Item 8.01 Other Events.

On July 1, 2009, Sepracor Inc. ("Sepracor") announced that it has completed the analysis and validation of the preliminary results of a Phase II, 514-patient study evaluating the efficacy and safety of SEP-225289 for the treatment of Major Depressive Disorder, including patients with melancholic and atypical features. Sepracor determined that SEP-225289 did not meet the primary efficacy endpoint, which was a reduction in symptoms of depression following eight weeks of treatment, as assessed using the clinician-rated, 17-item HAM-D scale (Hamilton Depression Rating Scale, a standard scale used to assess depression in clinical trials and consisting of a list of symptoms commonly associated with depression). The positive control in the study (venlafaxine extended-release) did achieve separation from placebo that was statistically significant on the primary endpoint.

In this study, the measured serum concentrations of SEP-225289 were found to be below expected levels of exposure for both doses studied and were well below exposure profiles observed in several Phase I studies. Further, the adverse event profile demonstrated by SEP-225289 was inconsistent with prior clinical experience and was similar to the side effect profile observed when patients were administered placebo. As such, preliminary data are inconclusive pending further investigation of the dose exposure relationship of SEP-225289.

Sepracor is in the process of further analysis of the dose response and secondary endpoints to determine how or if it will move forward with SEP-225289.

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