BioInvent And ThromboGenics Announce A Strategic Alliance With Roche For TB-403, A Novel Anti-Cancer Antibody

Main Category: Cancer / Oncology
Article Date: 19 Jun 2008 - 3:00 PDT

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BioInvent International AB (STO:BINV) and ThromboGenics NV (Euronext Brussels: THR) announce that they have entered into a license agreement with Roche (SWX: ROG) for their jointly developed anti-cancer agent TB-403. 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.

Under the terms of the agreement effective from June 17, 2008 (or if a U.S. anti-trust clearance is required, from the date of receipt of such clearance), Roche will pay BioInvent and ThromboGenics an upfront payment of €50 million. In addition, BioInvent and ThromboGenics could potentially receive up to €450 million over the term of the collaboration based on the successful completion of a series of development and commercial milestones for multiple indications, as well as double digit royalties on potential product sales, including any backup antibodies based on inhibition of PlGF. ThromboGenics, which discovered TB-403, will receive 60% and BioInvent 40% of the revenue from the deal. Roche will have a worldwide, exclusive license to develop and commercialize TB-403. BioInvent and ThromboGenics will retain co-promotion rights for the product in the Nordic, Baltic and Benelux regions.

BioInvent and ThromboGenics are responsible for any remaining costs associated with the recently completed Phase Ia trial in healthy volunteers. Roche will assume responsibility for all future development costs for this novel therapy, including the costs of the pending Phase Ib trial in patients to be run by BioInvent and ThromboGenics. BioInvent and ThromboGenics in conjunction with Roche will form a Joint Steering Committee to oversee research and development activities. In addition, Roche will also provide funding to BioInvent and ThromboGenics for research on non-cancer indications and supply of clinical material until transfer of manufacturing.

TB-403 (Anti-PIGF) has completed an initial Phase I clinical trial and recently received approval to enter a Phase Ib dose escalation trial. This Phase Ib trial will be conducted in patients with advanced cancer and is due to commence shortly in Denmark.

TB-403 has the potential to be a major advance 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 has the potential to minimise both the growth and spread of cancer cells.

Svein Mathisen, CEO of BioInvent, commented on the deal: "We believe that TB-403 has great potential for the treatment of cancer, with its unique mode of action targeting PlGF, and are delighted that Roche has recognised this potential. This agreement demonstrates our ability to identify innovative projects and to realize the clinical potential of a therapeutic antibody. We look forward to seeing the product progress further through clinical development and towards market."

Professor Désiré Collen, CEO and Chairman of ThromboGenics, said: "TB-403 has generated a great deal of interest from the pharmaceutical community. Therefore, we are delighted that we have signed this major licensing agreement with Roche, given their expertise and success in bringing novel anti-cancer agents to the market. This deal represents a significant milestone in ThromboGenics' development as a company. It also reflects TB-403's potential as a promising treatment for cancer, and is a testament to the hard work and high quality science on which ThromboGenics' business is based. The funding from this deal also gives us the financial resources to continue to build our strong pipeline. We look forward to working with Roche, and to the successful development of this unique anti-cancer agent."

Dan Zabrowski, Global Head of Pharma Partnering, Roche added; "We are very pleased to enter this partnership with BioInvent and ThromboGenics. This novel antibody, TB-403 has the potential to play a major role in the treatment of cancer and we are committed to driving ahead with its development. In addition, we look forward to developing a strong working relationship with BioInvent and ThromboGenics."

Legal disclaimer

This press release contains statements about the future, consisting of subjective assumptions and forecasts for future scenarios. Predictions for the future only apply as of the date they are made and are, by their very nature, in the same way as research and development work in the biotech segment, associated with risk and uncertainty. With this in mind, the actual outcome may deviate significantly from the scenarios described in this press release.

About TB-403

TB-403 was in-licensed by ThromboGenics from the Flanders Institute for Biotechnology (VIB) at the University of Leuven, Belgium, where the therapeutic potential of anti-PlGF agents to treat cancer was first developed in the laboratory of Prof. Peter Carmeliet.

Angiogenesis inhibitors such as TB-403 are therapeutic agents that work by blocking the development of new blood vessels, thereby depriving growing cancer tumour cells of oxygen and nutrients. This approach in turn is thought to stop the tumour from growing and spreading to other parts of the body. PlGF is a homologue of VEGF and current preclinical evidence suggests that it may not affect normal, physiological angiogenesis and is predominantly involved in angiogenesis of malignant tissue.

About BioInvent

BioInvent International AB, listed on the OMX Nordic Exchange Stockholm (BINV), is a research-based pharmaceutical company that focuses on developing antibody drugs. The Company is currently running innovative drug projects within the areas of thrombosis, cancer, atherosclerosis and ophthalmic diseases. In January 2007 the Company announced a major strategic alliance with American-based Genentech, Inc. in the cardiovascular field.

These projects are based on a competitive and in substance patented technology platform. The scope and strength of this platform is also utilised by partners, such as ALK-Abelló, Bayer HealthCare, ImmunoGen, OrbusNeich, Sanofi-Aventis, UCB and XOMA.

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, including 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 2008, and TB-403 (Anti-PlGF). ThromboGenics and BioInvent have recently signed a license agreement with Roche for TB-403 worth €500 million plus royalties. TB-403 is scheduled to enter a Phase Ib clinical trial in mid-2008 for the treatment of 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.

About Roche

Headquartered in Basel, Switzerland, Roche is one of the world's leading research-focused healthcare groups in the fields of pharmaceuticals and diagnostics. As the world's biggest biotech company and an innovator of products and services for the early detection, prevention, diagnosis and treatment of diseases, the Group contributes on a broad range of fronts to improving people's health and quality of life. Roche is the world leader in in-vitro diagnostics and drugs for cancer and transplantation, and is a market leader in virology. It is also active in other major therapeutic areas such as autoimmune diseases, inflammatory and metabolic disorders and diseases of the central nervous system. In 2007 sales by the Pharmaceuticals Division totalled 36.8 billion Swiss francs, and the Diagnostics Division posted sales of 9.3 billion francs. Roche has R&D agreements and strategic alliances with numerous partners, including majority ownership interests in Genentech and Chugai, and invested over 8 billion Swiss francs in R&D in 2007. Worldwide, the Group employs about 79,000 people.

Roche