Torii reports more Japanese data for dust mite immunotherapy
Torii Pharmaceutical Co. Ltd. (Tokyo:4551) said TO-203 missed the primary endpoint of reducing the risk of moderate to severe asthma exacerbations vs. placebo in a Japanese Phase II/III trial to treat house dust mite-induced allergic asthma. In March, Torii said TO-203 met the primary endpoint of reducing Total Combined Rhinitis Score (TCRS) vs. placebo in a separate Japanese Phase II/III trial to treat dust mite-induced allergic rhinitis. Based on the data, Torii said it plans to submit an NDA in Japan for TO-203 for the rhinitis indication. The pharma previously said results from both trials would determine plans for the Japanese NDA. ALK-Abello A/S (CSE:ALK-B) said Torii plans to submit the application in the next six to 10 months.
Torii has exclusive Japanese rights to TO-203 from ALK-Abello, which plans to submit a regulatory application for the product under the name Mitizax in the EU next half. Merck & Co. Inc. (NYSE:MRK) has exclusive North American rights, where the tablet-based sublingual allergen immunotherapy is known as MK-8237. ...