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ThromboGenics NV (Euronext Brussels: THR), a biopharmaceutical company focused on developing innovative ophthalmic medicines, today issued an update on its filing plans and pre-commercialization activities for its lead product ocriplasmin.
ThromboGenics is pleased to report that it is making good progress in preparing the dossiers that it plans to file with the EMA and FDA in order to gain marketing approval for ocriplasmin in Europe and the U.S. respectively. The Company expects to make the first ocriplasmin filing with the EMA in the next two months with the FDA filing taking place before year end. To-date ThromboGenics’ discussions with both regulatory authorities have been encouraging and supportive.
In parallel with this regulatory activity, ThromboGenics has continued to invest in its pre-commercialization activities for ocriplasmin. A key element of these activities has been the presentation of the positive Phase III MIVI-TRUST trial data by leading retinal specialists at many of the most important ophthalmology conferences in both the U.S. and Europe. The retinal community’s reaction to these presentations and to ThromboGenics’ other medical education activities for ocriplasmin has also been very positive.
Dr Patrik de Haes, CEO of ThromboGenics said, “I am very pleased to report that we are making excellent progress towards our key goal of bringing ocriplasmin to market by the end of 2012. We plan to make our first regulatory filing in Europe in the next two months and we intend to file with the FDA before year end. Our continuing dialogue with the retinal community based on our positive Phase III results gives me great confidence that ocriplasmin, if approved, will rapidly become an attractive pharmacological treatment option for patients with important retinal disorders such as symptomatic vitreomacular adhesion and macular hole.”
ThromboGenics is a biopharmaceutical company focused on the discovery and development of innovative medicines for the treatment of eye disease, vascular disease and cancer. The Company’s lead product ocriplasmin (microplasmin) has successfully completed two Phase III clinical trials for the pharmacological treatment of symptomatic vitreomacular adhesion (sVMA). Ocriplasmin is also being evaluated 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.
ThromboGenics is headquartered in Leuven, Belgium. The Company is listed on NYSE Euronext Brussels under the symbol THR.
Source: ThromboGenics
Tags: new products
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