Bayer submits Lucentis rival for European approval
pharmafile | June 7, 2011 | News story | Sales and Marketing | Bayer, Lucentis, Regeneron, VEGF Trap-Eye
Bayer Healthcare has submitted its new eye drug to European regulators for approval to treat age-related macular degeneration (wet AMD).
If approved VEGF Trap-Eye (aflibercept) will challenge Novartis/Roche’s Lucentis for a share of the eye disease’s lucrative treatment market.
Bayer is co-developing VEGF Trap-Eye with Regeneron and the partners are seeking a licence for it to treat the neovascular form of wet AMD.
Bayer Healthcare’s head of global development Kemal Malik said: “Currently available anti-VEGF therapies need to be dosed monthly to achieve the best possible efficacy. This has created a significant burden for wet AMD patients, their caregivers, and physicians because of the need to come to the doctor’s practice for monthly injections or monthly monitoring.
“Our large phase III programme demonstrated that patients treated with VEGF Trap-Eye 2mg every two months, following three loading doses, showed comparable efficacy compared to the current standard of care of monthly injections. We look forward to working closely with the EMA to bring this new medicine to patients with wet AMD.”
The VEGF Trap-Eye submission is based on the positive results from two phase III trials.
Results from the VIEW 1 and VIEW 2 trials showed various doses of the new drug were as good as the standard 0.5mg monthly injection of Lucentis. Significantly, this included a 2mg dose of VEGF Trap-Eye every two months – a dosing that is more convenient for patients, which the companies hope will give it an edge over Lucentis.
Lucentis has to be injected once a month into the eye to treat the degenerative eye disease, which is the leading cause of blindness for over 65s in the US and Europe.
The drug earned Novartis $1.2 billion in 2009 in markets outside the US, while it earned another $1.2 billion for Roche in the US alone.
Bayer and Regeneron hope to win a share of this lucrative market with their rival drug. Analysts Jeffries say VEGF Trap-Eye could hit peak sales of $2 billion, with Bayer and Regeneron splitting the revenues along the same ex-US/US lines as their rivals.
In February Regeneron submitted a Biologics License Application to the FDA for the drug in wet AMD in the US, where it has been granted Priority Review status.
The partners are also developing VEGF Trap-Eye for central retinal vein occlusion (CRVO), diabetic macular edema (DME), and myopic choroidal neovascularisation (mCNV).
Dominic Tyer
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