Jetrea

Treatment for Vitreomacular Adhesion

Update: Jetrea (ocriplasmin) Now FDA Approved - October 17, 2012

ThromboGenics Receives Notice From FDA of Advisory Committee Meeting for Ocriplasmin

LEUVEN, Belgium, June 7, 2012/PRNewswire-FirstCall/ -- ThromboGenics NV, a biopharmaceutical company focused on developing innovative ophthalmic medicines, today announces that the US Food and Drug Administration (FDA) has notified the Company that its new biologic license application (BLA) for ocriplasmin intravitreal injection will be discussed at the Dermatologic and Ophthalmic Drugs Advisory Committee scheduled for July 26, 2012.

Ocriplasmin is an investigational biological drug candidate intended for the treatment of symptomatic Vitreomacular Adhesion (VMA) including macular hole.

ThromboGenics resubmitted its BLA for ocriplasmin in April 2012 in anticipation of it being granted Priority Review by the FDA.

About ThromboGenics

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) including macular hole. The MAA for ocriplasmin has been accepted for review in Europe and the BLA has been re-submitted in the U.S. Ocriplasmin is in Phase II clinical development for additional vitreoretinal conditions.

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 EUR375 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:

    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: +44-20-7638-9571
    sita.shah@citigatedr.co.uk

    The Trout Group
    Todd James, Director
    Simon Harnest, Associate
    Tel: +1-646-378-2926
    tjames@troutgroup.com

 


Source: ThromboGenics

 
 
 

Posted: June 2012

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