BioSante Pharmaceuticals Says FDA Advisory Committee Recommendation Against Flibanserin has No Impact on LibiGel®
LibiGel Clinical Studies for Safety and Efficacy Continue as per FDA-Agreed Protocols
LINCOLNSHIRE, Illinois (June 21, 2010) – BioSante Pharmaceuticals, Inc. (NASDAQ: BPAX) commented today that the recommendation on June 18, 2010 by the FDA Advisory Committee regarding the safety and efficacy of flibanserin (Boehringer-Ingelheim) will have no impact on its own ongoing development program or approval pathway for LibiGel (testosterone gel), for the treatment of hypoactive sexual desire disorder (HSDD). The FDA Advisory Committee voted that flibanserin for treatment of HSDD did not show that its benefits outweighed its side effects, among which are daytime sleepiness, dizziness, nausea, and fatigue. Importantly, the Committee concluded that HSDD is a significant medical issue for women.
“There are important scientific differences between the way LibiGel and flibanserin work on the body, and differences in their clinical development programs,” stated BioSante President and CEO Stephen M. Simes. “The LibiGel safety and efficacy trials are being conducted under an SPA (Special Protocol Assessment) agreement with FDA, a level of agreement that the flibanserin program did not have. BioSante also is conducting a large safety study comparing LibiGel to placebo to show cardiovascular and breast-cancer safety. We are pleased also by comments made by the Advisory Committee stressing the need for a product to treat this unmet medical need. Given the recommendation of the Advisory Committee, we believe that LibiGel is positioned to be the first product approved for the treatment of HSDD.”
“The Advisory Committee’s judgment on flibanserin has no impact on the clinical development program of LibiGel and is not relevant to the potential for FDA approval of LibiGel for the treatment of HSDD in menopausal women,” said Michael C. Snabes, MD, PhD, BioSante’s vice president of clinical development.
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) 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 is a portfolio of cancer vaccines (GVAX), two of which have been granted orphan drug designation, currently in several Phase II clinical trials, at minimal cost to BioSante.
Other products in development are Bio-T-Gel™, a testosterone gel for male hypogonadism, licensed to Teva Pharmaceuticals (NASDAQ: TEVA) 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 as well as seeking opportunities for its 2A/Furin and other technologies. Additional information is available online at: biosantepharma.cdmail.biz.
Forward-Looking Statements 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 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.
For more information please contact:
Harris D. McKinney, Inc.
For information about participating in the LibiGel clinical studies call or visit the following:
877- BLOOM81 www.bloomstudy.com