By: Ryan E. Korn, BA
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.
1 Teva Reinforces Leadership Position in CNS with Acquisition of Auspex [Internet]. March 30, 2015. Available from: tevapharm.com/news/?itemid=%7BF45C98FD-CEA7-48C4- B9CB-A6BD00D0BEDB%7D.
2 Auspex Pharmaceuticals. Pipeline – Auspex Pharmaceuticals 2015 [May 8, 2015]. Available from: auspexpharma.com/ pipeline/.
3 The Economist. Invent it, swap it or buy it. The Economist. November 15, 2014. Available from: economist.com/news/ business/21632676-why-constant-dealmaking-amongdrugmakers-inevitable-invent-it-swap-it-or-buy-it?fsrc=rss
4 Actavis Completes Allergan Acquisition [Internet]. Online; 2015; March 17, 2015. Available from: prnewswire.com/newsreleases/actavis-completes-allergan-acquisition-300051633.html
5 Actavis Completes Forest Laboratories Acquisition [Internet]. July 1, 2014. Available from: actavis.com/news/news/ thomson-reuters/actavis-completes-forest-laboratoriesacquisition
6 Avanir Pharmaceuticals To Be Acquired By Otsuka Pharmaceutical For $3.5 Billion [Internet]. Online; December 2, 2014. Available from: prnewswire.com/newsreleases/avanirpharmaceuticals-to-be-acquired-by-otsuka-pharmaceuticalfor-35-billion-300003185.html
7 Acorda Therapeutics Completes Acquisition of Civitas Therapeutics [Internet]. Online; 2014; October 22, 2014. Available from: ir.acorda.com/investors/investor-news/ investor-news-details/2014/Acorda-Therapeutics-CompletesAcquisition-of-Civitas-Therapeutics/default.aspx
8 Allergan, Inc. to Acquire MAP Pharmaceuticals, Inc. [Internet]. Online; January 22, 2013. Available from: reuters.com/article/ 2013/01/23/ca-allergan-inc-idUSnBw4rFlD9a +114+BSW20130123
9 Mallinckrodt Announces Definitive Agreement to Acquire CNS Therapeutics, Inc. [Internet]. Online; September 24, 2012. Available from: newsroom.medtronic.com/phoenix.zhtml? c=251324&p=irol-newsArticle&ID=2004166
10 Teva to buy Cephalon for $6.8 billion, tops Valeant [Internet]. Online; May 2, 2011. Available from: reuters.com/article/ 2011/05/02/us-teva-cephalon-idUSTRE74133720110502
11 Biotie to Acquire CNS Therapeutics Firm Synosia in €93.6M All-Shares Deal [Internet]. Online; January 11, 2011. Available from: genengnews.com/gen-news-highlights/biotie-to-acquirecns-therapeutics-firm-synosia-in-93-6m-all-b-b/81244507/ Table.