Healthcare Industry News:  Bayer HealthCare Pharmaceuticals 

Biopharmaceuticals Dermatology

 News Release - May 7, 2007

Bayer HealthCare and Intendis Announce Strategic Alliance to Co-Promote Yaz(R) (Drospirenone/Ethinyl Estradiol) for Treatment of Moderate Acne

Alliance Announced as Yaz Acne Clinical Trial Data Presented at 55th Annual Clinical Meeting of the American College of Obstetricians and Gynecologists (ACOG)

WAYNE and MONTVILLE, N.J., May 7 (HSMN NewsFeed) -- Bayer HealthCare Pharmaceuticals Inc., a U.S.-based pharmaceuticals unit of Bayer HealthCare, and Intendis Inc., a U.S.-based affiliate of Bayer Schering Pharma AG, Germany, announced today that they will jointly promote YAZ® (drospirenone/ethinyl estradiol) as a treatment for moderate acne in women who desire an oral contraceptive for birth control. The agreement came into effect on May 1, as part of an overall strategy to introduce dermatologists to the anti-acne benefits of YAZ.

Investigators will present new clinical data demonstrating the efficacy of YAZ in the treatment of moderate acne at the American College of Obstetricians and Gynecologists Annual Clinical Meeting (ACOG) in San Diego. YAZ is the only oral contraceptive approved for the treatment of premenstrual dysphoric disorder (PMDD) in women who desire an oral contraceptive for birth control. PMDD is a condition in which women's premenstrual symptoms are severe enough to impact activities, work or relationships. In January, 2007, YAZ received FDA approval as a treatment for moderate acne in women who desire an oral contraceptive for birth control.

"Ob/gyns and now, dermatologists and their patients, are looking for contraceptive methods that go beyond birth control. YAZ is an ideal example of a treatment offering multiple benefits to more effectively meet women's needs," said Stefan Oelrich, Vice President of Women's Healthcare, Bayer HealthCare Pharmaceuticals. "This alliance combines the strengths of two Bayer businesses --- Bayer HealthCare Pharmaceutical's leadership in women's health and Intendis' established dermatology franchise -- to support an important milestone in the lifecycle of YAZ."

"Through this alliance, we hope to effectively engage dermatologists so that they can, in turn, have more informed conversations with their patients looking for a reduction of their acne and the benefits of a reliable contraceptive," said Bernhard Schefter, President and CEO of Intendis Inc. "Our proven track record in successfully marketing dermatologic products through a dedicated dermatology sales team, paired with the innovation that YAZ brings to the market, make this a win-win for both organizations."

New Data Reinforce Efficacy, Tolerability and Safety of Yaz for Acne

At this week's ACOG Annual Clinical Meeting, lead study investigator J. Michael Maloney, M.D., FAAD, will present, for the first time, results of two six-month trials examining the use of YAZ in treating moderate acne. The multicenter, double blind, placebo-controlled, randomized trials involve more than 1,000 women.

"The unique antiandrogenic property of drospirenone, found in YAZ, creates a functional blockage of male sex hormones that can be a cause of acne," said Dr. Maloney. "This factor, combined with a longer 24-day active pill cycle, allows for continuous presence of drospirenone throughout the cycle, thereby effectively treating moderate acne that often occurs just prior to or during, a woman's menstrual cycle."

These Trials Include:
  1. "Drospirenone 3mg/Ethinylestradiol 20 mcg COC In the Treatment of Acne Vulgaris: Lesion Count, ISGA" (This poster to be presented Monday, May 7th from 10:30am-5:00pm at the San Diego Convention Center Exhibit Hall {author will be present at Q&A session from 3:00pm-4:00pm})

  2. "Drospirenone 3mg/Ethinylestradiol 20 mcg COC In the Treatment of Acne Vulgaris: Patient Self-Assessment" (This poster to be presented Wednesday, May 9th from 10:30am-2:30pm at the San Diego Convention Center Exhibit Hall {author will be present at Q&A session from 10:30am-11:30am})
About YAZ:

YAZ is the first and only oral contraceptive ever approved by the FDA for three distinct indications, including: prevention of pregnancy, treatment of the emotional and physical symptoms of premenstrual dysphoric disorder (PMDD) in women seeking contraception and the treatment of moderate acne vulagris in women in women seeking contraception. Women who would like to learn more about YAZ should call the toll-free number 1-888-84-BAYER or visit http://www.yaz-us.com. For more information on PMDD, visit http://www.understandpmdd.com

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-ll 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 including venous and arterial thrombotic and thromboembolic events. Cigarette smoking increases the risk of serious cardiovascular side effects; women, particularly those 35 and older, who take OCs are strongly advised not to smoke.

About Bayer HealthCare Pharmaceuticals Inc.

Bayer HealthCare Pharmaceuticals Inc. is the U.S.-based pharmaceuticals unit of Bayer HealthCare LLC, a division of Bayer AG. One of the world's leading, innovative companies in the healthcare and medical products industry, Bayer HealthCare combines the global activities of the Animal Health, Consumer Care, Diabetes Care, and Pharmaceuticals divisions. In the United States, Bayer HealthCare Pharmaceuticals comprises the following business units: Women's Healthcare, Diagnostic Imaging, Specialized Therapeutics, Hematology/Cardiology and Oncology. The company's aim is to discover and manufacture products that will help improve human health worldwide by diagnosing, preventing and treating diseases.

About Intendis

Intendis is a dynamic fast growing specialist business of Bayer Schering Pharma AG, Germany -- dedicated to dermatology. Intendis is focused on the development, manufacturing and global marketing of high quality, innovative topical and systemic therapies, targeted to treat skin disorders. Intendis' objective is to become a leading partner in the field of dermatology. Intendis Inc., is an U.S.-based affiliate of Bayer Schering Pharma AG, Germany.


Source: Bayer HealthCare

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