BioSante Pharmaceuticals Strengthens Management and Reaffirms Bio-E-Gel(TM) NDA Filing Guidance.LINCOLNSHIRE, Ill. -- BioSante Pharmaceuticals, Inc. (AMEX AMEX See: American Stock Exchange :BPA BPA British Paediatric Association. ) today announced that BioSante has engaged Eugene V. DeFelice as an independent consultant to assist BioSante with corporate and business development activities, including licensing, mergers and acquisitions, as well as intellectual property management, regulatory affairs, and compliance. "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 (Non Disclosure Agreement) An agreement signed between two parties that have to disclose confidential information to each other in order to do business. In general, the NDA states why the information is being divulged and stipulates that it cannot be used for any ) for submission to the U.S. Food and Drug Administration," said Stephen M. Simes, BioSante's president & CEO (1) (Chief Executive Officer) The highest individual in command of an organization. Typically the president of the company, the CEO reports to the Chairman of the Board. . "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." Mr. DeFelice is the Managing Director of Novo Strategic Partners LLC (Logical Link Control) See "LANs" under data link protocol. LLC - Logical Link Control , a business consulting firm specializing in mergers and acquisitions, licensing, compliance, and legal services legal services n. the work performed by a lawyer for a client. 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 Reproductive endocrinology and infertility is a subspecialty of the specialty of obstetrics and gynecology dealing with infertility, fertility, contraception and the medicine and surgical procedures related to it. in the Department of Obstetrics and Gynecology obstetrics and gynecology Medical and surgical specialty concerned with the management of pregnancy and childbirth and with the health of the female reproductive system. at The University of Chicago Pritzker School of Medicine The Pritzker School of Medicine is the M.D. granting unit of the Biological Sciences Division of the University of Chicago. It is located on the University's main campus in the Hyde Park portion of Chicago proper, and matriculated its first class in 1927. . 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 This article or section needs sources or references that appear in reliable, third-party publications. Alone, primary sources and sources affiliated with the subject of this article are not sufficient for an accurate encyclopedia article. 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 FSD Female Sexual Dysfunction FSD File System Driver FSD Family Support Division FSD Fire Services Department (Hong Kong) FSD Full Scale Development FSD Full Scale Deflection FSD Federal Systems Division ). 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 ricin /ri·cin/ (ri´sin) a phytotoxin in the seeds of the castor oil plant (Ricinus communis), used in the synthesis of immunotoxins. ri·cin n. , 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 The Private Securities Litigation Reform Act of 1995 (PSLRA) implemented several significant substantive changes affecting certain cases brought under the federal securities laws, including changes related to pleading, discovery, liability, class representation and awards fees and 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. |
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