ThromboGenics Resubmits BLA for Ocriplasmin With the FDA
LEUVEN, Belgium, April 17, 2012 /PRNewswire/ --
ThromboGenics NV (Euronext Brussels: THR), a biopharmaceutical company focused on developing innovative ophthalmic medicines, today announced that it has resubmitted a Biologics License Application (BLA) with the U.S. Food and Drug Administration (FDA) for ocriplasmin intravitreal injection, 2.5 mg/mL, for the treatment of symptomatic Vitreomacular Adhesion (VMA) including macular hole.
In February 2012, the FDA indicated that it intended to assign a Priority Review designation to the original BLA submission for the same indication filed in December 2011. Today's re-submission will allow ThromboGenics to meet the FDA's Priority Review timelines and to manage the phasing of its resources to support both its European and U.S. ocriplasmin filings. The European Medicines Agency is currently reviewing ThromboGenics' Marketing Authorisation Application (MAA) for ocriplasmin for the same indication.
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 six months.
Dr Patrik De Haes, ThromboGenics' CEO, said: "The resubmission of the BLA filing is a significant step in our strategy to commercialize ocriplasmin in the U.S., if approved. Gaining Priority Review designation for ocriplasmin, as anticipated, would further validate the potential of this novel pharmacological drug in treating symptomatic VMA including macular hole. Following our recent commercialization agreement with Alcon for the non-U.S. rights to ocriplasmin and our successful fundraising, we are well positioned to invest in building a first-class commercial organization in the U.S. and to realize the full global potential of ocriplasmin."
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). The MAA for ocriplasmin has been accepted for review in Europe and the BLA has been re-submitted in the U.S. Ocriplasmin is in Phase II clinical development for additional vitreoretinal conditions.
In 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 two novel antibody therapeutics in collaboration with BioInvent International. These are TB-402 (anti-Factor VIII), a long-acting anticoagulant in Phase II, and TB-403 (anti-PlGF), in Phase Ib/II for cancer which has been partnered with Roche.
ThromboGenics is headquartered in Leuven, Belgium. The Company is listed on the NYSE Euronext Brussels exchange under the symbol THR. More information is available at www.thrombogenics.com.
Important information about forward-looking statements
Certain statements in this press release may be considered "forward-looking". Such forward-looking statements are based on current expectations, and, accordingly, entail and are influenced by various risks and uncertainties. The Company therefore cannot provide any assurance that such forward-looking statements will materialize and does not assume an obligation to update or revise any forward-looking statement, whether as a result of new information, future events or any other reason. Additional information concerning risks and uncertainties affecting the business and other factors that could cause actual results to differ materially from any forward-looking statement is contained in the Company's Annual Report.
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SOURCE ThromboGenics NV