ThromboGenics' JETREA® Gains Approval in Brazil
(Thomson Reuters ONE) -
Leuven, March 16, 2015 - ThromboGenics NV (Euronext Brussels: THR), an
integrated biopharmaceutical company focused on developing and commercializing
innovative ophthalmic medicines, today announces that JETREA® (ocriplasmin) has
gained approval in Brazil.
JETREA(® )has been indicated for the treatment of adults with vitreomacular
traction (VMT), including when associated with macular hole of diameter less
than or equal to 400 microns.
If left untreated, VMT generally leads to significant visual distortion,
deterioration in visual acuity, or even central blindness. With JETREA(®),
retina physicians in Brazil will have access to the world's first and only
pharmacological treatment option for VMT, allowing them to intervene earlier and
potentially stop the progression of this debilitating disease.
ThromboGenics' partner Alcon, which is commercializing JETREA(®) outside the US,
will be responsible for the launch of the drug in Brazil.
Ends
For further information please contact:
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|ThromboGenics |Citigate Dewe Rogerson |
| | |
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| |David Dible/ Malcolm Robertson |
|Wouter Piepers, Global Head of Corporate | |
|Communications & Investor Relations |Tel: +44 20 7282 2867 |
| | |
|+32 16 75 13 10 / +32 478 33 56 32 |malcolm.robertson(at)citigatedr.co.uk|
| | |
|wouter.piepers(at)thrombogenics.com | |
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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.
About ThromboGenics
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 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.
This announcement is distributed by GlobeNewswire on behalf of
GlobeNewswire clients. The owner of this announcement warrants that:
(i) the releases contained herein are protected by copyright and
other applicable laws; and
(ii) they are solely responsible for the content, accuracy and
originality of the information contained therein.
Source: ThromboGenics NV via GlobeNewswire
[HUG#1903527]
Unternehmensinformation / Kurzprofil:
Datum: 16.03.2015 - 07:00 Uhr
Sprache: Deutsch
News-ID 378545
Anzahl Zeichen: 6385
contact information:
Town:
Leuven
Kategorie:
Business News
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