Bradley Pharmaceuticals Announces FDA Approval of Elestrin(TM) (estradiol gel 0.06%)
19 Décembre 2006 - 1:45PM
PR Newswire (US)
Elestrin(TM) to Be the Lowest Effective Dose of Estradiol Available
FAIRFIELD, N.J., Dec. 19 /PRNewswire-FirstCall/ -- Bradley
Pharmaceuticals, Inc. (NYSE:BDY) announced today that the Company
has been notified by BioSante Pharmaceuticals (AMEX:BPA) that they
received approval from the Food and Drug Administration to market
Elestrin(TM) (formerly called Bio-E-Gel(R)), BioSante's estradiol
transdermal gel indicated for the treatment of moderate to severe
hot flashes in menopausal women. Elestrin(TM) will be the lowest
effective dose of estradiol available and will conform to the
recommendations directed to physicians by the FDA and the American
College of Obstetricians and Gynecologists (ACOG) to prescribe the
lowest effective dose of estrogen to control menopausal symptoms
such as hot flashes. An issued patent covers gel formulations into
2017, and pending patents, if issued, will protect the Elestrin(TM)
formulation beyond that date. The approval of Elestrin(TM) further
validates Bradley's strategic plan to in-license Phase II and Phase
III drugs with long-term intellectual property protection, develop
these products and bring to market brands that fill unmet patient
needs. The approval of Elestrin(TM) follows the FDA approval in
October 2006 of Polyphenon(R) E Ointment, 15%, a patent protected
product in-licensed by Bradley for the treatment of external
genital and perianal warts. Elestrin(TM) is an elegant,
easy-to-use, topically applied gel that will be commercialized in
the United States by the Kenwood Therapeutics Division of Bradley.
Elestrin(TM) is scheduled to be launched during the Summer of 2007,
and will be marketed to the OB/GYN community. This new product will
complement other therapies in the Kenwood portfolio promoted to the
same specialty physician audience, including Polyphenon(R) E. There
are approximately 14,000 OB/GYN physicians in the US who account
for the majority of prescriptions in the entire $1.3 billion US
estrogen therapy market which consists of oral and topical
products. Elestrin(TM) will compete in this marketplace by offering
a low dose alternative not currently available. Bradley Management
believes the approval of Elestrin(TM) is particularly timely in
view of recent media reports regarding the safety of estrogen
therapy, since Elestrin(TM) addresses the low dose recommendations
of the FDA and ACOG. Bradley Pharmaceuticals Chief Scientific
Officer, Ralph Landau, stated, "Elestrin(TM) will provide
physicians with an important treatment for their patients suffering
from hot flashes. In light of concerns over estrogen, we believe
that physicians may be more receptive to prescribing Elestrin(TM),
a low dose topical therapy of estradiol." Dr. James A. Simon, M.D.,
Clinical Professor of Obstetrics and Gynecology at George
Washington University, and lead investigator for the Elestrin(TM)
multicenter pivotal study stated, "The introduction of the low dose
regimen provides an important therapeutic option in the management
of hot flashes in post-menopausal women." Bradley Pharmaceuticals
President and CEO, Daniel Glassman, stated "Bradley is pleased to
provide a therapy that we are confident will make a significant
contribution to women's health, a growing medical specialty that
the Company's Kenwood Division is proud to serve." Bradley
Pharmaceuticals, Inc. invites you to participate in an Investor
Conference Call regarding Elestrin(TM) on Tuesday, December 19,
2006 at 4 PM ET. Participants in the conference call will include
Daniel Glassman, President and CEO of Bradley Pharmaceuticals,
Inc., Larry Klevans, Ph.D. and Ralph Landau, Ph.D., each of Bradley
Pharmaceuticals, Inc. Stephen M. Simes, CEO of BioSante
Pharmaceuticals, Inc., and James A. Simon, M.D., Clinical Professor
of Obstetrics and Gynecology at George Washington University. To
participate in the conference call, please dial 1-888-573-3046
approximately 10 minutes prior to the start of the call and enter
ID# 4824478. Playback of the conference call will be available
after 6 PM ET by calling 1-800-642-1687 and entering reservation
ID# 4824478. The call also will be available on our web page
http://www.bradpharm.com/ under Investor Relations Calendar of
Events for 30 days. Bradley Pharmaceuticals, Inc. was founded in
1985 as a specialty pharmaceutical company and markets to niche
physician specialties in the U.S. and 38 international markets.
