Recently, Regeneron Pharmaceuticals Inc. (REGN) and partner Bayer (BAYRY) announced the commencement of a phase III study (VIVID-DME) to evaluate the safety and effectiveness of their VEGF (vascular endothelial growth factor) trap-eye treatment. The late-stage study will evaluate patients suffering from Diabetic Macular Edema (DME).
DME refers to a disease of the retina that affects individuals suffering from diabetes and can lead to blindness. Positive results of VEGF trap-eye from a phase II study in DME patients (announced late last year) encouraged the partners to move the candidate into late-stage studies.
The VIVID-DME study is the first of the two late-stage studies for the indication. The study, conducted by Bayer, has started in Australia and will be expanded to Europe and Japan.
The other study (VISTA-DME) is expected to be initiated later in the year in the US, Canada and other countries. That study will be conducted by Regeneron. The successful development and commercialization of the candidate for the DME indication would strengthen the top line at Regeneron.
The partners are evaluating VEGF trap-eye in other eye disorders such as central retinal vein occlusion (CRVO) and choroidal neovascularisation (CNV) of the retina as a result of pathologic myopia.
CRVO is another major cause of blindness. While positive results from one late-stage study (COPERNICUS) for the indication were presented in December 2010, initial data from another late-stage study (GALILEO) is expected this year.
We note that in February 2011, Regeneron filed a biologics license application (BLA) to the US Food and Drug Administration (FDA) seeking approval to market the VEGF trap-eye therapy in the US to treat patients suffering from wet AMD.
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 (RHHBY)/Novartis’ (NVS) Lucentis (ranibizumab), an anti-angiogenic agent approved for treating wet AMD. Regeneron’s eye treatment was found to be as effective as Lucentis.
An application seeking approval of the eye treatment in Europe, for the wet AMD indication, is expected to be filed later in the year by Bayer. 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.
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. 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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