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Alk Abello A/S's Partner Merck & Co Inc Reaches Primary Endpoint in Phase III Trial with Grass Allergy Immunotherapy Tablet; Alk Abello Confirms FY 2015 Financial Guidance

Tuesday, 23 Oct 2012 08:06am EDT 

Alk Abello A/S announced that a Phase III clinical trial of its investigational sublingual grass allergy immunotherapy tablet (AIT), conducted by Alk Abello's strategic partner, Merck & Co Inc, has met primary efficacy endpoint. Known as GRAZAX in Europe, the product has been licensed by ALK to Merck for North America. Merck initiated the trial in 2011 to evaluate the efficacy and safety of grass AIT versus placebo in the treatment of grass pollen induced allergic rhinoconjunctivitis (hay fever). The primary endpoint was the combined rhinoconjunctivitis daily symptom score (DSS) and rhinoconjunctivitis daily medication score (DMS) during the grass pollen season. The trial included approximately 1,500 patients. The study was designed to form a pivotal part of the submission package for Merck's filing of a registration application for grass AIT with the United States. Food and Drug Administration (FDA). Merck has informed ALK that the new data supports and confirms the planned filing of the registration application with the FDA in 2013. Alk Abello also announced that this not change the Company's fiscal year 2015 financial outlook. The Company still expects to report fiscal year 2015 revenue of DKK 3 billion and fiscal year 2015 operating profit (EBITDA) of 25% of revenue. 

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