BioInvent International AB and ThromboGenics NV have entered into a license agreement with Roche 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. 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 per cent and BioInvent 40 per cent 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".