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FDA Approves New Indication For Berlex Inc.'s YAZ(R) To Treat Emotional And Physical Symptoms Of Premenstrual Dysphoric Disorder (PMDD)


10/5/2006 9:25:05 AM

WAYNE, N.J., Oct. 5 /PRNewswire/ -- Berlex, Inc., a U.S. affiliate of Schering AG, Germany (FSE: SCH; NYSE: SHR), announced today that the U.S. Food and Drug Administration (FDA) has approved YAZ® (3 mg drospirenone/20 mcg ethinyl estradiol) as the first and only oral contraceptive shown clinically effective for the treatment of the emotional and physical symptoms of premenstrual dysphoric disorder (PMDD) in women who choose to use an oral contraceptive as their method of contraception. YAZ, which received FDA approval for the prevention of pregnancy in March, 2006, is the fastest growing oral contraceptive brand in the U.S.*

PMDD is a condition in which women's emotional and physical premenstrual symptoms are disruptive enough to significantly impact relationships, social activities and work productivity. Symptoms of PMDD include mood swings, irritability, headaches, feeling anxious, bloating and food cravings. The symptoms regularly occur seven to 10 days before menstruation begins, and resolve within a few days of the onset of menses. While the symptoms of PMDD and premenstrual syndrome (PMS) are the same, women with PMDD experience five or more symptoms which are more severe. PMDD affects as many as 4.5 million women in the United States, and nearly 90 percent of these women remain undiagnosed and untreated. PMDD is also linked to higher healthcare costs related to more frequent visits to healthcare providers, decreased work productivity and absenteeism.

"For years, women overwhelmingly told us that they want more from their birth control pill than just reliable contraception," says Reinhard Franzen, President and CEO of Berlex. "Very high on their list of desired added benefits was the relief from the impact of menstrual symptoms. We knew that our innovative progestin, drospirenone, held promise due to its unique properties. We are very happy that we can now offer YAZ as an effective contraceptive, as well as a treatment for mood swings, bloating, and other symptoms of PMDD."

YAZ is the first birth control pill shown to treat the emotional and physical symptoms of PMDD. YAZ combines the innovative progestin drospirenone with 20 mcg of ethinyl estradiol in a 24-day active hormone pill regimen. Unlike other progestins, drospirenone has a mild diuretic effect (antimineralocorticoid property). Further, drospirenone has been shown to block the effects of male hormones in a woman's body (antiandrogenic property**). In addition, the 30-hour half life of drospirenone combined with the 24-day active hormone pill regimen result in less hormonal fluctuation during the menstrual cycle.

"Unlike other oral contraceptives, YAZ delivers the progestin, drospirenone, in combination with estrogen in a unique 24-day dosing regimen, both of which may account for its positive effect on PMDD," said Andrea Rapkin, M.D., Professor, Department of Obstetrics and Gynecology, David Geffen School of Medicine, UCLA. "For my PMDD patients who need a treatment to reduce their symptoms, as well as a safe and effective contraceptive to prevent pregnancy, YAZ is an important option that can meet both of their healthcare needs in a single pill."

PMDD Clinical Study Results

In a multicenter, double-blind, randomized, parallel clinical trial of 450 women aged 18-40 with symptoms of PMDD, YAZ was significantly superior to placebo in improving interpersonal relationships, work productivity and enjoyment of hobbies/social activities. Forty-eight percent of YAZ patients experienced a reduction in symptom severity by at least half, as measured by the Daily Record of Severity of Problems(1), a validated tool used to diagnose PMDD by tracking premenstrual symptoms and their severity on a daily basis.

In a separate multicenter, placebo-controlled, randomized, crossover, confirmatory trial, patients experienced twice the improvement in symptoms scores versus placebo.

YAZ was well tolerated by the majority of women in the clinical trials. Information About PMDD According to standard diagnostic criteria, five or more premenstrual symptoms must be present and severe enough to significantly interfere with a woman's life. At least one of the symptoms must be an emotional symptom such as mood swings, anger, irritability or tension. Physical symptoms of PMDD include breast tenderness, bloating and headache. Women with PMDD feel less interest in daily activities, have difficulty concentrating and may experience other symptoms such as food cravings.

About YAZ

As with YASMIN® (3 mg drospirenone/30 mcg ethinyl estradiol), YAZ contains the innovative progestin drospirenone. Drospirenone exhibits antimineralocorticoid and antiandrogenic** properties unlike any other progestin available in oral contraceptives. YAZ is available in the U.S. by prescription only.

The most common side effects were similar to other oral contraceptives and include upper respiratory infection, headache, breast pain, yeast infection (vaginal moniliasis), vaginal discharge (leukorrhea), diarrhea and nausea.

Important Information about YAZ

YAZ contains 3 mg of the progestin drospirenone that has antimineralocorticoid activity, including the potential for hyperkalemia in high-risk patients, comparable to a 25-mg dose of spironolactone. YAZ should not be used in patients with conditions that predispose to hyperkalemia (i.e., renal insufficiency, hepatic dysfunction, or adrenal insufficiency). Women receiving daily, long-term treatment for chronic conditions or diseases with medications that may increase serum potassium should have their serum potassium levels checked during the first treatment cycle. Medications that may increase serum potassium include ACE inhibitors, angiotensin-II receptor antagonists, potassium-sparing diuretics, potassium supplementation medications, aldosterone antagonists and NSAIDs.

OCs do not protect against HIV infection and other sexually transmitted diseases. The use of OCs is associated with increased risks of several serious side effects. Cigarette smoking increases the risk of serious cardiovascular side effects; women who take OCs are strongly advised not to smoke.

YAZ has been shown to be effective for the treatment of symptoms of PMDD but has not been evaluated for the treatment of premenstrual syndrome (PMS). The effectiveness of YAZ for the treatment of symptoms of PMDD has not been evaluated for more than three menstrual cycles in clinical trials.

Information for Consumers

Women who would like to learn more about YAZ should call the toll-free number 1-888-BERLEX-4 or visit http://www.yaz-us.com.

About Berlex

Berlex, a U.S. affiliate of Schering AG, Germany (FSE: SCH; NYSE: SHR), is committed to addressing unmet medical needs through research and development in the areas of oncology, gastroenterology, women's health diagnostics and neurology. Berlex also markets diagnostic imaging agents, innovative treatments in the areas of female healthcare and oncology, as well as specialized therapeutics for life-threatening and disabling diseases of the central nervous system and cardiovascular system. Berlex has business operations in New Jersey, California and Washington. For more information, please visit http://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 Berlex's plans and objectives to differ materially from those expressed or implied in the forward-looking statements. Berlex, Inc. 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.

* Source: Wolters Kluwer Health, Pharmaceutical Audit Suite, April 2006 - August 2006. Based on total monthly prescription counts from product launch in April 2006 to August 2006, compared to other branded oral contraceptives only. ** Antiandrogenic activity seen in preclinical studies. (1) Yonkers, K. et al. "Efficacy of a New Low-Dose Oral Contraceptive with Drospirenone in Premenstrual Dysphoric Disorder."

Source: Berlex, Inc.

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