BioSante Pharmaceuticals Announces Initiation of LibiGel(R) (Transdermal Testosterone Gel) Phase III Safety Study
LINCOLNSHIRE, Ill.--(Business Wire)--BioSante Pharmaceuticals, Inc. (NASDAQ:BPAX) announced today that
it has initiated its Phase III safety study of LibiGel. This study
design is a result of an agreement with the U.S. Food and Drug
Administration (FDA) on key FDA requirements for the development and
approval of LibiGel in the treatment of female sexual dysfunction
(FSD), specifically, hypoactive sexual desire disorder (HSDD).
The LibiGel Phase III safety study protocol was finalized after
meetings and discussions with FDA representatives from the Division of
Reproductive and Urologic Products, the Division of Cardio-Renal
Products and the Office of Biometrics III (statistics). The primary
focus of BioSante's LibiGel Phase III safety study is to evaluate the
cardiovascular risk of using testosterone in women, a key pre-approval
concern of the FDA. The final study protocol seeks to show the
relative safety of using a low dose testosterone versus placebo in the
treatment of FSD in menopausal women.
"We are quite excited by the initiation of the LibiGel Phase III
safety study," said Stephen M. Simes, BioSante's president & CEO. "We
are confident that the study covers the depth and scope of study
requested by the FDA. The study initiation and the protocol agreement
with FDA reaffirms our long-held belief that development of LibiGel
will be both reasonable and affordable from both the financial and
timeline aspects, especially considering the potential size of the FSD
market and the potential sales of LibiGel, if and when approved. We
have received written FDA meeting minutes that provide us with a
clearly defined LibiGel development path that can lead to the approval
of LibiGel for the treatment of FSD. In the U.S., no pharmaceutical
product is approved for the treatment of FSD making this a truly
unserved market. BioSante is committed to the development of LibiGel
which if approved by the FDA could be the first product approved for
this treatment in the U.S."
The Phase III safety study is a randomized, double-blind,
placebo-controlled, multi-center, cardiovascular events driven study
of between 2,400 and 3,100 women exposed to LibiGel or placebo for 12
months. A new drug application (NDA) can be filed and reviewed by FDA,
possibly leading to approval of LibiGel, at that time. After NDA
submission and potential approval of LibiGel, BioSante will continue
to follow the women enrolled in the study for an additional four
years.
The LibiGel safety study will track a list of cardiovascular
events including cardiovascular death, myocardial infarction and
stroke in women 50 years of age or older and suffering from at least
one cardiovascular risk factor including hypertension and diabetes.
The objective of the safety study is to show the relative safety of
testosterone compared to placebo in the number of cardiovascular
events. The incidence of breast cancer also will be tracked over the
course of the study.
In addition to the Phase III cardiovascular safety study, BioSante
will conduct two Phase III efficacy trials. The Phase III efficacy
trials of LibiGel in the treatment of FSD, one of which has been
initiated, are double-blind, placebo-controlled trials that will
enroll up to approximately 500 surgically menopausal women each for a
six-month clinical trial. The efficacy trial already initiated is
being conducted under a Phase III protocol reviewed by and on file
with the FDA and in which written FDA comments have been received and
incorporated. BioSante hopes to initiate the second Phase III efficacy
trial in early 2008.
As previously announced by BioSante, treatment with LibiGel in a
Phase II clinical trial significantly increased satisfying sexual
events in surgically menopausal women suffering from FSD. The Phase II
trial results showed LibiGel significantly increased the number of
satisfying sexual events by 238 percent versus baseline (p less than
0.0001); this increase also was significant versus placebo (p less
than 0.05). In this study, the effective dose of LibiGel produced
testosterone blood levels within the normal range for pre-menopausal
women and had a safety profile similar to that observed in the placebo
group. In addition, no serious adverse events and no discontinuations
due to adverse events occurred in any subject receiving LibiGel. The
Phase II clinical trial was a double-blind, placebo-controlled trial,
conducted in the United States, in surgically menopausal women
distressed by their low sexual desire and activity.
About LibiGel(R)
LibiGel is a gel formulation of bioidentical testosterone designed
to be quickly absorbed through the skin after application on the upper
arm, delivering testosterone to the bloodstream evenly over time and
in a non-invasive and painless manner. Though generally characterized
as a male hormone, testosterone also is present in women and its
deficiency has been found to decrease libido or sex drive. In
addition, studies have shown that testosterone therapy can increase
bone density, raise energy levels and improve mood, in addition to
boosting sexual desire and activity.
According to a study published in the Journal of the American
Medical Association, 43 percent of American women (about 40 million)
experience some degree of impaired sexual function. Among the more
than 1,400 women surveyed, 32 percent lacked interest in sex and 26
percent could not experience orgasm. The majority of women with FSD
are postmenopausal, experiencing FSD due to hormonal changes following
menopause, whether natural or surgical.
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
LibiGel(R) (transdermal testosterone gel) in Phase III clinical
development by BioSante for the treatment of female sexual dysfunction
(FSD) and Elestrin(TM) (estradiol gel) developed through U.S. Food and
Drug Administration (FDA) approval by BioSante indicated for the
treatment of moderate-to-severe vasomotor symptoms associated with
menopause, marketed in the U.S. by Bradley Pharmaceuticals, Inc.,
BioSante's licensee. Also in development are Bio-T-Gel(TM), a
testosterone gel for male hypogonadism, and an oral contraceptive in
Phase II clinical development using BioSante patented technology. The
current market in the U.S. for estrogen and testosterone products is
approximately $2.5 billion and for oral contraceptives approximately
$3.0 billion. The company also is developing its calcium phosphate
nanotechnology (CaP) for novel vaccines, drug delivery, and aesthetic
medicine (BioLook(TM)). 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 "will," "potential", "could," "can," "intends," "continue,"
"plans," "expects" or comparable terminology, are forward-looking
statements. Examples of forward-looking statements in this news
release include statements regarding the expected timing of the
initiation of clinical trials and the submission of regulatory
applications. 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 could cause actual results to differ
materially from those expressed in such forward-looking statements
include the difficulty of developing pharmaceutical products,
obtaining regulatory and other approvals and achieving market
acceptance, the success of clinical testing, and other factors
identified and discussed from time to time in BioSante's filings with
the Securities and Exchange Commission, including those factors
discussed in BioSante's most recent annual report on Form 10-K and
subsequent quarterly reports on Form 10-Q, which discussions also are
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.
McKinney/Chicago
Alan Zachary, 312-944-6784 ext. 316
azachary@mckinneychicago.com
www.mckinneychicago.com
Copyright Business Wire 2008
