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Monday, May 07, 2007

Bradley Pharmaceuticals to Preview New Products at ACOG Meeting

FAIRFIELD, N.J., May 4 /PRNewswire-FirstCall/ -- Bradley Pharmaceuticals, Inc. today announced that it will preview two new FDA-approved products at the annual clinical meeting of the American College of Obstetricians and Gynecologists (ACOG) to be held in San Diego, California, from May 5-9, 2007. The Company's Kenwood Therapeutics division will be offering package inserts and product information about Elestrin(TM) (estradiol gel 0.06%), and Veregen(TM) (sinecatechins) Ointment 15%, both of which are scheduled to be launched this year.Veregen(TM) is a topical ointment used for the treatment of external genital and perianal warts. Veregen(TM)'s novel active ingredient, sinecatechins, is derived from the extract of green tea. Veregen(TM), approved in October 2006, is the first botanical and one of 18 new molecular entities approved by the FDA last year. The product is patent protected until 2017. Bradley in-licensed Veregen(TM) from MediGene AG (TecDax: MDG) of Frankfurt, Germany. Both Bradley's Kenwood Therapeutics division and Doak Dermatologics subsidiary are currently scheduled to begin detailing Veregen(TM) to OB/GYN physicians, dermatologists, college health departments, planned parenthood organizations, and public health programs during the fourth quarter of this year."We are pleased to have the opportunity to preview both Elestrin(TM) and Veregen(TM) at ACOG. This conference offers the largest exhibition in the country for obstetricians and gynecologists and related health care professionals," said John Knoop, Vice President and General Manager of Bradley's Kenwood Therapeutics division."Part of Bradley's expanded business strategy is to in-license Phase II and Phase III drugs and develop and bring to market products with long-term intellectual property protection. We accomplished this quickly last year after signing agreements for Elestrin(TM) and Veregen(TM) and receiving FDA approval for both products during the fourth quarter. We are looking forward to successful launches as we progress through the year," commented Daniel Glassman, President and CEO of Bradley Pharmaceuticals.Elestrin(TM) 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(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, please request full prescribing information for Elestrin(TM) by contacting Bradley Pharmaceuticals.Important Product Safety Information About Veregen(TM):Veregen(TM) is indicated for the topical treatment of external genital and perianal warts (Condylomata acuminata) in immunocompetent patients 18 years and older.Veregen(TM) is for external use only. Skin reactions including erythema, erosion, edema, itching, and burning at the application site are common. Should a severe local skin reaction occur, the ointment should be removed and further doses held.Veregen(TM) has not been evaluated for the treatment of urethral, intra- vaginal, cervical, rectal, or intra-anal human papilloma viral disease and should not be used for these conditions.The safety and efficacy of Veregen(TM) in immunosuppressed patients, in the treatment of external genital and perianal warts beyond 16-weeks, or for multiple treatment courses have not been established.Veregen(TM) is not a cure and new warts might develop during or after therapy. If new warts develop during the 16-week treatment period, these should also be treated with Veregen(TM).The effect of Veregen(TM) on the transmission of genital/perianal warts is unknown.Sexual (genital, anal or oral) contact should be avoided while the ointment is on the skin. Veregen(TM) may weaken condoms and vaginal diaphragms. Therefore the use in combination with Veregen(TM) is not recommended.In clinical trials, the incidence of local adverse events leading to discontinuation or dose interruption included: application site reactions (local pain, erythema, vesicles, skin erosion/ulceration), phimosis, inguinal lymphadenitis, urethral meatal stenosis, dysuria, genital herpes simples, vulvitis, hypersensitivity, pruritus, pyodermitis, skin ulcer, erosions in the urethral meatus, and superinfection of warts and ulcers.For additional important information, please request full prescribing information for Veregen(TM) by contacting Bradley Pharmaceuticals.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 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 announcements:Bradley Pharmaceuticals will present at the 2007 UBS Global Generic and Specialty Pharmaceuticals Conference to be held at the Grand Hyatt in New York, NY, May 8-9, 2007.Bradley Pharmaceuticals will present at the Robbins Emerging Opportunities Investment Conference, to be held at The University Club in New York, NY, May 24, 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 - June 1, 2007.Bradley Pharmaceuticals will present at the FTN Midwest Securities Health Care Conference 2007, to be held at the Four Seasons Hotel in New York, NY, June 5, 2007.Safe Harbor for Forward-Looking StatementThis 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) and ELESTRIN(TM) during 2007; predict the safety and efficacy of these products in a commercial setting; estimate sales; maintain adequate inventory levels; 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, 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.

1 comment:

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