Bukwang initiates phase 3 study with lurasidone HCl for patients with Schizophrenia


Bukwang Pharmaceutical Co., Ltd. (“Bukwang”) announced on April 9, 2018 that it has randomized the first subject into the treatment arm of a phase 3 clinical trial evaluating lurasidone HCl, in-licensed from Sumitomo Dainippon Pharma Co., Ltd. (“Sumitomo Dainippon Pharma”), for the treatment of adult schizophrenia.

The initiation of this phase 3 study was approved by MFDS last year and is expected to be completed in the first half of 2019, with the final report to be finished in the second half of 2019.

Lurasidone is approved in the U.S. for the treatment of adults and pediatric patients (10 to 17 years of age) with bipolar depression as monotherapy and adjunctive therapy with lithium or valproate, and for the treatment of adolescents (13 to 17 years of age) and adults with schizophrenia. In Canada lurasidone is approved for the management of the manifestations of schizophrenia in adults and adolescents (15 to 17 years of age) and the acute management of depressive episodes associated with bipolar I disorder in adults. Lurasidone is also approved for the treatment of adult patients with schizophrenia in the EU, Switzerland, Australia, Taiwan, Russia, Singapore, Thailand, Hong Kong, Brazil and UAE.

Bukwang commented that Latuda is a blockbuster product with revenue over 1.5 billion USD in 2017 in the North America market.

Lurasidone is an atypical antipsychotic agent developed originally by Sumitomo Dainippon Pharma, and is 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.

As Bukwang licensed this excellent product in, it expects to strengthen its CNS product portfolio and to achieve the significant sales as tens of billions of won.


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