Kyowa to exclusively market Quetiapine Fumarate extended-release tablets in Japan
Lupin’s Japanese subsidiary Kyowa Pharmaceutical Industry and Astellas Pharma have entered into an agreement providing Kyowa the exclusive right to distribute and promote extended-release tablets of quetiapine fumarate in Japan. Astellas submitted a new drug application (NDA) with the Ministry of Health, Labour and Welfare in Japan for extended-release tablets of quetiapine fumarate for the indication of improvement of depressive symptoms associated with bipolar disorder.
When Astellas obtains an approval for the new drug application of extended-release tablets of quetiapine fumarate, based on the agreement, Kyowa will exclusively distribute and promote the products in Japan.
Dr Fabrice Egros, President – Asia Pacific & Japan, Lupin commented, “Following Kyowa’s recent acquisition of long-listed products from Shionogi & Co, Ltd, the Astellas agreement reinforces Kyowa’s transition toward a hybrid pharma speciality care company and bolsters its leadership in the CNS space in Japan. Post regulatory approval for the product, we hope to bring to market a new solution for the treatment of depressive symptoms associated with bipolar disorder addressing unmet need for patients as well as provide additional treatment option for health care professionals in Japan.”