Teva Pharmaceuticals has struck a deal to buy Emalex Biosciences for $700 million upfront, positioning the drugmaker to advance a Tourette syndrome candidate that is on the cusp of approval.
The deal centers on ecopipam, a dopamine D1 receptor antagonist that Teva expects to submit for FDA approval in the second half of the year. Emalex reported phase 3 data on the drug candidate last year, linking ecopipam to statistically significant improvements in control of vocal and motor tics compared to placebo.
Teva has flagged the asset as a good fit for its capabilities, leading the company to offer the upfront and up to $200 million in commercial milestones for Emalex. On an earnings call Wednesday, CEO Richard Francis said Teva’s sales, marketing, market access and patient services capabilities can drive uptake of the molecule.
Francis cited Teva’s handling of Austedo and Uzedy, neuroscience treatments that grew 41% and 62%, respectively, in the first quarter, as evidence that the company can expand the Tourette market once it launches ecopipam. The company will hire a small pediatric sales force for ecopipam, Francis said, but will also leverage its existing expertise in movement disorders and psychiatric conditions.
If approved, ecopipam will enter a market served by antipsychotics and the off-label use of alpha-2 adrenergic agonists. Francis said patients typically receive cognitive behavioral intervention therapy after presenting with symptoms, progressing to alpha-2 adrenergic agonists and later antipsychotics if needed.
Yet while drugs are available, Teva is betting that none of the treatments have the right mix of safety and efficacy. Alpha-2 adrenergic agonists “are generally safe but maybe do not offer the efficacy for many patients,” Francis said. One study found that up to 61.2% of people may have discontinued treatment with the drugs within three months.
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People failed by alpha-2 drugs are offered antipsychotics, but such drugs have metabolic and neurologic side effects that lead many families to discontinue or avoid the class, the Teva CEO said. Parents are hesitant to put a 10-year-old on an antipsychotic for the next decade, Francis said, and need a long-term solution for the chronic pediatric condition.
By delivering meaningful efficacy with a good side effect profile, ecopipam could become a preferred later-line therapy, the Teva CEO said. Francis predicted that ecopipam’s price will reflect its profile and the rarity of the condition, which the CEO said affects about 100,000 children. Teva’s CEO declined to provide a peak sales forecast for ecopipam when asked by an analyst on the earnings call.
