FDA approves Grastek

FDA approved a BLA for Grastek, a grass pollen sublingual allergy immunotherapy tablet (AIT) from Merck & Co. Inc. (NYSE:MRK) to treat grass pollen-induced allergic rhinitis, with or without conjunctivitis. The pharma plans to launch Grastek in the U.S. late this month. Merck has exclusive North American rights to develop and commercialize the product from ALK-Abello A/S (CSE:ALK-B), which markets it as Grazax in Europe. The U.S. approval triggers a milestone payment to ALK-Abello from Merck, but the companies could not be reached for details. Under a 2007 deal, ALK-Abello is eligible for up to DKK1.6 billion ($294.9 million) in milestones from Merck for a portfolio of AITs, including Grastek. ...