BioSante Pharmaceuticals Comments on Boehringer Ingelheim Clinical Test Results in Treatment of Female Sexual Dysfunction
LINCOLNSHIRE, Ill.--(BUSINESS WIRE)--Nov 16, 2009 - BioSante Pharmaceuticals, Inc. (NASDAQ: BPAX), a specialty pharmaceutical company developing products for female sexual health, including LibiGel® for the treatment of hypoactive sexual desire disorder (HSDD), applauds the efforts of Boehringer Ingelheim to develop a therapy to treat this unmet medical need. Boehringer today, at the European Society for Sexual Medicine annual meeting in Lyon, France, reported clinical test results of flibanserin, a drug candidate which treats HSDD by blocking the brain's release of serotonin, a chemical that regulates mood, appetite, sleep and memory and, in time, triggers the production of dopamine, a chemical associated with the stimulation of desire.
BioSante's product for this market is LibiGel, a transdermal testosterone gel targeting menopausal women. LibiGel currently is in late-stage Phase III clinical studies for the treatment of HSDD. BioSante President and CEO Stephen M. Simes, said, “The fact that one of the largest pharmaceutical companies in the world is targeting this condition is important and exciting medical news. For ten years, men have enjoyed the option of using drugs to treat erectile dysfunction but there is no pharmaceutical product approved by the FDA for the treatment of HSDD. BioSante is committed to bringing women an option in their decision-making about their own sexuality.”
Boehringer has been studying flibanserin in pre-menopausal women. Data, pooled from three Phase III studies, presented today from trials in Europe and the U.S., show a statistically significant improvement in satisfying sexual events (SSEs) compared to placebo, with an average difference of 0.70 SSEs per four week period. The results reported by Boehringer for flibanserin are similar to data reported by Proctor & Gamble for their Intrinsa testosterone patch (now owned by Warner Chilcott).
As previously announced by BioSante, treatment with LibiGel in a Phase II double-blind, placebo-controlled, clinical trial, conducted in the U.S., in surgically menopausal women distressed by their low sexual desire and activity, 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), an average difference of 3.4 SSEs per four week period. 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.
Mr. Simes said “Boehringer Ingelheim's commitment to HSDD validates the potential size of the market which could exceed $2 billion a year in U.S. sales. BioSante intends to submit a new drug application for LibiGel to the FDA in the first half of 2011 for potential approval by the end of that year. In addition, Phase II studies in pre-menopausal women are ongoing for a potential future indication.”
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 aesthetic medicine (BioLook™), as a vaccine adjuvant, including for an H1N1 (swine flu) vaccine, and drug delivery. In addition, BioSante will seek opportunities for its GVAX cancer immunotherapies and other newly acquired technologies. Additional information is available online at: www.biosantepharma.com.
This news release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. Forward-looking statements often can be identified by words such as “will,” “potential,” “could,” “can,” “believe,” “intends,” “continue,” “plans,” “expects,” “anticipates,” “estimates,” “may” or the negative of these words or other words of similar meaning. 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; BioSante's need for and ability to obtain additional financing; the effect of general business and economic conditions; and risks arising from BioSante's merger with Cell Genesys. 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 registration statement on Form S-4 filed in connection with the merger with Cell Genesys and BioSante's most recent annual report on Form 10-K and subsequent quarterly reports on Form 10-Q. The information set forth in this news release speaks only as of the date hereof, and BioSante undertakes no obligation to update or revise any forward looking statement, whether as a result of new information, future events or otherwise.
For information about participating in the LibiGel clinical studies call or visit the following: 877-BLOOM81; www.bloomstudy.com
Contact: Alan Zachary, McKinney/Chicago
(312) 944-6784 ext. 316
Posted: November 2009