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[LOGO] BIOSANTE PHARMACEUTICALS, INC.
175 Olde Half Day Road
Lincolnshire, Illinois 60069
www.biosantepharma.com
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FOR IMMEDIATE RELEASE BULLETIN BOARD: BTPH
CANADIAN VENTURE EXCHANGE: BAI
BIOSANTE PHARMACEUTICALS, INC. ANNOUNCES IN-LICENSE
OF FOUR HORMONE PRODUCTS FOR MEN'S AND WOMEN'S HEALTH
LINCOLNSHIRE, ILLINOIS, JUNE 13, 2000 - BioSante Pharmaceuticals, Inc.
(OTCBB-BTPH; CDNX-BAI) today announced that it has signed an in-license
agreement covering four hormone products for the treatment of testosterone
deficiency in men and estrogen deficiency in women. The license agreement was
signed with Permatec Technologies, AG of Switzerland.
"This agreement implements our in-licensing strategy which aims to build a
robust product pipeline of late-stage innovative pharmaceutical products," said
Stephen M. Simes, president and CEO of BioSante. "These products and their
unique delivery systems are ideal candidates for this strategy - not only do
they meet our in-licensing criteria, they also represent large market
opportunities."
These products will address a variety of hormone deficiencies that affect both
men and women. Symptoms of these hormone deficiencies include impotence, lack of
sex drive, muscle weakness and osteoporosis in men and menopausal symptoms in
women including hot flashes, vaginal atrophy, decreased libido and osteoporosis.
The market for testosterone and estrogen products is well over a billion dollars
in size in the U.S. alone, and that figure is expected to double over the next
five years.
Three of the four new products licensed by BioSante are gel formulations of
testosterone (the natural male hormone), estradiol (the natural female hormone)
and a combination of estradiol and a progestogen (another female hormone). The
gels are designed to be quickly absorbed through the skin after application on
the arms, abdomen or thighs, delivering the required hormone to the bloodstream
evenly and in a non-invasive, painless manner. The gels which should be applied
once per day and will be absorbed into the skin without a trace of residue. The
fourth product is an estradiol patch for application on the skin once per week
with delivery of estradiol lasting seven days. BioSante expects to begin human
clinical trials by the end of 2000, in order to obtain FDA approval to market as
soon as possible.
LICENSE TERMS AND TERRITORY
Under terms of the license agreement signed with Permatec, BioSante acquired
exclusive marketing rights, with the right to grant sub-licenses, to the three
testosterone and estradiol products for all therapeutic indications in the U.S.,
Canada, Mexico, Israel, Australia, New Zealand, China, Malaysia, Indonesia and
South Africa. BioSante acquired exclusive marketing rights, with the right to
grant sub-licenses, for the combination estradiol and progestogen product in the
U.S. and Canada. BioSante will make an upfront payment, expects to fund the
development of the products, make milestone payments and once regulatory
approval to market is received, pay royalties on sales of the products.
-more-
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ABOUT PERMATEC TECHNOLOGIE, AG
BioSante entered into the license agreement with Permatec Technologie, AG, a
drug delivery company that specializes in developing transdermal systems and
topical dermatological products. Permatec, a company of the Permatec Group of
Muttenz (Basel), Switzerland, is a private company founded in 1995 by Dr. J.
Gonella, who also was the founder of JAGO now known as SkyePharma (NASDAQ:
SKYE). Permatec employs 15 people most of whom are research and development
scientists involved in formulation and product development. Permatec has
expertise in the formulation of patch and gel products and has granted a similar
license to the estradiol/progestogen combination gel to a multi-national
pharmaceutical company headquartered in Europe for marketing in other countries
to which BioSante does not have the rights. Earlier this year Permatec announced
its intention to merge with Medi-Ject Corporation (NASDAQ: MEDJ) of Minneapolis,
Minnesota. According to Medi-Ject, it is the world's leading marketer of
needle-free injectable drug delivery systems.
ABOUT BIOSANTE PHARMACEUTICALS, INC.
BioSante is an emerging pharmaceutical company, developing its
nanoparticulate-based platform technology for novel vaccines, vaccine adjuvants
and drug delivery systems. BioSante intends to grow through developing its
platform technology and by in-licensing additional late-stage pharmaceuticals to
expand its product portfolio.
THIS PRESS RELEASE CONTAINS FORWARD-LOOKING STATEMENTS WITHIN THE MEANING OF
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 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 COULD CAUSE
SUCH MATERIAL DIFFERENCES ARE IDENTIFIED AND DISCUSSED FROM TIME TO TIME IN
BIOSANTE'S FILINGS WITH THE SECURITIES AND EXCHANGE COMMISSION, INCLUDING THOSE
FACTORS DISCUSSED ON PAGES 12 TO 20 OF BIOSANTE'S FORM 10-KSB, WHICH DISCUSSION
ALSO IS INCORPORATED HEREIN BY REFERENCE.
FOR MORE INFORMATION, PLEASE CONTACT:
Phillip Donenberg Joanna Longo
CFO Investor Relations
BIOSANTE PHARMACEUTICALS, INC. THE EQUICOM GROUP INC.
847-793-2458 tel 416-815-0700 ext. 233 tel
847-793-2457 fax 416-815-0080 fax
[email protected] [email protected]
THE CANADIAN VENTURE EXCHANGE HAS NEITHER APPROVED NOR DISAPPROVED THE
INFORMATION HEREIN CONTAINED.
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