ThromboGenics' JETREA(R) Gains Approval in South Korea
LEUVEN, Belgium, Sept. 8, 2014 (GLOBE NEWSWIRE) -- ThromboGenics NV
(Euronext Brussels: THR), an integrated biopharmaceutical company
focused on developing and commercializing innovative ophthalmic
medicines, today announces that JETREA(R) (ocriplasmin) has been
approved in South Korea for the treatment of adults with symptomatic
vitreomacular adhesion (VMA) including when associated with macular
hole of diameter less than or equal to 400 microns.
South Korea is the fourth country in Asia to grant JETREA(R) approval.
The product has already gained approval in Malaysia, Singapore and
ThromboGenics' partner Alcon, which is commercializing JETREA(R)
outside the US, will be responsible for the launch of the drug in South
For further information please contact:
Citigate Dewe Rogerson
David Dible/ Sita Shah
About JETREA (R) (ocriplasmin)
JETREA(R) (ocriplasmin) is a truncated form of human plasmin. In the
US, JETREA(R) is indicated for the treatment of symptomatic VMA. In
Europe, JETREA(R) 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(R) 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(R) 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(R) (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(R) outside the United
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.