ThromboGenics’ JETREA® Available in Germany Public and Private Market
LEUVEN, Belgium, May 2, 2013 /PRNewswire/ –
ThromboGenics NV (Euronext Brussels: THR), an integrated biopharmaceutical company
focused on developing and commercializing innovative ophthalmic medicines, today announces
that its partner Alcon has launched JETREA(R)in Germany, the second European market where
the product is now available.
Since May 1st, 2013, JETREA(R)is listed in the “Lauer-Taxe” (Grosse Deutsche
Spezialitatentaxe) with an ex-factory price of EUR3,078.
In mid-March 2013, JETREA(R)was approved by the European Commission (EC)for the
treatment of vitreomacular traction (VMT), including when associated with macular hole of
diameter less than or equal to 400 microns.
Today’s kick off in Germany’s private and public market, follows Alcon’s first
European launch of JETREA(R) which took place in the UK last month. Alcon, a division of
Novartis, acquired the rights to commercialize JETREA(R)outside the United States in March
Under the terms of this deal ThromboGenics has already received EUR165 million in
upfront and milestone payments, including EUR90 million following EMA approval of
JETREA(R)and first injection (UK) in patients. The company could receive a further EUR210
million in milestones plus significant royalties on Alcon’s sales of JETREA(R).
ThromboGenics launched JETREA(R) 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: “We are very excited to see that
JETREA(R)has quickly become available as a privately and publicly reimbursed drug in
Germany. Today’s launch by Alcon in Germany is a key step in making this exciting new
pharmacological treatment for VMT available to more patients in Europe.”
JETREA(R) contains the active substance ocriplasmin. It is administered through a
one-time, single intravitreal injection to treat adults with vitreomacular traction (VMT).
VMT, which in the US is referred to as symptomatic VMA, is an age-related progressive,
sight-threatening condition. It is caused by the vitreous humour 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 recognising faces.
When the vitreous humour 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(R) breaks down the protein fibers which cause the abnormal traction between
vitreous and macula that causes VMT. By dissolving these proteins, JETREA(R)releases the
traction, and helps to complete the detachment of the vitreous from the macula.
JETREA(R) can also be used when VMT has progressed and caused a small hole in the
macula (central part of the light-sensitive layer at the back of the eye).
It is estimated that 250,000 to 300,000 patients in Europe alone suffer from this
Prof. Albert Augustin, Ophthalmology Department Head at Klinikum Karlsruhe, said: “The
introduction of JETREA(R) into Germany represents a significant advancement in the way
retina specialists can treat vitreomacular traction and certain stages of macular holes.
These vision-threatening conditions, associated with many common retinal disorders, are
more frequently identified due to the advancement of new ophthalmic diagnostics, optical
coherence tomography, and had been previously addressed by the limited options of either
physician observation or vitrectomy. JETREA(R) now offers a new and effective treatment
option, particularly for those patients whose conditions are not yet advanced enough to
warrant surgery, to help physicians restore patients’ vision and improve overall quality
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., 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.,
ThromboGenics continues to work closely with Alcon to help develop the necessary
infrastructure so that patients across Europe and beyond can access this innovative
medicine and receive JETREA(R) as soon as it becomes available in the respective
 ThromboGenics and Alcon internal estimates
 Idiopathic macular hole. American Academy of Ophthalmology; 2008
 Stalmans P. Management and intervention strategies for symptomatic vitreomacular
adhesions. Retinal Physician 2011
 Koerner F & Garweg J. Vitrectomy for macular pucker and vitreomacular traction
syndrome. Doc Ophthalmol 1999;97:449-458
 Dugel PU, Brown DM, Humayun MS et al. Symptomatic vitreomacular adhesion:
diagnosis, pathologic implications, and management. Retina Today 2011;(Suppl):1-14
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 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.
In March 2012, ThromboGenics signed a strategic partnership with Alcon (Novartis) for
the commercialization of JETREA(R) outside the United States. Under this agreement,
ThromboGenics could receive up to a total of EUR375 million in up-front and milestone
payments. It will receive significant royalties from Alcon’s net sales of JETREA(R).
ThromboGenics and Alcon intend to share the costs equally of developing JETREA(R) for a
number of new vitreoretinal indications.
In Europe, JETREA(R) is approved for the treatment of vitreomacular traction (VMT),
including when associated with macular hole of diameter less than or equal to 400 microns.
It has been launched by Alcon in the UK and Germany.
ThromboGenics is also further exploring anti-PIGF (Placental Growth Factor), also
referred to as TB-403, for the treatment of ophthalmic and oncology 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
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obligation to update or revise any forward-looking statement, whether as a result of new
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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
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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.
For further information please contact: Thrombogenics Wouter Piepers, Global Head of Corporate Communications +32-16-75-13-10 / +32-478-33-56-32 Wouter.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 DeweRogerson David Dible/ Nina Enegren/ Sita Shah Tel: +44-(0)20-7638-9571 email@example.com The Trout Group (US investor relations) Todd James/ Simon Harnest Tel: +1-646-378-2926 firstname.lastname@example.org