Teva Pharmaceutical Industries (NYSE:TEVA) acquires Auspex Pharmaceuticals (NASDAQ:ASPX) for $101 per share ($3.2B) in an all-cash transaction. The deal will enhance Teva's revenue and earnings growth profile as well as strengthen its central nervous system franchise.
Auspex's lead product candidate is SD-809, a small molecule inhibitor of vesicular monoamine 2 transporter (VMAT2), that is designed to regulate the levels of dopamine in the brain. It is being investigated for the treatment of various movement disorders.
Auspex Pharmaceuticals (NASDAQ:ASPX) completes enrollment in a 90-patient Phase 2/3 clinical trial evaluating its lead product candidate, SD-809, in patients with tardive dyskinesia (TD), a hyperkinetic movement disorder caused by widely used medications to treat psychiatric conditions such as schizophrenia and bipolar disease and certain drugs used to treat various gastrointestinal diseases. It affects ~500K people in the U.S.
Study subjects will be randomized 1:1 to receive either SD-809 or placebo, titrated to the optimal dose over six weeks and then administered that dose for another six weeks. The primary efficacy endpoint is the change in the Abnormal Involuntary Movement Scale (AIMS) from baseline to end of therapy as assessed by centralized video rating.
Based on feedback from the FDA, this trial may qualify as one of two studies needed for a New Drug Application (NDA) under the 505(b)(2) pathway.
Auspex Pharmaceuticals (NASDAQ:ASPX) prices its public offering of 4M shares (1M by existing stockholders) of common stock at $56.50 per share. Underwriters over-allotment is an additional 600K shares.
Auspex Pharmaceuticals (NASDAQ:ASPX) commences a public offering of 4M shares of common stock, 3M offered by the company and 1M from existing shareholders. Underwriters over-allotment is an additional 600K shares. Pricing has yet to be disclosed.
The FDA designates Auspex Pharmaceuticals' (ASPX +2.1%) investigational compound, SD-809, an Orphan Drug for the treatment of pediatric patients with Tourette syndrome. The product is currently in Phase 1b development.
Among the benefits of Orphan Drug status is a seven-year period of market exclusivity if approved.
In a Phase 3 trial, Auspex Pharmaceuticals' (NASDAQ:ASPX) investigational treatment for chorea associated with Huntington's disease (HD), SD-809 (dutetrabenazine), achieves its primary endpoint a statistically significant improvement in Total Maximum Chorea (TMC) versus baseline. Almost all (90%) of HD patients develop chorea, which is characterized as involuntary, excessive movements that can impact all parts of the body and interferes with motor functions.
Patients receiving SD-809 demonstrated a 2.5-point improvement in TMC score over placebo (4.4 point improvement vs. 1.9 point improvement) (p<0.0001). The percent change improvement was 21% over placebo (37% improvement vs. 16% improvement) (p<0.0001). The improvement in Total Motor Score compared to placebo was 4.0 points (7.4 vs. 3.4) (p=0.002).
Complete results from the study will be reported in 2015.
The FDA designates Auspex Pharmaceuticals' (ASPX +1%) investigational compound, SD-809, an Orphan Drug for the treatment of Huntington's disease (HD). The company is currently evaluating the safety and efficacy of SD-809 for treating chorea associated with HD in a Phase 3 registration clinical trial. Top-line data should be available by the end of this year.
Among the benefits of Orphan Drug status is a seven-year period of market exclusivity.