Bradley's success is based upon strategically expanding from an
Acquire, Enhance and Grow to an In-License, Develop and Bring to
Market business model: In-license phase II and phase III drugs with
long-term intellectual property protection; Develop these products
and submit completed clinical studies to the FDA for NDA approvals
and commercialization; Bring to Market these patent-protected
brands to fill unmet needs and leverage Bradley's marketing and
sales expertise to increase shareholder value. Bradley
Pharmaceuticals is comprised of Doak Dermatologics, specializing in
therapies for dermatology and podiatry; Kenwood Therapeutics,
providing gastroenterology, OB/GYN, respiratory and other internal
medicine brands; and A. Aarons, which markets authorized generic
versions of Doak and Kenwood therapies. Important announcement:
Bradley Pharmaceuticals will present at the Wachovia Securities
Small and Mid-Cap Healthcare Conference, January 30, 2007, at 8:30
AM at the Langham Hotel in the Timberlay Room, Boston MA. Bradley
Pharmaceuticals will present at the Raymond James & Associates
28th Annual Institutional Investors Conference, to be held at the
Hyatt Regency Grand Cypress in Orlando, FL, March 4-7, 2007. Please
visit Bradley Pharmaceuticals web site at:
http://www.bradpharm.com/ Bradley Pharmaceuticals common stock is
listed on the NYSE under the symbol BDY. Safe Harbor for
Forward-Looking Statements This release contains "forward-looking
statements" within the meaning of the Private Securities Litigation
Reform Act of 1995. Forward-looking statements include statements
that address activities, events or developments that Bradley
expects, believes or anticipates will or may occur in the future,
such as launches by Bradley of new products, market acceptance of
Bradley's products, sales and earnings estimates, other predictions
of financial performance, timing of payments on indebtedness,
timing and repurchases of shares of common stock, and the
achievement of initiatives to enhance corporate governance and
long-term shareholder value. Forward-looking statements are based
on Bradley's experience and perception of current conditions,
trends, expected future developments and other factors it believes
are appropriate under the circumstances and are subject to numerous
risks and uncertainties, many of which are beyond Bradley's
control. These risks and uncertainties include Bradley's ability
to: successfully acquire, develop, integrate, or sell new products,
including POLYPHENON E(R) Ointment, Elestrin(TM) and the products
incorporating the delivery systems to be developed by Polymer
Science; estimate sales; comply with the restrictive covenants
under its credit facility; refinance its credit facility, if
necessary; access the capital markets on attractive terms or at
all; favorably resolve the pending SEC informal inquiry and file
required financial statements with the SEC in a timely manner;
remediate its material weaknesses in its internal controls;
maintain sales of its products; or effectively react to other risks
and uncertainties described from time to time in Bradley's SEC
filings, such as fluctuation of quarterly financial results,
estimation of product returns, chargebacks, rebates and allowances,
concentration of customers, reliance on third party manufacturers
and suppliers, litigation or other proceedings (including the
pending class action and shareholder derivative lawsuits),
government regulation, stock price volatility and ability to
achieve strategic initiatives to enhance long-term shareholder
value. Further, Bradley cannot accurately predict the impact on its
business of the approval, introduction, or expansion by competitors
of generic or therapeutically equivalent or comparable versions of
Bradley's products or of any other competing products. In addition,
actual results may differ materially from those projected. Bradley
undertakes no obligation to publicly update any forward-looking
statement, whether as a result of new information, future events or
otherwise. DATASOURCE: Bradley Pharmaceuticals, Inc. CONTACT:
Anthony Griffo, Investor Relations of Bradley Pharmaceuticals,
Inc., +1-973-882-1505, ext. 313 Web site: http://www.bradpharm.com/
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