- Israeli pharmaceutical giant Teva said Wednesday it is looking into next steps for its neurology drug Austedo after two studies that could have supported an approval for treating tics associated with Tourette syndrome produced negative results.
- Teva said it received this week data from the ARTISTS 1 and 2 studies, in which Austedo didn't meet the primary endpoints of reducing motor and verbal tics in children with moderate to severe Tourette's. Specific data points weren't disclosed, though Teva noted researchers didn't see any safety signals inconsistent with what's already known about the drug.
- Austedo gained its first U.S. approval in April 2017 as a treatment for the involuntary movements associated with Huntington’s disease. A second approval came a few months later, making the drug available for another involuntary movement condition known as tardive dyskinesia. Teva, hammered by a challenging generics market and competition to its top-selling medicine, Copaxone, has identified Austedo as a key growth product.
Like many diseases of the central nervous systems, Tourette's has proven a difficult target for pharmaceutical companies.
Ingrezza, a Neurocrine Biosciences drug approved for tardive dyskinesia patients, failed a couple Phase 2 Tourette's studies from 2017 to 2018. A drug patch from Zynerba Pharmaceuticals didn't even make it to Tourette's patients, having missed in an early-stage study that tested safety and dosing in healthy volunteers.
Yet with few treatment options for the millions of children thought to have Tourette's, the disease continues to see industry investment. Lundbeck, a Danish drugmaker focused on CNS therapeutics, shelled out $250 million last year to acquire Abide Therapeutics and its lead candidate, an enzyme inhibitor in clinical testing for both Tourette's and neuropathic pain.
For Teva and its partner, Nuvelution, the ARTISTS 1 and 2 studies were meant to show the bet that Austedo could be a useful addition to Tourette's treatment was well placed. The negative readouts, however, make it harder to justify further study.
"The results of the trials are disappointing, especially as there is such an unmet need for this community of pediatric patients," Teva's global R&D head, Hafrun Fridriksdottir, said in a Wednesday statement.
The setbacks could be especially painful given Teva management has been bullish on the opportunity in Tourette's.
"It's quite clear that if we were to see positive outcome of the Phase 3 trial and, following that, if we were to get an approval from FDA, this is a very clear medical need for thousands of patients," Teva CEO Kåre Schultz said during a mid-February earnings call.
While Austedo revenue hit $412 million last year, more than double what it was in 2018, that wasn't near enough to offset declines elsewhere in the business. Revenue from Teva's multiple sclerosis drug Copaxone fell by 42%, or $742 million, in 2019 due to generic competition. Revenue from the company's own generics business, meanwhile, dropped by roughly $100 million.
Teva also marks its migraine prevention shot Ajovy as a key growth driver, though the market is crowded and competitive. Amgen and Eli Lilly each have a drug that works similarly to Ajovy and, according to a recent RBC Capital Markets survey of neurologists, they're each prescribed to a higher percentage of new migraine patients.
Shares of Teva were down 3% in late morning trading Thursday.