ThromboGenics Receives Positive CHMP Opinion for Ready Diluted Formulation of JETREA®
(Thomson Reuters ONE) -
Leuven, March 2, 2015 - ThromboGenics NV (Euronext Brussels: THR), an integrated
biopharmaceutical company focused on developing and commercializing innovative
ophthalmic medicines, today announces that the Committee for Medicinal Products
for Human Use (CHMP) of the European Medicines Agency (EMA) has adopted a
positive opinion for a new ready-diluted formulation of JETREA(®) (ocriplasmin).
JETREA(®) is approved in the EU for the treatment of vitreomacular traction
(VMT), including when associated with macular hole of diameter less than or
equal to 400 microns. VMT is an age-related progressive, sight-threatening
condition that may lead to visual distortion, decreased visual acuity and
central blindness.
The introduction of the new formulation of JETREA(®) will eliminate the
preparatory dilution steps prior to injection.
At the point of administration into the eye, the strength, potency, composition
and pharmaceutical form of the ready-diluted formulation remain identical to the
currently available formulation after dilution.
Dr. Patrik De Haes, CEO of ThromboGenics, said, "We are very pleased that the
CHMP has provided a positive recommendation for our new ready-diluted
formulation of JETREA(®). With this new formulation, it will be easier and more
convenient for retina physicians to use this novel pharmacological option for
the treatment of patients with VMT. We anticipate a final approval decision from
the European Commission within the next 2 to 3 months paving the way for the
eventual introduction of this new formulation across all 28 European Union
Member States plus Iceland and Norway."
ThromboGenics' partner Alcon, who is commercializing JETREA(®) outside the US,
will be responsible for planning the launch of the new ready-diluted
formulation.
For further information please contact:
+------------------------------------------+-----------------------------------+
| | |
|ThromboGenics |Citigate Dewe Rogerson |
| | |
|Wouter Piepers, |David Dible/Malcolm Robertson |
|Global Head of Corporate Communications &| |
|IR |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 | |
| | |
+------------------------------------------+-----------------------------------+
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.
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.
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#1898823]
Unternehmensinformation / Kurzprofil:
Datum: 02.03.2015 - 17:48 Uhr
Sprache: Deutsch
News-ID 375445
Anzahl Zeichen: 7102
contact information:
Town:
Leuven
Kategorie:
Business News
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"ThromboGenics Receives Positive CHMP Opinion for Ready Diluted Formulation of JETREA®"
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