European Medicines Agency validates Schering-Plough's MAA for nomegestrol acetate/17 beta-estradiol

Aug 27 2009

Schering-Plough Corporation, (NYSE: SGP), today announced that the European Medicines Agency (EMEA) has validated (accepted for review) the company's Marketing Authorization Application (MAA) for a fixed-dose combination of mometasone furoate and formoterol fumarate for the maintenance treatment of asthma in patients 12 years of age and older. The company also announced today that the EMEA has validated the MAA for nomegestrol acetate (2.5 mg) / 17 beta-estradiol (1.5mg), a combined oral contraceptive (COC) containing a unique combination of a natural estrogen identical to the estrogen produced by a woman's own body and a selective progestin.

Mometasone furoate/formoterol fumarate combines mometasone furoate, the active ingredient of the inhaled corticosteroid, ASMANEX(R), with formoterol fumarate, the active ingredient of the long-acting beta2-agonist, FORADIL(R), administered via a single metered-dose inhaler.

Marketing approval from the EMEA is being sought for nomegestrol acetate/17 beta-estradiol as an oral treatment for women to prevent pregnancy.

Both applications will follow the Centralized Procedure.

"These two regulatory milestones are important steps toward advancing our late-stage pipeline and meeting patient needs. If approved by the EMEA, the mometasone furoate/formoterol fumarate combination would represent an important additional treatment option for physicians and their patients and further strengthen Schering-Plough's portfolio of respiratory products," said Thomas P. Koestler, Ph.D., executive vice president and president, Schering-Plough Research Institute. "Schering-Plough is also committed to providing women a variety of birth control options to meet diverse lifestyle needs and choices."

About the Investigational Mometasone Furoate and Formoterol Fumarate Combination

Schering-Plough has exclusive worldwide rights for the development and commercialization of the mometasone furoate and formoterol fumarate fixed-dose combination. In the United States, a New Drug Application (NDA) for the fixed-dose combination of mometasone furoate and formoterol fumarate for the maintenance treatment of asthma in patients 12 years of age and older is currently under review by the U.S. Food and Drug Administration (FDA).

Combination products containing inhaled corticosteroids and long-acting beta2-agonists are the largest segment of the worldwide market for asthma and chronic obstructive pulmonary disease (COPD) medications, in terms of dollar sales.(1) The fixed-dose combination of mometasone furoate and formoterol fumarate for the treatment of asthma in patients younger than 12 years of age and for use in COPD is currently in Phase III development.

About Nomegestrol Acetate/17 beta-estradiol

Nomegestrol acetate/17 beta-estradiol is a combined oral contraceptive in a monophasic dosing regimen. The progestin (nomegestrol acetate) is derived from, and structurally similar to, the naturally occurring steroid hormone progesterone, while 17 beta-estradiol, a natural estrogen is identical to the endogenous estrogen a woman's body produces on its own. If approved, this unique monophasic combination of a progestin and natural estrogen can offer women effective pregnancy prevention.

In clinical trials with nomegestrol acetate/17 beta-estradiol, commonly reported in-treatment adverse events included acne, weight increase, headache and irregular withdrawal bleeding.

Nomegestrol acetate/17 beta-estradiol is licensed from Theramex, S.A.M., an affiliate of Merck KGaA, Darmstadt, Germany. Theramex has retained rights for marketing and distribution of the product in certain countries. In Europe, the filing was made by Merck Serono, the division for innovative pharmaceuticals of Merck KGaA, Darmstadt, Germany. In the U.S., Schering-Plough is working with the FDA and anticipates filing nomegestrol acetate/17 beta-estradiol in 2010.