
 in addition to boosting sexual desire and activity.

 According to a study published in the Journal of the American Medical Association,  43
 percent of American women (about 40 million) experience some degree of impaired sexual
 function. Among the more than 1,400 women surveyed, 32 percent lacked interest in sex
 and 26 percent could not experience orgasm. According to IMS data, 2.0 million
 testosterone prescriptions were written off-label for women by U.S. physicians in 2007.
 The majority of women with FSD are postmenopausal, experiencing FSD due to hormonal
 changes following menopause, whether natural or surgical.

 About BioSante Pharmaceuticals, Inc.

 BioSante is a specialty pharmaceutical company focused on developing products for female
 sexual health, menopause, contraception and male hypogonadism. BioSante's lead products
 include LibiGel® (transdermal testosterone gel) in Phase III clinical development by
 BioSante under a U.S. Food and Drug Administration (FDA) SPA (Special Protocol
 Assessment) for the treatment of female sexual dysfunction (FSD), and Elestrin™ (estradiol
 gel) developed through FDA approval by BioSante, indicated for the treatment of
 moderate-to-severe vasomotor symptoms associated with menopause, currently marketed
 in the U.S. Also in development are Bio-T-Gel™, a testosterone gel for male
 hypogonadism, and an oral contraceptive in Phase II clinical development using BioSante
 patented technology. The current market in the U.S. for estrogen and testosterone products
 is approximately $2.5 billion and for oral contraceptives approximately $3 billion. The
 company also is developing its calcium phosphate technology (CaP) for novel vaccines,
 drug delivery and aesthetic medicine (BioLook™). Additional information is available online
 at: http://www.biosantepharma.com.
 

 
©2009, 2010, 2011 Health & Wealth Guardian, Ltd. All Rights Reserved.
 

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©2009, 2010, 2011 Health & Wealth Guardian, Ltd. All Rights Reserved.