Sandoz's Less Frequently Dosed Copaxone Generic Glatopa Hits Teva Two Months Early
Teva said its 2018 revenue guidance reflected an April launch for the 40 mg dose of Glatopa, but Sandoz and partner Momenta announced FDA approval and the US launch of their less frequently administered Copaxone generic on Feb. 13.
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Teva announced lower third quarter sales, said it would miss it's 2017 profit forecasts and acknowledged looming debt challenges. It was only CEO Kare Schultz's second day on the job.
FDA cleared Mylan's generic version of Copaxone 40mg even after management warned investors not to expect action until 2018. Mylan said it will launch "imminently, but Teva said a launch ahead of the pending appeals case would be "at risk."
An FDA warning letter cites deficiencies at the Pfizer-owned manufacturing facility poised to produce a Momenta/Sandoz generic competitor. It’s unclear how long Pfizer might take to resolve the violations, which include particulates in finished products.