An application for a new drug by Teva Pharmaceutical Industries Ltd (ADR) (NYSE:TEVA) has been accepted by the Food and Drug Administration. Teva’s drug that is used to treat tardive dyskinesia, SD-809, has also been given priority review. This will allow the drug to be evaluated at a faster rate.
“SD-809 has the potential to reduce the severity of the abnormal involuntary movements of tardive dyskinesia which lead to social isolation for these patients. Currently, there is no approved therapy in the U.S. for TD…” Michael Hayden, Teva’s chief scientific officer, and global research and development president said.
Phase III studies
Two phase III studies on SD-809 have already been conducted and the results have been encouraging. As there is no therapy for tardive dyskinesia that has been approved yet, the success of SD-809 could be a breakthrough event for this disease which is characterized by movements that are uncontrollable and repetitive. These movements are mostly on the face, lips, and tongue. Approximately half a million individuals in the U.S are affected by the disorder. The disease results from use of medications for a range of psychiatric conditions including bipolar disorder and schizophrenia.
Legal problems
The priority review granted Teva comes in the wake of a string of problems affecting the drug maker. This includes losing four patents that protected Copaxone, a drug for treating multiple sclerosis. The company’s chief executive officer, Erez Vigodman also resigned following a bribery scandal in Mexico, Ukraine, and Russia which also saw the U.S. Department of Justice open an investigation into the matter.
Though the pharmaceutical firm will appeal the case in which it lost its patents, the current chief executive officer, Yitzhak Peterburg has warned that the firm would continue to experience price erosion due to fierce competition from generics drug manufacturers. Teva is also heavily in debt for which it must pay over $21 billion in the next five years. Some of the payments will cater for a generics business it bought.
In Tuesday’s trading session, shares of Teva Pharmaceutical Industries fell by 1.24% to close the day at $35.02.