Regeneron's pre-filled Eylea syringe makes the FDA cut; CureVac inks pact with Yale
→ As the FDA reviews Novartis‘ $NVS rival brolucizumab (setting the stage for approval by the end of the year) — the formidable maker of Eylea, Regeneron, has managed to get a pre-filled syringe version of the eye treatment across the finish line — after an initial rejection — as it works to fortify its blockbuster franchise. Last August, the FDA allowed Regeneron $REGN to start marketing a 12-week regimen for Eylea for wet AMD patients, versus the original bi-monthly regimen. Brolucizumab is also a 12-week regimen, although Novartis has argued pivotal trial data suggests the drug was “consistently superior” to its Regeneron rival, which generated more than $4 billion in net US sales last year.
→ mRNA-focused CureVac, which so far received $420 million in equity investments from the likes of the Bill & Melinda Gates Foundation, is joining forces with Yale University to develop mRNA-based lung therapies. Typically, mRNA molecules teach human cells to produce therapeutic proteins or to mount an immune response. Under the deal, a Yale team, led by Geoffrey Chupp, will take charge of the discovery phase and present therapeutic candidates to CureVac for preclinical and subsequent clinical development. CureVac will shoulder the cost of the discovery research, and retain the option to acquire any rights to the potential assets. Financial details of the pact were not disclosed.