Tavapadon

Mizuho Securities analysts model peak annual U.S. sales of tavapadon of $532 million. The backing singer in AbbVie’s $8.7 billion takeover of Cerevel Therapeutics is having its moment in the spotlight. Cerevel thrust tavapadon to the fore Thursday, reporting the success of a phase 3 Parkinson’s disease trial and providing a small boost to AbbVie as it works to close a deal focused on another asset.  Emraclidine, Cerevel’s midphase schizophrenia prospect, was the headline act when AbbVie disclosed the deal to buy the biotech late last year but tavapadon represents the first chance to start generating a return on the outlay. Tavapadon is a once-daily oral dopamine D1/D5 receptor partial agonist that is designed to balance meaningful motor control activity with a favorable tolerability profile. On Thursday, Cerevel provided the strongest evidence yet that the molecule strikes that balance. The data come from a phase 3 trial that randomized 507 adults with Parkinson’s and motor fluctuations. Subjects had to be on a stable dose of levodopa for at least four weeks prior to screening and continued to take the drug in combination with tavapadon or placebo once the trial began. Over the 27-week trial, patients who took tavapadon spent significantly more time without troublesome uncontrolled, involuntary movements, known medically as dyskinesia, than their peers on placebo. The study, which collected data using a self-completed home diary for motor function status, showed people on the drug spent 1.7 hours without troublesome dyskinesia, compared to 0.6 hours in the control arm. Cerevel also reported a significant reduction in the time patients had symptoms but is yet to share data on that secondary endpoint. Similarly, the biotech said the molecule was generally well tolerated, with no surprises and most adverse events being mild or moderate, but is holding off on providing a closer look at the safety data until medical meetings.  The meetings are part of a roadmap of updates on tavapadon that includes regulatory submissions and topline results from a pair of phase 3 studies that are testing the molecule as a monotherapy. Cerevel expects to share data from the other phase 3 trials in the second half of the year, by when AbbVie intends to close the acquisition.  Jeffrey Stewart, chief commercial officer at AbbVie, discussed tavapadon on a call with investors when the drugmaker announced the Cerevel takeover. AbbVie already has a presence in advanced Parkinson’s, with Duopa and is developing ABBV-951, but is absent from the earlier, oral segment targeted by tavapadon.  “Tavapadon ... could be a nice complementary product up in the more early phases of the condition, so distinct from where we play now, but also complementary in terms of our commercial infrastructure. We believe it's relatively modest—the bulk of the value does sit on emraclidine—but nonetheless a nice fit to where we can slot that in with our global teams across the world,” Stewart said. Mizuho Securities analysts model peak annual U.S. sales of $532 million, making it a “relatively small revenue contributor” in the context of Cerevel’s wider pipeline. That fact, coupled with the fact AbbVie is already set to buy the biotech, led the analysts to predict the data will have “very little material impact to the current [Cerevel] investment narrative” in a note to investors.