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ThromboGenics Confirms JETREA® US Launch Date of Monday January 14th, 2013
By: PR Newswire
Jan. 4, 2013 01:30 AM
LEUVEN, Belgium, January 4, 2013 /PRNewswire/ --
JETREA® US Price Set at USD 3,950 per Vial
ThromboGenics NV (Euronext Brussels: THR), an integrated biopharmaceutical company focused on developing and commercializing innovative ophthalmic medicines, confirms its JETREA®US launch date of Monday January 14th, 2013.
JETREA® (ocriplasmin) Intravitreal Injection is a proteolytic enzyme indicated for the treatment of symptomatic vitreomacular adhesion (VMA). The US price for a single-use glass vial of JETREA® is set at USD 3,950.
Next week, Dr. Patrik De Haes, Chief Executive Officer of ThromboGenics, will present during the 31st Annual J.P. Morgan Healthcare Conference from January 7th to 9th, 2013 in San Francisco, USA.
The ThromboGenics presentation will be held on Wednesday, January 9th at 11.00 am PST (20.00 CET) at the Westin St. Francis Hotel in San Francisco. It will include the Company's plans for launching JETREA® (ocriplasmin) in January through its own U.S. commercial organization, which will mark a major milestone for transforming ThromboGenics into a fully operational biopharmaceutical company that provides innovative ophthalmic medicines.
JETREA® represents a paradigm shift and for the first time offers a pharmacological treatment option to patients suffering with symptomatic VMA. The U.S. Food and Drug Administration (FDA) approved JETREA® in October 2012 as the first pharmacological agent for the treatment of symptomatic VMA. Symptomatic VMA is a progressive, sight-threatening condition that, when left untreated, frequently leads to retinal distortion, further deterioration in vision, and irreversible damage to eyesight. The recommended dose of JETREA® is 0.125 mg (0.1 mL) of the diluted solution administered by intravitreal injection to the affected eye once as a single injection.
The approval was based on the data from ThromboGenics' Phase III program where JETREA® was shown to be superior to placebo for the treatment of symptomatic VMA (26.5% versus 10.1%; p<0.01). Treatment with JETREA® was associated with some, mainly transient, ocular adverse events.
Important safety and prescribing information about JETREA® is available at http://www.jetrea.com.
About JETREA® (ocriplasmin)
JETREA®(ocriplasmin) is a truncated form of human plasmin that has been approved by the U.S. Food and Drug Administration (FDA) 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 (US) 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.
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