ThromboGenics' JETREA®, the First and Only Medicine for Treating Vitreomacular Traction, now Launched in the UK

ThromboGenics' JETREA®, the First and Only Medicine for Treating Vitreomacular
                       Traction, now Launched in the UK

  PR Newswire

  LEUVEN, Belgium, April 11, 2013

LEUVEN, Belgium, April 11, 2013 /PRNewswire/ --

 First EU JETREA ^®  order triggers €45 million milestone payment from Alcon
                               to ThromboGenics

ThromboGenics NV (Euronext Brussels: THR), an integrated biopharmaceutical
company focused on developing and commercializing innovative ophthalmic and
oncology medicines, today announces that its partner Alcon has launched JETREA
^® (ocriplasmin) in the UK, its first market in Europe. The first sale of
JETREA ^® by Alcon triggers a €45 million milestone payment to ThromboGenics.
ThromboGenics recently received €45 million from Alcon when JETREA ^® gained
European approval for the treatment of vitreomacular traction (VMT), including
when associated with macular hole of diameter less than or equal to 400
microns.

Alcon, a division of Novartis, acquired the rights to commercialize JETREA ^®
outside the United States in March 2012. ThromboGenics retains the right to
commercialize the drug in the US. ThromboGenics launched JETREA ^® in the US
in mid-January 2013 where it is approved for the treatment of patients with
symptomatic vitreomacular adhesion (VMA).

JETREA ^® is currently undergoing a single technology appraisal (STA) by the
National Institute for Health and Care Excellence (NICE) as part of the
process to gain reimbursement when used by the UK National Health Service. The
outcome of the STA, in the form of NICE guidance, is expected in the final
quarter of 2013.

Dr Patrik De Haes, CEO of ThromboGenics, says:   " The launch of JETREA ^® 
in Europe  by Alcon so shortly after gaining European approval is testimony
of our joint commitment to ensuring patients in Europe have access to this
innovative drug as soon as possible. The additional €45 million payment from
Alcon for reaching this milestone means we are well placed to continue
investing in the commercialization of JETREA ^®  in the  US  via our own
commercial organization. We expect that Alcon will roll out  JETREA ^®  into
other European markets in the coming months and are working with our partner
to ensure that all the support for physicians, payers and patients is fully in
place. "   

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
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 ^® 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 ^] ^  

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 is continuing to work with Alcon, across Europe, to ensure the
necessary market access and reimbursement infrastructure in place so that
patients can receive JETREA ^® as soon as it is available.   

References

^[ ^1 ^] ^. ThromboGenics and Alcon internal estimates

^[ ^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
2011;(Suppl):1-14

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.

About ThromboGenics

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
indications.

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. 

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 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.piepers@thrombogenics.com Dr. Patrik
De Haes, CEO +32-16-75-13-10 Patrik.dehaes@thrombogenics.com Chris Buyse, CFO
+32-16-75-13-10 Chris.buyse@thrombogenics.com

Citigate Dewe Rogerson David Dible/ Nina Enegren/ Sita Shah Tel:
+44(0)20-7638-9571  sita.shah@citigatedr.co.uk The Trout Group (US investor
relations) Todd James/ Simon Harnest Tel: +1-646-378-2926
tjames@troutgroup.com
 
Press spacebar to pause and continue. Press esc to stop.