1 Biotech, 1 Week, 2 FDA Decisions
Jul 30th 2012 3:21PM
Updated Aug 1st 2012 4:14PM
Regeneron Pharmaceuticals (NAS: REGN) has two Food and Drug Administration decisions coming up this week.
Only one has a chance at resulting in an approval, though.
First the bad news: An FDA advisory panel unanimously recommended against expanding Arcalyst's indication to include the treatment of gout. Arcalyst is currently approved for treating cryopyrin-associated periodic syndromes, but those are ultra-orphan diseases that don't affect that many patients. In the second quarter, Arcalyst sales were just $6 million.
The biotech is expected to hear from the FDA today about the approval, but given the advisory committee's recommendation, I'd be shocked if the agency went against the strong recommendation and approved the expanded indication. Regeneron's management has basically conceded defeat, waiting for the FDA rejection so it has an outline of what's required before Arcalyst can be resubmitted. Given that the FDA's outside advisors were worried about the safety of the drug, there may be nothing that Regeneron can do but leave the gout market to Savient (NAS: SVNT) , AstraZeneca (NYS: AZN) , BioCryst Pharmaceuticals (NAS: BCRX) and others developing gout treatments.
Regeneron's Zaltrap, which has a PDUFA date on Saturday, has a much better chance at an approval. The drug passed its phase 3 clinical trial in metastatic colon cancer, and side effects shouldn't be a problem given the life-threatening nature of colon cancer.
While an approval looks likely, it doesn't look like Zaltrap will be providing much to Regeneron's bottom line in the near future since the biotech got its partner Sanofi (NYS: SNY) to pick up the development cost, but has to repay that before it can start reaping profits from the drug.
For now, Regeneron will have to rely on its macular degeneration drug, Eylea. Good thing the launch is going better than planned.
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