BioSante Pharmaceuticals, Inc. Presents LibiGel Clinical and Market Information at ISSWSH Conference
LINCOLNSHIRE, Ill.--(BUSINESS WIRE)--Feb 17, 2009 - BioSante Pharmaceuticals, Inc. (NASDAQ: BPAX), presented LibiGel clinical and market information at the 2009 Annual Meeting of the International Society for the Study of Women's Sexual Health (ISSWSH).
Michael C. Snabes, MD, PhD, BioSante's vice president of clinical development, presented on Friday February 13, 2009 at the ISSWSH Conference, details about the LibiGel clinical development program and details about current prescribing practices of physicians who treat Hypoactive Sexual Desire Disorder (HSDD) and the need for an FDA approved pharmaceutical product for the treatment of HSDD in the U.S.
According to a research survey commissioned by BioSante among practicing gynecologists and general practitioners, 80 percent of physicians believe there is a need or great need for an FDA approved treatment for women who suffer from HSDD, for which there is no FDA approved prescription product today. The majority of physicians surveyed currently prescribe testosterone to women “off-label,” which means they prescribe testosterone for women even though currently it is not approved for this use. A significant majority of the physicians said they would switch patients to an FDA approved treatment and would prescribe an FDA approved treatment for new patients not currently being treated for HSDD. According to IMS Health, there were approximately two million testosterone prescriptions written off-label in the U.S. for women in 2007. This number of off-label prescriptions does not include “compounded” testosterone for women which could total an additional million prescriptions.
BioSante is in Phase III development of LibiGel for the treatment of HSDD in menopausal women under an FDA approved SPA (Special Protocol Assessment). BioSante is enrolling women in three Phase III clinical trials with a new drug application (NDA) planned for late 2010. “We believe LibiGel is the only product in active development for HSDD in menopausal women, and we hope to be first to market for this potential multi-billion dollar indication,” said Stephen M. Simes, BioSante's president & CEO.
The annual ISSWSH conference brings together doctors, other healthcare providers, researchers, investors and companies in a meeting dealing with all issues related to women's sexual health including HSDD.
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/III 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: www.biosantepharma.com.
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,” “would,” “plans,” “believes,” “expects” or comparable terminology, are forward-looking statements. Examples of forward-looking statements in this news release include statements regarding the expected timing of the submission of a new drug application for LibiGel and the size of the potential markets. 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.
Contact: for BioSante Pharmaceuticals, Inc.
Alan Zachary (312) 944-6784 ext. 316;
Investor Relations: The Investor Relations Group
Media: Laura Colontrelle /Janet Vasquez 212-825-3210
Investors: Adam S. Holdsworth 212-825-3210
Posted: February 2009