LEUVEN, Belgium, August 28 /PRNewswire-FirstCall/ -- ThromboGenics NV (Euronext Brussels: THR), a biotechnology company focused on innovative treatments for eye disease, vascular disease and cancer, is today issuing a business update and its financial results for the six month period ending June 30, 2008.
During the first half of 2008, ThromboGenics has achieved a number of
key milestones which have positioned the Company to successfully pursue the
next stage of its corporate strategy. In this period, ThromboGenics signed
a high value strategic alliance with Roche for its novel anti-cancer
product TB-403 and has seen important new clinical data for its lead
product, microplasmin, in patients with back of the eye disease. Given this
progress, ThromboGenics is confident that the next twelve months will see
further significant shareholder value being generated as it continues to
maximise value from its product pipeline.
- Major partnering deal: In June, 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 received an upfront payment of
EUR50 million and could potentially share up to EUR450 million in
milestone payments as well as double digit royalties. TB-403 is a novel
monoclonal antibody which blocks Placental Growth Factor (PIGF), one of
the growth factors responsible for the development of new blood
vessels. TB-403 is being developed as an anti-cancer agent, and is
currently in Phase I of clinical development. It acts by selectively
inhibiting tumor growth by blocking its blood supply without affecting
- TB-403 : Positive results announced in first Phase Ia study
with TB-403 and start of Phase Ib study in late stage cancer patients.
The first Phase l study showed that TB-403 was safe and well tolerated,
with a pharmacokinetic profile which would allow it to be developed as
a treatment for cancer. TB-403 has moved into a Phase Ib trial. This
study will look at the tolerability, pharmacokinetics and
pharmacodynamics of TB-403 in patients with advanced cancer.
- Microplasmin: Positive results announced in Phase II
clinical trials for ophthalmic 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 micro g) was able to
resolve the underlying disease in approximately 30% of patients and
consequently achieved the avoidance of surgical intervention in those
Further positive six month follow-up results from the Phase IIa MIVI IIT trial, designed to evaluate both the safety and efficacy of microplasmin injection for the treatment of vitreomacular traction, were presented at the Euretina Congress in Vienna, Austria in June.
ThromboGenics has continued to work to broaden the Company's
shareholder base. In July, ThromboGenics announced the acquisition of an 8%
stake in the Company by a group of private investors based in Belgium in a
transaction coordinated by Petercam. Their stake was purchased from Biggar
Limited, a charitable foundation that is ThromboGenics' largest
shareholder. Biggar intends to remain an important shareholder in
ThromboGenics for the long term.
- In the first six months of 2008, revenue amounted to EUR30.3
million. This much higher level of revenue is due to Roche's upfront
payment following the signed co-development deal on TB-403. Operating
expenses were EUR13.0 million in the first half, the majority of which
were due to R&D expenses related to the Company's increasing number of
clinical development programs. The net profit over the reported period
amounts to EUR 18.0 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 the second half of the year as it starts to invest in the
Phase III program for microplasmin in back of the eye disease
- As of June 30, 2008, ThromboGenics had EUR 40.4 million in
cash and cash equivalents. This compares to EUR49.3 million on June 30,
2007 and EUR 46.1 million on December 31, 2007. This cash position does
not yet include the upfront payment from Roche of EUR 30 million that
was only received in July 2008.
Prof. Desire Collen, CEO and Chairman of ThromboGenics, commenting on today's announcement, said: "ThromboGenics has made excellent progress in the first half of 2008. We have not only seen very promising clinical data with our lead product, microplasmin, but also signed a significant co-development deal with Roche for our unique anti-cancer agent, TB-403. The ability of microplasmin to resolve certain back of the eye conditions coupled with the financial benefits which our alliance with Roche brings, means we are now well-positioned to advance microplasmin into its Phase III clinical development program. As ThromboGenics continues to transform itself into a late-stage development company, I am confident that we have all the tools available to ensure our corporate success."
For the full report of these results please go to http://www.thrombogenics.com
ThromboGenics is a biotechnology company focused on discovery and development of biopharmaceuticals for the treatment of eye disease, vascular disease and cancer. 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. 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 by the end of 2008, and TB-403 (Anti-PlGF). ThromboGenics and its development partner BioInvent, have recently signed a license agreement with Roche for TB-403 worth up to EUR500 million plus royalties. A Phase Ib clinical trial with TB-403 has recently begun in patients with late stage 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 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 Company's Annual Report.
For further information please contact:
Patrik De Haes, COO Tel : +32-16-75-13-10
Chris Buyse, CFO Tel : +32-16-75-13-10
Citigate Dewe Rogerson
Amber Bielecka/Sylvie Berrebi/David Dible Tel: +44(0)207-638-95-71
|SOURCE ThromboGenics NV|
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