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Fourth Quarter Earnings Calls, In Brief

Executive Summary

Vertex/FDA in discussions on “breakthrough therapies”; Ipsen earnings hurting in EU; Pfizer discusses biosimilars; Krka likes emerging markets; Novo sees GLP-1 market competition stiffening

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Vertex Phase III For CF Combo Shows Power Of “Breakthrough” Designation

Pivotal trials for the combination of Kalydeco and VX-809 will measure safety and efficacy over 24 weeks, whereas Kalydeco monotherapy gained FDA approval on the basis of 56 weeks of data; Vertex and FDA developed the protocol together following a recent “breakthrough therapy” designation for the two-drug combo.

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