Biosante Pharma (AMEX:BPA)
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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.