ThromboGenics and BioInvent Complete Patient Recruitment of Phase II DVT Prophylaxis Study With Anti-Factor VIII (TB-402)

Wednesday, October 28, 2009 General News
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LEUVEN, Belgium and LUND, Sweden, October 28

- Recruitment of 315 Patients Completed Ahead of Schedule - ResultsAnticipated in the second quarter of 2010

ThromboGenics NV (Euronext Brussels: THR) and co-development partnerBioInvent International (OMXS: BINV) announce that they have completedrecruitment of their Phase II trial of TB-402 ahead of schedule. TB-402 is anovel, long acting anticoagulant that is being developed for the preventionof deep vein thrombosis (DVT) following orthopaedic surgery. The results ofthis study, which has recruited 315 patients, are anticipated in the secondquarter of 2010.

TB-402 has the potential to be a very important new entrant into theanticoagulant market. TB-402 is a recombinant human monoclonal antibody thatpartially inhibits Factor VIII, a key component of the coagulation cascade.This novel mode of action is expected to reduce the risk of undesirablebleeding events, even at high doses, as well as the need for patientmonitoring. These are the two main drawbacks associated with currentanticoagulant therapy. In addition, TB-402 is a long-acting agent, whichmeans it could be given as a single dose to prevent the development of DVT inpatients undergoing surgery. This would be an attractive option, as allcurrent anticoagulant treatment options require daily treatment for up toseveral weeks.

The Phase II trial is an active (enoxaparin)-controlled, dose-escalating,multicenter, prospective, randomised, open label trial evaluating TB-402 forthe prophylaxis of DVT after knee surgery. The study is assessing threedifferent doses of TB-402 (0.3, 0.6 and 1.2 mg/kg) each given as a singleintravenous bolus injection post knee replacement surgery. The objective ofthe study is to assess the safety and efficacy of the three escalating dosesof TB-402. The study enrolled a total of 315 patients across 30 centers,mainly in Europe.

Patrik De Haes, CEO of ThromboGenics, commented, "We are very pleased toannounce the completion of enrolment ahead of schedule for TB-402. We believethat based on its novel profile, TB-402 could be an important new entrantinto the anticoagulant therapy market. Given the size of commercialopportunity for TB-402 and the sales reach that will be needed to engage withall of the potential prescribers of TB-402, it is our intention to seek apartner to undertake the later stage development and commercialisation ofthis exciting new agent. We very much look forward to announcing the resultsfrom this study in Q2 next year."

Svein Mathisen, CEO of BioInvent, also commented, "At BioInvent, we areproud to have maintained excellent momentum in the Phase II study of TB-402,which is on track to be completed ahead of schedule. We look forward toannouncing the results of the study in Q2 next year. Our expectation is thatthe ongoing clinical development will underpin the product profile as a safeand effective long acting new anticoagulant."

About Deep Vein Thrombosis (DVT)

DVT is caused when a blood clot forms in a deep vein, most commonly inthe deep veins of the lower leg. DVT is a major public health issue and it isestimated that in the U.S. alone, more than 600,000 patients are treated forvenous thromboembolisms such as DVT or pulmonary embolism (PE) each year.[1]Moreover, DVT and PE together may be responsible for more than 100,000 deathsin the U.S. each year.[2]

It is estimated that by 2015, 1.4 million patients will undergo kneereplacement and 600,000 patients will undergo hip replacement in the U.S. ifcurrent trends persist.[3] Patients undergoing hip replacement or kneesurgery are particularly at risk of developing DVT and all patients aretherefore treated with anticoagulants prophylactically in order to reduce therisks of blood clots. The annual sales of anticoagulants worldwide are over$5 billion. Nevertheless, available anticoagulants are still inconvenient andassociated with an increased risk of bleeding. Improved anticoagulants aretherefore required. In particular, agents that allow for improved ease ofadministration (without requirement for daily dosing and frequent doseadjustment) would fill a significant unmet need.

Legal disclaimer

This press release contains statements about the future, consisting ofsubjective assumptions and forecasts for future scenarios. Predictions forthe future only apply as of the date they are made and are, by their verynature, in the same way as research and development work in the biotechsegment, associated with risk and uncertainty. With this in mind, the actualoutcome may deviate significantly from the scenarios described in this pressrelease.

Notes to Editors:

About ThromboGenics

ThromboGenics is a biopharmaceutical company focused on the discovery anddevelopment of innovative medicines for the treatment of eye disease,vascular disease and cancer. The Company's lead product microplasmin is inPhase III clinical development for the non-surgical treatment of back of theeye diseases. Microplasmin is also being evaluated in Phase II clinicaldevelopment for additional vitreoretinal conditions. In addition,ThromboGenics is developing novel antibody therapeutics in collaboration withBioInvent International; these include TB-402 (Anti-Factor VIII), a longacting anti-coagulant, and TB-403 (anti-PlGF) for cancer.

ThromboGenics has built strong links with the University of Leuven andthe Flanders Institute for Biotechnology (VIB) and has exclusive rights tocertain therapeutics developed at these institutions. ThromboGenics isheadquartered in Leuven, Belgium. The Company is listed on Eurolist byEuronext Brussels under the symbol THR. More information is available

About BioInvent

BioInvent International AB, listed on the NASDAQ OMX Stockholm (BINV), isa research-based pharmaceutical company that focuses on developing antibodydrugs. The Company is currently running innovative drug projects within theareas of thrombosis, cancer and atherosclerosis. The Company has signedvarious strategic alliances around these product candidates and is developingthem in collaboration with partners including Genentech, Roche andThromboGenics.

These projects are based around a competitive and in substance patentedantibody development platform. The scope and strength of this platform isalso utilised by partners, such as ALK-Abello, Bayer HealthCare, ImmunoGen,Mitsubishi Tanabe Pharma Corporation, OrbusNeich, UCB and XOMA. Moreinformation is available at


[1] Barclays Capital Equity Research Report on New Anticoagulants, August5, 2009

[2] "The Surgeon General's Call to Action to Prevent Deep Vein Thrombosisand Pulmonary Embolism," September 15, 2008, p.1.

[3] "Changes in Surgical Loads and Economic Burden of Hip and KneeReplacements in the US: 1997-2004," Sunny Kim, Arthritis & Rheumatism(Arthritis Care & Research), April 15, 2008; 59:4, pp. 481-488.For further information, please contact: ThromboGenics NV Patrik De Haes, MD Chief Executive Officer Tel : +32-(0)-16-75-13-10 E-mail: Andy De Deene, MD Clinical Director Europe Tel: +32-(0)-16-75-13-10 E-mail: Citigate Dewe Rogerson Amber Bielecka, David Dible, Nina Enegren Tel: +44-(0)-207-638-95-71 E-mail: BioInvent International AB Svein Mathisen President & CEO Tel: +46-(0)46-286-85-67 Mobile: +46-(0)708-97-82-13 E-mail: Cristina Glad Executive Vice President Tel: +46-(0)46-286-85-51 Mobile: +46-(0)708-16 85-70 E-mail: College Hill (media enquiries) Holly Griffiths, Sue Charles, John McIntyre Tel: +44-(0)20-7866-7856 E-mail: ThromboGenics NV Gaston Geenslaan 1 B-3001 Leuven Belgium Tel: +32-(0)16-75-13-10 BioInvent International AB (publ) Co. reg. No. 556537-7263, Address: Solvegatan 41 Mailing address: SE-223 70 LUND Tel: +46-(0)46-286-85-50

SOURCE ThromboGenics NV

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