BioSante Pharmaceuticals Reports Product Development Highlights and Second Quarter 2005 Financial Results
August 12 2005 - 12:20PM
Business Wire
BioSante Pharmaceuticals (AMEX:BPA) today reported on certain
product development highlights and announced financial results for
the second quarter ended June 30, 2005. "Our positive topline data
from the Bio-E-Gel(TM) Phase III trial and progress made with our
CaP nanotechnology program drove this successful quarter for
BioSante," said Stephen M. Simes, BioSante's president and chief
executive officer. "We plan to present full Bio-E-Gel data at a
medical meeting this fall, with publication in a peer-reviewed
journal to follow. Currently, we are preparing a New Drug
Application for submission to the U.S. Food and Drug Administration
for Bio-E-Gel, and anticipate initiating Phase III LibiGel(TM)
studies by year end." Product and Corporate Highlights -- BioSante
announced significant safety and efficacy results of its 12-week,
randomized, double-blind, placebo-controlled Phase III clinical
trial of Bio-E-Gel (bioidentical estradiol transdermal gel) for the
treatment of moderate-to-severe hot flashes in menopausal women.
The 484-patient study, which included three doses of Bio-E-Gel to
maximize the safety profile by identifying the lowest effective
dose, had four co-primary endpoints of a significant decrease over
placebo in both the number and severity of hot flashes at Week 4
and Week 12 of treatment. By Week 4, the mid and high doses of
Bio-E-Gel showed highly significant decreases in the number and
severity of hot flashes versus placebo (p less than 0.0001), a
response that was maintained until Week 12. At Week 5, the low dose
showed a highly significant decrease in the number (p less than
0.001) and severity (p less than 0.01) of hot flashes verses
placebo. These significant responses were maintained through Week
12 (p less than 0.0001), therefore suggesting identification of the
lowest effective dose. There were no significant differences in the
safety profile of any dose of Bio-E-Gel compared to placebo. -- The
Company presented a review of progress toward the use of
BioVant(TM), BioSante's patented calcium phosphate (CaP)
nanoparticle technology, in viral and bacterial vaccine candidates
at the International Conference on Immunopotentiators in Modern
Vaccines in Spain. BioSante also presented BioVant data at the
annual World Vaccine Congress in Montreal, focusing on the
intranasal mucosal surface delivery of an anthrax vaccine, and
highlighting the simultaneous immune adjuvant effects and
non-injected vaccine delivery potential of BioVant. -- BioSante
announced a new manufacturing agreement with a U.S.-based current
good manufacturing practices (cGMP) manufacturer for large-scale
quantities of CaP nanotechnology. -- BioSante was added to the
Russell Microcap(TM) Index, which measures the performance of the
microcap segment and includes the smallest 1,000 securities in the
small-cap Russell 2000 Index plus the next 1,000 securities, based
on descending market capitalization. As of the latest
reconstitution, the average market capitalization of the Index was
approximately $217 million. Second Quarter 2005 Financial Overview
BioSante incurred a net loss of approximately $2.58 million, or
$(0.13) per basic and diluted share for the quarter ended June 30,
2005, compared to a net loss of approximately $2.57 million, or
$(0.15) per basic and diluted share for the second quarter of 2004.
For the first six months of 2005, the Company's net loss totaled
approximately $5.35 million, or $(0.28) per basic and diluted
share, compared to a net loss of approximately $5.02 million, or
$(0.32) per basic and diluted share, for the first six months of
2004. As of June 30, 2005, the Company's cash, cash equivalents and
short-term investments were approximately $12.1 million. The
Company anticipates a cash burn rate of approximately $750,000 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. (Amex:AIS). 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 factors
discussed on pages 19 to 31 of BioSante's Form 10-KSB, 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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