Yesterday, Schering-Plough Corp. (SGP) revealed that the European Medicines Agency (EMA) will review its candidate for maintenance treatment of asthma in patients 12 years and above and an oral contraceptive for marketing in Europe.
While the fixed-dose combination of mometasone furoate and formoterol fumarate for the maintenance treatment of asthma in patients 12 years and above is currently under review by the U.S. Food and Drug Administration (FDA), the filing for FDA approval of the contraceptive is expected in 2010.
The oral contraceptive is a combination of a natural estrogen (which is identical to the estrogen produced by a woman’s body) and a selective progestin. The drug was licensed from Merck KGaA. Schering is seeking marketing approval in Europe for the combination to prevent pregnancy.
The approval of the combination of mometasone furoate and formoterol fumarate would further consolidate the company’s respiratory portfolio.
Asthma, a chronic lung disease characterized by inflammation of the air passages, affects 30 million people in Europe and 300 million people globally. The indication is likely to affect an additional 100 million people by 2025.
Schering-Plough is currently gearing up for its proposed merger with Merck & Co., Inc. (MRK). The $41.1 billion deal is expected to close in the fourth quarter of this year. The combined company will have a more diverse portfolio across important therapeutic areas, including cardiovascular, respiratory, oncology, neuroscience, infectious disease, immunology, women’s health and other areas.
Top-selling products of both the companies will come under one roof following the merger. The merger should enable the combined entity to become one of the top five drug makers in the world.
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