Biosante Pharma (AMEX:BPA)
Historical Stock Chart
From Jul 2019 to Jul 2024
![Click Here for more Biosante Pharma Charts. Click Here for more Biosante Pharma Charts.](/p.php?pid=staticchart&s=A%5EBPA&p=8&t=15)
BioSante Pharmaceuticals, Inc. (AMEX:BPA) today reported
product development highlights and financial results for the third
quarter ended September 30, 2005.
"We achieved milestones across our key clinical programs this
quarter. We presented positive Phase III data for Bio-E-Gel(TM),
licensed three patents that cover the use of testosterone
(LibiGel(TM)) to treat hypoactive sexual desire disorder in women on
hormone contraception, and entered into an allergy licensing option
agreement for our CaP nanotechnology," said Stephen M. Simes,
BioSante's president and chief executive officer. "We continue to
prepare our New Drug Application for Bio-E-Gel. Regarding LibiGel, we
are using recent updated guidance from the FDA for testosterone-based
products in defining our Phase III protocols, and expect to initiate
Phase III clinical studies of LibiGel in the first quarter of 2006."
Product and Corporate Highlights
-- BioSante presented Phase III clinical data on Bio-E-Gel
(bio-identical estradiol gel) at the North American Menopause
Society (NAMS) annual meeting in San Diego. Results from the
484-patient study identified three effective doses as well as
the lowest effective dose. In the study, Bio-E-Gel
significantly decreased the number of hot flashes by 88
percent, from 12.9 per day at baseline to 1.6 after treatment
(p less than 0.0001). The decrease was also significant versus
placebo, with a mean decrease of 11.3 hot flashes per day with
Bio-E-Gel versus a decrease of 6.1 with placebo (p less than
0.0001). Bio-E-Gel produced low estradiol blood levels and had
a safety profile similar to that observed in the placebo
group. Notably, there was minimal application site irritation
reported, a side effect known to be associated with
transdermal patches.
-- BioSante signed a worldwide license agreement with Wake Forest
University Health Sciences and Cedars Sinai Medical Center
covering three patents encompassing triple hormone
contraception technology, a novel combination of estrogens and
progestins with androgens. BioSante plans to study LibiGel
(bioidentical testosterone gel) as the androgen component to
help restore sexual desire and activity to women taking
traditional oral contraceptives who have experienced this side
effect. Financial terms include regulatory milestone payments,
maintenance payments and royalty payments if a product
incorporating the licensed technology is approved and
subsequently marketed. In a Phase II study of LibiGel in
surgically menopausal women, LibiGel was shown to increase the
number of satisfying sexual events by 238 percent. This
increase was statistically significant compared to baseline
and placebo.
-- In September, BioSante signed a Material Transfer and Option
Agreement for an exclusive option to obtain a license to use
BioSante's calcium phosphate nanotechnology (CaP) in the
development of a series of allergy products. The undisclosed
European partner company will fund its development of
potential products for the treatment of conditions including
rhinitis, asthma, conjunctivitis, dermatitis, and allergic
gastrointestinal diseases. BioSante received a non-refundable
$250,000 upfront payment, and could potentially receive more
than $10 million dollars in additional maintenance, milestone
and royalty payments if the option is exercised and the
parties enter into an exclusive license agreement.
Third Quarter 2005 Financial Overview
BioSante incurred a net loss of approximately $1.85 million, or
$(0.10) per share for the quarter ended September 30, 2005, compared
to a net loss of approximately $2.87 million, or $(0.16) per share for
the third quarter of 2004. For the first nine months of 2005, the
Company's net loss totaled approximately $7.2 million, or $(0.37) per
share, compared to a net loss of approximately $7.89 million, or
$(0.48) per share, for the first nine months of 2004. As of September
30, 2005, the Company's cash, cash equivalents and short-term
investments were approximately $10.3 million. The Company anticipates
a cash burn rate of approximately $600,000 per month for the remainder
of 2005.
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. The Company 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. 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
risk factors discussed in BioSante's most recent quarterly report on
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.