Teva partner flunks second program this year
- Teva Pharmaceuticals and partner Xenon Pharmaceuticals revealed Tuesday morning their topical drug for post-herpetic neuralgia (PHN) did not meet primary or secondary endpoints in a mid-stage study.
- TV-45070 is a small molecule inhibitor of the sodium channel Nav 1.7, which are found in abundance in nerve endings and are expected to contribute to pain. The study included three treatment groups that received topical ointment containing 4% or 8% TV-45070 or placebo, dosed twice daily.
- The primary endpoint of the trial was a statistically significant reduction in pain from baseline to week four as assessed by the numeric rating scale. Secondary endpoints include the percentage of patients with greater than 30% and greater than 50% improvement in pain scores, respectively, quality of life measurements and adverse events measurements.
Teva signed on with Xenon in 2012 for $41 million upfront and agreed to $335 million in milestones. The big generic drugmaker at the time was hoping to switch directions and focus more on its central nervous system portfolio, building on the success of its multiple sclerosis drug Copaxone (glatiramer).
Competition to Copaxone isn’t Teva’s only problem; the company has been going through significant transition on the management level as its goes through a revolving door of CEOs.
Xenon is no stranger to turmoil either. The company’s stock crashed in March after it announced a Phase 2 failure of its acne drug XEN801.
"Though disappointing results for TV-45070, we believe a longer-term business opportunity remains intact," wrote Jefferies analyst Maury Raycroft in a note to clients.
Raycroft added GDC-0310 likely has a better shot of making it to market than TV-45070. GDC-0310 is an oral Nav 1.7 sodium channel blocker partnered with Genentech in pain. The drug is expected to start Phase 2 trials by the end of the year.
- Teva Pharmaceuticals Press release
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