Sanofi ($SNY) and partner Regeneron ($REGN) have become the latest biopharmas to be hit by a complete response letter from the FDA this year for manufacturing concerns as its experimental arthritis med sarilumab now faces months of delay.
Earlier this year, it had seemed so straightforward that at the end of October, its PDUFA date, the Big Pharma-Big Biotech pairing would get the U.S. nod for its IL-6R contender in rheumatoid arthritis.
It had a strong data package for the FDA, and in March also showed that it could beat out AbbVie's ($ABBV) top-selling Humira (adalimumab) in a Phase III head-to-head.
But on Friday, the French and U.S. companies released a statement saying they had been hit with a formal letter from the FDA saying it would not be approving the med over “certain deficiencies identified during a routine good manufacturing practice inspection of the Sanofi Le Trait facility where sarilumab is filled and finished.”
Timings have not been given, but the French drugmaker said: “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 company said the FDA was not worried about any safety issues with the med.
The treatment has long been pegged as a blockbuster in waiting, with 2020 sales predicted to hit $1.8 billion, according to analyst estimates compiled by EvaluatePharma.
Evercore said in a note to clients over the weekend that though a setback, it believes Sanofi when it says the manufacturing issues appear to be fixable, “although the exact timeline is unclear.”
The firm added that although the “news is not ideal,” it does not see sarilumab as a major driver for Regeneron’s top line in coming years, and said its consensus peak end-user sales are “slightly more than ~$1B in 2025.” As Regeneron profit shares with Sanofi on this, “a delay in launch does not significantly affect valuation.”
The two companies are also awaiting an EU decision on the med, after submitting to the EMA back in August.
There are other agents against the IL-6 axis either marketed or in development, including Roche’s ($RHHBY) Actemra (tocilizumab) and Glaxo’s ($GSK) sirukumab (an IL-6 ligand), and other meds from UCB and Ablynx.
This follows a number of manufacturing CRLs this year, most notably AstraZeneca’s ($AZN) hyperkalemia drug ZS-9, which was knocked back by the FDA in May for issues relating to its new biotech addition ZS Pharma and concerns over a “pre-approval manufacturing inspection.” It took AZ 5 months to get a new submission to the FDA.
Back in July, Valeant ($VRX) also saw the FDA slap a CRL on the company in regards to its NDA for Vesneo (latanoprostene bunod ophthalmic solution), again over manufacturing concerns.