Teva Catches A Break On Copaxone 40mg, But For How Long?
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.
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Execs were pushed for details during earnings call but offer minimal clarity. Teva is sticking by the guidance issued before its loss in Copaxone patent case, and is upping investment in promoting the brand while the decision is appealed.
After a damaging court ruling on Copaxone 40 mg and some management missteps, CEO Erez Vigodman will step down as CEO of the Israeli generic drug leader. Chairman Yitzhak Peterburg will fill in on an interim basis.
Teva is seeking injunction to block generic entry after court rules four patents on the three-times-a-week dosage are invalid; analysts expect launch soon after FDA approves an ANDA, with Sandoz/Momenta generic the likely leader.