Mitsubishi Tanabe Pharma : Launch of Rupafin tablets in Japan ―Allergy treatment agent with new mechanism of action shows strong effectiveness with dual action (anti-PAF and antihistamine action)

November 22, 2017

Press release

Teikoku Seiyaku Co., Ltd. Mitsubishi Tanabe Pharma Corporation

Allergy treatment agent with new mechanism of action shows

strong effectiveness with dual action (anti-PAF and antihistamine action)

Teikoku Seiyaku Co., Ltd. (Head Office: Higashikagawa City, Kagawa; President and CEO: Misako Fujioka) and Mitsubishi Tanabe Pharma Corporation (Head

Office: Osaka City; President and Representative Director: Masayuki Mitsuka) have

announced today that the both companies would launch Rupafin® tablets (generic name: rupatadine fumarate) in Japan on November 27, 2017, following today's inclusion of Rupafin® in the National Health Insurance drug price list.

This oral allergy treatment agent has a new mechanism of action. In addition to antihistamine action, Rupafin® tablets also have anti-PAF (platelet activating factor) action. Histamine is widely known as a chemical mediator that brings about allergic reactions. PAF induces vasodilation, vascular permeability enhancement, vascular nerve stimulation, and white blood cell activation. As a result, it brings about such symptoms as sneezing, runny nose, and nasal congestion, and it is closely involved in the pathology of allergic disorders.

Rupafin® tablets control these two chemical mediators and show strong dual action (anti-PAF and antihistamine), thereby controlling the symptoms of allergic disorders.

This drug was discovered by J. Uriach Y COMPANIA, S.A., of Spain, and had been

approved in more than 80 countries around the world as of November 2017. Overseas, it has indications of allergic rhinitis and urticaria and is administered orally at a dosage of 10mg once a day. In Japan, in May 2014 Teikoku Seiyaku concluded a development and sales licensing agreement with J. Uriach Y COMPANIA, and Teikoku Seiyaku has advanced development on its own.

In October 2016, Teikoku Seiyaku and Mitsubishi Tanabe Pharma reached a basic agreement for sales of Rupafin® tablets. Teikoku Seiyaku will supply the product to Mitsubishi Tanabe Pharma, which will distribute and market it. In addition, the two companies will jointly implement information provision activities for medical institutions.