ThromboGenics Announces Business Update and 2008 Full Year Results
By Prne, Gaea News NetworkWednesday, March 11, 2009
LEUVEN, Belgium - ThromboGenics Reports Pre-Tax Profit of EUR12.2 Million For 2008
ThromboGenics NV (Euronext Brussels: THR), a biotechnology
company focused on the discovery and development of innovative treatments
that will make a real difference to patient care in a number of important
therapeutic areas, is today issuing a business update and its financial
results for the full year ending December 31, 2008.
During the last twelve months, ThromboGenics has made
considerable progress across all aspects of its business culminating in the
recent start of the Phase III clinical development program for its lead
product microplasmin in back of the eye disease. The decision to start the
Phase III program was based on the positive Phase II clinical results which
were announced over the course of 2008.
In June 2008, ThromboGenics announced a further important
corporate milestone, the signing of a high value strategic alliance with
Roche for its novel anti-cancer antibody TB-403 (anti-PIGF). This deal, which
generated an upfront payment of EUR30 million, has provided significant
funding to allow ThromboGenics to invest in its other development programs.
The upfront payment from the Roche deal has enabled
ThromboGenics to report a pre-tax profit of EUR 12.2 million in 2008.
Given its recent progress, ThromboGenics is confident that
over the next eighteen months it will be able to generate significant
shareholder value as it continues to maximize the value of its exciting
product pipeline.
Business Highlights
Clinical Highlights
Microplasmin - Eye Disease: Positive results announced in
Phase II clinical trials for back of the eye indications. Positive results
were reported in ThromboGenics’ Phase IIb (MIVI III) trial in patients with a
number of back of the eye conditions. The trial showed that the most
effective dose of microplasmin studied (125 μg) was able to resolve the
underlying disease in approximately 30% of patients within 1 week of
treatment, removing the need for surgical intervention in these patients.
Microplasmin - Eye Disease: Phase III clinical program to
evaluate non surgical treatment of patients with vitreomacular adhesion. In
January 2009, ThromboGenics announced the start of the Phase III clinical
program of microplasmin for the non-surgical treatment of back of the eye
disease. The Phase III program comprises two clinical trials, taking place in
the United States (TG-MV-006 trial) and combined Europe and US (TG-MV-007
trial). The initial indication for both of the Phase III microplasmin trials
is the non-surgical treatment of focal vitreomacular adhesion. Both of these
trials will use the 125μg dose of microplasmin and include 320 patients
each.
Microplasmin for Vascular Disease - Encouraging Phase II results in acute
ischemic stroke. In September, Professor Vincent Thijs, KULeuven, presented
the results from this 40 patient study at the World Stroke Congress in
Vienna, Austria. It remains ThromboGenics’ intention that it will only move
forward with the development of microplasmin for the treatment of stroke in
conjunction with a partner.
TB-402 - Anti-coagulant: Begins Phase II trial in patients
undergoing orthopaedic surgery. In February 2009, ThomboGenics announced that
the first patient had been enrolled in the Phase II trial with their
long-acting anticoagulant TB-402 for the prophylaxis of Deep Vein Thrombosis
(DVT) following orthopaedic surgery. TB-402, which is given as a single
injection post surgery, could overcome the major drawbacks such as bleeding
and the need for extensive patient monitoring associated with current
anti-coagulant therapy.
TB-403 - Anti-cancer: Positive results announced in Phase Ia
study with TB-403 and start of Phase Ib study in late stage cancer patients.
The first Phase l study with TB-403 showed that it was well tolerated, with a
pharmacokinetic profile which would allow it to be developed as a treatment
for cancer. TB-403 is currently in a Phase Ib trial which studies its
tolerability, pharmacokinetics and pharmacodynamics in patients with advanced
cancer.
