Concert Pharmaceuticals has achieved a $2 million milestone under its development and license agreement with Avanir Pharmaceuticals, Inc. for the progression of the clinical development of AVP-786. The milestone is a result of Avanir initiating dosing of patients in a Phase 3 clinical trial with AVP-786 for the treatment of agitation in patients with Alzheimer’s disease.
“We are very pleased that AVP-786 has advanced to Phase 3 clinical evaluation,” said Roger Tung, Ph.D., President and CEO of Concert Pharmaceuticals. “Agitation associated with Alzheimer’s disease is an important unmet medical need, with no currently-approved treatments, that affects up to half of the 5.3 million patients in the U.S. and their caregivers. We look forward to the continued progress of AVP-786 in this indication.”
The collaboration agreement between Concert and Avanir provides Avanir with worldwide rights to develop and commercialize AVP-786 and other deuterium-modified dextromethorphan (d-DM) compounds. Under the agreement, Concert is eligible to receive additional milestone payments based upon achievement of certain predefined regulatory and commercial targets. Avanir will continue to have overall responsibility for research, development and commercialization of d-DM compounds, including AVP-786, and Concert is eligible to receive tiered royalties on worldwide sales of any products containing d-DM. The milestone announced today is the third development milestone Concert has earned under this agreement.
Avanir is a subsidiary of Otsuka America, Inc. (OAI), a holding company established in the U.S. in 1989. OAI is wholly owned by Otsuka Pharmaceutical Co., Ltd.