Regeneron Pharmaceuticals, Inc. (REGN) and the HealthCare unit of Bayer (BAYRY) announced recently that their eye-drug Eylea has been cleared by the Australian Therapeutic Goods Administration (TGA). The regulatory body cleared Eylea for treating patients suffering from neovascular (wet) age-related macular degeneration (wet AMD).
The recommended dosage for the drug, also known as VEGF (vascular endothelial growth factor) trap-eye, is 2mg on a monthly basis for three successive months. The subsequent recommended dosage is 2 mg every 2 months.
The approval down under came on the basis of 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 Eylea versus Roche/Novartis’ (RHHBY/NVS) Lucentis (ranibizumab), an anti-angiogenic agent approved for treating wet AMD.
We note that Eylea is already available in the US since November 2011. Regeneron and Bayer are seeking to make Eylea available in additional markets for the wet AMD indication to increase the sales potential of the drug. The Australian approval is a step in that direction. Applications seeking marketing approval of the candidate in markets such as the European Union and Japan have already been filed by Bayer.
Per the agreement between the two companies, Bayer is responsible for marketing Eylea 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. Regeneron owns the entire US rights pertaining to the eye-drug. Following the Australian approval, Bayer intends to launch the drug in the second half 2012.
Apart from wet AMD, Bayer and Regeneron are studying Eylea for other eye-disorders such as central retinal vein occlusion (US target date September 23, 2012), diabetic macular edema and myopic choroidal neovascularization.
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. We have a similar stance on Bayer.
BAYER A G -ADR (BAYRY): Free Stock Analysis Report
NOVARTIS AG-ADR (NVS): Free Stock Analysis Report
REGENERON PHARM (REGN): Free Stock Analysis Report
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