Come July 26, 2012 and Belgian biopharmaceutical company ThromboGenics NV will face an FDA advisory panel that will review its biologic license application for Ocriplasmin intravitreal injection, which is being developed for an eye disease.
ThromboGenics is listed on the NYSE Euronext Brussels under ticker (THR.BR) and on the OTC under ticker (TBGNF).
ThromboGenics is seeking approval for Ocriplasmin, whose proposed trade name is Jetrea, for the treatment of symptomatic Vitreomacular Adhesion, or VMA, otherwise termed Vitreomacular Traction, including macular hole, a debilitating eye disease. The company resubmitted the Ocriplasmin BLA with the FDA in April of this year after withdrawing the initial filing that was made on December 23, 2011.
ThromboGenics has a strategic partnership with Alcon, a division of Novartis AG (NVS), for the commercialization of Ocriplasmin in all markets outside the U.S. The total up-fronts and milestones, which ThromboGenics is entitled to receive from Alcon under the agreement that was signed on March 16 of this year is 375 million euros.
According to ThromboGenics, there are about 500,000 patients in the U.S. and major markets of the EU who would benefit from Ocriplasmin if it were approved for symptomatic VMA including macular holes.
A single injection of Ocriplasmin has been shown to resolve VMA and the visual symptoms associated with it in 29.8% of VMT (Vitreomacular traction syndrome) patients, compared with 7.7% of patients on placebo.
Ocriplasmin BLA, which has a priority review status, has a final FDA decision date set for October 17, 2012. The FDA usually follows the recommendations of its advisory panels, although it is not required to do so.
Ocriplasmin is also under review with the European Medicines Agency for the same indication - symptomatic Vitreomacular Adhesion including macular hole.
Will Ocriplasmin get a green signal from the FDA advisory panel? Stay tuned...
THR.BR closed Friday's session at 25.82EUR, down 0.23% on a volume of 128,400 shares.
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