ALISO VIEJO, Calif. and LEXINGTON, Mass., February 29, 2012 — Avanir Pharmaceuticals, Inc. (Nasdaq: AVNR) and Concert Pharmaceuticals, Inc. announced today that they have entered into an exclusive license agreement that provides Avanir worldwide rights to develop and commercialize Concert’s deuterium-modified dextromethorphan (d-DM) for the potential treatment of neurological and psychiatric disorders. The agreement includes the rights to multiple deuterium-modified dextromethorphan compounds.
Under the terms of the agreement, Concert will receive an upfront payment and is eligible to receive additional milestone payments upon achievement of certain predefined clinical, regulatory and commercial targets as well as tiered royalties on worldwide sales of products containing d-DM. Avanir will have overall responsibility for research, development and commercialization of d-DM. Concert will provide manufacturing support for investigational new drug enabling studies.
“Concert’s DCE Platform (Deuterated Chemical Entity Platform) has produced several deuterium-modified dextromethorphan compounds that we believe may provide therapeutically effective levels of dextromethorphan, potentially without the need for an enzyme inhibitor such as quinidine,” said Greg Flesher, senior vice president of corporate development and chief business officer of Avanir Pharmaceuticals. “As part of our portfolio strategy, we intend to explore the utility of d-DM in neurological and psychiatric disorders where dual NMDA antagonists and sigma-1 agonists may be beneficial.”
“We are very pleased to enter into this collaboration with Avanir, who we believe has the unique expertise to best maximize the broad clinical potential of d-DM. Avanir’s knowledge of dextromethorphan-based therapeutics and their proven track record to bring drugs to the market make them the ideal partner for this program,” said Roger Tung, Ph.D., president and chief executive officer of Concert Pharmaceuticals. “d-DM is a great example of how deuterium modification can, in favorable cases, create drug candidates with the unique opportunity for both substantially improved therapeutic properties over existing medicines, and lower development expense and risk compared to typical new chemical entities.”
About Deuterated Chemical Entity Platform
d-DM was developed using Concert’s proprietary DCE Platform™ (Deuterated Chemical Entity Platform), and is a deuterium-containing analog of dextromethorphan. The deuterium-modified dextromethorphan compounds are covered under U.S. patent 7,973,049 that was issued to Concert in July 2011, as well as patent applications in other countries.
The incorporation of deuterium into specific molecular positions of dextromethorphan, resulting in d-DM, maintained the pharmacology of dextromethorphan and provided significantly enhanced resistance to CYP2D6 metabolism and improved plasma exposure in preclinical testing. As a result, d-DM has the potential to be effective as a treatment for neurological and psychiatric disorders for which dextromethorphan has shown pharmacological activity.
About Avanir Pharmaceuticals, Inc.
Avanir Pharmaceuticals, Inc. is a biopharmaceutical company focused on bringing innovative medicines to patients with nervous system disorders of high unmet medical need. As part of our commitment, we have extensively invested in our pipeline and are dedicated to advancing medicines that can substantially improve the lives of patients and their loved ones. For more information about Avanir, please visit www.avanir.com.
Concert Pharmaceuticals, Inc is a clinical stage biotechnology company focused on applying the company’s DCE Platform™ (deuterated chemical entity platform) to create novel and differentiated small molecule drugs. Concert’s approach leverages decades of pharmaceutical and clinical experience to reduce the time, risk and expense needed to create important new medicines. The company has a broad research pipeline encompassing many therapeutic areas including antiviral disease, renal disease, and CNS disorders, among others. Founded in 2006, Concert has raised more than $110 million of venture and institutional capital. For more information on Concert Pharmaceuticals, please visit www.concertpharma.com.
Concert Pharmaceuticals, the CoNCERT logo and the DCE Platform are trademarks of Concert Pharmaceuticals, Inc. Avanir is a trademark or registered trademark of Avanir Pharmaceuticals, Inc. in the United States and other countries. All other trademarks are those of their respective owners.
Forward Looking Statements
Except for the historical information contained herein, the matters set forth in this press release, including statements regarding Avanir’s plans, potential opportunities, financial or other expectations, projections, goals objectives, milestones, strategies, market growth, timelines, legal matters, product pipeline, clinical studies, product development, therapeutic effectiveness of deuterium- modified dextromethorphan, the regulatory approval pathway, FDA approval and the potential benefits of products under development are forward-looking statements within the meaning of the “safe harbor” provisions of the Private Securities Litigation Reform Act of 1995. These forward-looking statements are subject to risks and uncertainties that may cause actual results to differ materially, including the risks and uncertainties associated with Avanir’s operating performance and financial position, the market demand for and acceptance of Avanir’s products domestic ally and internationally, research, development and commercialization of new products domestically and internationally, obtaining and maintaining regulatory approvals domestically and internationally, risks associated with meeting the objectives of any planned clinical study, including, but not limited to, delays or failures in enrollment, and the occurrence of adverse safety events, and risks associated with initiating a study using deuterium modified dextromethorphan and uncertainties around the ability to reduce quinidine levels, and other risks detailed from time to time in the Company's most recent Annual Report on Form 10-K and other documents subsequently filed with or furnished to the Securities and Exchange Commission. These forward-looking statements are based on current information that may change and you are cautioned not to place undue reliance on these forward-looking statements, which speak only as of the date of this press release. All forward-looking statemen ts are qualified in their entirety by this cautionary statement, and the Company undertakes no obligation to revise or update any forward-looking statement to reflect events or circumstances after the issuance of this press release.