Otsuka Pharamaceutical Co., Ltd.

November 12, 2019

Otsuka Pharmaceutical and Avanir Pharmaceuticals to Continue Clinical Development of
Investigational AVP-786 for the Treatment of Agitation in Patients with Alzheimer's Dementia

Otsuka Pharmaceutical Co., Ltd. and its U.S.-based, indirect subsidiary Avanir Pharmaceuticals, Inc. announce that they have decided to continue the clinical development program of AVP-786 (a combination of deudextromethorphan hydrobromide and quinidine sulfate) for the treatment of agitation in patients with Alzheimer's dementia.

The decision is based on insights derived from detailed analysis of data from the first and the second phase 3 AVP-786 clinical trials.*

The ongoing third phase 3 clinical trial (17-AVP-786-305) will be continued, and additional phase 3 trial activity will be started in the 2020.

* Preliminary results of the first and the second phase 3 clinical trials (15-AVP-786-301 and 15-AVP-786-302) were released March 25 and September 27, 2019, respectively.