Regeneron Seeks Label Expansion

Regeneron Pharmaceuticals Inc. (REGN - Analyst Report), which is looking to expand the label of its drug Arcalyst into the gout indication, recently announced that the US Food and Drug Administration (FDA) has accepted the company’s marketing application for review. A decision from the US regulatory body is expected to be out in the third quarter of 2012 (target date: July 30, 2012).

We remind investors that Arcalyst is already available in the US since 2008 as an injection for subcutaneous use for the treatment of cryopyrin-associated periodic syndromes (CAPS). CAPS is a group of rare genetic inflammatory conditions, including familial cold auto-inflammatory syndrome and Muckle-Wells Syndrome. The drug is marketed for treating adults and children 12 years and above.

However, since the population affected by CAPS is small, Arcalyst is not a significant contributor to Regeneron’s top line. Hence the move to expand the label of the drug is prudent.

Regeneron is seeking to get Arcalyst approved for preventing attacks of gout in patients initiating uric acid-lowering therapy. Regeneron submitted the supplemental biologics license application (sBLA) to the FDA in the third quarter of 2011. The application was submitted on the basis of encouraging data from late-stage studies.

If the FDA clears Arcalyst for the new indication then it would be a further boost for Regeneron. The company received FDA clearance to market its injectable eye drug Eylea (aflibercept) for treating patients suffering from the neovascular form of age-related macular degeneration (wet AMD) earlier in the month. The approval of Eylea was based on positive results from the VIEW program (VEGF (vascular endothelial growth factor) trap-eye: Investigation of Efficacy and Safety in Wet AMD) which consisted of two studies, VIEW 1 and VIEW 2.

Apart from wet AMD, Regeneron and partner Bayer (BAYRY - Analyst Report) are studying VEGF trap for other eye-disorders

Our Recommendation

Currently, we have a Neutral stance on Regeneron in the long run. The company carries a Zacks #3 Rank (Hold rating) in the short run.

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