Concert Pharmaceuticals, Inc. Achieves $2 Million Milestone From AVANIR Pharmaceuticals For Phase III Initiation Of AVP-786 For Agitation In Patients With Alzheimer’s Disease

LEXINGTON, Mass.--(BUSINESS WIRE)--Concert Pharmaceuticals, Inc. (NASDAQ:CNCE) today announced that it 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.

“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.”

“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., a global healthcare company with the corporate philosophy: ‘Otsuka-people creating new products for better health worldwide.’

About AVP-786

AVP-786 is a novel, next-generation investigational drug product consisting of a combination of deuterated (d6)-dextromethorphan (an uncompetitive NMDA receptor antagonist, sigma-1 receptor agonist and inhibitor of the serotonin (SERT) and norepinephrine (NET) transporters), and an ultra-low dose quinidine. Incorporation of deuterium into the dextromethorphan molecule has been shown to reduce first pass liver metabolism. By having a lower rate of metabolism, deuterated (d6)-dextromethorphan requires a substantially lower level of quinidine (an inhibitor of the enzyme CYP 2D6) in the AVP-786 formulation than with the earlier generation. This may result in a reduced potential for drug interactions and cardiac effects. AVP-786 is an investigational drug not approved by the FDA.

About Concert

Concert Pharmaceuticals is a clinical stage biopharmaceutical company focused on applying its DCE Platform® (deuterated chemical entity platform) to create novel small molecule drugs. This approach starts with approved drugs, advanced clinical candidates or previously studied compounds that have the potential to be improved with deuterium substitution to enhance clinical safety, tolerability and efficacy. The Company is developing a broad pipeline targeting CNS disorders, genetic diseases, renal disease, inflammatory diseases and cancer. For more information, please visit www.concertpharma.com.

Cautionary Note on Forward Looking Statements

Any statements in this press release about our future expectations, plans and prospects, including statements about clinical development of AVP-786 and other statements containing the words “anticipate,” “believe,” “continue,” “could,” “estimate,” “expect,” “intend,” “may,” “plan,” “potential,” “predict,” “project,” “should,” “target,” “would,” and similar expressions, constitute forward-looking statements within the meaning of The Private Securities Litigation Reform Act of 1995. Actual results may differ materially from those indicated by such forward-looking statements as a result of various important factors, including: the uncertainties inherent in the initiation of future clinical trials, availability and timing of data from ongoing and future clinical trials and the results of such trials, whether preliminary results from a clinical trial will be predictive of the final results of that trial or whether results of early clinical trials will be indicative of the results of later clinical trials, expectations for regulatory approvals and other factors discussed in the “Risk Factors” section of our most recent Quarterly Report on Form 10-Q filed with the Securities and Exchange Commission and in other filings that we make with the Securities and Exchange Commission. In addition, any forward-looking statements included in this press release represent our views only as of the date of this release and should not be relied upon as representing our views as of any subsequent date. We specifically disclaim any obligation to update any forward-looking statements included in this press release.

Concert Pharmaceuticals Inc., the CoNCERT Pharmaceuticals Inc. logo and DCE Platform are registered trademarks of Concert Pharmaceuticals, Inc.