LEUVEN, Belgium, July 31, 2014 (GLOBE NEWSWIRE) -- ThromboGenics NV (Euronext Brussels: THR) a biopharmaceutical company focused on developing and commercializing innovative ophthalmic medicines, announces today that JETREA® (ocriplasmin) has been nominated for the 2014 Prix Galien USA Award in the Best Biotechnology Product category. This is the second time that JETREA®, a novel pharmacological treatment for symptomatic vitreomacular adhesion (VMA), has been nominated for this award. This latest nomination follows last month's nomination of JETREA® for the Prix Galien UK Award.
The Prix Galien USA, now in its eighth year, is an international award that recognizes outstanding achievements in improving human health through the development of innovative therapies. The winner is selected by a committee of nine experts in the biomedical industry and academia, including five Nobel Laureates.
Dr Patrik De Haes, CEO of ThromboGenics, said: "We are extremely proud that JETREA® has been nominated for the second time for such a prestigious award. JETREA® is the first pharmacological option that allows patients with symptomatic VMA/VMT to have access to earlier treatment. ThromboGenics is committed to working with the global retina community to continue to capture additional real-world data on the optimal use of JETREA® so that it can be used to assist as many patients as possible around the world who could benefit from this innovative drug."
JETREA® is the only drug approved by the US Food and Drug Administration for the treatment of symptomatic vitreomacular adhesion (VMA). ThromboGenics launched the drug in the US in mid-January 2013.
JETREA® was approved in the European Union in March 2013. Partner Alcon, a division of Novartis, Alcon acquired the rights to commercialize JETREA® outside the United States in March 2012 and is and is rolling out the drug across Europe and the rest of the world.
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About JETREA ® (ocriplasmin)
JETREA® (ocriplasmin) is a truncated form of human plasmin. In the US, JETREA® is indicated for the treatment of symptomatic VMA. In Europe, JETREA® is indicated for the treatment of vitreomacular traction (VMT), including when associated with macular hole of diameter less than or equal to 400 microns. JETREA® is a selective proteolytic enzyme that cleaves fibronectin, laminin and collagen, three major components of the vitreoretinal interface that play an important role in vitreomacular adhesion.
JETREA® has been evaluated in two multi-center, randomized, double-masked Phase III trials conducted in the U.S. and Europe involving 652 patients with vitreomacular adhesion. Both studies met the primary endpoint of resolution of VMA at day 28.
JETREA's Phase III program found that 26.5% of patients treated with ocriplasmin saw resolution of VMA, compared with 10.1% of patients receiving placebo (p<0.01). The Phase III program also showed that JETREA was generally well tolerated with most adverse events being transient and mild in severity.
ThromboGenics is an integrated biopharmaceutical company focused on developing and commercializing innovative ophthalmic and oncology medicines. The Company's lead product, JETREA® (ocriplasmin), has been approved by the US FDA for the treatment of symptomatic VMA and was launched in January 2013.
ThromboGenics signed a strategic partnership with Alcon, a division of Novartis, for the commercialization of JETREA® outside the United States. ThromboGenics and Alcon intend to share the costs equally of developing JETREA® for a number of new vitreoretinal indications.
ThromboGenics is also further exploring anti-PIGF (Placental Growth Factor), also referred to as TB-403, for the treatment of oncology indications.
ThromboGenics is headquartered in Leuven, Belgium, and has offices in Iselin, NJ (US) and Dublin, Ireland. 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.
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.
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