This account is pending registration confirmation. Please click on the link within the confirmation email previously sent you to complete registration. Need a new registration confirmation email? Click here
February 2, 2012 /PRNewswire/ --
Company to Re-Submit Ocriplasmin BLA to Meet Priority Review Timelines
ThromboGenics NV (Euronext Brussels: THR), a biopharmaceutical company focused on developing innovative ophthalmic medicines, today announces that the FDA intended to grant its recently-submitted ocriplasmin BLA (Biological License Application) for Priority Review. The FDA grants Priority Review designation to drugs that may offer major advances in treatment, or provide a treatment where no adequate therapy exists. The FDA has a goal of completing a Priority Review in just six months.
Consequently, ThromboGenics has withdrawn its current filing and will re-submit a BLA for ocriplasmin for symptomatic VMA including macular hole by
April 2012. The re-submission,for which the FDA is expected to grant a Priority Review, will allow ThromboGenics to meet the Pre-Approval Inspection timelinesand to manage the phasing of its resources to support both its European and U.S. ocriplasmin filings.ThromboGenics made its original BLA filing for ocriplasmin, for standard review for the same indication, just over one month ago.
Dr. Patrik De Haes, the CEO of ThromboGenics, said:"We are pleased that the FDA has indicated that ocriplasmin meets its criteria for Priority Review. This reflects our view that ocriplasmin could represent an important advance in the treatment of symptomatic VMA including macular hole. We remain on track to meet our timelines for making ocriplasmin available to the many patients suffering from this sight-threatening disorder."
ThromboGenics is a biopharmaceutical company focused on developing innovative ophthalmic medicines. The Company's lead product ocriplasmin has successfully completed two Phase III clinical trials for the pharmacological treatment of symptomatic vitreomacular adhesion (VMA). The MAA for ocriplasmin has been accepted for review in
Europe and the BLA will be re-submitted in the U.S.by
April 2012. Ocriplasmin is in Phase II clinical development for additional vitreoretinal conditions.
ThromboGenics is also developing novel antibody therapeutics in collaboration with BioInvent International. These include TB-402 (anti-Factor VIII), a long-acting anticoagulant in Phase II, and TB-403 (anti-PlGF), in Phase Ib/II for cancer in partnership with Roche.