Recently, Merck (MRK) presented positive data from two phase III trials of a combination of mometasone furoate and formoterol fumarate at the American Academy of Allergy, Asthma & Immunology (AAAAI) annual meeting. A New Drug Application (NDA) for the combination is currently under review by the US Food and Drug Administration (FDA). The company has also submitted a Marketing Authorization Application (MAA) to the European Medicines Agency.

The investigational drug combines the active ingredient of an inhaled corticosteroid, Asmanex Twisthaler (mometasone furoate inhalation powder) with a long-acting beta2-agonist (LABA), Foradil Aerolizer (formoterol fumarate inhalation powder) to be administered through a single metered-dose inhaler (MDI).

The study assessed the efficacy and safety of the combination drug in two dosages (100 and 10 mcg) to be administered twice daily in patients above 12 years of age. Asthma patients numbering 746, who were treated earlier with a low dose of inhaled corticosteroids with or without LABA, were randomized to a 26-week study.

It was observed that compared with formoterol and mometasone furoate alone, the combination drug improved lung function significantly. Similar results were observed in the second study as well where the asthma patients selected were treated with a medium dose of inhaled corticosteroids with or without LABA.

The safety issue of LABA has been an area of concern for quite some time. However, in February this year, the FDA announced that the benefits of LABA in treating asthma symptoms outweigh the potential risks when used with an asthma controller medication in patients who need the addition of LABA.

At the AAAAI meeting, Merck also presented data from a late stage trial of sublingual grass (Phleum pratense) allergy immunotherapy tablet (AIT) in 345 children of 5?17 years of age who have grass pollen allergic rhinoconjunctivitis. It was observed that the drug improved allergy symptoms by 26% compared to placebo.

Recently, Merck updated its pipeline status following its merger with Schering-Plough. The pipeline consists of a broad and diversified portfolio of drugs and vaccines with more than 20 candidates in phase III or under regulatory review and more than 20 candidates in phase II stages of development. The company is aiming to strengthen its pipeline since many of its best selling drugs are slated to lose patent exclusivity in the next few years. We have a “Neutral” recommendation on the stock.

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