Bradley Pharmaceuticals Announces FDA Approval Of Elestrin (estradiol gel 0.06%)
FAIRFIELD, N.J., Dec. 19 -- Bradley Pharmaceuticals, Inc. announced today that the Company has been notified by BioSante Pharmaceuticals (Amex: BPA - News) that they received approval from the Food and Drug Administration to market Elestrin(TM) (formerly called Bio-E-Gel®), 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® 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® 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 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: 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® 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.
Source: Bradley Pharmaceuticals, Inc.