Healthcare Industry News: Berlex Laboratories
News Release - March 17, 2006
FDA Approves YAZ(R), the First Oral Contraceptive to Offer Drospirenone in a 24-Day, Active-Pill RegimenWAYNE, N.J., March 17 (HSMN NewsFeed) -- 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), a new monophasic oral contraceptive (OC) and the first pill to combine 20 mcg of ethinyl estradiol with the innovative progestin drospirenone (drsp). The 24-day, active hormone pill regimen of YAZ results in less hormonal fluctuation than traditional OCs that provide 21 days of active pills. YAZ will be available in the U.S. by prescription in April, 2006.
"YAZ represents a clear advancement in oral contraception, and underscores the Berlex commitment to provide novel and innovative options in birth control to allow for individual choice," said Reinhard Franzen, President and CEO of Berlex Laboratories. "We are continuing our dialogue with the FDA in order to take YAZ even further by bringing women the first oral contraceptive for the treatment of the emotional and physical symptoms of premenstrual dysphoric disorder, or PMDD."
As with YASMIN®, the number one brand of birth control in the United States and worldwide, YAZ contains the innovative progestin drospirenone, a spironolactone analogue with antimineralocorticoid properties. The 24-day active hormone pill regimen of YAZ combined with the 30-hour half life of drospirenone results in less hormonal fluctuation between cycles, compared to traditional oral contraceptives with 21 days of active pills and seven days of placebo. Preclinical studies indicate that drospirenone also provides an antiandrogenic effect, which means that it counteracts the effects of male hormones in the body.
Oral contraceptives have evolved dramatically since their introduction in the 1960s. The traditional dosing regimen, which includes 21 days of active pills and seven days of placebo, was an attempt to simulate the natural menstrual cycle. A longer (seven day) placebo interval was used at the time to help counteract higher estrogen-dose oral contraceptives and enable monthly withdrawal bleeding. Today's birth control pills now have appreciably lower estrogen doses, thus allowing for shorter pill-free intervals. In addition to lower estrogen doses, a variety of progestins have been introduced, and the regimens have been altered to provide women with dosing schedules that may better fit their needs. In YAZ, each of these advancements are available in one product.
Data Demonstrate Safety, Efficacy and Tolerability
A large clinical trial involving 1,027 women, who completed 11,480 treatment cycles, established the safety of YAZ and demonstrated 99 percent contraceptive efficacy. The clinical trial also found that YAZ provides women with predictable monthly withdrawal bleeding (periods), with breakthrough bleeding rates comparable to other low dose oral contraceptives. Only 0.7 percent (7 out of 1,027) of women participating in the clinical trial discontinued YAZ because of irregular bleeding.
YAZ was well tolerated by the majority of women in the clinical trial. The most common side effects were similar to other OCs and include upper respiratory infection, headache, breast pain, vaginal moniliasis (yeast infection), leukorrhea (vaginal discharge), 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-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. Cigarette smoking increases the risk of serious cardiovascular side effects; women who take OCs are strongly advised not to smoke.
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.berlex.com.
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 health care 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 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.
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