BDY Bradley Pharmaceuticals

Elestrin(TM) Represents An Effective Low Dose Treatment Option to Treat Hot Flashes NEW YORK, June 20 /PRNewswire-FirstCall/ -- Bradley Pharmaceuticals, Inc. (NYSE:BDY) today introduced Elestrin(TM) (estradiol gel 0.06%) to the national media. Elestrin(TM) is an effective, low dose transdermal estrogen therapy approved by the Food and Drug Administration (FDA) in December 2006 for the treatment of moderate-to-severe vasomotor symptoms associated with menopause. Elestrin(TM) was launched last week by the Company's Kenwood Therapeutics division and is now available by prescription at pharmacies nationwide. An editors' launch meeting was held today in New York City led by Marie Lugano, founder of the American Menopause Foundation. Dr. Michelle Warren of Columbia University, a key opinion leader on menopause, provided an overview of the menopause marketplace. Dr. Michael Snabes, an expert in the field of reproductive endocrinology, provided information on clinical studies about Elestrin(TM). "Every woman is unique, and so is the way she experiences menopause," said Ms. Lugano. "It is critical, therefore, that women research the issues, understand the various treatment options available, and discuss them with their doctor. Armed with the right information, women can better manage their menopause symptoms effectively." "Menopause therapy is shifting toward low-dose regimens, and Elestrin(TM) offers women a new, effective low dose treatment option," said Daniel Glassman, President and CEO of Bradley Pharmaceuticals. "Elestrin(TM) addresses the guidelines set forth by the FDA, American College of Obstetricians and Gynecologists (ACOG), North American Menopause Society (NAMS), and the New England Journal of Medicine that hormone therapy should be used at a low effective dose for the shortest duration of time." In addition to being an effective low dose estrogen therapy, Elestrin(TM) dries quickly within five minutes and is applied once-daily over a small area of the upper arm and/or shoulder. Dr. Michael Snabes, co-author of "Low Dose of Transdermal Estradiol Gel for the Treatment of Symptomatic Postmenopausal Women," which was published in the March 2007 edition of Journal of Obstetrics & Gynecology, noted that "During the 12-week clinical trial, Elestrin(TM) was proven to significantly reduce the frequency and severity of hot flashes. Reductions in both the frequency and severity of hot flashes varied depending on the dosage." "We now have the option to prescribe a new, low effective dose of estrogen therapy to patients," said Dr. Michelle Warren, Medical Director of The Center for Menopause, Hormonal Disorders and Women's Health at Columbia University. "Elestrin(TM) will provide physicians with an important treatment option for patients who choose to manage their hot flashes." Important Product Safety Information About Elestrin(TM): 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. The most frequently reported adverse events in clinical trials were nasopharyngitis, breast tenderness, upper respiratory tract infection, and metrorrhagia. For additional important information about Elestrin(TM), please view full prescribing information at http://www.bradpharm.com/ or request full prescribing information by contacting Bradley Pharmaceuticals at 973-882-1505. About Bradley Pharmaceuticals, Inc. Bradley Pharmaceuticals, Inc. was founded in 1985 as a specialty pharmaceutical company and markets to niche physician specialties in the U.S. and international markets. Bradley's success is based upon its core strengths in marketing and sales, which enable 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, OB/GYN, respiratory and other internal medicine brands; and A. Aarons, which markets authorized generic versions of Doak and Kenwood therapies. 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 Bradley's plans to in-license, develop and launch new and enhanced products with long-term intellectual property protection or other significant barriers to market entry, 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: Launch VEREGEN(TM) at the end of 2007; predict the safety and efficacy of ELESTRIN(TM) and VEREGEN(TM) in a commercial setting; estimate sales; maintain adequate inventory levels; implement the returns and inventory optimization plan timely, if at all; reduce product returns; 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; maintain or increase 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 and stock price volatility. 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: Elizabeth Hewitt, +1-212-829-0002, Ext. 107, , for Bradley Pharmaceuticals, Inc.; or Cecelia Heer of Bradley Pharmaceuticals, Inc., +1-973-882-1505, Ext. 252, Web site: http://www.bradpharm.com/

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