Healthcare Industry News: The North American Menopause Society
News Release - June 13, 2007
Bradley Pharmaceuticals Announces Launch of Elestrin(TM)FAIRFIELD, N.J., June 13 (HSMN NewsFeed) -- Bradley Pharmaceuticals, Inc. (NYSE: BDY ) today announced the launch of Elestrin(TM) (estradiol gel 0.06%) by the Company's Kenwood Therapeutics Division. Elestrin(TM) is an effective, low dose transdermal estrogen therapy that was approved by the Food and Drug Administration (FDA) in December 2006 for the treatment of moderate-to-severe vasomotor symptoms associated with menopause. Bradley in-licensed the product from BioSante Pharmaceuticals (Amex: BPA ) late last year and has exclusive marketing rights for Elestrin(TM) in the U.S. Elestrin(TM) is patent protected until 2022.
There are approximately 14,000 OB/GYN physicians in the U.S. who account for the majority of prescriptions in the $1.3 billion U.S. estrogen therapy market, which consists of oral and topical products. The topical market segment is about $300 million. In order to support the launch of Elestrin(TM) to the OB/GYN specialty market, the Company will immediately increase Kenwood's sales representatives and expects Kenwood to have up to 60 representatives.
"After the Women's Health Initiative (WHI) study in July 2002 detailed potential health risks associated with estrogen therapy, women have been seeking new alternatives," stated John Knoop, Vice President and General Manager of Bradley's Kenwood Therapeutics division. "Elestrin(TM) will enter the market as an effective, low dose estrogen therapy that follows dosing recommendations by the FDA and leading women's health organizations such as the American College of Obstetrics and Gynecologists (ACOG) and The North American Menopause Society (NAMS) to use the lowest effective dose of estrogen therapy."
In addition to being an effective low dose estrogen therapy, Elestrin(TM) is an elegant, fast-drying gel that is applied once-daily over a small, easy- to-reach area of the upper arm and/or shoulder. Elestrin(TM) delivers a consistent supply of estrogen to the bloodstream over 24-hours and in clinical trials patients experienced no endometrial hyperplasia during the twelve week study.
"The lower dose regime of Elestrin(TM) offers physicians a new and different treatment option for patients suffering from climacteric symptoms of menopause," stated Dr. Ruby Huttner, Chairman of the OB/GYN department at Hunterdon Medical Center, Flemington, New Jersey.
"Elestrin(TM) will provide physicians with an important treatment option for patients who choose to manage their hot flashes. We are confident that Elestrin(TM) will make a significant contribution to women's healthcare and look forward to working with key OB/GYN physicians to make Elestrin(TM) a success," stated Daniel Glassman, President and CEO of Bradley Pharmaceuticals.
The launch of Elestrin(TM) marks the execution of an important part of Bradley's strategic plan to in-license Phase II and Phase III drugs with long- term intellectual property protection, develop these licensed drugs into successful products and bring to market brands that fill unmet patient needs.
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.
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(TM) 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.
For additional important information about Elestrin(TM), please view full prescribing information at www.bradpharm.com or request full prescribing information by contacting Bradley Pharmaceuticals.
Please visit Bradley Pharmaceuticals web site at: www.bradpharm.com.
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 these products 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.
Source: Bradley Pharmaceuticals
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