Biosante Pharma (AMEX:BPA)
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Add after "www.antarespharma.com" in the contact
information of the release (dated Feb. 16, 2006):
-0-
*T
Equity Communications
Steve Chizzik, 973-912-0980
*T
The corrected release reads:
NDA FILED BY ANTARES PHARMA LICENSEE FOR TRANSDERMAL ESTRADIOL GEL
(BIO-E-GEL(TM))
Antares Pharma, Inc. (Amex:AIS) announced today that its licensee
BioSante Pharmaceuticals, Inc. (Amex:BPA),has submitted a New Drug
Application (NDA) to the Food and Drug Administration (FDA) for
Bio-E-Gel(TM) (a product based on Antares' proprietary ATD(TM) gel
technology) to treat moderate-to-severe hot flashes in menopausal
women. Across the low, mid, and high doses tested in the Phase III
trial, it was reported that there was a clear dose response in the
reduction in the number and severity of hot flashes. The NDA is
seeking approval for all three doses. Results of the Phase III study
also reported that beginning in Week 5, the low dose showed a highly
significant decrease in the number of and severity of hot flashes
versus placebo, therefore suggesting identification of the lowest
effective dose. This significant response was also maintained through
Week 12. Importantly, over 80 percent of women who used Bio-E-Gel(TM)
reported "moderate" or "great" results. It was also reported that
there were no significant differences in the safety profile of any
doses when compared to placebo other than for predictable estrogen
effects such as breast tenderness.
Bio-E-Gel(TM) utilizes Antares Pharma's proprietary (ATD(TM))
Advanced Transdermal Delivery gel system designed to allow delivery of
hormones and other active ingredients across the skin. This system
allows active ingredients to be absorbed quickly following
application. The current U.S. market for estrogen products is
estimated at approximately $1.4 billion in annual sales and the
European market is estimated to be equally substantial. While Antares
has licensed its ATD(TM) estradiol gel to BioSante for North America
and certain other territories, Antares retains rights to market its
own estradiol ATD(TM) gel products in Europe, Japan, and other
important markets and has the rights to utilize the data developed
from the FDA trials to do so.
"We are pleased that the NDA for Bio-E-Gel(TM) has been submitted
and especially pleased that the three doses tested in Phase III are
being submitted for approval," Jack E. Stover, President and CEO
reported. "We look forward to receiving data from the studies to
embark on our own filings. Additionally, it is welcome news to know,
that if approved, Bio-E-Gel(TM) may be the lowest effective dose of
estrogen available on the market to treat hot flashes," concluded Mr.
Stover.
About Antares Pharma
Antares Pharma is a specialized pharma product development company
with patented drug delivery systems and injectable device engineering
capabilities. Antares' current technology platforms include its
ATD(TM) Advanced Transdermal Delivery system, Easy Tec(TM) oral
fast-melt technology, and subcutaneous injection technology platforms
including both Vibex(TM) disposable mini-needle injection device and
Valeo(TM)/Vision(R) reusable needle-free injection devices. Antares
Pharma is committed to leveraging its multiple drug delivery platforms
to add value to existing drugs and to create new pharmaceutical
products and injectable devices. Overall, Antares' product pipeline
will address unmet medical needs by reducing side effect profiles,
improving safety, increasing effectiveness, and improving patient
compliance and convenience. Antares Pharma has corporate headquarters
in Exton, Pennsylvania, with subsidiaries performing research,
development, manufacturing and product commercialization activities in
Minneapolis, Minnesota and Basel, Switzerland.
Statements included in this press release that are not historical
in nature are "forward-looking statements" within the meaning of the
Private Securities Litigation Reform Act of 1995. The Company cautions
readers that forward-looking statements are subject to certain risks
and uncertainties, which could cause actual results to differ
materially and which are identified from time to time in the Company's
reports filed with the U.S. Securities and Exchange Commission.
Antares Pharma claims the protection of the Safe Harbor for
forward-looking statements contained in the Private Securities
Litigation Reform Act of 1995.