BioSante Pharmaceuticals Reports Product Development Highlights and First Quarter 2006 Financial Results
May 12 2006 - 7:00AM
Business Wire
BioSante Pharmaceuticals (AMEX:BPA) today reported product
development highlights and financial results for the first quarter
ended March 31, 2006. "We were pleased to start the year by
submitting our new drug application for Bio-E-Gel(R), which we
believe, if and when approved, may offer the lowest effective dose
of estrogen on the market for the treatment of hot flashes," said
Stephen M. Simes, BioSante's president and chief executive officer.
"Also in the first quarter, positive data from pre-clinical trials
with BioVant(TM), our calcium phosphate nanoparticle technology,
demonstrated its effectiveness as an adjuvant for flu vaccines,
including bird flu. Looking to the remainder of 2006, we aim to
continue our success by initiating Phase III clinical studies of
LibiGel(R) in female sexual dysfunction." Product Development
Highlights -- BioSante submitted a new drug application (NDA) to
the U.S. Food and Drug Administration (FDA) for Bio-E-Gel
(transdermal estradiol gel) to treat moderate to severe hot flashes
in menopausal women. The NDA includes data from a 12-week pivotal
Phase III, randomized, double-blind, placebo controlled study of
484 symptomatic women, as well as data from a transfer study, a
sunscreen study, and a pharmacokinetic study. Low, mid, and high
doses of Bio-E-Gel were tested. We believe the lowest effective
dose was identified and all three dosages showed a significant
reduction in the number and severity of hot flashes compared to
placebo. -- BioSante announced positive results from three
pre-clinical studies, demonstrating that BioVant (calcium phosphate
nanoparticle technology, or CaP) may serve as an adjuvant for the
development of vaccines for M1 protein, H3N1 and H5N1 (bird flu)
flu virus strains. Results of the studies show that BioVant can
enhance flu-specific immunity, elicit high titers of bird
flu-specific antibodies, and potentially serve as a good adjuvant
for an H5N1 vaccine. -- BioSante signed an exclusive option and
license agreement with Medical Aesthetics Technology Corporation
for the use of CaP technology in the field of aesthetic medicine.
-- BioSante was awarded a subcontract by the University of
Nebraska-Lincoln valued at $250,000 for the development of
recombinant Factor IX formulations using CaP technology for
alternate routes of administration. The current subcontract is for
the first year of the University's grant and, if warranted,
BioSante can apply to renew the subcontract with a total possible
value of $1.25 million over five years. First Quarter 2006
Financial Overview BioSante incurred a net loss of approximately
$3.2 million or ($0.17) per share for the quarter ended March 31,
2006, compared to a net loss of $2.8 million or ($0.14) per share
for the same period in 2005. This increase was due primarily to the
impact of BioSante adopting SFAS No. 123R "Share-Based Payment" and
increases in general and administrative expenses, partially offset
by reductions in research and development expense and an increase
in licensing and grant revenue. The Company's cash, cash
equivalents and short-term investments as of March 31, 2006 were
approximately $7.1 million, as compared to approximately $9.1
million on December 31, 2005. The Company's cash burn rate for the
first quarter of 2006 was approximately $2 million, slightly lower
than the projected burn rate mentioned in BioSante's announcement
regarding its 2005 financial results. We remain confident that our
cash balance is sufficient to allow for the initiation of LibiGel
Phase III clinical development in 2006. 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 (transdermal estradiol gel) for the
treatment of women with menopausal symptoms, and LibiGel
(transdermal testosterone gel) for the treatment of female sexual
dysfunction (FSD). A Bio-E-Gel New Drug Application was submitted
to the FDA in the first quarter of 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. BioSante
also is developing its calcium phosphate nanotechnology (CaP) for
novel vaccines, including avian flu and 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 approve Bio-E-Gel for marketing or that if approved,
Bio-E-Gel may not achieve commercial success. 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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