Germany's G-BA Confirms That ThromboGenics' JETREA® Demonstrates Significant
Therapeutic Benefits for Vitreomacular Traction (VMT) Patients, Including When
Associated With Macular Hole
LEUVEN, Belgium, October 17, 2013
LEUVEN, Belgium, October 17, 2013 /PRNewswire/ --
Decision confirms therapeutic benefits for treatment of VMT patients
suffering from mild and moderate symptoms , or 94% of the indicated VMT
ThromboGenics NV (Euronext Brussels: THR), a biopharmaceutical company focused
on developing and commercializing innovative ophthalmic medicines, announces
today that the Final Early Benefit Assessment from the German Federal Joint
Committee (G-BA) has concluded that JETREA ^® (ocriplasmin) demonstrates
significant added benefit for VMT patients with mild and moderate symptoms
when compared with existing comparative treatment (watchful waiting). The mild
to moderate VMT population, as referred to by G-BA in its final assessment,
represents the vast majority (94%) of the total patient population covered by
the approved label.
G-BA is the highest decision-making body of the joint self-government of
physicians, dentists, hospitals and health insurance funds in Germany. Since
the introduction of the early benefit assessment procedure in Germany in
January 2011, G-BA has assessed more than sixty innovative new drugs. JETREA
^® is to-date one of only six innovative medicines appraised by G-BA to
provide significant additional therapeutic benefits for patients.
'Significant' demonstrates a sustained and large improvement in the
therapy-relevant benefit. In its assessment, G-BA particularly considered the
potential improvement in visual acuity and the avoidance of surgery in the
back of the eye by JETREA ^® as beneficial for patients.
G-BA's final guidance confirms the recommendation made by the German Institute
for Quality and Efficiency in Health Care (IQWiG) in August 2013. IQWiG is an
independent federal organization that evaluates a drug's quality and
efficiency and makes recommendations to G-BA.
"Given the low risk profile of the injection , it is now possible to
intervene in patients with VMT at a very early stage" , says Prof. Dr. Anselm
Kampik , Director of the eye clinic of the University of Munich
(LMU). "Many early stage patients still have a good visual function which ,
with a timely intervention , can be preserved , or even improved. So a
better functional outcome can be expected , than when only treating the
patient after a period of watchful waiting."
Dr Patrik De Haes , CEO of ThromboGenics , said: " The confirmation from
G-BA that JETREA ^® represents a significant value treatment for patients with
mild VMT is a very positive development. For the first time , patients can
be treated early , meaning that they can avoid the adverse consequences of
the current watch and wait approach. With the NICE FAD in the UK also
supporting the use of JETREA ^® in patients with the early symptoms of VMT
such as metamorphopsia , our partner Alcon now has a solid platform to start
building the European sales of this innovative new drug in the largest
population of VMT patients. "
JETREA ^® is the first pharmacological treatment indicated for use in patients
diagnosed with VMT, also when associated with macular hole of diameter less
than or equal to 400 microns. It was approved for this indication in the
European Union in March 2013. ThromboGenics' commercial partner Alcon launched
the drug in Germany at the beginning of May.
There are no other pharmacological treatments available for this condition. At
present, patients 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
JETREA ^® contains the active substance ocriplasmin. It is administered
through a single intravitreal injection to treat adults with VMT.
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 disease progresses the traction may eventually result in the
formation of a hole in the macula (called a macular hole).
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. ^[ ^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 ^]
^[ ^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
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
About German Federal Joint Committee (Gemeinsamer Bundesausschuss , G-BA)
The Federal Joint Committee (G-BA) is the supreme decision-making body of the
so-called self-governing system in Germany. Physicians, dentists, hospitals,
sickness funds and patients are represented in the G-BA. The G-BA issues
directives and thus determines the benefit package of the statutory health
insurance (GKV) covering about 70 million people. Finally, the G-BA is
responsible for reimbursement decisions in the GKV. The directives issued by
the G-BA are legally binding for insured people as well as for the providers
and payers of health care: physicians, hospitals and sickness funds. They are
valid for ambulatory treatment, dentistry, hospital care and psychotherapy.
Furthermore, the directives define the provision and reimbursement of
pharmaceuticals, diagnostic and therapeutic procedures, medical devices and
non-medical treatment. In addition, the G-BA has responsibilities regarding
quality assurance measures for in- and out-patient care.
Alcon, the global leader in eye care, provides innovative products that
enhance quality of life by helping people worldwide see better. The three
Alcon businesses - Surgical, Pharmaceutical and Vision Care - offer the widest
spectrum of eye care products in the world. Alcon is the second largest
division of the Novartis Group with sales of USD 10.2 billion in 2012.
Headquartered in Fort Worth, Texas, USA, Alcon has more than 24,000 employees
worldwide, operations in 75 countries and products available in 180 markets.
For more information, visit http://www.alcon.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 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/ Sita Shah
Tel: +44-20-7638-9571 email@example.com The Trout Group (US
investor relations) Todd James/ Simon Harnest Tel: +1-646-378-2926
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