Manufacturing woes derail a blockbuster contender from Sanofi/Regeneron. Who’s next?

Sanofi wasn’t fretting needlessly over the upcoming FDA decision regarding sarilumab.

The pharma giant and its biotech partner Regeneron $REGN announced Friday afternoon that the agency has turned thumbs down on the drug, issuing a complete response letter for a drug that was widely expected to be on a short path to a blockbuster approval.

As Sanofi $SNY flagged earlier in its Q3 review, the problem has more to do with the pharma giant’s manufacturing woes than Regeneron’s data on a drug expected to earn more than a billion dollars a year.

Here’s the statement:

The CRL refers to certain deficiencies identified during a routine good manufacturing practice inspection of the Sanofi Le Trait facility where sarilumab is filled and finished, one of the last steps in the manufacturing process.  Satisfactory resolution of these deficiencies is required before the BLA can be approved.  Sanofi submitted a comprehensive corrective action plan to the FDA and is implementing the corrective actions specified in that plan.  Sanofi is working closely with the FDA towards a timely resolution that addresses these concerns. The CRL does not identify any concerns relating to the safety or efficacy of sarilumab.

As we reported earlier Friday, Sanofi was worried that an FDA citation on manufacturing could prevent regulators from approving the drug, which has already beat out Humira in a head-to-head test on rheumatoid arthritis.

A number of companies have also been held back this year on manufacturing issues, including Portola $PTLA. On the same day that Sanofi/Regeneron put out word on their setback, Cempra $CEMP was also dinged after it told investors that it needed to scramble to line up a fresh supply of solithromycin — now under review — after regulators flagged issues with their main contract manufacturer. And the string of issues puts manufacturing concerns squarely in the center of biopharma’s problems with R&D productivity in 2016, as new drug approvals lag well behind last year.

Regeneron can shrug off a temporary setback like this, but Sanofi is likely to feel the sting.

Sanofi now ends up with a black eye on manufacturing after dealing with a retreat on its diabetes franchise, a largely fruitless solo R&D effort and a failed effort by new CEO Olivier Brandicourt to acquire Medivation. The company did get an OK for their PCSK9 drug, but that launch has started off much more slowly than expected.

For the pharma giant, it’s another sour note on a rough year. And some analysts are fretting that the setback on sarilumab could translate into a problem for the upcoming decision on dupilumab, which has much bigger implications. Leerink’s Geoffrey Porges, who thinks the manufacturing issue could be resolved in a few months, notes:

(I)f the remediation is not completed in the next 3 months, then it becomes more material, since it could then impinge on our expected timing for the dupilumab approval (PDUFA date 03/29/2017). At this stage we are pushing our timeline for sarilumab approval out to mid 2017, but are leaving our dupilumab approval timeline at the PDUFA date of March 29, 2017. While five months seems more than enough time to address issues in a fill-finish facility, the process of re-inspection, agency endorsement and then re-starting the approval process can be surprisingly slow in such situations.

We’ll keep you posted.

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Research Scientist - Immunology
Recursion Pharmaceuticals Salt Lake City, UT
Director of Operations
Atlas Venture Cambridge, MA

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