Sanofi, Regeneron buoyed by Ph3 colon cancer success for aflibercept

Just weeks after Sanofi-Aventis and Regeneron ($REGN) reported that their cancer drug aflibercept stumbled in a late-stage study of non-small cell lung cancer, researchers gave a thumbs-up to their top-line results produced in a Phase III study for colon cancer. While holding back the data for a scientific meeting, the two developers said that the drug--which will be sold as Zaltrap--is now on track to be filed for marketing approval later this year.

Robyn Karnauskas, a Deutsche Bank analyst, noted that the data could position aflibercept for about $200 million in annual sales, a solid though not spectacular revenue stream. The analyst added that "Zaltrap will take a piece of the pie," according to a report from Bloomberg's veteran biotech writer Rob Waters. Aflibercept is an angiogenesis inhibitor, which uses a new mechanism of action to shut down the blood supply that feeds tumors. The news offered a boost to Regeneron, which saw its shares surge more than 10 percent after it announced the late-stage results.

"We are pleased with the results of the Zaltrap Phase III study in this group of patients," said Debasish Roychowdhury, senior vice president and head of Sanofi's global oncology division. "We are committed to bringing Zaltrap to patients with advanced colorectal cancer and maximizing the therapeutic potential of this unique and exciting medicine."

Aflibercept has had mixed results for a range of ambitious studies mounted by the two developers. In the Phase III lung cancer study researchers reported that the drug failed the primary endpoint of increased overall survival, but hit a secondary goal of progression-free survival. At the time, some top cancer analysts agreed with Roychowdhury that lung cancer was a particularly difficult target. The two companies had also halted a program for ovarian cancer, leaving the colon cancer and hormone-refractory metastatic prostate cancer study in place.

Sanofi and Regeneron have developed a close working relationship over the years. Back in the fall of 2009 the pharma giant expanded its partnership with the Tarrytown, NY-based biotech company, making a commitment to pay more than a billion dollars to Regeneron over an eight-year period as they collaborated on promising new antibodies.

- here's the Sanofi release
- read the Bloomberg report