Advertise With UsAdvertise on our extensive network of industry websites and newsletters.
Get the PBR newsletterSign up to our free email to get all the latest PBR
news.Insmed, a developer of follow-on biologics and biopharmaceuticals, and Premacure, a biopharmaceutical company, have announced that the European Medicines Agency has granted Premacure orphan designation for Insmed's Iplex product, also known as mecasermin rinfabate, for the prevention of retinopathy of prematurity in neonates of less than 32 weeks of gestational age.
Subscribe to our email newsletter
Premacure intends to initiate a Phase II multicenter trial for Iplex in the retinopathy of prematurity indication during the second quarter of 2009.
With an orphan designation in Europe, Premacure is eligible for protocol assistance, as well as fee reductions for pre-authorization activities, including the application for marketing authorization, and inspections. Post-authorization activities, such as variations and annual fees, are also subject to fee reductions.