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OUCH! FDA Spurns Regeneron (REGN), Sanofi (SNY)'s RA Drug Over Plant Deficiencies

10/31/2016 6:03:46 AM

OUCH! FDA Spurns Regeneron, Sanofi's RA Drug Over Plant Deficiencies October 31, 2016
By Alex Keown, Breaking News Staff

TARRYTOWN, N.Y. – Shares of Regeneron (REGN) are down 3 percent this morning as the company digests Friday’s Complete Response Letter issued by the U.S. Food and Drug Administration regarding the Biologics License Application for sarilumab, the rheumatoid arthritis drug it was co-developing with French drugmaker Sanofi.

The FDA objected to the drug due to certain deficiencies identified during a routine good manufacturing practice inspection of the Sanofi Le Trait facility in France where sarilumab is filled and finished, Regeneron said in a statement on Friday. Sanofi said it was addressing the issues cited, which are one of the last steps in the manufacturing process. The French company has filed a comprehensive corrective action plan with the FDA and “working towards a timely resolution that addresses these concerns.” Once the issues are addressed, both companies said they intend to seek a way to bring the drug to market.

The FDA’s CRL did not cite any concerns of efficacy or safety of sarilumab, an investigational interleukin-6 receptor (IL-6R) antibody. Data from a Phase III trial released in March showed that sarilumab outperformed AbbVie (ABBV)’s Humira. Regeneron and Sanofi (SNY) said its experimental sarilumab improved the signs and symptoms of rheumatoid arthritis (RA) patients after 24 weeks of use. Sarilumab is an investigational, human IL-6 receptor antibody designed to inhibit the inflammatory activity in. IL-6 is the most abundant cytokine in the serum and synovial fluid of patients with RA, and levels of IL-6 correlate with both disease activity and joint destruction, the companies said.
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Rheumatoid arthritis is the most common form of autoimmune arthritis. It’s a painful affliction affecting the hands and joints, but there are numerous treatments, such as Genentech (RHHBY)’s Rituxan or AbbVie’s Humira, that provide tremendous relief to patients. If approved, Sanofi and Regeneron’s sarilumab could become part of that treatment regimen. In January, the companies announced the U.S. Food and Drug Administration accepted the biologics license application for sarilumab for review. The FDA has a target action date of Oct. 30, 2016.

If approved sarilumab is expected to generate $557 million in annual revenue by 2022, according to analysts’ projections. In a filing with the U.S. Securities and Exchange Commission last week, Regeneron said the BLA for sarilumab continues to be under active review by the FDA and has an expected action date of Oct. 30, which was yesterday. It would seem the action date has been pushed back, but by how long, is not yet known.

Following the FDA CRL, shares of Sanofi stock slid, but not as much as Regeneron. Shares of Sanofi are trading at $38.87 as of 11:50 a.m. and Regeneron shares are at $346.89 as of 11:51 a.m. Last week, before the CRL was made public, Regeneron stock was trading at $365.35 per share.

The FDA has pegged other companies for manufacturing issues this year, including Valeant Pharmaceuticals (VRX), which had its experimental glaucoma drug was rejected due to issues at a Florida manufacturing site.

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