ThromboGenics Announces FDA Accepts Filing and Grants Priority Review to Its Biologics License Application for Ocriplasmin Intravitreal Injection
LEUVEN, Belgium, July 3, 2012 /PRNewswire/ --
ThromboGenics NV (Euronext Brussels: THR), a biopharmaceutical company focused on developing innovative ophthalmic medicines, today announced that the U.S. Food and Drug Administration (FDA) has informed the Company that it has officially accepted the filing of the Biologics License Application for ocriplasmin intravitreal injection, 2.5 mg/ml and granted it Priority Review. The proposed indication of ocriplasmin intravitreal injection is for the treatment of symptomatic Vitreomacular Adhesion (VMA) including macular hole.
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's goal for completing a Priority Review and delivering a decision on marketing approval is six months. Given its decision to grant Priority Review the FDA has already scheduled an Advisory Committee meeting on 26 July 2012 to discuss the ocriplasmin BLA. The recommendation of the Advisory Committee will form part of the FDA's overall assessment of the ocriplasmin BLA. The FDA has assigned the ocriplasmin BLA a Prescription Drug User Fee Act (PDUFA) goal date of 17 October, 2012.
Dr Patrik De Haes, ThromboGenics' CEO, said: "The Company is happy that the FDA has granted ocriplasmin Priority Review. We are looking forward to our discussions with the FDA as we work to make ocriplasmin available to the many patients in the U.S. that could benefit from this novel treatment option."
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), otherwise termed Vitreomacular Traction (VMT), including when associated with macular hole. The MAA for ocriplasmin has been accepted for review in Europe and in the U.S. the FDA has accepted the BLA filing and granted it Priority Review.
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 TB-403, a novel antibody therapeutic, in collaboration with BioInvent International, for cancer and non-cancer, including ophthalmology, indications.
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.
This press release does not constitute an offer or invitation for the sale or purchase of securities or assets of ThromboGenics in any jurisdiction. No securities of ThromboGenics may be offered or sold within the United States without registration under the U.S. Securities Act of 1933, as amended, or in compliance with an exemption therefrom, and in accordance with any applicable U.S. state securities laws.
For further information please contact:
Dr. Patrik De Haes, CEO
Chris Buyse, CFO
Citigate Dewe Rogerson
David Dible/ Nina Enegren/ Sita Shah
The Trout Group
Todd James, Director
Simon Harnest, Associate
SOURCE ThromboGenics NV