Japanese approval for AstraZeneca/Astellas' Symbicort; AZ fined $115 million in USA

Anglo-Swedish drug major AstraZeneca's Symbicort Turbuhaler (budesonide/formoterol) has been approved by Japan's Ministry of Health, Labor and Welfare (MHLW) for the maintenance treatment of bronchial asthma in patients aged 16 and over when a combination therapy of an inhaled steroid and a long-acting beta-2 agonist is necessary.

AstraZeneca and Japanese drug major Astellas Pharma signed an agreement to co-promote Symbicort Turbuhaler in August 2009. The product will be manufactured and developed by AstraZeneca and distributed and sold by Astellas, while promotion will be jointly carried out by both companies. Under the terms of that deal, Astellas will make an upfront payment of 3 billion yen ($31.5 million) to AstraZeneca in addition to milestone payments of up to 5.5 billion yen depending on the achievement of certain sales and approval of an additional indication by the Japanese authority. Symbicort generated worldwide sales of $1.07 billion in the first half of 2009.

'The approval of Symbicort Turbuhaler in Japan will provide patients and physicians with a new treatment option for the approximately five million adults living with asthma in Japan,' said Bruno Angelici, executive vice president for international sales and marketing at AstraZeneca.