Teva Pharmaceutical Industries Ltd (ADR) (NYSE:TEVA) and Xenon Pharmaceuticals Inc. reported top line results from the double-blind, placebo-controlled Phase 2b study designed to evaluate the safety and efficacy of topically applied TV-45070 (4% and 8% w/w ointment) in patients with chronic pain due to osteoarthritis (OA) of the knee.
TV-45070 is a small molecule inhibitor of the sodium channel Nav1.7 and other sodium channels, including those that are expressed in the pain-sensing peripheral nervous system. Results from this trial showed that TV-45070 4% and 8% did not demonstrate statistically significant difference from placebo in efficacy endpoints of reductions in pain due to OA.
TV-45070 did demonstrate a favorable safety and tolerability profile, with no drug-related serious adverse events. This is important given the ongoing Phase 2b study of TV-45070 in post-herpetic neuralgia (PHN). The most common adverse events were application site dermal skin reactions which were mostly mild and less frequent than seen with other topical analgesics. There were no cardiac or CNS safety issues.
“The rationale for development of TV-45070 in OA has unfortunately not been confirmed with these results. However, neuropathic pain represents a distinct mechanism of chronic pain to OA and, as such, the potential for positive study results in PHN is not impacted by these data,” said Richard Malamut M.D. Teva’s Vice President and Head of Pain Therapeutic Development. “Given the favorable safety and tolerability profile demonstrated, we remain hopeful that TV-45070 can offer a new and valuable option to patients with neuropathic pain.”
“While we are disappointed that the Phase 2b trial top-line results did not indicate efficacy in OA, Teva and Xenon have always been committed to a broad development plan for TV-45070 in both nociceptive and neuropathic pain,” said Dr. Simon Pimstone, Xenon’s President and Chief Executive Officer. “The Phase 2b trial in PHN being conducted by Teva is progressing as planned, and we look forward to seeing top-line results from that trial in the second half of 2016. In addition, Xenon will continue to focus on advancing our partnered and proprietary pipeline programs, and leveraging the potential of our Extreme Genetics platform and expertise in ion channel target discovery. We look forward to other near-term milestone opportunities across our diverse product candidate pipeline.” (Original Source)
Shares of Teva Pharmaceutical Industries closed yesterday at $59.1 . 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 $60.36 and its 200-day moving average is $59.31.
On the ratings front, Teva Pharmaceutical Industries has been the subject of a number of recent research reports. In a report issued on June 19, Maxim Group analyst Jason Kolbert maintained a Buy rating on TEVA, with a price target of $68, which implies an upside of 15.1% from current levels. Separately, on June 4, Deutsche Bank’s Gregg Gilbert maintained a Buy rating on the stock and has a price target of $73.
According to TipRanks.com, which ranks over 7,500 financial analysts and bloggers to gauge the performance of their past recommendations, Jason Kolbert and Gregg Gilbert have a total average return of 0.5% and 18.9% respectively. Kolbert has a success rate of 39.9% and is ranked #2007 out of 3683 analysts, while Gilbert has a success rate of 75.0% and is ranked #228.
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 23.5% 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.