Bukwang Pharmaceutical Co., Ltd. (“Bukwang”) announced today that the company has concluded an exclusive license agreement with Sumitomo Dainippon Pharma Co., Ltd. (“Sumitomo Dainippon Pharma”) relating to development, marketing, sales and distribution of lurasidone HCI (“lurasidone”) in Korea, for the treatment of schizophrenia and depressive episodes associated with bipolar I disorder (bipolar depression) both as monotherapy and as adjunctive therapy with lithium or valproate. Lurasidone is an atypical antipsychotic agent originally created by Sumitomo Dainippon Pharma, characterized by a unique chemical structure and an affinity for dopamine D2, serotonin 5-HT2A and serotonin 5-HT7 receptors where it has antagonist effects. In addition, lurasidone is a partial agonist at the serotonin 5-HT1A receptor and has no appreciable affinity for histamine H1 or muscarinic M1 receptors. Lurasidone is approved in the U.S. and Canada for the treatment of adult and adolescent (only in the U.S.) patients with schizophrenia, and for the treatment of adult patients with depressive episodes associated with bipolar l disorder (bipolar depression) as monotherapy or as adjunctive therapy with lithium or valproate. Lurasidone is approved for the treatment of adult patients with schizophrenia in the EU, Switzerland, Australia, Taiwan, Russia, Singapore, Thailand and Hong Kong. It is a blockbuster product with revenue over 1 billion USD from April 2015 to March 2016, and revenue over 0.9 billion USD in the following 9 months from April to December 2016, in the North America market. As Bukwang licensed this product in, it expects to strengthen its CNS product portfolio and to significantly increase the sales. Bukwang will conduct (and thus is planning to submit an IND in the near future) bridging clinical studies to obtain approvals of lurasidone in Korea. Following the in-licensing of LONASEN® (blonanserin) from Sumitomo Dainippon Pharma in 2005, Bukwang will establish a stronger relationship with its partner, Sumitomo Dainippon Pharma by lurasidone in-licensing. An officer of Bukwang revealed, “In the antipsychotic area which is a wasteland of new drugs in Korea since 2009, we are very pleased to make lurasidone, a product that is already approved in multiple countries and regions including the U.S. and Europe, available for Korean patients. Bukwang expects to closely work together with Sumitomo Dainippon Pharma to launch lurasidone and maximize the product value for Korean patients.
About Sumitomo Dainippon Pharma.
Sumitomo Dainippon Pharma is among the top-ten listed pharmaceutical companies in Japan operating globally in major pharmaceutical markets, including Japan, the United States, China and the European Union. Sumitomo Dainippon Pharma aims to create innovative pharmaceutical products in the Psychiatry & Neurology area and the Oncology area, which have been designated as the focus therapeutic areas. Sumitomo Dainippon Pharma is based on the merger in 2005 between Dainippon Pharmaceutical Co., Ltd., and Sumitomo Pharmaceuticals Co., Ltd. Today, Sumitomo Dainippon Pharma has about 6,500 employees worldwide. Additional information about Sumitomo Dainippon Pharma is available through its corporate website at http://www.ds-pharma.com/.