Health Canada Approves ThromboGenics' JETREA® for the Treatment of Symptomatic
LEUVEN, Belgium, August 16, 2013
LEUVEN, Belgium, August 16, 2013 /PRNewswire/ --
Canada is first market outside the US and Europe where JETREA ^® is approved
ThromboGenics NV (Euronext Brussels: THR), an integrated biopharmaceutical
company focused on developing and commercializing innovative ophthalmic
medicines, today announces that Health Canada has approved JETREA®
(ocriplasmin) for the treatment of symptomatic vitreomacular adhesion (VMA).
The priority review of the New Drug Submission for JETREA in Canada was
conducted within 180 calendar days. Canada is the first market where JETREA®
is approved outside the US and Europe. ThromboGenics' partner Alcon holds the
commercialization rights to JETREA® outside the US and will be responsible for
the launch of the drug in Canada.
Alcon, a division of Novartis, acquired the rights to commercialize JETREA®
outside the United States in March 2012. It launched the drug in the UK, its
first European market, in April, followed by launches in Germany, Denmark,
Finland, Norway and Sweden.
ThromboGenics is commercializing the drug in the US and launched JETREA® in
the US in mid-January 2013 where it is approved for the treatment of patients
with symptomatic vitreomacular adhesion (VMA).
Dr Patrik De Haes, CEO of ThromboGenics, says: " The Priority Review
approval of JETREA ^® in Canada , the first market outside the US and
Europe , is further evidence that all stakeholders are committed to making
this first pharmacological drug available quickly to as many patients as
possible. Symptomatic VMA is increasingly being recognized as an important
sight-threatening condition that can lead to distorted vision, and even
central blindness. Canada is an important market and we are confident that
the Alcon Canada team will be able to grasp this opportunity. We are looking
forward to announcing further approvals of JETREA ^® in other markets
JETREA ^® contains the active substance ocriplasmin. It is administered
through a one-time, single intravitreal injection to treat adults with
vitreomacular traction (VMT).
Symptomatic VMA is an age-related progressive, sight-threatening condition. It
is caused by the vitreous having an abnormally strong attachment to the
central part of the retina (the light sensitive membrane at the back of the
eye). The macula provides central vision that is needed for everyday tasks
such as driving, reading and recognizing faces.
When the vitreous shrinks, the strong attachment results in a pulling force on
the retina, which may lead to visual distortion, decreased visual acuity and
central blindness. When the disease progresses the traction may eventually
result in the formation of a hole in the macula (called a macular hole).
JETREA ^® breaks down the protein fibers which cause the abnormal traction
between vitreous and macula. By dissolving these proteins, JETREA ^® releases
the traction, and helps to complete the detachment of the vitreous from the
JETREA ^® can also be used when symptomatic VMA has progressed and caused a
small hole in the macula (central part of the light-sensitive layer at the
back of the eye).
Currently the only available treatment in the EU is 'observation' or 'watchful
waiting' until a patient becomes a surgical candidate, usually at a late stage
of the disease. ^[ ^1 ^] ^, ^[ ^2 ^] A patient would then receive a surgical
procedure and repair of the retina. However, for many patients this is not a
suitable option, as irreversible damage to the retina may have already
occurred. ^[ ^3 ^] ^, ^[ ^4 ^]
ThromboGenics continues to work closely with Alcon to support the regulatory
activities and help develop the necessary infrastructure so that patients can
access this innovative medicine and receive JETREA ^® as soon as it becomes
available in the respective countries outside US.
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 ≤ 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
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 (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
Alcon has launched JETREA ^® in the UK, Germany, Denmark, Finland, Norway and
ThromboGenics is also further exploring anti-PIGF (Placental Growth Factor),
also referred to as TB-403, for the treatment of ophthalmic and oncology
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
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
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future events or any other reason. Additional information concerning risks and
uncertainties affecting the business and other factors that could cause actual
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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.
^[ ^1 ^] ^. Idiopathic macular hole. American Academy of Ophthalmology ;
^[ ^2 ^] ^. Stalmans P. Management and intervention strategies for symptomatic
vitreomacular adhesions. Retinal Physician 2011
^[ ^3 ^] ^. Koerner F & Garweg J. Vitrectomy for macular pucker and
vitreomacular traction syndrome. Doc Ophthalmol 1999;97:449-458
^[ ^4 ^] ^. Dugel PU, Brown DM, Humayun MS et al . Symptomatic vitreomacular
adhesion: diagnosis, pathologic implications, and management. Retina Today
For further information please contact: Thrombogenics Wouter Piepers, Global
Head of Corporate Communications +32-16-75-13-10 / +32-478-33-56-32
firstname.lastname@example.org Dr. Patrik De Haes, CEO +32-16-75-13-10
Patrik.email@example.com Chris Buyse, CFO +32-16-75-13-10
Chris.firstname.lastname@example.org Citigate Dewe Rogerson David Dible/ Nina
Enegren/ Sita Shah Tel: +44-20-7638-9571 email@example.com The
Trout Group (US investor relations) Todd James/ Simon Harnest Tel:
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