Developers: Sanofi and Regeneron
Discovery: Regeneron scientists designed the biologic
Lead indication: Colorectal cancer
Key date: PDUFA date is Aug. 4
Sanofi ($SNY) and Regeneron Pharmaceuticals ($REGN) have a solid case for grabbing an approval for Zaltrap for treating colorectal cancer after they scored positive survival data in a Phase III trial of the drug last year. U.S. regulators have granted a speedy review of the companies' application for approval in those tumors, as announced early this month.
While the anti-angiogenesis drug has shown promise in attacking colorectal cancer, Zaltrap has flunked major studies in prostate and lung cancers, limiting the commercial potential of the drug. Most recently Sanofi and Regeneron revealed that a late-stage study of the drug had failed to meet the overall survival endpoint in prostate cancer, disappointing news for a program that Sanofi CEO Chris Viehbacher has highlighted as one of the most promising in the French drug giant's pipeline.
With the failures in lung and prostate cancer, Viehbacher might not be looking at a blockbuster drug in Zaltrap. Based on the data on the drug in colon cancer, Zaltrap could bring in somewhere in the vicinity of $200 million in annual sales, Deutsche Bank analyst Robyn Karnauskas said last year, as quoted by Bloomberg. For Regeneron, which is much smaller than Sanofi, the approval of Zaltrap could have a greater impact.