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The company has also reported that the EMEA has validated the marketing authorization application (MAA) for nomegestrol acetate (2.5mg)/17 beta-estradiol (1.5mg), a combined oral contraceptive containing a unique combination of a natural estrogen identical to the estrogen produced by a woman's own body and a selective progestin.
According to Schering-Plough, mometasone furoate/formoterol fumarate combines mometasone furoate, the active ingredient of the inhaled corticosteroid, Asmanex, with formoterol fumarate, the active ingredient of the long-acting beta2-agonist, Foradil, 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.
Nomegestrol acetate/17 beta-estradiol is licensed from Theramex, SAM, an affiliate of Merck KGaA. 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 pharmaceuticals of Merck KGaA. In the US, Schering-Plough is working with the FDA and anticipates filing nomegestrol acetate/17 beta-estradiol in 2010.
Thomas Koestler, executive vice president and president of Schering-Plough Research Institute, said: "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."
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