Recently, the US Food and Drug Administration (FDA) announced that it will decide upon approving Regeneron Pharmaceuticals Inc.’s (REGN) eye treatment VEGF (vascular endothelial growth factor) trap-eye by November 18, 2011. The fate of the eye-drug, trade-named Eylea was to be decided originally by August 20, 2011.
The US regulatory body extended the review period as it requires more time to scrutinize the recent responses to queries regarding the chemistry, manufacturing, and controls (CMC) section present in the biologics license application (BLA) submitted by Regeneron. The BLA seeks marketing approval of the drug for treating patients suffering from the neovascular form of age-related macular degeneration (wet AMD) was submitted 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 no less effective than Lucentis.
Regeneron has co-developed the eye-therapy with Bayer (BAYRY). Per the agreement, Bayer is responsible for marketing VEGF trap-eye in ex-US markets on approval. The profit earned from the sales of the candidate in those markets will be shared equally by the companies. However, Regeneron will reserve the entire US rights pertaining to VEGF trap-eye. Applications seeking marketing approval of the candidate have already been filed by Bayer in the European Union and Japan.
Apart from wet AMD, Bayer and Regeneron are studying VEGF trap for other eye-disorders such as Central retinal vein occlusion (CRVO), diabetic macular edema (DME) and myopic choroidal neovascularization (mCNV). Approval of the candidate for multiple indications would boost the top line both at Bayer and Regeneron.
Our Recommendation
Currently, we have a Neutral stance on Regeneron in the long run. The company carries a Zacks #4 Rank (Sell rating) in the short run.
BAYER A G -ADR (BAYRY): Free Stock Analysis Report
NOVARTIS AG-ADR (NVS): Free Stock Analysis Report
REGENERON PHARM (REGN): Free Stock Analysis Report
Get all Zacks Research Reports and be alerted to fast-breaking buy and sell opportunities every trading day.
Be the first to comment