Recently, the US Food and Drug Administration (FDA) delivered some encouraging news to Regeneron Pharmaceuticals Inc. (REGN) by deciding to review the biologics license application (BLA) for the company’s VEGF (vascular endothelial growth factor) trap-eye treatment on a priority basis. A response from the FDA is expected to be out by August 20, 2011. The BLA was submitted in February 2011.
Regeneron is seeking clearance from the US regulatory body to market the drug for treating patients suffering from 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.
Regeneron had requested the US regulatory body to review the application on a priority basis at the time of its submission. 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. Applications for priority review designated drugs are reviewed by the FDA within six months of submission as against the usual ten months.
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.
The approval of the candidate for wet AMD would not only bolster Regeneron’s top line but would 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 first half of the year by partner Bayer (BAYRY).
Our Recommendation
Currently, we have a Neutral stance on Regeneron in the long run, which is supported by the Zacks #3 Rank (short-term Hold rating) carried by the company.
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