NEW DELHI, Feb 27: Drug major Lupin Ltd today said its Japanese subsidiary Kyowa Pharmaceutical Industry Co Ltd has entered into an agreement with Astellas Pharma Inc for exclusive right to distribute and promote extended-release tablets of quetiapine fumarate in Japan.
In a BSE filing, Lupin said “its Japanese subsidiary Kyowa Pharmaceutical Industry Co, Ltd and Astellas Pharma Inc have entered into an agreement providing Kyowa the exclusive right to distribute and promote extended-release tablets of quetiapine fumarate in Japan”.
It further said: “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,” it added.
Lupin President – Asia Pacific & Japan Dr. Fabrice Egros said the Astellas agreement reinforces Kyowa’s transition toward a hybrid pharmaceutical specialty 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,” he added.