MONTVILLE, N.J., Sept. 15 /PRNewswire-FirstCall/ -- Berlex, Inc., a U.S. affiliate of Schering AG, Germany , announced today that the U.S. Food and Drug Administration (FDA) issued an approvable letter for the novel hormone therapy ANGELIQ(R) (drospirenone and estradiol) tablets, pending the submission of additional manufacturing information. ANGELIQ is an oral therapy intended to help alleviate menopausal symptoms such as hot flashes and vaginal dryness, which often interrupt a woman's day-to-day functioning.
"In a market that now requires treatment to be highly individualized, we will be proud to provide women with a new option -- the first and only hormone therapy that combines estradiol with the novel progestin drospirenone," said Reinhard Franzen, President and CEO of Berlex Laboratories. "Now is the most important time for women to have a variety of options in managing the effects of menopause. We designed ANGELIQ to contain hormones that are as close as possible to the natural hormones a woman's body produces before menopause."
The Company will begin compiling the manufacturing data required by FDA immediately. "We are optimistic that we will obtain final approval for ANGELIQ in 2005," says Franzen.
Once available, ANGELIQ will contain 0.5 mg drospirenone and 1 mg estradiol.
"Given current hormone therapy prescribing recommendations to use the lowest effective dose to meet treatment goals, the 0.5 mg drospirenone dose of ANGELIQ will be an excellent choice for the treatment of menopausal symptoms," says Marie Foegh, MD, DSc, Vice President, Medical Affairs at Berlex Laboratories.
Since the 0.5 mg is the lowest effective dose of drospirenone studied in the ANGELIQ menopausal symptom trials, Berlex has agreed to withdraw the higher doses of drospirenone from the New Drug Application, without prejudice, for ANGELIQ pending completion of studies investigating its potential blood pressure lowering effects.
Committed to addressing unmet medical needs, Berlex, a U.S. affiliate of Schering AG, Germany , develops and markets diagnostic imaging agents, treatments in the areas of female health care 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 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.
Berlex, Inc.
"In a market that now requires treatment to be highly individualized, we will be proud to provide women with a new option -- the first and only hormone therapy that combines estradiol with the novel progestin drospirenone," said Reinhard Franzen, President and CEO of Berlex Laboratories. "Now is the most important time for women to have a variety of options in managing the effects of menopause. We designed ANGELIQ to contain hormones that are as close as possible to the natural hormones a woman's body produces before menopause."
The Company will begin compiling the manufacturing data required by FDA immediately. "We are optimistic that we will obtain final approval for ANGELIQ in 2005," says Franzen.
Once available, ANGELIQ will contain 0.5 mg drospirenone and 1 mg estradiol.
"Given current hormone therapy prescribing recommendations to use the lowest effective dose to meet treatment goals, the 0.5 mg drospirenone dose of ANGELIQ will be an excellent choice for the treatment of menopausal symptoms," says Marie Foegh, MD, DSc, Vice President, Medical Affairs at Berlex Laboratories.
Since the 0.5 mg is the lowest effective dose of drospirenone studied in the ANGELIQ menopausal symptom trials, Berlex has agreed to withdraw the higher doses of drospirenone from the New Drug Application, without prejudice, for ANGELIQ pending completion of studies investigating its potential blood pressure lowering effects.
Committed to addressing unmet medical needs, Berlex, a U.S. affiliate of Schering AG, Germany , develops and markets diagnostic imaging agents, treatments in the areas of female health care 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 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.
Berlex, Inc.
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