LEUVEN, Belgium, August 28 /PRNewswire/ -- 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.
Partnership - 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 normal tissues. Clinical Highlights - 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 patients.
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.
Financial Summary - 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: ThromboGenics Patrik De Haes, COO Tel : +32-16-75-13-10 email@example.com Chris Buyse, CFO Tel : +32-16-75-13-10 firstname.lastname@example.org Citigate Dewe Rogerson Amber Bielecka/Sylvie Berrebi/David Dible Tel: +44(0)207-638-95-71 email@example.com
For further information please contact: ThromboGenics, Patrik De Haes, COO, Tel : +32-16-75-13-10, firstname.lastname@example.org; Chris Buyse, CFO, Tel : +32-16-75-13-10, email@example.com; Citigate Dewe Rogerson, Amber Bielecka/Sylvie Berrebi/David Dible Tel: +44(0)207-638-95-71, firstname.lastname@example.org