Development-stage orphan drug company sold for $3.5bn

Pharma's buying frenzy for orphan drugs continues.

Israeli generics giant, Teva, has announced that it will pay $3.5 billion to acquire development-stage, orphan drug biopharma, Auspex Pharmaceuticals.

Teva has been seeking to boost its neurology arm as it faces potential generic competition this year for its best-selling multiple-sclerosis drug, Copaxone.

US-based Auspex is focused on developing novel medicines for people with orphan hyperkinetic movement disorders, such as chorea (abnormal involuntary movements) associated with Huntington’s disease (an orphan disease) and tardive dyskinesia and Tourette syndrome ( subsets of either of which may be deemed to be orphan diseases).

Auspex is using deuterium, or heavy hydrogen, to reformulate existing drugs to try to broaden their range of action. Its experimental products include new versions of Tetrabenazine, a product already sold to ease the jerky body movements associated with Huntington’s disease and Tourette’s syndrome, and levodopa for Parkinson’s symptoms.

The company’s lead product candidate, deutetrabenazine or SD-809, is designed to regulate the levels of the neurotransmitter, dopamine, in the brain. A number of hyperkinetic movement disorders are triggered by abnormal dopamine regulation in the brain.

The company has recently completed a successful Phase 3 clinical trial of SD-809 for the potential treatment of chorea associated with Huntington’s disease. It plans to seek US approval mid-year.

Two safety and efficacy clinical trials of SD-809 for the potential treatment of tardive dyskinesia have also been initiated. One is a Phase 2/3 trial of SD-809 in approximately 90 patients. Topline results from this trial are expected in mid-2015. The second trial is in approximately 200 people with tardive dyskinesia and topline results are expected in 2016. Contingent upon successful completion of both studies, the company plans to file an NDA for SD-809 for the treatment of tardive dyskinesia in 2016.

A Phase 1b clinical trial of SD-809 for the treatment of tics associated with Tourette syndrome has also been commenced, with a planned enrolment of approximately 20 subjects.

Auspex is also evaluating a second drug, SD-560 (a deuterium-containing form of pirfenidone), in a Phase 1 clinical trial in the treatment of idiopathic pulmonary fibrosis.


http://www.auspexpharma.com/pipeline/

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