Corporate highlights
Major partnering deal: In June 2008, ThromboGenics and its
co-development partner BioInvent signed a strategic alliance deal with Roche
for its novel anti-cancer agent, TB-403 (anti-PIGF). Under the terms of the
agreement ThromboGenics and BioInvent shared 60/40, an upfront payment of
EUR50 million and could potentially share up to EUR450 million in milestone
payments as well as double digit royalties on the same basis. TB-403 is being
developed as an anti-cancer agent, and is currently in a Phase Ib clinical
trial. TB-403 acts selectively by inhibiting the growth of new blood vessels
in cancer tissue but not in normal tissue.
Financial Highlights
- In 2008, ThromboGenics revenue amounted to EUR30.4 million.
This much higher level of revenue is due to Roche’s upfront payment
Following the signed deal on TB-403. Operating expenses for the full
year were EUR19.2 million, the vast majority of which were due to R&D
expenses related to the Company’s clinical development programs. The
net profit over the reported period amounts to EUR 12.1 million against
a loss of EUR16.0 million over the full year 2007.
- The Company expects to see an increase in its operating
expenses in 2009 as it invests in the Phase III clinical program for
microplasmin in back of the eye disease. This program began in January
2009.
- As of 31 December 2008, ThromboGenics had EUR58.9 million in
cash and investments, including EUR28.6 million in short term, near
liquid investments. This compares to EUR 40.1 million in cash and EUR
6.7 million in short term investments at December 31, 2007. This level
of cash resources is expected to allow ThromboGenics to drive forward
its operational plans for the next two years.
Patrik De Haes, CEO of ThromboGenics, commenting on today’s
announcement, said: “ThromboGenics had a very successful 2008, making
excellent progress with its development pipeline and reporting a pre-tax
profit for the period. The recent start of our Phase III program with
microplasmin in patients with back of the eye disease is a major milestone
for the Company. Our decision to initiate this pivotal clinical program was
driven by the excellent clinical Phase II data that we have generated,
combined with our strong financial position. This is the result of the EUR30m
upfront payment we received as part of our major strategic licensing deal for
TB-403 with Roche, signed in June 2008. We are also making good progress with
TB-402, a novel long acting anti-coagulant which we believe has advantages
over currently marketed products. As ThromboGenics continues to transform
itself into a late-stage development company, I am confident that we have all
the tools needed to ensure our corporate success.”
For the full report of these results please go to
www.thrombogenics.com
About ThromboGenics
ThromboGenics is a biotechnology company focused on the
discovery and development of biopharmaceuticals for the treatment of eye
disease, vascular disease and cancer. The Company’s lead product Microplasmin
is in Phase III clinical development for the non-surgical treatment of back
of the eye diseases. Microplasmin is also being evaluated in Phase II
clinical development for additional vitreoretinal indications and as a
potential therapy for stroke. ThromboGenics is also developing novel antibody
therapeutics in collaboration with BioInvent International; these include
TB-402 (Anti-Factor VIII), a long acting anti-coagulant, and TB-403
(anti-PlGF) for cancer.
ThromboGenics has built strong links with the University of
Leuven and the Flanders Institute for Biotechnology (VIB) and has exclusive
rights to certain therapeutics developed at these institutions. ThromboGenics
is headquartered in Leuven, Belgium. The Company is listed on Eurolist by
Euronext Brussels under the symbol THR. More information is available at
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.
For further information please contact:
ThromboGenics
Dr. Patrik De Haes, CEO
Tel: +32-16-75-13-10
patrik.dehaes@thrombogenics.com
Chris Buyse, CFO
Tel: +32-16-75-13-10
chris.buyse@thrombogenics.com
Citigate Dewe Rogerson
Amber Bielecka/ David Dible/ Nina Enegren
Tel: +44-(0)207-638-95-71
amber.bielecka@citigatedr.co.uk
Source: ThromboGenics NV
For further information please contact: ThromboGenics, Dr. Patrik De Haes, CEO, Tel: +32-16-75-13-10, patrik.dehaes at thrombogenics.com. Chris Buyse, CFO, Tel: +32-16-75-13-10, chris.buyse at thrombogenics.com. Citigate Dewe Rogerson, Amber Bielecka/ David Dible/ Nina Enegren, Tel: +44-(0)207-638-95-71, amber.bielecka at citigatedr.co.uk
Tags: belgium, Leuven