Lund, Sweden and Leuven, Belgium - 3 July 2009 - BioInvent International AB (OMXS: BINV) and ThromboGenics NV (Euronext Brussels: THR) announce that they have started recruitment of a second cohort of patients for their Phase II trial of TB-402. This follows completion of recruitment of the first cohort of 100 patients ahead of schedule. TB-402 is a novel, long acting anticoagulant that is being developed for the prevention of deep vein thrombosis (DVT) following orthopaedic surgery. The decision to move ahead with the second cohort of this trial follows unanimous advice from the external efficacy and safety monitoring board to proceed using a higher dose of TB-402.

The Phase II trial is an active (enoxaparin)-controlled, dose-escalating, multicenter, prospective, randomised, open label trial evaluating TB-402 for the prophylaxis of DVT after knee surgery. The study is assessing three different doses of TB-402 given as a single intravenous bolus injection post knee replacement surgery and will enrol a total of 300 patients across 36 centers in Europe. The objective of the study is to assess the safety and efficacy of the three escalating doses of TB-402.

TB-402 is a recombinant human monoclonal antibody that partially inhibits Factor VIII, a key component of the coagulation cascade. This novel mode of action is expected to reduce the risk of undesirable bleeding events, even at high doses, as well as the need for patient monitoring. These are the two main drawbacks associated with current anticoagulants. In addition, TB-402 is a long-acting agent, which means it could be given as a single dose after surgery to prevent the development of DVT. This would be an attractive option, as all current anticoagulant treatment options require daily treatment for up to several weeks.

Professor Peter Verhamme from the University of Leuven will present additional data from the earlier successful Phase I study at the XXII Congress of the International Society on Thrombosis and Haemostasis (ISTH) on 15 July, 2009, in Boston.

Svein Mathisen, CEO of BioInvent, commented, "We are pleased that there has been rapid progress in this study and that the efficacy and safety monitoring board unanimously recommended that we proceed to a higher dose of TB-402. It is testament to the strength of our partnership with ThromboGenics and the exciting potential of this product candidate."

Patrik De Haes, CEO of ThromboGenics, also commented, "We are very happy that this important study with TB-402 is progressing rapidly. TB-402's profile, including its novel mode of action, could allow it to address the many drawbacks associated with current anticoagulant therapy. We remain confident in the large market potential for TB-402, and believe that the current Phase II study will provide additional data to further highlight the attractive differentiating properties of this novel long-acting anticoagulant."

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 About Deep Vein Thrombosis (DVT)
 DVT is caused when a blood clot forms in a deep vein, most commonly in the deep veins of the lower leg.  DVT is a major public health issue and it is estimated that in the US alone, more than 350,000 individuals are affected by DVT or pulmonary embolism (PE) each year.  Moreover, DVT and PE together may be responsible for more than 100,000 deaths in the U.S. each year.   

 It is estimated that by 2015, 1.4 million patients will undergo knee replacement and 600,000 patients will undergo hip replacement in the U.S. if current trends persist.   Patients undergoing hip replacement or knee surgery are particularly at risk of developing DVT and all patients are therefore treated with anticoagulants prophylactically in order to reduce the risks of blood clots. The annual sales of anticoagulants worldwide are over $5 billion. Nevertheless, available anticoagulants are still inconvenient and associated with an increased risk of bleeding. Improved anticoagulants are therefore required. In particular, agents that allow for improved ease of administration (without requirement for daily dosing and frequent dose adjustment) would fill a significant unmet need.  

For further information, please contact:

BioInvent International AB
Svein Mathisen
President & CEO
Tel: +46 (0)46-286 85 67
Mobile: +46 (0)708-97 82 13
E-mail: [email protected]

Cristina Glad
Executive Vice President
Tel: +46 (0)46-286 85 51
Mobile: +46 (0)708-16 85 70
E-mail: [email protected]

College Hill (media enquiries)
Holly Griffiths, Sue Charles and John McIntyre
Tel: +44 (0)20 7457 2020
E-mail: [email protected]

ThromboGenics NV
Patrik De Haes MD
Chief Executive Officer
Tel : +32 (0) 16 75 13 10
E-mail: [email protected]

Andy De Deene MD
Clinical Director Europe
Tel: +32 (0) 16 75 13 10
E-mail: [email protected]

 Citigate Dewe Rogerson
 Amber Bielecka, David Dible, Nina Enegren
 Tel: +44 (0) 207 638 95 71	
 E-mail: [email protected] 

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.

Information disclosed in this press release is provided herein pursuant to the Swedish Securities Markets Act and/or the Swedish Financial Instruments Trading Act. The information was submitted for publication at 7.30 a.m. CET, on 3 July, 2009.