New Once-A-Week Patch Alleviates Menopausal Hot Flashes/Night Sweats

Main Category: Menopause
Article Date: 10 Feb 2004 - 0:00 PST

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New once-a-week patch offers effective and convenient treatment with lowest estrogen dose available in combination therapy

Montville, NJ (USA) - Berlex, Inc., a U.S. affiliate of Schering AG, Germany (NYSE:SHR), announced today that Climara Protm (estradiol/levonorgestrel transdermal system), is now available to U.S. women in pharmacies nationwide.

Climara Pro effectively relieves moderate to severe vasomotor symptoms such as hot flashes and night sweats with the lowest estrogen dose of any combined hormone therapy in a convenient, once-a-week patch.

'The availability of Climara Pro provides the thousands of U.S. women impacted by these debilitating menopausal symptoms with a significantly different and much-needed new option,' said Marie Foegh, M.D., D.Sc., Vice President of Medical Affairs for Female Healthcare at Berlex.

'Climara Pro offers effective symptom relief with one-twentieth of the estradiol dose of standard oral hormone therapy products and is the first HT to use the trusted progestin, levonorgestrel.'

The transdermal technology of Climara Pro allows for continuous delivery of the hormones estradiol, which simulates the estrogen made by the ovaries (0.045 mg/day), and levonorgestrel, (0.015 mg/day) at doses substantially lower than in pills, through a thin, translucent patch that is easily affixed to the skin and virtually invisible after being applied.

Transdermal delivery, unlike oral therapy, also avoids first-pass effects through the liver during absorption.

This translates to no increase in triglycerides or sex hormone binding globulin (SHBG). 'Estrogen therapy remains the most effective means of relieving vasomotor symptoms and, in fact, recent studies are showing a significant number of women return to hormone therapy after discontinuation.

They restart this therapy because they are again experiencing symptoms that significantly and negatively affect their lives,' said James A. Simon, M.D., Clinical Professor, George Washington University, menopause specialist, and Climara Pro investigator.

'New Climara Pro is an important option to consider in individualized treatment for menopausal women.'

Like Climara (r) (estradiol transdermal system), Berlex's once-a-week estrogen-only patch, Climara Pro delivers the hormones continuously and directly through the skin, with the benefits of unique 3M Drug Delivery Systems technology.

With the addition of levonorgestrel, Climara Pro is indicated for use by women with an intact uterus, whereas Climara is appropriate for women who have had a hysterectomy.

Data Demonstrate Safety, Efficacy and Tolerability

Two well-controlled, randomized clinical trials showed that Climara Pro rapidly and effectively controlled these menopausal symptoms.

For many patients, the frequency and severity of hot flashes was significantly reduced as early as week one, and 90 percent of women experienced an 80 percent reduction in hot flash frequency by week 12.

Climara Pro has a favorable side effect profile. Clinical trial participants using Climara Pro also experienced a low skin irritation rate, no effect on body weight and a bleeding profile comparable to other combination hormone therapies.

Estrogen/progestin combinations should not be used by women with known or suspected pregnancy, breast cancer, estrogen-dependent neoplasia, undiagnosed abnormal genital bleeding, active thrombophlebitis, thromboembolic disorders or stroke, liver dysfunction or disease, or any known hypersensitivity to estrogen, progestin or any Climara Pro transdermal system components.

Estrogens with or without progestins should not be used to prevent heart disease, heart attacks, or strokes. Using estrogens with or without progestins may increase a woman's risk of heart attacks, strokes, breast cancer, and blood clots.

A woman and her healthcare provider should discuss regularly whether she still needs estrogen treatment. In the absence of data on Climara Pro comparable in scope to that of the Women's Health Initiative (WHI), the risks identified in the WHI should be assumed to be similar for all postmenopausal hormone therapy.

Committed to developing novel diagnostics and therapeutics that address unmet medical needs, Berlex, Inc., a US affiliate of Schering AG, Germany (NYSE: SHR), develops and markets diagnostic imaging agents, treatments in the areas of female healthcare and dermatology, as well as specialized therapeutics for life-threatening and disabling diseases in the fields of the central nervous and cardiovascular systems, oncology, and gastroenterology. Berlex has business operations in New Jersey, California and Washington. For more information, please visit www.berlex.com.

Certain statements in this press release that are neither reported financial results nor other historical information are forward-looking statements, including but not limited to, statements that are predictions of or indicate future events, trends, plans or objectives. Undue reliance should not be placed on such statements because, by their nature, they are subject to known and unknown risks and uncertainties and can be affected by other factors that could cause actual results and Schering AG's plans and objectives to differ materially from those expressed or implied in the forward-looking statements. Certain factors that may cause such differences are discussed in our Form 20-F and Form 6-K reports filed with the U.S. Securities and Exchange Commission. Schering AG undertakes no obligation to update publicly or revise any of these forward-looking statements, whether to reflect new information or future events or circumstances or otherwise.

Contact: Kim Schillace, Berlex
kimberly_schillace@berlex.com
973-487-2461
Porter Novelli

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