BioSante Encouraged by FDA Panel on Exubera, Superior Results of Own Inhaled Insulin Study
September 21 2005 - 7:55AM
Business Wire
BioSante Pharmaceuticals, Inc. (Amex:BPA) today expressed
encouragement by the U.S. Food & Drug Administration (FDA)
Advisory Panel's recommended approval of Pfizer, Inc.'s Exubera
inhaled insulin therapy, and noted superior results in preclinical
studies with its own inhalable insulin delivery system. "The FDA
Advisory Panel's recommended approval of Exubera is highly
encouraging as we continue to develop our own inhaled insulin
therapy," said Stephen M. Simes, president and chief executive
officer of BioSante. "The most recent study found our aerosolized
pulmonary insulin formulation offered equivalent insulin
bioavailability compared to subcutaneous injection, which
translates to about 60 percent absolute bioavailability. For
comparison, the bioefficacy of the Exubera inhaled insulin is
approximately 10 percent, according to data presented at the
American Diabetic Association annual meeting." Mr. Simes said
development continues on BioSante's inhalable insulin product using
the company's proprietary BioAir(TM) calcium phosphate
nanoparticulate (CaP) delivery system. A previously announced
preclinical study, conducted by scientists at the University of
North Carolina and BioSante and published in the journal AAPS
PharmSci, demonstrated that CaP-polyethylene glycol (PEG) particles
significantly reduced the elimination of insulin, increasing its
systemic residence time and duration of action. Consequently, the
amount of insulin that became available through the bloodstream
(bioavailability) using the BioAir insulin-CaP-PEG formulation was
equivalent to or higher than that of insulin injected
subcutaneously. "This may mean that fewer or lower dosings will be
required, resulting in greater convenience and safety potential,"
Simes said. He noted that the company will soon begin testing its
innovative inhaled insulin in rabbits. "The availability of
inhalable insulin therapy will be a great advance in diabetes
treatment, providing an easy, pain-free alternative to insulin
injections and allowing diabetics to live more comfortable lives,"
he said. BioSante's proprietary calcium phosphate nanoparticles are
vehicles for delivering drugs and vaccines more efficiently and
enhancing their therapeutic effects. The CaP technology consists of
microscopic particles of a natural compound similar to that found
in teeth and bones. The patented formulation is nontoxic and
biodegradable, offering a multitude of potential medical
applications. 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
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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