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ThromboGenics N.V. - Business Update

    LEUVEN, Belgium, May 13 /PRNewswire-FirstCall/ --

    - Regulated Information

    ThromboGenics NV (Euronext Brussels: THR), a biotechnology company
focused on innovative treatments for vascular disease, eye disease and
cancer, is today issuing a business update for the three month period ended
31 March 2008.

    Prof. Desire Collen, CEO and Chairman of ThromboGenics, commenting on
today's announcement, said: "ThromboGenics' clinical development programs
are continuing to make the good progress that we had anticipated. During
the first three months of 2008, we achieved a number of important clinical
milestones that have clearly added further value to our exciting product
pipeline. The positive results of our trials with microplasmin are giving
us confidence that it has the potential to make a real difference in the
field of eye disease. Our exciting new anti-cancer antibody TB-403 has also
begun its clinical development. We anticipate seeing further encouraging
results across our development pipeline during the remainder of 2008; a
year in which we expect to advance ThromboGenics' business significantly."

    Financial Update

    - In the first quarter of 2008, revenue amounted to EUR 0.1 million,
mainly coming from out-licensing. Operating expenses were EUR 3.2 million
in the first quarter, the majority of which were due to R&D expenses
related to our increasing number of clinical development programs.

    - As of 31 March 2008, ThromboGenics had EUR 41.7 million in cash and
cash equivalents. This compares to EUR 29.1 million on 31 March, 2007 and
EUR 46.1 million on 31 December 2007.

    Clinical Update

    Highlights

    - ThromboGenics completed patient enrolment for its Phase IIb MIVI III
trial in the United States for microplasmin in vitrectomy.

    Microplasmin is being developed as an adjunct for vitrectomy. A
vitrectomy is an increasingly common surgical procedure which is carried
out in the treatment of many back of the eye diseases such as retinal
detachment, diabetic vitreous hemorrhage and macular hole. It is estimated
that 600,000 vitrectomies are carried out annually worldwide.

    Vitrectomy is used to induce a posterior vitreous detachment (PVD),
which involves removing the vitreous from the eye. As microplasmin is a
proteolytic enzyme, it is able to cleave the molecular structures which
link the vitreous to the retina, meaning that it could facilitate, and in
some cases even avoid, vitrectomy and therefore induce PVD without the
risks inherent in the current surgical procedure.

    The MIVI III trial, which has recruited a total of 125 patients, is
designed to assess the safety and efficacy of administering microplasmin
intravitreal injection 7 days prior to vitrectomy.

    - ThromboGenics completed patient enrolment for its Phase II MITI IV
trial

    Microplasmin is also being studied for the treatment of acute ischemic
stroke. In this indication, the fact that it is a direct-acting
thrombolytic agent (breaks down blood clots) and is independent of
plasminogen means that it could restore blood flow efficiently for a longer
period after the stroke event, and with potentially fewer side-effects than
other thrombolytic agents. The MITI IV study is placebo controlled and is
evaluating the safety and preliminary efficacy of microplasmin in three
different doses when administered intravenously to acute stroke patients
between four and twelve hours after the onset of the stroke. This trial has
recruited a total of 40 patients.

    - In January, ThromboGenics announced that its novel anti-cancer
antibody TB-403 had begun its initial Phase I clinical trial in Denmark.

    TB-403 (Anti-PIGF) is a potential breakthrough in the treatment of
cancer. It is a humanized monoclonal antibody that blocks the formation of
the new blood vessels that are needed by solid tumours to support their
growth. TB-403 therefore has the potential to minimise the growth and
spread of cancer cells. It is unique because, in contrast to competing
agents, TB-403 only blocks blood vessels in tumour tissue and not in
healthy tissue. This novel product, which acts on PIGF, is being
co-developed with BioInvent International.

    TB-403 is attracting growing interest from potential pharma partners
based on both the need for improved products for the treatment of cancer
and the exciting pre-clinical results which were published in a Cell
feature article in the November 2, 2007 issue.(1)

    The commercial potential of TB-403 could also be enhanced as TB-403
could also be used to treat a number of important back of the eye diseases.
This is because common eye diseases such as age-related macular
degeneration and diabetic retinopathy are caused by uncontrolled blood
vessel growth, which could be halted using TB-403.

    The Remainder of 2008

    ThromboGenics expects to deliver a number of value creating clinical
milestones during the remainder of 2008. The expected milestones over this
period are:

    Microplasmin

    - Top line results are expected from the MIVI III Phase IIb trial of
microplasmin in vitrectomy in June 2008.

    ThromboGenics began the MIVI III Phase IIb trial in January 2007. The
trial is evaluating the safety and efficacy of microplasmin intravitreal
injection seven days prior to vitrectomy. The results from this trial will
be presented at the World Ophthalmology Congress in Hong Kong on June 28,
2008.

    Based on the results of this trial, ThromboGenics will select the best
dose of microplasmin for use in two separate Phase III studies, one US and
one European based. These trials, which are designed to clearly demonstrate
the efficacy of microplasmin, are expected to begin before the end of 2008.

    - Six month results from the MIVI IIT Phase IIa trial of microplasmin
in vitreomacular traction are to be presented at the Euretina Conference in
May.

