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Regeneron shares up on AMD studies

Data from two phase III studies suggests Regeneron/Bayer AMD treatment, VEGF Trap-Eye, may have advantage over Genentech's Lucentis

Regeneron Pharmaceuticals and Bayer HealthCare have released data from two phase III studies suggesting that their investigational treatment for age-related macular degeneration VEGF Trap-Eye (aflibercept) may have a significant advantage over Genentech's marketed drug for the indication, which is among the company's top-ten products in terms of annual sales.

Following the release of the data, shares of Regeneron spiked more than 19 per cent, closing at $29.53 on Monday, November 22. 

The studies, known as VIEW-1 and VIEW-2, enrolled patients with the neovascular form of age-related macular degeneration (wet AMD) and found that VEGF Trap-Eye demonstrated statistical non-inferiority compared to Genentech's Lucentis (ranibizumab) in the proportion of patients who maintained or improved their vision over 52 weeks. 

Because VEGF Trap-Eye can be dosed every two months, whereas Lucentis must be given every month, it is likely to be preferred by healthcare providers and patients, particularly given that both drugs must be administered as injections directly into the eye. 

The North American VIEW 1 study found that 95 per cent of patients receiving VEGF Trap-Eye 2mg every two months achieved maintenance of vision over 52 weeks, compared to 94 per cent of patients receiving Lucentis 0.5mg once a month.  The VIEW 2 study was conducted internationally and found that 96 per cent of patients receiving VEGF Trap-Eye 2mg every two months achieved maintenance of vision over 52 weeks compared to 94 per cent of patients receiving Lucentis 0.5mg dosed every month.   

Both drugs have a generally positive safety profile, with the most frequent adverse events being associated with the injection procedure, the underlying disease, and/or the aging process, according to Regeneron and Bayer. 

The studies will be continued for another year to test the efficacy of dosing VEGF Trap-Eye just once every three months.   

Regeneron and Bayer plan to submit US and European marketing applications for VEGF Trap-Eye, which is a fully human fusion protein, in the first half of 2011.

The market for wet AMD treatments is expected to grow as the population ages. The disease, in which new blood vessels grow beneath the retina and leak blood and fluid, is the leading cause of blindness for people over the age of 65 in the US and Europe.

VEGF Trap-Eye is also in phase III development for the treatment of central retinal vein occlusion and phase II development for the treatment of diabetic macular edema. Initial data from the CRVO programme are anticipated in early 2011, while one-year results from the DME trial should be available before the end of 2010.

23rd November 2010

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