Intra-Cellular Therapies fought hard to secure its antipsychotic Caplyta an initial FDA nod in schizophrenia in late 2019. Early sales in the first half of 2020 were only in the single-digit millions, but one analyst sees an opportunity for more than $1 billion after a new clinical trial win.
Top-line phase 3 results showed that Caplyta, added to lithium or valproate, led to significant improvement in depression over placebo in patients with bipolar disorder, as measured by two different questionnaires clinicians use to evaluate the severity of depressive episodes, Intra-Cellular said Wednesday.
The latest success, from Study 402, adds to a previous positive readout from the phase 3 Study 404 trial that tested Caplyta as a monotherapy. Now, the company plans to file the drug for an expanded label in late 2020 or early 2021.
Encouraged by the data, RBC Capital Markets analyst Brian Abrahams figured Caplyta could eventually hit $1.2 billion in global sales across several indications. “[W]e believe these results should clearly support label expansion in bipolar and ultimately give Caplyta a broad label akin to current branded next-gen atypical antipsychotics which sell $450M to $700M annually in the U.S. alone,” he wrote in a Wednesday note to clients.
As Abrahams sees it, Caplyta’s efficacy compares “reasonably well” to other existing bipolar depression meds, including Allergan's Vraylar and Sunovion’s Latuda. Plus, the drug’s safety profile “will be an important differentiator and driver of Caplyta’s future commercial success,” he said.
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The win is for Caplyta at a 42 mg daily dose, the same strength that’s approved for the treatment of schizophrenia. A lower, 28 mg regimen also showed a trend for a dose-related improvement in symptoms, though the data didn’t cross the statistical significance bar, according to the company.
However, there’s one uncertainty hanging over Intra-Cellular’s head. In the U.S.-only Study 401 trial, Caplyta monotherapy failed to top placebo on the Montgomery–Åsberg Depression Rating Scale (MADRS). The company attributed the flop to a strong showing for placebo. But to further complicate the situation, 28 mg Caplyta performed even worse than placebo in terms of mean MADRS change in that study.
That showing aside, there’s a ways to go before Caplyta can reach blockbusterland, if ever. The atypical antipsychotic brought in sales of only $1.9 million in the second quarter, below consensus of $2.9 million.
On the positive side, the drug has reached coverage of over 95% of patients in Medicare Part D and Medicaid, the two largest channels for the product, SVB Leerink analyst Marc Goodman noted in an investor report last month. New-to-brand scripts have been growing week over week, Intra-Cellular management said during a conference call on its Q2 performance. The company also just launched its first DTC campaign, dubbed “Real Progress.”
This year, Intra-Cellular also plans to start a clinical trial of Caplyta in major depressive disorder and launch first-in-human testing of a long-acting injectable formulation.