- Teva Pharmaceutical Industries Ltd. and Nuvelution Pharma Inc. have signed a U.S. agreement to develop Austedo for the treatment of Tourette syndrome in children.
- Deal terms hold that Nuvelution will fund and manage clinical development, after which Teva will take over, leading the regulatory and commercialization processes for the drug. The Phase 3 program for Austedo in Tourette's is expected to begin by the end of 2017, according to a Tuesday statement.
- Should Austedo gain approval in this new indication, Teva has agreed to give Nuvelution a return on its investments, though the companies didn't disclose specific financial terms.
On average, children ages three to nine develop Tourette syndrome. In the year between 2011 and 2012, the syndrome affected about 140,000 U.S. children aged 6 to 17, according to the Centers for Disease Control and Prevention, though the agency noted that research suggests roughly half of all cases of Tourette's in children go undiagnosed.
If this deal between Teva and Nuvelution comes to fruition, Tourette syndrome would be the third indication for Austedo (deutetrabenzine).
The drug snagged an approval from the Food and Drug Administration in April for chorea associated with Huntington’s disease, although it carries a black box warning for an increased risk of depression and suicidality in patients with Huntington’s disease. It racked up another approval in August for tardive dyskinesia in adults.
"Following the successful development programs for Austedo in chorea associated with Huntington's disease and tardive dyskinesia, we believe this partnership represents a win, win, win scenario for patients, Teva and Nuvelution, and our investors Clarus and Novo Holdings," Nuvelution CEO Sandy Zweifach said in the Sept. 19 statement.
While no early sales figures have been spotted so far for Austedo, analysts predicted revenues of $29 million in 2017 and $207 million by 2021 following the Huntington's disease approval. There are only three drugs green lighted by the FDA to treat Tourette syndrome — haloperidol, pimozide, and aripiprazole — and these come with a range of unwanted side effects.
Neurocrine Biosciences Inc. is developing its own potential treatment, Ingrezza (valbenazine), but the drug failed to reach its primary endpoint in the Phase 2 T Force GREEN study. So the introduction of a new indication for Austedo could provide another option for children with Tourette's, as well as a much-needed new source of income for Teva.
The company has been struggling of late, with debt and legal challenges, and it hopes to solve some of its financial woes through the sale of its global women's health business. Through three separate deals over the last week or so, Teva offloaded its portfolio for about $2.5 billion. The Israeli drugmaker also plans to divest its European oncology and pain businesses, leaving it with a focus on CNS and respiratory disease.