Novartis, which is cutting back on its U.S generics business in the face of a deteriorating U.S. market, has started the clock ticking for some of the 450 employees at a Colorado plant which it is closing as part of its consolidation.
Sandoz, the generics unit of the Swiss drugmaker, filed a WARN notice last week in Colorado, giving the required 60-day notification for the first 65 employees whose jobs will be lost as it prepares to close the solid dose plant in Broomfield.
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Sandoz said last fall it intended to wind down operations at the Broomfield plant over the course of two years and consolidate production of drug ingredients at a plant in Wilson, North Carolina. At the time, the drugmaker said in a statement that with the tough pricing situation in the U.S. generics market, it would discontinue or sell off “limited growth products.” Then a couple of months later, Novartis execs, including outgoing CEO Joseph Jimenez, suggested that the company was looking at all options for the U.S. generics operations, including spinning off the U.S. oral solids portion of its portfolio. They said the company will concentrate its U.S. efforts in complex generics and biosimilars.
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As their name suggests, however, complex generics are more difficult to develop, and Sandoz had a setback in that realm last week. Approval of its Advair generic was sidelined by an FDA complete response letter asking for more data for the drug. Novartis now says it’s “highly unlikely” the generic will launch this year. It was the third substitutable version of GlaxoSmithKline’s big-selling respiratory drug that the FDA has declined to approve for generics makers.