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Bad News Teva Really Doesn't Need: A Potential Delay For Fremanezumab

 
• By Jessica Merrill

One of Teva's few bright spots is its leading position in the big new commercial opportunity for migraine, but its CGRP drug fremanezumab could now be delayed by an issue at third-party manufacturer Celltrion.

production line

Investors in Teva Pharmaceutical Industries Ltd. don't have much reason for optimism, and now news that an important new drug, fremanezumab for migraine, could be delayed at the US FDA because of a manufacturing issue casts a dark cloud over one of the only bright spots.

Teva reported in its fourth quarter and full year 2017 earnings release Feb. 8 that fremanezumab could be delayed at the FDA because of a manufacturing issue at its third-party manufacturer Celltrion Inc. The South Korean biologics manufacturer is the sole source for active pharmaceutical ingredient (API) production for fremanezumab, which is one of three CGRP inhibitors pending at FDA for migraine

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