Merck announces results from AIT Phase III clinical study for ragweed allergy

Merck (NYSE: MRK), known as MSD outside the United States and Canada, today announced the results from a Phase III clinical study of its investigational allergy immunotherapy tablet (AIT) for ragweed pollen. The study results showed that the use of ragweed AIT significantly reduced the total combined score that measured nasal and eye symptoms and use of rescue allergy medicines, compared to placebo, in ragweed-allergic adults with or without asthma. The study was conducted during peak ragweed pollen season. These data were presented at the American Academy of Allergy, Asthma & Immunology (AAAAI) Annual Meeting in Orlando.

Merck's AIT is an investigational, dissolvable oral tablet designed to treat the underlying cause of allergies, and is being studied to determine whether AIT may help to prevent allergy symptoms by generating an immune response to protect against targeted allergens. The company is investigating disease-modifying AITs for the treatment of allergies caused by ragweed pollen, grass pollen and house dust mites. Merck has partnered with ALK-Abello to develop AITs to treat these allergens in North America and plans to file New Drug Applications (NDAs) for its ragweed and grass AITs with the U.S. Food and Drug Administration (FDA) in 2013.

"Merck is pleased that patients who took its AIT in this study experienced a significant reduction in the nasal and eye symptoms caused by ragweed allergies, and these positive results are an important step in the development of this investigational therapy," said Rupert Vessey, M.D., Ph.D, senior vice president and franchise head, Respiratory & Immunology, Merck Research Laboratories. "We are committed to providing physicians and patients with a broad range of treatment options for allergies and other respiratory diseases."

Additional results from this Phase III study will be presented at the AAAAI meeting in an oral presentation titled, "Ragweed Allergy Immunotherapy Tablet Reduces Nasal and Ocular Symptoms of Allergic Rhinoconjunctivitis Over the Peak Ragweed Pollen Season in North America" on March 6, 2012, 2 p.m. EST. A second, pivotal Phase III study of similar design with ragweed AIT in 784 patients was also presented at AAAAI.



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