Biosante Pharma (AMEX:BPA)
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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.