HD Insights™

Vol. 11 - Spring 2015

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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. 1 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. 2 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). 3 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."

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