Tokyo, Japan, August 4, 2009 - AstraZeneca K.K., the Japanese subsidiary of AstraZeneca PLC and Astellas Pharma Inc. (“Astellas”) today announced that AstraZeneca AB (“AstraZeneca”) and Astellas have concluded an agreement (“Agreement”) for the co-promotion alliance on the inhalant combination drug of budesonide and formoterol (generic names) for the treatment of bronchial asthma (“the Product”) in Japan.
Pursuant to the Agreement, while AstraZeneca K.K. will manufacture and develop, and Astellas will distribute and sell the Product, AstraZeneca K.K. and Astellas will jointly carry out promotion of the Product (co-promotion).
Based upon the Agreement, Astellas will make an upfront payment of ¥3.0 billion to AstraZeneca in addition to milestone payments of up to ¥5.5 billion depending on the achievement of certain sales and approval of an additional indication by the Japanese authority.
The Product is an inhaled twice-daily treatment for asthma. It combines an inhaled corticosteroid budesonide and a rapid and long-acting β2 agonist formoterol within a single inhalation device. It has been approved in over 100 countries and regions since it was approved in Europe in 2000 under the brand name Symbicort®. In Japan, an NDA has been submitted for the treatment of bronchial asthma as a target indication. Development is also underway for future indications for chronic obstructive pulmonary disease (COPD) for the Product.
Bronchial asthma is characterized by bronchial inflammation and narrowing of the respiratory tract, and those patients suffering from it experience symptoms such as breathing difficulties. In Japan, the number of patients is estimated to total approximately 5 million, and approximately 2,500 patients die annually due to this disease, and this mortality is one of the highest among advanced countries.
AstraZeneca K.K. and Astellas are committed to maximizing the value of the Product and making further contribution to the treatment of bronchial asthma through close cooperation between the companies.