Germany's IQWiG Confirms That ThromboGenics' JETREA® Demonstrates Major Added
Value for the Treatment of Vitreomacular Traction and Macular Hole
LEUVEN, Belgium, August 2, 2013
LEUVEN, Belgium, August 2, 2013 /PRNewswire/ --
ThromboGenics NV (Euronext Brussels: THR) a biopharmaceutical company focused
on developing and commercializing innovative ophthalmic medicines, announces
today that the German Institute for Quality and Efficiency in Health Care
(IQWiG) has confirmed that JETREA ^® (ocriplasmin) demonstrates major /
significant added value in VMT patients with mild / moderately severe symptoms
compared with existing comparative treatment, when treating vitreomacular
traction (VMT) including when associated with a macular hole of less than or
equal to 400microns.
JETREA ^® is the first pharmacological treatment indicated for use in patients
diagnosed with VMT and macular hole of diameter less than or equal to 400
microns. It was approved for this indication in the European Union in March
2013. Partner Alcon launched the drug in Germany at the beginning of May.
There are no other pharmacological treatments in development for VMT.
Currently patients either have to watch and wait before they are considered
eligible for surgery. Surgery is typically performed only at a later stage of
a patient's disease, once symptoms progress and their sight deteriorates
IQWiG is an independent federal organization that evaluates a drug's quality
and efficiency, which makes a recommendation to the Federal Joint Committee
(G-BA). G-BA is expected to issue final guidance on JETREA ^® in mid-October
IQWiG recognizes that the data submitted by ThromboGenics in the course of the
value assessment provides an indication ( Hinweis ) for a major added value
for VMT patients with mild symptoms and a significant added value for patients
with moderately severe symptoms. Since the introduction of the Early Benefit
Assessment in Germany in January 2011, this is the very first time that IQWiG
confirms an indication for a major added value ( Hinweis auf einen erheblichen
Zusatznutzen ) for an innovative new drug substance.
Dr Patrik De Haes, CEO of ThromboGenics , said: " IQWiG ' s assessment
confirming the significant additional benefits of JETREA ^® for VMT validates
the importance of our novel drug in treating patients with this major
sight-threatening disease. For the first time, patients can be treated at an
earlier stage of their disease, rather than having to watch and wait until
their symptoms worsen. We, and our partner Alcon, look forward to working with
G-BA to ensure that the positive benefits shown by JETREA ^® are reflected in
its final guidance. "
Earlier this year, JETREA ^® was classified as a breakthrough innovation, the
highest rating in the so-called 'Fricke and Klaus' assessment ^1 . This
assessment evaluates how innovative the mechanism of action of a new medicine
is compared to existing therapies available in Germany.
JETREA ^® contains the active substance ocriplasmin. It is administered
through a single intravitreal injection to treat adults with vitreomacular
VMT is a progressive, sight-threatening condition. It is caused by the
vitreous humour having an abnormally strong attachment to the macula, 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 humor 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 the vitreous and the 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).
The current approach in the EU is 'observation', 'watchful waiting' or 'watch
and wait' until a patient becomes a candidate for surgical treatment, 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
ThromboGenics is continuing to work closely with Alcon to ensure patients
across Europe and rest of the world can access this innovative medicine and
receive JETREA ^® as soon as it becomes available in the respective countries.
^1. German pharmaceutical journal PZ online
^2. Idiopathic macular hole. American Academy of Ophthalmology ; 2008
^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 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
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. Alcon has launched JETREA ^® in the UK, Germany,
Denmark, Norway, Finland and Sweden.
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
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.
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 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: +1 646 378
Press spacebar to pause and continue. Press esc to stop.