    The six month results from the first two cohorts of this trial will be
presented by the lead investigator, Prof. Peter Stalmans, at the Euretina
Conference on May 23, in Vienna. The third and fourth cohorts from this
trial will be presented at major ophthalmic conferences in the second half
of 2008.

    - Results are expected from the Phase II MITI IV trial in mid 2008.

    This Phase II trial is evaluating the safety and preliminary efficacy
of microplasmin when administered intravenously to acute stroke patients.
Once these data from the study have been reviewed, a decision will be made
on the future development plans for microplasmin in the treatment of acute
stroke.

    It is ThromboGenics' current intention that it will only move forward
with the development of microplasmin for the treatment of stroke in
conjunction with a partner. This intention is based on both the risks and
cost associated with the development of new stroke therapies and the
Company's desire to invest in its other attractive pipeline product
candidates, such as microplasmin in the treatment of back of the eye
diseases and TB-403.

    TB-403

    - Results from the initial Phase I trial of this novel anti-cancer
agent in healthy volunteers are expected in the third quarter of 2008.

    Following the successful completion of this initial Phase I study,
ThromboGenics expects to begin a Phase Ib trial with TB-403 in end stage
cancer patients in mid 2008. This study, which will recruit approximately
24 patients, is designed to provide both safety data on TB-403 when used in
cancer patients and some early efficacy data on the product.

    TB-402

    - Top line results of the interaction studies to be announced by
mid-2008.

    TB-402 is being developed as an anti-coagulant for the prevention of
deep vein thrombosis (DVT) after orthopaedic surgery and prevention of
venous emboli in patients with atrial fibrillation. It is a novel human
antibody that partially blocks Factor VIII, an essential blood clotting
factor. The implication of this is that spontaneous bleeding events, which
are a potential unwanted side effect if Factor VIII is completely
inhibited, should not occur. Hence, there would be no need for the
monitoring of coagulation parameters in the patient.

    ThromboGenics is developing TB-402 in collaboration with BioInvent
International.

    In comparison to other current anticoagulants that require daily
dosage, TB-402 has a prolonged half-life that will allow for a single-dose
treatment in orthopaedic surgery patients and/or once-a-month
administration for long-term stroke prevention in atrial fibrillation (AF).

    Staphylokinase

    - Initiation of Phase III by Bharat Biotech International Ltd in India.

    ThromboGenics has entered into a partnership with Bharat Biotech to
continue the clinical development and commercialization of THR-100. This
novel variant of Recombinant Staphylokinase is initially being developed by
Bharat in India for the treatment of acute myocardial infarction (AMI), or
heart attack. Given the commercial strengths of Bharat in this market and
the clinical advantages of THR-100, it is hoped that this novel product
will quickly become the market leader for the treatment of heart attacks in
India. It is currently anticipated that THR-100 Phase III will be started
in India in the third quarter.

    Patrik De Haes, COO of ThromboGenics, commenting on today's release
said, "ThromboGenics is confident that 2008 will be a transformational year
for the Company. The important clinical milestones that we expect to
achieve will further highlight the attractiveness of our clinical pipeline
of innovative vascular biopharmaceuticals. These milestones will also
provide us with a platform for signing partnership deals, which are an
important element of our strategy to develop ThromboGenics into an
important player in the areas of vascular disease, eye disease and cancer."

    ThromboGenics will provide a further update when the Company reports
its half year results on the 28th August, 2008.

    About ThromboGenics

    ThromboGenics is a biotechnology company focused on discovery and
development of biopharmaceuticals for the treatment of a range of vascular
diseases. The Company has several programs in Phase II clinical development
including microplasmin, which is being evaluated as a treatment for
vitreoretinal disorders and as a thrombolytic agent for vascular occlusive
diseases such as acute stroke. ThromboGenics is also developing novel
antibody therapeutics in collaboration with BioInvent International; these
include TB-402 (Anti-Factor VIII), scheduled to enter Phase II clinical
development in late 2008, and TB-403 (Anti-PlGF), which has begun Phase I
clinical trials for the treatment of cancer. ThromboGenics has built strong
links with the University of Leuven and has exclusive rights to certain
therapeutics developed at the University. ThromboGenics is headquartered in
Leuven, Belgium and has subsidiaries in Dublin, Ireland and New York, U.S.
The Company is listed on Eurolist by Euronext Brussels 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 prospectus.

    ---------------------------------

    (1) Cell, 2 November 2007, ANTI-PlGF INHIBITS GROWTH OF
VEGF(R)-INHIBITOR RESISTANT TUMORS WITHOUT AFFECTING HEALTHY VESSELS -
Christian Fischer, Bart Jonckx, Massimiliano Mazzone, Serena Zacchigna,
Monica Autiero, Emmanuel Chorianopoulos, Marta Koch, Maria Demol, Sabine
Wyns, Lucia Pattarini, Nico van Rooijen, Stephane Plaisance, Mauro Giacca,
Mieke Dewerchin, Lieve Moons, Jean Marie Stassen, Desire Collen & Peter
Carmeliet


For further information please contact: ThromboGenics: Prof. Desire Collen, Tel: +32(0)16-34-61-94; Dr. Patrik De Haes, Fax +32(0)16-34-61-34. Citigate Dewe Rogerson: Sylvie Berrebi / Amber Bielecka / David Dible, Tel: +44(0)207-638-95-71, Mobile: +44(0)7767-771-533.
SOURCE ThromboGenics NV




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