Recently, the US Food and Drug Administration (FDA) announced that its Dermatologic and Ophthalmic Advisory Committee will meet on June 17, 2011 to review the biologics license application (BLA) submitted by Regeneron Pharmaceuticals Inc. (REGN) for its VEGF (vascular endothelial growth factor) trap-eye treatment.
The BLA seeking marketing approval of the drug was submitted by Regeneron in February 2011. The BLA was based on positive results from the VIEW program (VEGF Trap-Eye: Investigation of Efficacy and Safety in Wet AMD) which consisted of two studies, VIEW 1 and VIEW 2.
The studies evaluated the efficacy of VEGF trap-eye versus Roche/Novartis’ (RHHBY/NVS) Lucentis (ranibizumab), an anti-angiogenic agent approved for treating wet AMD. Regeneron’s eye treatment was found to be as effective as Lucentis.
At the time of submitting the application, Regeneron requested the FDA to review it on a priority basis which would mean a six-month review period as against the usual ten months. The FDA granted the request in April 2011 and assigned a target date of August 20, 2011. We note that the US regulatory authority generally reviews those drugs on a priority basis which offer major advances in treating diseases having no adequate therapy.
Regeneron is seeking clearance from the US regulatory body to market the drug for treating patients suffering from the neovascular form of age-related macular degeneration (wet AMD).
The condition results from the growth of new blood vessels beneath the retina which leak blood and fluid. The leakage causes the retina to function improperly thereby resulting in distortion and/or blind spots in central vision. The disorder is the leading cause of blindness in patients above 65 years in the US and Europe.
FDA approval of the candidate would not only bolster Regeneron’s top line but would also provide additional options for patients suffering from the eye-disease. Moreover, an application seeking approval of the eye treatment in ex-US markets is expected to be filed in the second quarter of the year by partner Bayer (BAYRY).
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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