Biosante Pharma (AMEX:BPA)
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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.