ThromboGenics' JETREA® Available in Germany Public and Private Market
LEUVEN, Belgium, May 2, 2013
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 ^® in
Germany, the second European market where the product is now available.
Since May 1st, 2013, JETREA ^® is listed in the "Lauer-Taxe" (Große Deutsche
Spezialitätentaxe) with an ex-factory price of € 3,078 .
In mid-March 2013, JETREA ^® 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 ^® which took place in the UK last month. Alcon, a
division of Novartis, acquired the rights to commercialize JETREA ^® outside
the United States in March 2012.
Under the terms of this deal ThromboGenics has already received €165 million
in upfront and milestone payments, including €90 million following EMA
approval of JETREA ^® and first injection (UK) in patients. The company could
receive a further €210 million in milestones plus significant royalties on
Alcon's sales of JETREA ^® .
ThromboGenics launched JETREA ^® in the US in mid-January 2013 where it is
approved for the treatment of patients with symptomatic vitreomacular adhesion
Dr Patrik De Haes, CEO of ThromboGenics, says: " We are very excited to
see that JETREA ^® 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 ^® 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
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
JETREA ^® breaks down the protein fibers which cause the abnormal traction
between vitreous and macula that causes VMT. By dissolving these proteins,
JETREA ^® releases the traction, and helps to complete the detachment of the
vitreous from the macula.
JETREA ^® 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 condition. ^[ ^1 ^] ^
Prof. Albert Augustin, Ophthalmology Department Head at Klinikum Karlsruhe,
said: " The introduction of JETREA ^® 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 ^® 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 of life . "
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. ^[ ^2 ^] ^, ^[ ^3 ^] 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. ^[ ^4 ^] ^, ^[ ^5 ^]
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 ^® as soon as it becomes available
in the respective countries.
^[ ^1 ^] ThromboGenics and Alcon internal estimates
^[ ^2 ^] Idiopathic macular hole. American Academy of Ophthalmology ;
^[ ^3 ^] Stalmans P. Management and intervention strategies for symptomatic
vitreomacular adhesions. Retinal Physician 2011
^[ ^4 ^] Koerner F & Garweg J. Vitrectomy for macular pucker and vitreomacular
traction syndrome. Doc Ophthalmol 1999;97:449-458
^[ ^5 ^] Dugel PU, Brown DM, Humayun MS et al . Symptomatic vitreomacular
adhesion: diagnosis, pathologic implications, and management. Retina Today
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 severity.
ThromboGenics is an integrated biopharmaceutical company focused on developing
and commercializing innovative ophthalmic 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.
In March 2012, 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
In Europe, JETREA ^® 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
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
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