Bayer has applied for marketing authorisation in Europe of VEGF Trap-Eye, partnered with Regeneron Pharmaceuticals, for the treatment of wet age-related macular degeneration.
The submission is based on results from two Phase III trials which showed that all regimens of VEGF Trap-Eye (aflibercept), including 2mg dosed every two months (following three loading doses) successfully met the primary endpoint of non-inferiority compared to the current standard of care, Roche and Novartis' blockbuster Lucentis (ranibizumab) 0.5mg, which is dosed every month.
Kemal Malik, head of global development at Bayer HealthCare, noted that 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,” he added.
Regeneron submitted a Biologics License Application for marketing approval in wet AMD in the USA in February and received a priority review designation. As well as wet AMD, the companies are developing VEGF Trap-Eye for central retinal vein occlusion, diabetic macular oedema and myopic choroidal neovascularisation.
End of Philogen pact finalised
Meantime, the terms of Bayer's termination of its collaboration with the Italian-Swiss biotech Philogen have been announced.
In February, the Siena-based firm, whose Philochem R&D unit is headquartered in Zurich, pulled an initial public offering at the last minute after Bayer pulled out of a pact the cancer treatments radretumab and darleukin, which are in Phase II. Now the 12-year collaboration has been "consensually resolved".
Philogen says Bayer has agreed to return full ownership of the two products and will make an undisclosed payment, mainly for the completion of the ongoing studies. In return, the German drugmaker will receive royalties on any future sales from the drugs.