ThromboGenics Ltd. Announces That the FDA Intends to Grant Ocriplasmin Priority Review
LEUVEN, Belgium, February 2, 2012 /PRNewswire/ --
Company to Re-Submit Ocriplasmin BLA to Meet Priority Review Timelines
ThromboGenics NV (Euronext Brussels: THR), a biopharmaceutical company focused on developing innovative ophthalmic medicines, today announces that the FDA intended to grant its recently-submitted ocriplasmin BLA (Biological License Application) for Priority Review. 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 just six months.
Consequently, ThromboGenics has withdrawn its current filing and will re-submit a BLA for ocriplasmin for symptomatic VMA including macular hole by April 2012. The re-submission,for which the FDA is expected to grant a Priority Review, will allow ThromboGenics to meet the Pre-Approval Inspection timelinesand to manage the phasing of its resources to support both its European and U.S. ocriplasmin filings.ThromboGenics made its original BLA filing for ocriplasmin, for standard review for the same indication, just over one month ago.
Dr. Patrik De Haes, the CEO of ThromboGenics, said:"We are pleased that the FDA has indicated that ocriplasmin meets its criteria for Priority Review. This reflects our view that ocriplasmin could represent an important advance in the treatment of symptomatic VMA including macular hole. We remain on track to meet our timelines for making ocriplasmin available to the many patients suffering from this sight-threatening disorder."
About ThromboGenics
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 MAA for ocriplasmin has been accepted for review in Europe and the BLA will be re-submitted in the U.S.by April 2012. Ocriplasmin is 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 the NYSE Euronext Brussels exchange 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:
ThromboGenics
Dr. Patrik De Haes, CEO
Tel: +32-16-75-13-10
patrik.dehaes@thrombogenics.com
Chris Buyse, CFO
Tel: +32-16-75-13-10
chris.buyse@thrombogenics.com
Citigate Dewe Rogerson
David Dible/ Nina Enegren/ Sita Shah
Tel: +44(0)207-638-9571
sita.shah@citigatedr.co.uk
SOURCE ThromboGenics NV