Deficiencies Found at Manufacturing Site Could Delay Approval of Sanofi Genzyme's Next Blockbuster

Deficiencies Found at Manufacturing Site Could Delay Approval of Sanofi Genzyme's Next Blockbuster October 28, 2016
By Mark Terry, BioSpace.com Breaking News Staff

Paris-based Sanofi and its partner Regeneron are waiting on the U.S. Food and Drug Administration to make a decision on their drug sarilumab for rheumatoid arthritis. The drug’s PDUFA date is Sunday, October 30, so it is possible the FDA will make the decision today. However, in its third-quarter report, released this morning, Sanofi noted that “manufacturing deficiencies have been raised by the FDA during a routine Current Good Manufacturing Practice (CGMP) inspection of a Sanofi manufacturing facility.”

The facility, dubbed “Le Trait,” is located in Normandy, France. The company indicated in a statement, “Given that the CGMP status of this facility is still under review by the FDA, it is unclear whether this situation will impact the approval for sarilumab.”

The drug is also being reviewed by the European Medicines Agency (EMA). The drug is a human monoclonal antibody against the IL-6 receptor.

The two companies have projected peak sales for the drug at over $1 billion if approved. It showed itself in clinical trials to be more effective than AbbVie ’s Humira for RA.

Sanofi stated that the facility “conducts ‘fill and finish’ activities. Sanofi has provided comprehensive responses to the FDA for the cited deficiencies.”

In its third-quarter report, Sanofi also indicated that the FDA was reviewing its Biologics License Application (BLA) for Dupixent (dupilumab) for moderate-to-severe atopic dermatitis. The PDUFA date for that drug is March 29, 2017. The company’s SAR342434 (insulin ilispro) was being reviewed in Europe for the treatment of diabetes.

In August, the company submitted updated information as part of the New Drug Application (NDA) for iGlarLixi, also known as LixiLan to treat type 2 diabetes. The additional information as requested by the FDA, and is a “Major Amendment to the NDA, resulting in an extension of the Prescription Drug User Fee Act goal date by three months, to late November 2016.”

Sanofi also indicated that, at the end of October, it had 43 new molecular entities in its research-and-development pipeline, and 12 are in Phase III trials or have been submitted for approval to regulators.

The financial report also showed that its biotechnology division in Cambridge, Mass. was the largest growth driver for the company. Sanofi Genzyme revenue increased 17 percent to $1.4 billion in the third quarter compared to the same period last year. The division’s revenue for the first nine months of this year rose 19 percent to more than $4 billion.

Regeneron is also partnered with Sanofi for dupilumab, to treat eczema. That drug is projected to bring in more than $3 billion in sales if approved. It was accepted for review by the FDA in September.

The current headache with the manufacturing facility may or may not send ripples through its relationship with Regeneron. Arsalan Arif, writing for Endpoints News, says, “For Sanofi, it’s a fresh reminder of just how much is riding on its relationship with Regeneron, which is also advancing dupilumab under their collaborative relationship. For Regeneron, it’s also a reminder of Sanofi’s often star-crossed attempt to advance new meds into the market.”

Sanofi is currently trading for $39.07.

Regeneron is currently trading for $356.91.

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