HD Insights, Vol. 11 1
On March 30, 2015, Auspex Pharmaceuticals, Inc. (La Jolla, CA, USA) and Teva Pharmaceutical Industries, Ltd. (Tel Aviv, Israel)
announced that Teva will buy Auspex in a cash deal valued at $3.5 billion. The deal will enhance Teva's central nervous system
portfolio with the addition of Auspex's deuterated compounds for movement disorders, including SD-809 (dutetrabenazine),
which recently demonstrated efficacy and safety in Phase 3 trials conducted by the Huntington Study Group (see HD Insights,
Vol. 10). The transaction is expected to be completed by mid-2015. Auspex plans to submit a New Drug Application (NDA) to
the US Food and Drug Administration for SD-809 in HD during 2015. The company expects to receive regulatory approval and
begin marketing the drug commercially in the US in 2016.
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Auspex has used its deuteration technology to develop therapeutic candidates for other orphan, hyperkinetic movement
disorders, including Tourette syndrome and tardive dyskinesia (TD). The company is currently conducting two studies using
SD-809 to reduce involuntary movement in individuals with TD. The ARM-TD (Aim to Reduce Movements in Tardive
Dyskinesia) study is a Phase 2/3 randomized, double-blind, placebo-controlled, dose-titration trial of SD-809 in 90 people with
TD. Topline results are expected in mid-2015. The AIM-TD (Addressing Involuntary Movements in Tardive Dyskinesia) study is
a double-blind, placebo-controlled, parallel group trial in approximately 200 people with TD.
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Dr. Michael Hayden, President of Global R&D and Chief Scientific Officer at
Teva, told HD Insights, "Teva has a longstanding commitment to patients
and clinicians in the HD community. The acquisition of Auspex represents
an exciting new dimension to Teva's deep focus in this field, and adds to the
broadest and most ambitious development portfolio in the industry." Teva
has two ongoing phase II HD clinical trials: the LEGATO-HD study of
laquinimod (see HD Insights, Vol. 10), and the PRIDE-HD trial of pridopidine. Teva's large, international development
infrastructure is expected to allow faster development and distribution of Auspex's deuterated compounds.
Teva's acquisition of Auspex is part of an ongoing trend toward consolidation within the pharmaceutical industry, including
companies that develop central nervous system therapies (Table).
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HD Insights
A H u n t i n g t o n d i s e a s e r e s e a r c h
Issue N
o
11-- Spring 2015
p e r i o d i c a l
TM
Copyright © Huntington Study Group 2015. All rights reserved.
Highlights of CHDI 2015
Francesca Cicchetti, PhD,
shares the highlights of the
February 2015 meeting in
Palm Springs, CA.
Page 11
Meet the Attorney
We interview Frank
Sasinowski, JD, about his
work with orphan drug
development.
Page 2-3, 14-15
Future of HD therapy
Daniel Zielonka, MD,
PhD, summarizes
disease-modifying
therapies in development.
Page 10
Clinical Trials Update
We bring you the latest
in HD clinical trials.
Pages 8-9
(continued on Page 2...)
Teva acquires Auspex for $3.5 billion
HD Research at UBC
Dagmar Ehrnhoefer, PhD,
and Shaun Sanders, PhD,
describe their research on
post-translational
modification of HTT.
Pages 6-7
By: Ryan E. Korn, BA
"The acquisition of Auspex…
adds to the broadest and most
ambitious development portfolio
in the industry."