Teva Pharmaceutical Industries Ltd (ADR) (NYSE:TEVA) announced positive top-line results from the pivotal clinical study Aim to Reduce Movements in TardiveDyskinesia (ARM-TD) designed to evaluate the efficacy of SD-809 (deutetrabenazine) in the treatment of moderate to severe tardive dyskinesia. Top-line data showed that the study met its primary endpoint and demonstrated a positive trend in all secondary endpoints. Importantly, the study also showed a favorable safety and tolerability profile, including low rates of depression, somnolence, insomnia and akathisia.
The primary endpoint of ARM-TD was the change in the Abnormal Involuntary Movement Scale (AIMS) from baseline to end of therapy, assessed by blinded centralized video rating. The study results show patients taking SD-809 achieved an improvement of 3.0 points on the AIMS score from baseline to end of therapy compared to 1.6 points in placebo (p = 0.0188) for a clinically meaningful effect. Study results also demonstrated a favorable safety and tolerability profile of SD-809. Fewer patients taking SD-809 than placebo experienced serious adverse events (SAEs) Three patients discontinued from the study for adverse events (1 in SD-809 group vs. 2 in placebo group). For all other side effects reported in the study, rates in the SD-809 group were similar or lower than the placebo group. Further analysis of the additional data from the study is ongoing and details will be shared at future medical meetings and through peer-reviewed publication.
Tardive dyskinesia, a condition for which there are no approved therapies in the United States, is a hyperkinetic movement disorder characterized by repetitive and uncontrollable movements of the tongue, lips, face, trunk and extremities. The often debilitating disorder affects about 500,000 people in the United States and is a result of treatment with widely used medications for psychiatric conditions such as schizophrenia and bipolar disease, and certain drugs used for treating various gastrointestinal disorders.
“SD-809 is an exciting addition to Teva’s CNS portfolio and has the potential to offer a meaningful and much needed therapeutic option to patients suffering from involuntary movements related to a number of disorders. Currently our development program includes studies in tardive dyskinesia, Huntington’s disease and Tourette syndrome,” said Michael Hayden, M.D., Ph.D., President of Global R&D and Chief Scientific Officer at Teva. “We are committed to developing innovative medicines in this therapeutic area and we are making great progress in bringing a potential new treatment to the patients and their families who can benefit most.”
SD-809 became part of Teva’s central nervous system (CNS) product portfolio with the acquisition of Auspex Pharmaceuticals in May 2015. Teva has numerous development programs in CNS focused on neurodegeneration and movement disorders which include Huntington’s disease, Tourette syndrome, Parkinson’s disease, multiple sclerosis, and tardive dyskinesia. In addition to SD-809, Teva is developing pridopidine, laquinimod and other undisclosed assets in the neurodegenerative category.
“We are extremely pleased with these data of SD-809 in another condition with people in great need,” said Pratik Shah, Ph.D., president and CEO, Auspex Pharmaceuticals. “We believe strongly in the potential of SD-809 to become a treatment of choice for tardive dyskinesia and other seriously debilitating movement disorders.”
“These clear and clinically meaningful efficacy and safety results for SD-809 in a rigorously performed global multicenter clinical trial for tardive dyskinesia are very encouraging,” said Hubert Fernandez, M.D., Professor of Neurology at the Center for Neurological Restoration at the Cleveland Clinic and Principal Investigator of the SD-809 ARM-TD clinical study. “There is a serious and growing medical need as tardive dyskinesia is one of the most debilitating and often irreversible side effects of dopamine receptor blocking agents, which are increasingly being used in the United States for various psychiatric disorders and gastrointestinal conditions. With no approved treatments of this serious condition currently available, the need for a therapeutic solution is urgent and overdue.”(Original Source)
Shares of Teva closed yesterday at $60.68 . TEVA has a 1-year high of $68.75 and a 1-year low of $47.36. The stock’s 50-day moving average is $60.74 and its 200-day moving average is $59.04.
On the ratings front, Teva has been the subject of a number of recent research reports. In a report issued on June 4, Deutsche Bank analyst Gregg Gilbert maintained a Buy rating on TEVA, with a price target of $73, which represents a potential upside of 20.3% from where the stock is currently trading. Separately, on April 30, Oppenheimer’s Akiva Felt maintained a Buy rating on the stock and has a price target of $77.
According to TipRanks.com, which ranks over 7,500 financial analysts and bloggers to gauge the performance of their past recommendations, Gregg Gilbert and Akiva Felt have a total average return of 21.8% and 35.3% respectively. Gilbert has a success rate of 77.6% and is ranked #190 out of 3629 analysts, while Felt has a success rate of 68.8% and is ranked #25.
In total, one research analyst has assigned a Hold rating and 7 research analysts have given a Buy rating to the stock. When considering if perhaps the stock is under or overvalued, the average price target is $73.00 which is 20.3% above where the stock closed yesterday.
Teva Pharmaceutical Industries Ltd develops, produces and markets generic, branded & OTC medicines. Some of its products are Copaxone, Azilect & Provigil.