Sanofi has experienced a series of internal setbacks on the R&D front in recent months, but its close partnership with Regeneron is still paying off with promising late-stage data.
On the heels of new guidelines casting doubts on a much-hyped new class of cholesterol drugs, the FDA said it would not demand long and costly outcomes trials before approving PCSK9 treatments from the likes of Amgen, Sanofi and Regeneron, clearing the way for treatments expected to rake in up to $3 billion a year.
Regeneron once again beat expectations with its quarterly earnings. And once again, the company raised its forecast for Eylea, the vision-loss drug that's fueling much of its growth. But once again, Regeneron said that sales growth for Eylea was slowing down as patients use fewer doses.
With sales of eye drug Eylea growing at breakneck pace and a couple of promising candidates in its pipeline, Regeneron needs some more space.
With blockbuster sales of Eylea spurring some gangbuster projections for Regeneron's future, the booming biotech today launched construction of a 300,000-square-foot R&D facility at its campus in Westchester County, NY.
The positive data keep rolling in for Regeneron's Eylea. Monday, the company said its blockbuster eye drug improved vision loss in patients with a condition caused by blood clots in the retinal veins, opening up another potential avenue for its rapidly expanding market.
Sanofi and Regeneron have rolled out promising Phase III data on their cholesterol drug alirocumab, which handily breezed by Merck's Zetia in lowering bad LDL cholesterol. The partners are in a high-stakes race to win the first regulatory approval for a PCSK9 inhibitor.
In drug development, everything's a gamble, if you're doing something new and shooting at a big target. But there has to be a reasonable assumption that if safety issues aren't being glossed over and the efficacy data hold up, these top drugs can change standards of care and grab market share. So here's my pick of the likely big winners >>
Being an R&D chief at a major biopharma company in today's environment of major research cutbacks, patent expirations and pressure from investors to speed new drugs to market is no easy...
In an industry like pharma, you're only as good as your next big Phase III study. And hopes are running very, very high for the first round of late-stage results on the PCSK9 drug alirocumab from Sanofi and Regeneron.