BioSante Pharmaceuticals Strengthens Management and Reaffirms Bio-E-Gel(TM) NDA Filing Guidance
"We are pleased to be working with Gene in his areas of expertise. He already has joined and contributed to our team to finalize our Bio-E-Gel(TM) new drug application (NDA) for submission to the U.S. Food and Drug Administration," said Stephen M. Simes, BioSante's president & CEO. "To this end, we also are pleased to reaffirm our prior guidance that we expect to file our Bio-E-Gel NDA in the first quarter 2006. Dr. Michael Snabes, who we engaged in November, has been instrumental in leading our team of professionals to complete this very important work."
“We are pleased to be working with Gene in his areas of expertise. He already has joined and contributed to our team to finalize our Bio-E-Gel(TM) new drug application (NDA) for submission to the U.S. Food and Drug Administration”
Mr. DeFelice is the Managing Director of Novo Strategic Partners LLC, a business consulting firm specializing in mergers and acquisitions, licensing, compliance, and legal services management in the healthcare and technology sectors. Mr. DeFelice holds a Masters in Business Administration and a Juris Doctorate and has served as the general counsel of several publicly traded pharmaceutical and medical device companies. Additionally, Mr. DeFelice has had extensive executive operations experience including responsibility for a clinical research organization, and has led regulatory affairs teams in the healthcare industry.
Dr. Snabes is a board certified reproductive endocrinologist, as well as holding 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 over 100 publications to his credit.
About BioSante Pharmaceuticals, Inc.
BioSante is developing a pipeline of hormone therapy products to treat both men and women. These hormone therapy products are gel formulations for transdermal administration that deliver bioidentical estradiol and testosterone. BioSante's lead products include Bio-E-Gel(TM) (bioidentical estradiol gel) for the treatment of women with menopausal symptoms, and LibiGel(TM) (bioidentical testosterone gel) for the treatment of female sexual dysfunction (FSD). The current market in the U.S. for estrogen and testosterone products is approximately $2.5 billion. The transdermal gel formulations used in the women's gel products are licensed by BioSante from Antares Pharma Inc. BioSante also is developing its calcium phosphate nanotechnology (CaP) for novel vaccines, including biodefense vaccines for toxins such as anthrax and ricin, and drug delivery systems. 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 press release that are not historical in nature, particularly those that utilize terminology such as "may," "will," "should," "likely," "expects," "anticipates," "estimates," "believes" or "plans," or comparable terminology, are forward-looking statements. An example of a forward-looking statement in this press release is the expected timing of the filing of our Bio-E-Gel new drug application. 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 cause actual results to differ materially from those expressed in such forward-looking statements are the difficulty of developing pharmaceutical products, obtaining regulatory and other approvals and achieving market acceptance, and other factors identified and discussed from time to time in BioSante's filings with the Securities and Exchange Commission, including those factors discussed on pages 22 to 34 of BioSante's most recent Form 10-Q, which discussion also is 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.