BioSante Pharmaceuticals Strengthens Management and Reaffirms Bio-E-Gel(TM) NDA Filing Guidance
January 09 2006 - 8:01AM
Business Wire
BioSante Pharmaceuticals, Inc. (AMEX:BPA) 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) 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." 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.
Biosante Pharma (AMEX:BPA)
Historical Stock Chart
From Jun 2024 to Jul 2024
Biosante Pharma (AMEX:BPA)
Historical Stock Chart
From Jul 2023 to Jul 2024