Valeant upbeat on Phase 3 success for psoriasis drug
- Valeant Pharmaceuticals got a small dose of good news Thursday, reporting positive Phase 3 results for its psoriasis treatment IDP-118.
- The lotion, which contains halobetasol propionate and tazarotene, showed statistical significance to treatment with the "vehicle", hitting a treatment success rate of 45.33%.
- Combining the two ingredients, both approved for psoriasis as a single agent, may allow expanded use with fewer side effects. Data from a second confirmatory Phase 3 trial is expected in 2017.
Valeant is in the midst of trying to pivot away from a year filled with setbacks and self-inflicted wounds. Following accounting scandals , accusations of racketeering accusations and Congressional scrutiny, the company hopes to jumpstart its long-neglected R&D engine and separate itself from the "acquire and hike" tactics for former CEO Michael Pearson.
New chief executive Joseph Papa was upbeat about the data released, and the announcement led to a small uptick in the company's stock. Still, a crushing debt burden and floundering efforts to divest assets have kept optimism in Valeant's new look low.
As of January, Valeant had eight early- and seven late-stage dermatology products in its pipeline. Yet getting those products through development hasn't been completely smooth.
While Valeant's psoriasis monoclonal antibody brodalumab cleared an FDA advisory panel in July, the committee recommended a label warning of an increased risk of suicide due to the observation of six suicides in Phase 3 testing. In an additional stumble, Valeant lost the European rights to brodalumab to Leo Pharma that same month.
Elsewhere, the drugmaker was hit with a complete response letter for its eye drug Vesneo over the summer, setting back its regulatory timeline for a product once counted as a potential blockbuster.
- Valeant Pharmaceuticals Statement
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