Drug Development Acquisition Focuses on Treatment for Movement Disorders

The purchase of a biomedical company that develops drugs for treatment of hyperkinetic movement disorders by one of the world's largest producers of generic drugs is expected to strengthen the generics manufacturer's position in the market for central nervous system condition treatments.

One of the world's largest producers of generic medicines, Teva Pharmaceutical Industries Ltd. (Jerusalem, Israel), is reportedly buying the drug development company Auspex Pharmaceuticals (La Jolla, CA, USA) for about 3.2 billion USD.

Auspex does not yet have a product on the market, but they plan to register their lead product SD-809 (Austedo) with the [US] Food and Drug Administration (FDA) later this year. Last December, Auspex reported positive results from a Phase III clinical trial evaluating SD-809 in chorea associated with Huntington's disease. In that randomized, double-blind, placebo-controlled, parallel-group trial, patients with Huntington’s disease (n=90) received SD-809 or placebo and monitored for 13 weeks. The primary endpoint was the change from baseline to maintenance therapy in the Total Maximal Chorea (TMC) score of the Unified Huntington's Disease Rating Scale (UHDRS). Numerous pre-specified secondary endpoints were also tested [treatment success based on patient global impression of change (PGIC) and clinical global impression of change (CGIC), quality of life and balance.]

At the end of the study, patients taking SD-809 achieved a meaningful improvement of 2.5 points on the TMC score from baseline to maintenance therapy compared to placebo. The secondary endpoints were also very impressive with significant differences in PGIC and CGIC scores. Equally important, the drug was well tolerated and safe with no differences being reported with adverse events between patients given SD-809 and those given placebo.

"The acquisition of Auspex is a significant step in strengthening Teva's leadership position in central nervous system (disorders) and advances us into underserved movement disorder markets," said Erez Vigodman, president and CEO of Teva.

Teva anticipates initiating marketing of Austedo in 2016.

Related Links:
Teva Pharmaceutical Industries Ltd.
Auspex Pharmaceuticals