ADDING AND REPLACING NDA Filed by Antares Pharma Licensee for Transdermal Estradiol Gel (Bio-E-Gel(TM))
18 February 2006 - 3:34AM
Business Wire
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.
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