BioSante Pharmaceuticals Reports Product Development Highlights and Third Quarter 2005 Financial Results
11 November 2005 - 8:57AM
Business Wire
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.
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