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Merck (NYSE:MRK), known as MSD outside the United States and Canada, today announced the regulatory approval and launch of GRASTEK
® (Timothy grass pollen allergen extract) sublingual tablets in Canada. This represents the first approval of GRASTEK for Merck. The product is currently marketed by ALK-Abello in Europe as GRAZAX.
Merck previously announced that the U.S. Food and Drug Administration (FDA) had accepted for review Biologics License Applications for GRASTEK and for its investigational ragweed sublingual allergy immunotherapy tablet. Merck expects the FDA’s review for both to be completed in the first half of 2014.
Merck has partnered with ALK-Abello to develop its sublingual allergy immunotherapy tablets for Timothy grass pollen, ragweed pollen and house dust mite-induced allergic rhinitis in North America.
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This news release includes “forward-looking statements” within the meaning of the safe harbor provisions of the United States Private Securities Litigation Reform Act of 1995. These statements are based upon the current beliefs and expectations of Merck’s management and are subject to significant risks and uncertainties. There can be no guarantees with respect to pipeline products that the products will receive the necessary regulatory approvals or that they will prove to be commercially successful. If underlying assumptions prove inaccurate or risks or uncertainties materialize, actual results may differ materially from those set forth in the forward-looking statements.