Sanofi CEO believes application-killing problems at fill-finish plant fixed this time around

Syringe
Sanofi expects an FDA reinspection at a fill-finish plant in France where issues led the FDA to turn down a drug application.

Sanofi CEO Olivier Brandicourt is looking for FDA inspectors to return to the scene of the crime this quarter and give a fill-finish plant in France the OK to manufacture two expected blockbusters that are key to the company’s future.

It was because of a long list of deficiencies at the fill-finish plant in Le Trait, France, that the FDA last October issued a complete response letter to Sanofi and partner Regeneron for experimental rheumatoid arthritis drug sarilumab. During a conference call about Q4 earnings (PDF), Brandicourt today said the FDA, based on responses the company submitted, deemed the plant now “acceptable.”

The CEO has said the company got positive feedback from the FDA after presenting a corrective plan to the agency. 

Assuming the on-site visit also plays out positively, the companies will resubmit their application for sarilumab by the end of March. Brandicourt said a successful revisit should also mean there will be no delay in the anticipated approval of dupilumab, a treatment for a severe form of eczema, which is also developed with Regeneron. The PDUFA date for it is March 29.

According to a forecast from Bloomberg, dupilumab should breach the $1 billion sales mark by 2019 and reach nearly $4 billion in sales five years out. The company is in need of a significant revenue boost given that its diabetes franchise is under pricing pressure in the U.S., resulting in relatively flat sales for 2016 and the expectation that earnings could be down as much as 3% this year.

At the point that the companies received the CRL, Sanofi had already been responding to the concerns that turned up during a July visit to the facility, a follow-up to an earlier inspection. And it was no small list of concerns: The FDA had more than a dozen observations, some for problems left unresolved from the earlier inspection.

A Form 483 from the visit included sharp rebukes to the company for repeatedly refusing “requested documentation for review of the CBER regulated product…” It also points to issues with mold and bacteria contamination at the plant that the FDA says Sanofi did not thoroughly explore to sufficiently determine a root cause.

Despite written or verbal assurances, there are no guarantees once inspectors get in the doors that they will not find new issues of concern. India’s Sun Pharma, after several years of work on a plant that was key to its U.S. offerings, had an FDA reinspection last December. Sun had hoped the visit would free the facility to submit applications for new products. Instead, Sun said that it had been issued another Form 483 with a list of items to be addressed.