Critical Market Data Presented at ISSWSH Meeting
LINCOLNSHIRE, Ill.--(BUSINESS WIRE)-- BioSante Pharmaceuticals, Inc. (NASDAQ: BPAX), a pharmaceutical company developing products for the treatment of female sexual health, presented critical female sexual dysfunction market data at the ISSWSH (The International Society for the Study of Women’s Sexual Health) annual meeting. The data presented include results of a survey of over 100 Obstetrician/Gynecologists and Primary Care Physicians regarding the need for an FDA-approved drug to treat a form of Female Sexual Dysfunction (FSD) known as Hypoactive Sexual Desire Disorder (HSDD).
There are currently no FDA-approved therapeutic treatment options for women with HSDD. A significant number of physicians (over 90 percent) reported that they prescribe off-label testosterone for women to treat FSD, however, these physicians are dissatisfied with the non-FDA approved, off-label alternatives. The physicians indicated that they hear an average of 37 unsolicited inquiries per month from women regarding sexual dysfunction. Nationally, it is estimated that 4.1 million off-label testosterone prescriptions are filled annually.
“The need for an FDA-approved treatment to cope with this condition is astonishing, as stated by the physicians surveyed. This position also was strongly supported by the attendees at the ISSWSH meeting,” said Michael C. Snabes, M.D., Ph.D., BioSante’s senior vice president of medical affairs. “It has been more than a decade since the FDA approved Viagra for the treatment of male sexual dysfunction; it is time women have a safe and effective option for the treatment of their sexual health.” BioSante is developing LibiGel® (testosterone gel) for the treatment of HSDD in menopausal women. LibiGel is currently in three Phase III clinical studies to prove its safety and efficacy.
The physicians in the survey were asked their reaction to an unnamed therapeutic that fit LibiGel’s profile. An overwhelming 94% responded favorably, as long as it is proven to be safe. To that end, BioSante is conducting a Phase III multicenter cardiovascular and breast cancer safety study. BioSante reported at the ISSWSH meeting that with 2,869 women enrolled and over 3,000 women-years of exposure in its LibiGel Phase III cardiovascular and breast cancer safety study, there have been 17 adjudicated cardiovascular (CV) events, with a lower than anticipated event rate of approximately 0.57 percent. There have been eight breast cancers reported, a rate of approximately 0.27 percent.
The survey, conducted independently for BioSante by Campbell Alliance Group, Inc., revealed sexual dysfunction to be one of the most common complaints received in these doctors’ offices. The physicians described themselves as dissatisfied with the current lack of therapeutic options for HSDD, a loss of libido or sexual desire.
LibiGel is a testosterone gel in Phase III clinical development for the treatment of women who suffer from female sexual dysfunction (FSD). The on-going Phase III efficacy trials are double-blind, placebo-controlled trials that will enroll up to approximately 500 surgically menopausal women each for a six-month clinical trial. The efficacy trials are being conducted under an FDA-approved special protocol assessment (SPA) agreement. LibiGel is absorbed quickly through the skin after applying a once-daily pea-sized topical application on the upper arm that delivers testosterone to the bloodstream evenly over time.
In a Phase II trial, LibiGel significantly increased the number of satisfying sexual events in surgically menopausal women suffering from FSD 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 BioSante Pharmaceuticals, Inc.
BioSante is a specialty pharmaceutical company focused on developing products for female sexual health and oncology. BioSante’s lead products include LibiGel® (transdermal testosterone gel) for the treatment of female sexual dysfunction (FSD) which is in Phase III clinical development under a U.S. Food and Drug Administration (FDA) Special Protocol Assessment. BioSante also is developing a portfolio of cancer vaccines, four of which have been granted Orphan Drug designation, and are currently in several Phase II clinical trials. Other products in development are Bio-T-Gel™, a testosterone gel for male hypogonadism licensed to Teva Pharmaceuticals and an oral contraceptive in Phase II clinical development using BioSante patented technology. The company also is seeking opportunities for its other technologies. Additional information is available online at: www.biosantepharma.com.
To the extent any statements made in this news release deal with information that is not historical, these are forward-looking statements under the Private Securities Litigation Reform Act of 1995. Such statements include, but are not limited to, statements about BioSante’s plans, objectives, expectations and intentions with respect to future operations and products, the timing of anticipated regulatory submissions and other statements identified by words such as “will,” “potential,” “could,” “can,” “believe,” “intends,” “continue,” “plans,” “expects,” “anticipates,” “estimates,” “may,” other words of similar meaning or the use of future dates. Forward-looking statements by their nature address matters that are, to different degrees, uncertain. Uncertainties and risks may cause BioSante’s actual results to be materially different than those expressed in or implied by BioSante’s forward-looking statements. For BioSante, particular uncertainties and risks include, among others, the difficulty of developing pharmaceutical products, obtaining regulatory and other approvals and achieving market acceptance; the marketing success of BioSante’s licensees or sublicensees; the success of clinical testing; and BioSante’s need for and ability to obtain additional financing. More detailed information on these and additional factors that could affect BioSante’s actual results are described in BioSante’s filings with the Securities and Exchange Commission, including its most recent annual report on Form 10-K and subsequent quarterly reports on Form 10-Q. All forward-looking statements in this news release 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.
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INDUSTRY KEYWORDS: Women Health Biotechnology Clinical Trials Pharmaceutical Other Health Research Other Science FDA Consumer Science General Health