LEUVEN, Belgium, November 29, 2012 /PRNewswire/ --
ThromboGenics NV (Euronext Brussels: THR), an integrated biopharmaceutical company focused on developing and commercializing innovative ophthalmic medicines, announces that it won the Licensing Deal of the Year Award at the Scrip Awards 2012 event held in London last night. The Company received the global industry recognition for its partnership agreement with Alcon (Novartis) to commercialize JETREA® (ocriplasmin) outside the U.S. JETREA® is the first pharmacological treatment for vitreomacular adhesion (VMA), a progressive sight-threatening disease. JETREA® was recently approved by the U.S. Food and Drugs Administration for the treatment of symptomatic Vitreomacular Adhesion (VMA). The JETREA® European Marketing Authorisation Application is currently under review by the European Medicines Agency. A decision on European approval is expected in the first half of 2013.
The Scrip Awards, now in their eighth year, are one of the most prestigious awards recognizing excellence in the global biopharmaceutical and clinical research industries. The awards are judged by an independent panel of senior executives from these sectors against strict criteria.
The Licensing Deal of the Year reflects the major partnership alliance that ThromboGenics and Alcon signed for the commercialization of JETREA® in Europe and Rest of the World (ROW). In the US, ThromboGenics will commercialize the drug by itself.
Upon the signing of the deal in March 2012, ThromboGenics received an upfront payment of €75 million. ThromboGenics is eligible to receive up to a further €300 million in potential milestone payments. ThromboGenics could also receive an attractive level of royalties based on the net sales of JETREA® in the ROW, which would give it a significant share of the product's economics outside the U.S. In addition, ThromboGenics and Alcon have agreed to work together and share the costs of developing new clinical applications or presentations of JETREA®.
Dr Patrik De Haes, CEO of ThromboGenics, said: "Winning this prestigious industry award is a clear recognition of the strategic importance of this licensing deal for both ThromboGenics and Alcon. As a result of this agreement, we now have the best possible partner to commercialize JETREA® outside the U.S. With JETREA®, Alcon has gained access to a novel pharmacological treatment option that could lead to paradigm shift in the treatment of symptomatic vitreomacular adhesion."
About JETREA® (ocriplasmin)
JETREA® (ocriplasmin) is a truncated form of human plasmin for the treatment of symptomatic VMA. 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 medicines. The Company's lead product, JETREA®(ocriplasmin), has been approved by the FDA for the treatment of symptomatic VMA. The Marketing Authorisation Application (MAA) for ocriplasmin is under review in Europe.
In March 2012, ThromboGenics signed a strategic partnership with Alcon (Novartis) for the commercialization of JETREA® outside the United States. Under this agreement, ThromboGenics could receive up to a total of €375 million in up-front and milestone payments. It will receive significant royalties from Alcon's net sales of JETREA®. 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), formerly referred to as TB-403, for the treatment of ophthalmic indications.
ThromboGenics is headquartered in Leuven, Belgium, and has offices in Iselin, NJ (U.S) and Dublin, Ireland. 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:
Wouter Piepers, Global Head of Corporate Communications
+32-16-75-13-10 / +32-478-33-56-32
Dr. Patrik De Haes, CEO
Chris Buyse, CFO
Citigate Dewe Rogerson
David Dible/ Nina Enegren/ Sita Shah
The Trout Group
US Investor Relations
Todd James/ Simon Harnest
SOURCE ThromboGenics NV