Healthcare Industry News: estradiol gel
News Release - April 15, 2008
BioSante Pharmaceuticals Appoints Michael C. Snabes, M.D., PhD, Vice President, Clinical DevelopmentLINCOLNSHIRE, Ill.--(HSMN NewsFeed)--BioSante Pharmaceuticals, Inc. (NASDAQ: BPAX ) today announced the appointment of Michael C. Snabes, M.D., Ph.D. as vice president, clinical development. Dr. Snabes has served as a medical consultant to BioSante on clinical and regulatory matters since November 2005. His primary responsibility will remain the development of LibiGel® (testosterone gel) in the treatment of female sexual dysfunction (FSD). Dr. Snabes was instrumental in the submission of BioSante’s New Drug Application (NDA) of Elestrin™ (estradiol gel), an effort that resulted in the full non-conditional FDA approval of Elestrin in December 2006. Dr. Snabes also played a key role in BioSante obtaining a Special Protocol Assessment (SPA) for LibiGel as well as an agreement with the FDA on the key safety study for the approval of LibiGel in FSD.
“We are very pleased that Michael has agreed to accept this position with BioSante,” said Stephen M. Simes, president and CEO of BioSante. “Michael has been an important part of our clinical team for more than two years and his full-time involvement will help us to implement fully and accelerate our development of LibiGel in the treatment of FSD, specifically hypoactive sexual desire disorder (HSDD) in menopausal women.”
“HSDD is a disorder that has become clearly defined in recent years and physicians nationally now realize how widespread this problem is. I am pleased to continue to work with BioSante and LibiGel. This is a unique opportunity that could lead to the first approval of a medical treatment of HSDD in menopausal women.” said Dr. Snabes. “A treatment for HSDD could lead to an improved quality of life for millions of women and significantly improve their relationship with their partners. I am heartened by the commitment of BioSante’s management and board of directors to LibiGel and its Phase III development program. The LibiGel program has full FDA agreement which provides BioSante a clear roadmap to FDA approval of LibiGel.”
Dr. Snabes is a board certified reproductive endocrinologist, as well as a Ph.D. in physiology and reproductive endocrinology. Most recently, Dr. Snabes was an Associate Professor in the Section of Reproductive Endocrinology and Infertility in the Department of Obstetrics and Gynecology at The University of Chicago Pritzker School of Medicine. From 2003 to 2004, Dr. Snabes served as Medical Advisor and Associate Director in Clinical Research and Development in Inflammation, Arthritis, and Pain at Pfizer, Inc. and from 1999 to 2003 in the same position at Pharmacia, Inc. From 1997 to 1999, Dr. Snabes served as Associate Director in Clinical Research in women’s health at Searle/Monsanto, Inc. In these positions, Dr. Snabes specifically worked on phase IIIB and phase IV clinical trials in women’s health and in COX-2 phase I to IV clinical trials. Dr. Snabes is a Fellow of the American College of Obstetrics and Gynecology, the American College of Surgeons and the American College of Endocrinology. Dr. Snabes has more than 135 publications to his credit.
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. by Nycomed US, BioSante's licensee. 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 $3.0 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,” “continue,” “could,” “believe,” ”intends,” “plans,” “expects” or comparable terminology, are forward-looking statements. Examples of forward-looking statements in this news release include statements regarding the continued role of Dr. Snabes in BioSante’s clinical efforts, the anticipated path to FDA approval of LibiGel, the anticipated effect of LibiGel on the treatment of HSDD and the potential market for LibiGel and BioSante’s other products. 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, 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.
Source: BioSante Pharmaceuticals
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