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
announced updated product development highlights, recent milestones
and financial results for the year ended December 31, 2005.
"We achieved a number of significant milestones with our late
stage hormone therapy products and CAP nanotechnology," commented
Stephen M. Simes, BioSante's president and chief executive officer.
"We announced positive Phase III clinical results for Bio-E-Gel(TM),
our transdermal estradiol gel for the treatment of moderate-to-severe
hot flashes in menopausal women, and presented these data at a key
medical conference. The data paved the way for the submission of our
New Drug Application (NDA) for Bio-E-Gel with the U.S. Food and Drug
Administration (FDA) in early 2006. We are proud of this first NDA
submission for BioSante which is an important milestone and
achievement for the company. We also are very pleased and encouraged
by the Phase II results for our transdermal testosterone product,
LibiGel(TM), and further encouraged by the FDA's guidance on
testosterone's potential as an effective therapy for female sexual
dysfunction. We hope soon to finalize the Phase III development plan
for LibiGel and initiate Phase III clinical trials in 2006. We are
dedicated to women's health, an important and growing area because of
the aging of women in the baby boom generation."
"Our CaP nanotechnology continues to generate significant interest
from the medical, business, and government communities, particularly
in areas such as biodefense and pandemic flu. In the last year, we
signed a number of agreements with other companies to use CaP in their
product development. We look forward to a successful and productive
2006, both with CaP and our transdermal hormone therapies," concluded
Simes.
Product Development Highlights
Hormone Therapy Achievements
-- We completed our 12-week pivotal Phase III clinical trial to
evaluate the safety and efficacy of Bio-E-Gel (transdermal
estradiol gel) for the treatment of moderate-to-severe hot
flashes in menopausal women. We believe we have identified the
"lowest effective dose" of Bio-E-Gel. We believe this dose
will be among the lowest estrogen doses on the market for the
treatment of hot flashes.
-- We submitted an NDA for Bio-E-Gel in early 2006.
-- We are making progress toward finalizing a Phase III
development plan for LibiGel in the treatment of female sexual
dysfunction.
-- We exercised an option for a license to three patents
encompassing triple hormone contraception technology, a novel
combination of estrogens and progestins with androgens, such
as testosterone, from Wake Forest University Health Sciences
and Cedars Sinai Medical Center. Paradoxically, many women who
use oral contraceptives have low sexual desire and activity
due to low levels of testosterone. We believe that LibiGel has
an important role for these women.
CaP Nanotechnology Achievements
-- We signed a Material Transfer and Option Agreement with a
European pharmaceutical company for an option for an
exclusive, worldwide license to use CaP to develop a series of
allergy products, including treatments for rhinitis, asthma,
conjunctivitis, dermatitis, and allergic gastrointestinal
diseases. Under the terms of the agreement, BioSante received
a $250,000 upfront payment and, if the parties enter into the
exclusive license agreement, BioSante will receive a one-time
license fee, annual maintenance payments, milestone payments
upon achievement of regulatory milestones, and royalties on
commercial sales.
-- We signed an option and license agreement with Medical
Aesthetic Technologies for the use of CaP in the medical
aesthetic field including cosmetic and dermatological
applications.
-- We received a subcontract for the development of recombinant
Factor IX formulations for delivery of CaP via alternative
routes of administration for the treatment of hemophilia.
-- We signed a manufacturing agreement with a US-based cGMP
(current good manufacturing practices) manufacturer for
large-scale quantities of CaP to be used by us and other
pharmaceutical companies for pre-clinical and clinical testing
of protein products as well as vaccines.
Financial Results for 2005
BioSante incurred a net loss of approximately $9.7 million or
($0.50) per share for the year ended December 31, 2005, compared to a
net loss of $12.0 million or ($0.70) per share for the same period in
2004. The company's cash, cash equivalents and short-term investments
as of December 31, 2005 were approximately $9.1 million, compared to
$17.3 million at December 31, 2004. The decrease in cash in 2005 was
primarily due to the completion of Bio-E-Gel clinical activities and
the NDA filing. The burn rate in early 2006 is estimated to be
approximately $750,000 per month. We believe our cash balance is
sufficient to allow us to initiate planned LibiGel Phase III
development.
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) (transdermal estradiol gel) for the treatment of women
with menopausal symptoms, and LibiGel(TM) (transdermal testosterone
gel) for the treatment of female sexual dysfunction (FSD). A Bio-E-Gel
new drug application (NDA) was submitted to the FDA on February 16,
2006. 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 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, 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 22 to 34 in BioSante's most recent Form
10-K, which discussion also is incorporated herein by reference.
Additional risk factors include the risk that the FDA will not accept
the Bio-E-Gel NDA for filing, the risk that the burn rate may exceed
projections, the risk that the cash requirements may be more than
anticipated, and the risk that the Company may not commence the
LibiGel Phase III clinical trials in a timely way. 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.