Teva Pharmaceutical Industries Ltd (ADR) (NYSE:TEVA) announced that the New Drug Application (NDA) for SD-809 (deutetrabenazine) has been accepted by the U.S. Food and Drug Administration (FDA) for the treatment of chorea associated with Huntington disease (HD), a rare and fatal neurodegenerative disorder caused by the progressive breakdown of nerve cells in the brain that affects about five to seven people per 100,000 in western countries, according to the World Health Organization.
“The opportunity to bring a new treatment option to those battling the devastating illness of Huntington disease is an important first step and an indication of our profound commitment to improving the lives of patients with this and other debilitating movement disorders,” said Michael Hayden, M.D., Ph.D., President of Global R&D and Chief Scientific Officer at Teva. “With this filing and an ongoing investment in HD research, Teva has further established itself as a leader in the development of treatments focusing on movement disorders.”
“Teva plans to commercialize SD-809 in the U.S. by drawing from vast experience in facilitating therapy initiation and patient support in other disease areas. Within Global Specialty Medicines, we have a rich history of demonstrating our commitment to the patient and bringing value to the neurology community,” said Rob Koremans, MD, President and CEO of Global Specialty Medicines at Teva. “People living with neurodegenerative disorders and those around them often need support and services beyond medications. We intend to meet these needs with our proven infrastructure and our focus on the patient.”
The NDA filing is based on positive results from two Phase-III studies, FIRST-HD and ARC-HD. In the placebo-controlled, randomized FIRST-HD study, SD-809 reduced chorea in patients with HD. Positive top-line data from the Phase-III, open-label ARC-HD study demonstrated that patients were able to safely convert from tetrabenazine, currently the only approved HD treatment, to SD-809 overnight with continued control of chorea.
SD-809 was granted Orphan Drug Designation for the treatment of HD by the FDA in November 2014and became part of Teva’s CNS portfolio with the acquisition of Auspex Pharmaceuticals in May 2015.
The FDA designates orphan status to drugs and biologics that are intended for the treatment of rare diseases affecting fewer than 200,000 people in the U.S. (Original Source)
Shares of Teva Pharmaceutical Industries closed yesterday at $69.6. TEVA has a 1-year high of $72.31 and a 1-year low of $47.36. The stock’s 50-day moving average is $64.62 and its 200-day moving average is $61.23.
On the ratings front, Teva Pharmaceutical has been the subject of a number of recent research reports. In a report issued on August 10, Goldman Sachs analyst Jami Rubin assigned a Buy rating on TEVA, with a price target of $80, which represents a potential upside of 14.9% from where the stock is currently trading. Separately, on August 3, J.P. Morgan’s Chris Schott assigned a Buy rating to the stock and has a price target of $82.
According to TipRanks.com, which ranks over 7,500 financial analysts and bloggers to gauge the performance of their past recommendations, Jami Rubin and Chris Schott have a total average return of 12.2% and 20.0% respectively. Rubin has a success rate of 71.4% and is ranked #575 out of 3731 analysts, while Schott has a success rate of 70.0% and is ranked #299.
The street is mostly Bullish on TEVA stock. Out of 8 analysts who cover the stock, 7 suggest a Buy rating and one recommends to Hold the stock. The 12-month average price target assigned to the stock is $73.00, which represents a slight upside potential from current levels.
Teva Pharmaceutical Industries Ltd develops, produces and markets generic, branded & OTC medicines. Some of its products are Copaxone, Azilect & Provigil.