BioSante Pharmaceuticals Signs Oral Contraceptive License with Pantarhei Bioscience
May 07 2007 - 8:00AM
Business Wire
BioSante Pharmaceuticals, Inc. (Amex: BPA) today announced that it
has signed an exclusive agreement with Pantarhei Bioscience, a
Netherlands-based pharmaceutical company for the development and
marketing of an oral contraceptive in the United States. BioSante
will co-fund the early development of the oral contraceptive up to
$1.0 million. Pantarhei will be responsible for all other expenses
to develop and market the product. In addition to the $1.0 million
upfront signing fee, BioSante may receive certain development and
regulatory milestones for the first product developed under the
license. In addition, BioSante will receive royalty payments on
sales of the product in the U.S. If the product is sublicensed by
Pantarhei to another company BioSante will receive a percentage of
any and all payments received by Pantarhei for the sublicense from
a third party. BioSante has retained all rights under the
BioSante-licensed patents to the transdermal delivery of triple
hormone contraceptives. �We are excited to sign this hormone oral
contraceptive license agreement,� said Stephen M. Simes, president
& CEO of BioSante. �We have known Herjan Coelingh Bennink, the
founder and CEO of Pantarhei for many years and we believe this is
an excellent company to develop further our issued patents for oral
contraceptive uses. This license is another example of how BioSante
can increase our product development potential and maximize our
assets while carefully controlling our own expenses,� Simes
continued. The oral contraceptive market in the U.S. was
approximately $3.0 billion in sales in 2006, with about 12 million
women in the U.S. using hormonal contraception, approximately 25
percent of sexually active women. 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
bio-identical estradiol and testosterone. BioSante's lead products
include Elestrin� (estradiol gel), developed through U.S. Food and
Drug Administration (FDA) approval by BioSante, indicated for the
treatment of moderate-to-severe vasomotor symptoms associated with
menopause, and LibiGel� (transdermal testosterone gel) in Phase III
development 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 company also is
developing its calcium phosphate nanotechnology (CaP) for novel
vaccines, including hepatitis B, avian flu and biodefense vaccines
for toxins such as anthrax, as well as a system for delivering
drugs via alternative routes of administration. Additional
information is available online at: www.biosantepharma.com. About
Pantarhei Bioscience B.V. Pantarhei Bioscience B.V. is a bioscience
company located in Zeist, the Netherlands. It employs nine persons
with an extensive track record in the pharmaceutical industry.
Pantarhei develops in the clinic, patent protected new medical uses
of existing molecules (hormones, biologicals and approved drugs)
for gender related diseases. Pantarhei operates in a close to
virtual set-up with the objective to obtain patent protection of
concepts and demonstrate proof of concept in the human. For
development and commercialization into the next phases, Pantarhei
will generally seek partnerships with pharmaceutical companies.
Additional information is available online at: www.pantarheibio.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 �may,� �will,� �should,� �likely,� �expects,�
�anticipates,� �estimates,� �believes,� �plans,� �hopes,� or
comparable terminology, are forward-looking statements.
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, the success of clinical
testing, 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 in BioSante's most
recent Forms 10-K and 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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