ThromboGenics Business Update
LEUVEN, Belgium, November 7, 2013
LEUVEN, Belgium, November 7, 2013 /PRNewswire/ --
*JETREA ^® slowly continues to gain acceptance with the US retina
*Company increasing US medical education efforts: increasing number of
US-based Medical Science Liaison managers to 12.
*US Organizational update: Dr Keith Steward appointed Head of US Business
*Benefits of JETREA ^® , particularly in early stage patients, confirmed by
positive reimbursement guidance from both the GB-A in Germany and NICE in
*Alcon delivers important milestones with JETREA ^® in Rest of the World:
Product approved in Canada, important clinical bridging study initiated in
Japan, other multiple submissions are ongoing and planned.
*Continued focus on diabetic eye diseases: Prevention of Proliferative
Diabetic Retinopathy (PDR) is next JETREA ^® target indication.
*On September 30, 2013, the Company's cash position is Euro 183 Million,
from Euro 193.6 Million on June 30, 2013.
ThromboGenics NV (Euronext Brussels: THR), an integrated biopharmaceutical
company focused on developing and commercializing innovative ophthalmic
medicines, today issued a business update for the period ending 30 September,
ThromboGenics has developed JETREA ^® , the first and only pharmacological
treatment indicated for an important sight-threatening condition, symptomatic
vitreomacular adhesion (VMA)/ vitreomacular traction (VMT) in the US and
Europe respectively. VMT/ symptomatic VMA is a progressive, sight-threatening
condition that may lead to visual distortion, decreased visual acuity and
In mid-January 2013, the Company launched JETREA ^® in the US through its own
In April 2013, its partner Alcon launched JETREA ^® in Europe after it was
approved by the European Commission in March. In Europe the drug is now
available in the UK, Germany, Finland, Norway, Denmark and Sweden. First
patients were also treated in Belgium, France and the Netherlands.
ThromboGenics received €90 million in milestone payments from Alcon for the EU
approval and first European sale of JETREA ^® .
In October, G-BA, the highest German decision-making body responsible for
determining the health care services which will be reimbursed for over 70
million publicly insured persons in Germany, confirmed the exceptional benefit
appraisal JETREA ^® received from IQWiG. G-BA concluded in its value
assessment of JETREA ^® that JETREA ^® demonstrates significant therapeutic
benefits for patients suffering from mild and moderate symptoms of VMT when
compared with watchful waiting.
In October, UK's National Institute for Health and Care Excellence (NICE)
final guidance has recommended that JETREA ^® (ocriplasmin) should be
reimbursed within the National Health Service (NHS) in England and Wales as an
option for treating VMT patients.
The NICE final guidance highlighted metamorphopsia as a 'severe and
distressing' symptom, with its impact on the patient being comparable to a
loss of two lines in visual acuity. In its final ruling, NICE has recommended
reimbursing JETREA ^® when used to treat patients suffering from
metamorphopsia, one of the early signs of VMT.
In RoW, JETREA ^® was approved in Canada in August, for the treatment of
symptomatic vitreomacular adhesion. This was the first approval of this
innovative drug in a market outside the US and Europe.
In Japan, Alcon has started its first clinical study with JETREA ^® . This
clinical bridging study is recruiting patients with symptomatic VMA/VMT
including those associated with macular hole. The study is an important step
in potentially gaining regulatory approval for ocriplasmin in Japan, the
world's second largest pharmaceutical market.
Dr Patrik De Haes, CEO of ThromboGenics comments : " We are continuing to work
to drive the adoption of this novel treatment option in patients with
symptomatic VMA/VMT. Our medical education efforts are focused on changing a
treatment paradigm for early stage patients who usually undergo a period of
watchful waiting prior to surgery. We are increasing the number of MSLs in the
US so we are better placed to highlight to retina physicians the
multiple benefits of treating mild to moderate patients early.
"It is clear that these expanded educational efforts along with the provision
of reimbursement and medical information support will require more time before
they lead to a significant uptick in JETREA ^® 's prescribing. However,
given the positive outcomes we have seen in a number of JETREA ^®
excellence centers across the US, we remain confident of generating a higher
level of sales with this innovative new drug.
"In Europe, with our partner Alcon, we are encouraged by the very positive
final guidance from the G-BA in Germany and NICE in the UK. Particularly
important is that both of these rulings highlight the significant value of
using JETREA ^® for the treatment of patients with early symptoms. We are
looking forward to further launches of JETREA ^® across the EU during the
next twelve months.
Outside Europe, Alcon is continuing to make good progress with JETREA ^® ,
having recently received approval for the drug in Canada and having started an
important clinical bridging study in Japan. This study is a key step in
potentially gaining approval for JETREA ^® in the world's second largest
For the full report please visit http://www.thrombogenics.com .
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
The phase III program also showed that JETREA ^® was generally well tolerated.
Any adverse reactions were ocular. The most commonly reported were vitreous
floaters, eye pain and photopsia, as well as conjunctival haemorrhage
resulting from the injection procedure. Most of the adverse reactions occurred
within the first week after the injection. The majority of these reactions was
non-serious, mild in intensity and resolved within 2 to 3 weeks. ^
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.
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 and the
ThromboGenics is also further exploring anti-PIGF (Placental Growth Factor),
also referred to as TB-403.
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
1. Stalmans P, Benz MS, Gandorfer A et al. Enzymatic vitreolysis with
ocriplasmin for vitreomacular traction and macular holes. N Engl J Med
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 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
The Trout Group (US investor relations) Todd James / Simon Harnest Tel:
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