Concert Pharmaceuticals Announces Milestone Achievement in Avanir Pharmaceuticals Collaboration

  Concert Pharmaceuticals Announces Milestone Achievement in Avanir
  Pharmaceuticals Collaboration

Business Wire

LEXINGTON, Mass. -- February 7, 2013

Concert Pharmaceuticals, Inc. today announced that it has achieved a milestone
under its licensing agreement with Avanir Pharmaceuticals, Inc. for the
development of AVP-786 (also known as CTP-786 or deuterated dextromethorphan).
Avanir has successfully completed the first of a two-stage pharmacokinetic
study in healthy subjects with AVP-786. The worldwide licensing agreement with
Avanir was entered into in 2012.

Based on interim data, Avanir believes that it has identified a formulation of
AVP-786 with a comparable pharmacokinetic, safety and tolerability profile to
a previously investigated fixed dose combination of dextromethorphan
hydrobromide and quinidine sulfate, AVP-923. Avanir has requested a meeting
with the FDA to discuss the full development path for AVP-786.

“The results of this study are very encouraging,” said Joao Siffert, MD, chief
scientific officer for Avanir. “We were able to successfully replicate the
steady-state plasma levels of AVP-923, but with a substantially lower dose of
quinidine. Given these results, we believe that AVP-786 would be an ideal
candidate to test in one or more of our ongoing clinical programs.”

“We are very pleased with these results and with Avanir’s commitment to this
program,” said Roger Tung, Ph.D., President and CEO of Concert
Pharmaceuticals.

The exclusive license agreement provides Avanir with worldwide rights to
develop and commercialize AVP-786 and other deuterium-modified
dextromethorphan (d-DM) compounds that are believed to have potential for the
treatment of neurological and psychiatric disorders. Under the agreement,
Concert is eligible to receive additional milestone payments upon achievement
of certain predefined clinical, 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.

About AVP-786

AVP-786 is a novel compound developed through incorporation of deuterium into
specific molecular positions of dextromethorphan. The compound maintains
similar pharmacology to that of dextromethorphan, but is less susceptible to
metabolism by the CYP2D6 enzyme.

About Concert

Concert Pharmaceuticals 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
renal disease, hematologic disorders 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 Inc., the CoNCERT Pharmaceuticals Inc. logo and DCE
Platform are registered trademarks of Concert Pharmaceuticals, Inc. All other
trademarks are those of their respective owners.

Contact:

Investors
Concert Pharmaceuticals
Justine E. Koenigsberg, 781-674-5284
ir@concertpharma.com
or
Media
The Yates Network
Kathryn Morris, 845-635-9828
 
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