BioSante Pharmaceuticals Reports Product Development Highlights and Financial Results for 2005
March 31 2006 - 7:00AM
Business Wire
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.
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