ThromboGenics Announces EMA Acceptance for Review of Marketing Authorisation Application for Ocriplasmin
LEUVEN, Belgium, October 19, 2011 /PRNewswire/ --
If Approved, Ocriplasmin Will be the First Pharmacological Treatment for Symptomatic Vitreomacular Adhesion (VMA) Including Macular Hole
ThromboGenics NV (Euronext Brussels: THR), a biopharmaceutical company focused on developing innovative ophthalmic medicines, today announced that the European Medicines Agency (EMA) has accepted for review the Marketing Authorisation Application (MAA) for ocriplasmin (2.5 mg/ml, solution for injection) for the treatment of symptomatic vitreomacular adhesion (VMA) including macular hole.
The ocriplasmin MAA will be evaluated through the EMA's Centralised Procedure with an official start date of October 19, 2011. If approved, ocriplasmin will gain marketing authorisation for all EU Member States simultaneously.
Symptomatic VMA is a progressive condition that if left untreated generally leads to retinal distortion, further decrease in vision and has potential for irreversible damage and complications. Market surveys conducted by ThromboGenics suggest that there are approximately 500,000 patients annually in the major markets of the EU and the US who could potentially benefit from ocriplasmin.
Dr Patrik De Haes, ThromboGenics' CEO, said: "The global ThromboGenics team is proud to have achieved the successful acceptance for review of the European MAA for ocriplasmin, a major corporate milestone. Ocriplasmin is also expected to be filed with the FDA in the U.S. by the end of the year. If approved, ocriplasmin will be the first pharmacological treatment for a condition that is currently only treated via surgery, and only after the patient's vision has significantly deteriorated.
"We are continuing to make excellent progress in building our commercial organisation in order to educate and support the retina specialist community, with the aim of ensuring ocriplasmin achieves its full therapeutic potential and delivers maximum benefit to patients."
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 Marketing Authorization Application for ocriplasmin has been accepted for review in Europe and the BLA is expected to be filed in the U.S. by the end of 2011. Ocriplasmin is also 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. More information is available at http://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.
For further information please contact:
Dr. Patrik De Haes, CEO
Chris Buyse, CFO
Citigate Dewe Rogerson
David Dible/ Nina Enegren/ Sita Shah
SOURCE ThromboGenics NV