Testosterone Effective in Female Sexual Dysfunction BioSante Conducting Long-Term Safety Study of LibiGel® in FSD
Company Comments on Paper in the New England Journal of Medicine
Lincolnshire, Illinois (November 11, 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.
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: biosantepharma.cdmail.biz.
This news release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. The statements regarding BioSante contained in this news release that are not historical in nature, particularly those that utilize terminology such as “will,” “potential”, “could,” “can,” “intends,” “continue,” “plans,” ìexpects” or comparable terminology, are forward-looking statements. Examples of forward-looking statements in this news release include statements regarding the expected timing of the initiation of clinical trials and the submission of regulatory applications. Forward-looking statements are based on current expectations and assumptions, and entail various risks and uncertainties that could cause actual results to differ materially from those expressed in such forward-looking statements.
Important factors known to BioSante that could cause actual results to differ materially from those expressed in such forward-looking statements include the difficulty of developing pharmaceutical products, obtaining regulatory and other approvals and achieving market acceptance, the success of clinical testing, and other factors identified and discussed from time to time in BioSante’s filings with the Securities and Exchange Commission, including those factors discussed in BioSante’s most recent annual report on Form 10-K and subsequent quarterly reports on Form 10-Q, which discussions also are incorporated herein by reference. All forward-looking statements speak only as of the date of this news release. BioSante undertakes no obligation to update or revise any forward-looking statement, whether as a result of new information, future events or otherwise.
For more information please contact:
Harris D. McKinney, Inc.
Investor Relations: The Investor Relations Group
Media: Laura Colontrelle /Janet Vasquez 212-825-3210
Investors: Adam S. Holdsworth / Christine Berni 212-825-3210