Biohaven suckerpunched by CRL tied to Apotex warning letter

FDA Building 2
Biohaven Pharmaceutical has submitted new information to the FDA after getting a CRL for its use of an Apotex API two years ago. (FDA)

The sting of the FDA slapping Apotex with a warning letter has been felt by a U.S. biotech which used an API from the cited facility in a bioequivalence study. 

Biohaven Pharmaceuticals says it was issued the complete response letter for an application for its version of riluzole for treating amyotrophic lateral sclerosis (ALS). The only reason the FDA gave for issuing the CRL, Biohaven says, was the use of the Apotex API that was manufactured at a plant in India between 2014 and 2016 and used in Biohaven’s 2017 bioequivalence study.

"We are doing everything possible to work with the FDA and the API manufacturer to resolve this matter, which we believe to be more technical in nature,” Biohaven Chief Medical Officer Robert Berman said in a statement. “We believe that the quality issues surrounding the Apotex manufacturing facility do not affect the conclusions of our bioequivalence study but will work collaboratively with the FDA to resolve this matter as quickly as possible." 

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The New Haven, Connecticut company says it learned from the CRL that FDA had issued with the Apotex plant before it did its study using the API and had given Apotex recommendations for resolving them. Apotex never even gave the biotech a heads up about the problems identified by FDA inspectors that would lead to the 2018 warning letter.

“Apotex did not provide Biohaven with notice of the FDA communication, either during the course of its bioequivalence trial or during the submission of its 505(b)2 application for Nurtec (riluzole),” Biohaven explained. 

Just this month, the FDA accepted from Apotex the surrender of 31 drug approvals which the company had voluntarily withdrawn in late 2017 shortly before the FDA issued the warning letter for the Indian plant, its third in four years. The July 10 decision, which came after Apotex declined a hearing, formalized the Apotex surrender. 

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Biohaven, which has a different supplier for commercial production of its treatment Nurtec, says it is working to resolve the issue with the FDA. It has already submitted additional info to the agency. The company said that while it works with the FDA on a “path forward” and timeline to resolve the concerns, it will “redeploy the associated funds for Nurtec (riluzole) commercialization to other commercial needs of the organization.”

Apotex has a long history of FDA actions for a number of its plants. Its future has come into question since the still-unsolved murder in December 2017 of its founder and chairman Barry Sherman and his wife, Honey, at their suburban Toronto home. There have been reports that the company will go on the market. 

Biohaven's future is also being discussed as it grabs attention with its offering in a new class of CGRP migraine drugs, which analysts at Piper Jaffray think has blockbuster potential and Jefferies analyst Michael Yee has suggested that Biogen might be sizing up Biohaven as a takeout target.