FAIRFIELD, N.J., March 2 /PRNewswire-FirstCall/ -- Bradley Pharmaceuticals, Inc. reports a growing trend in medical literature and general media in support of low-dose estrogen replacement therapies and transdermal estradiol products. The most recent article appears in the March issue of Obstetrics and Gynecology, the journal of the American College of Obstetrics and Gynecology (ACOG). The article discusses the safety and effectiveness of Elestrin(TM) (estradiol gel 0.06%), Bradley’s low-dose transdermal estradiol gel indicated for the treatment of moderate to severe vasomotor symptoms, specifically hot flashes, associated with menopause. It is anticipated that prescription only Elestrin(TM) will be available to physicians, pharmacists and patients mid-2007.
The medical peer-reviewed journal reports the results of a major Phase III multicenter study titled, “Low Dose of Transdermal Estradiol (E2) Gel for Treatment of Symptomatic Postmenopausal Women,” conducted to evaluate the efficacy and tolerability of Elestrin(TM). At the conclusion of the study, 80% of the women who used Elestrin(TM) reported “great” or “moderate” results, a highly significant improvement over placebo treatment.
In addition, a February 25, 2007 article released by the Associated Press reported on a study conducted by the Estrogen and Thromboembolism Risk (ESTHER) Study Group. According to the results of this study, transdermal estrogen may be safer than oral estrogen, concluding that transdermal delivery reduces the risk of venous blood clots in women. The same conclusions were presented in a November 30, 2006 article in the New England Journal of Medicine. Moreover, Newsweek magazine ran an in-depth article on menopause and its effect on a woman’s body, including a discussion on the risks and benefits of hormone replacement therapy. The article reinforced the position iterated by the Food and Drug Administration (FDA), the Women’s Health Initiative (WHI) and ACOG to use the lowest dose of hormones that provides symptomatic relief for the shortest time possible. A January 26, 2007 article in The Wall Street Journal and a December 26, 2006 article from the New York Times echoed the conclusion that the benefits of conservative use of estrogen replacement therapy likely outweigh the risks, particularly in younger women.
These articles support the premise of Elestrin(TM), a low-dose, topical transdermal estradiol gel formulation that will be promoted by Bradley’s Kenwood Therapeutics division. On December 18, 2006, the Food and Drug Administration approved Elestrin(TM), which offers the lowest dose of estradiol currently available on the market, fully 50% lower than the nearest current competitor.
Dr. James A. Simon, M.D., Clinical Professor of Obstetrics and Gynecology at George Washington University, and lead investigator for the Elestrin(TM) multicenter study stated, “The recent tide of media attention to menopause and hormone therapy highlights the need for a low-dose, transdermal estradiol therapy in line with the FDA, ACOG, North American Menopause Society and WHI dosage recommendations. This attention is also raising awareness about this issue among a large number of women who are going through, or approaching, menopause.”
Bradley President and CEO, Daniel Glassman, stated, “Bradley is pleased to bring Elestrin(TM) to market, fulfilling the important need in the marketplace for a low dose and effective product. Patent-protected until 2021, the promotion of Elestrin(TM) is a major part of Bradley’s strategic initiative to increase shareholder value.”
Important Product Safety Information:
Elestrin is indicated for the treatment of moderate-to-severe vasomotor symptoms associated with menopause.
Close clinical surveillance of all women taking estrogens is important. Adequate diagnostic measures should be undertaken to rule out malignancy in cases of undiagnosed, persistent or recurring abnormal vaginal bleeding.
Long-term continuous administration of estrogen, with or without progestin, has shown an increased risk of endometrial, breast and ovarian cancers.
Estrogens with or without progestins should not be used for the prevention of cardiovascular disease or dementia. An increased risk of developing probable dementia in postmenopausal women 65 years of age or older was reported with estrogen-alone use, as well as, in combination with progestin.
Estrogen-alone therapy has been associated with an increased risk of stroke and deep vein thrombosis. Estrogen plus progestin therapy has been associated with an increased risk of myocardial infarction, stroke, invasive breast cancer, pulmonary emboli and deep vein thrombosis. Estrogens should be discontinued immediately if any of these events occur or are suspected.
Estrogen with or without progestin should be prescribed at the lowest effective doses and for the shortest duration consistent with treatment goals and risks for the patient.
An increase in gallbladder disease requiring surgery in postmenopausal women receiving estrogens has been reported. Estrogen therapy may lead to severe hypercalcemia in patients with breast cancer and bone metastases. Retinal vascular thrombosis has been reported in patients receiving estrogens.
Estrogen products should not be used in women with undiagnosed abnormal genital bleeding; known, suspected or history of breast cancer; known or suspected estrogen-dependent neoplasia; active or history of deep vein thrombosis or pulmonary embolism; active or recent (within the past year) arterial thromboembolic disease (e.g., stroke, myocardial infarction); liver dysfunction or disease; known or suspected pregnancy.
Blood pressure should be monitored during estrogen use. Caution should be exercised in patients with hypertriglyceridemia, impaired liver function or a history of cholestatic jaundice, conditions that might be influenced by fluid retention, hypocalcemia, asthma, diabetes mellitus, epilepsy, migraine, porphyria, systemic lupus erythematosus, and hepatic hemangiomas. Patients dependent on thyroid hormone replacement therapy may require increased doses of such therapy. The addition of progestin should be considered in patients with residual endometriosis post-hysterectomy. Concomitant application of sunscreen and Elestrin to the same site for more than 7 days should be avoided.
The most frequently reported adverse events in clinical trials were nasopharyngitis, breast tenderness, upper respiratory tract infection, and metrorrhagia.
Please request Package Insert for full Prescribing Information by contacting the Company.
Please visit Bradley Pharmaceuticals web site at: www.bradpharm.com
Bradley Pharmaceuticals common stock is listed on the NYSE under the symbol BDY.
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 its core strengths in marketing and sales which enables the company to Commercialize brands that fill unmet patient and physician needs; Develop new products through life cycle management; and In-License phase II and phase III drugs with long-term intellectual property protection that upon approval 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, OBGYN, 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 Raymond James & Associates 28th Annual Institutional Investors Conference, at 11 AM at the Hyatt Regency Grand Cypress in Orlando, FL, March 5, 2007.
Bradley Pharmaceuticals will present at the CIBC World Markets Annual Biotechnology and Specialty Pharmaceuticals Conference at the Millennium Broadway Hotel in New York City, April 11-12, 2007
Bradley Pharmaceuticals will present at the Banc of America Securities Health Care Conference 2007, to be held at The Four Seasons Hotel in Las Vegas, Nevada, May 30 through June 1, 2007.
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 sales and earnings estimates, other predictions of financial performance, timing of payments on indebtedness, launches by Bradley of new products, market acceptance of Bradley’s products, 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 Veregen(TM), Elestrin(TM) and the products incorporating the delivery systems to be developed by Polymer Science; the safety and efficacy of these products in a commercial setting; estimate sales; comply with the restrictive covenants under its credit facility; refinance its credit facility; access the capital markets on attractive terms or at all; favorably resolve the pending SEC informal inquiry; 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.
Bradley Pharmaceuticals, Inc.
CONTACT: Anthony Griffo, Investor Relations, Bradley Pharmaceuticals,Inc., +1-973-882-1505, ext. 313
Web site: http://www.bradpharm.com/
