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July 3, 2012 /PRNewswire/ --
ThromboGenics NV (Euronext Brussels: THR), a biopharmaceutical company focused on developing innovative ophthalmic medicines, today announced that the U.S. Food and Drug Administration (FDA) has informed the Company that it has officially accepted the filing of the Biologics License Application for ocriplasmin intravitreal injection, 2.5 mg/ml and granted it Priority Review. The proposed indication of ocriplasmin intravitreal injection is for the treatment of symptomatic Vitreomacular Adhesion (VMA) including macular hole.
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's goal for completing a Priority Review and delivering a decision on marketing approval is six months. Given its decision to grant Priority Review the FDA has already scheduled an Advisory Committee meeting on
26 July 2012 to discuss the ocriplasmin BLA. The recommendation of the Advisory Committee will form part of the FDA's overall assessment of the ocriplasmin BLA. The FDA has assigned the ocriplasmin BLA a Prescription Drug User Fee Act (PDUFA) goal date of
17 October, 2012.
Dr Patrik De Haes, ThromboGenics'CEO, said: "The Company is happy that the FDA has granted ocriplasmin Priority Review. We are looking forward to our discussions with the FDA as we work to make ocriplasmin available to the many patients in the U.S. that could benefit from this novel treatment option."
ThromboGenics is a biopharmaceutical company focused on developing and commercializing 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), otherwise termed Vitreomacular Traction (VMT), including when associated with macular hole. The MAA for ocriplasmin has been accepted for review in
Europe and in the U.S. the FDA has accepted the BLA filing and granted it Priority Review.
March 2012, ThromboGenics signed a strategic partnership with Alcon (Novartis) for the commercialization of ocriplasmin outside
the United States. Under this agreement, ThromboGenics could receive up to a total of €375 million in up-front and milestone payments, plus an attractive level of royalties on Alcon's net sales of ocriplasmin. ThromboGenics and Alcon intend to share the costs equally of developing ocriplasmin for a number of new vitreoretinal indications.
ThromboGenics is also developing TB-403, a novel antibody therapeutic, in collaboration with BioInvent International, for cancer and non-cancer, including ophthalmology, indications.