BioInvent and ThromboGenics Announce Results from Phase IIb Venous Thromboembolism Prevention Study with TB-402

05 Jun 2012

All further development of TB-402 will be stopped

Lund, Sweden and Leuven, Belgium - 5 June, 2012 - BioInvent International AB (OMXS: BINV) and co-development partner ThromboGenics NV (Euronext Brussels: THR) announce today the results from a Phase IIb trial comparing TB-402, a long acting anticoagulant, against rivaroxaban (XareltoÂ®; Bayer), an oral anticoagulant. The study showed that the incidence of venous thromboembolism (VTE) was similar with both drugs but patients receiving TB-402 had a significantly higher incidence of bleeding events. Based on these results, BioInvent and ThromboGenics have decided to stop further development of TB-402.

The Phase IIb trial was a multicenter, randomised, double blind trial, evaluating single doses of either 25 or 50 mg TB-402 against rivaroxaban in patients undergoing hip replacement surgery. Rivaroxaban is a recently approved oral factor Xa inhibitor for the prevention of VTE after elective hip or knee replacement surgery.

TB-402 was administered as a single intravenous infusion two to four hours post-operatively, and rivaroxaban was administered as 10 mg once daily for 35 days. A total of 632 patients were enrolled between April and December 2011 in 36 centers across nine countries.

The primary efficacy outcome of the study was the incidence of total VTE up to 35 days post operatively. VTE consisted of both asymptomatic deep vein thrombosis (DVT), as detected by bilateral venography, and symptomatic VTE, i.e. DVT or pulmonary embolism (PE). The principle safety outcome was major bleeding or clinically relevant non-major bleeding events up to 35 days after surgery.

The study showed that the incidence of VTE was similar for TB-402 and rivaroxaban. In the pooled TB-402 group, 5.3% of patients had VTE, compared with 4.7% in the group treated with rivaroxaban. All incidences were asymptomatic DVT. However, major or clinically relevant non-major bleeding occurred in 6.5% of the patients treated with TB-402 compared to 1.4% of patients treated with rivaroxaban, a statistically significant difference.

Svein Mathisen, CEO of BioInvent, commented, "In our collaboration with ThromboGenics we decided to raise the bar for TB-402 by pitching it in a head-to-head trial against Xarelto. Â Investment decisions should be based on business context and solid science. In this disappointment it is comforting to know that we did get a clear answer. As we face a number of important data points later this summer both in our collaboration with Genentech as well as in the study of our proprietary multiple myeloma drug it is this principle which guides us.''

Dr. Patrik De Haes, CEO of ThromboGenics, also commented, "The decision to conduct this study comparing TB-402 with a potential future market leader, rivaroxaban, has been validated. The result, while disappointing, means that we do not need to invest any further in the development of TB-402. We intend to utilize our resources to support the commercialization of our lead product ocriplasmin and to develop our ophthalmology pipeline."

- END -

To the editors:

About BioInvent
BioInvent International AB, listed on the NASDAQ OMX Stockholm (BINV), is a research-based pharmaceutical company focusing on developing antibody drugs. The Company currently has four clinical development projects within the areas of thrombosis, cancer and atherosclerosis. The Company has signed various strategic alliances to strengthen the product pipeline and increase the likelihood of success. These partners include Genentech, Human Genome Sciences and ThromboGenics.

The company's competitive position is underpinned by its proprietary antibody development platform. The scope and strength of this platform is also utilised by partners, such as Bayer HealthCare, Daiichi Sankyo, Mitsubishi Tanabe, UCB and XOMA. More information is available at www.bioinvent.com.

About ThromboGenics
ThromboGenics is a biopharmaceutical company focused on developing and commercializing innovative ophthalmic medicines. The company's lead product, ocriplasmin, has successfully completed two Phase III clinical trials for the pharmacological treatment of symptomatic Vitreomacular Adhesion (VMA)/ Vitreomacular Traction (VMT). The MAA for ocriplasmin has been accepted for review in Europe and the BLA has been re-submitted in the U.S. Ocriplasmin is in Phase II clinical development for additional vitreoretinal conditions.

In March 2012, ThromboGenics signed a strategic partnership with Alcon (Novartis) for the commercialization of ocriplasmin outside the United States. Under this agreement, ThromboGenics could receive up to a total of EUR375 million in up-front and milestone payments, plus an attractive level of royalties on Alcon's net sales of ocriplasmin. ThromboGenics and Alcon intend to share the costs equally of developing ocriplasmin for a number of new vitreoretinal indications.

ThromboGenics is also developing TB-403 a novel antibody therapeutic, in collaboration with BioInvent International, for cancer and non-cancer, including ophthalmology, indications.

ThromboGenics is headquartered in Leuven, Belgium. The Company is listed on the NYSE Euronext Brussels exchange under the symbol THR. More information is available at www.thrombogenics.com.

For further information, please contact:

BioInvent International AB
Svein MathisenÂ Â Â Â Â Â Â Â Â Â Â Â Â Â Â Â Â Â Â Â Â Â Â Â Â Â Â Â Â Â Â Â Â Â Â Â Â Â Â Â Â Â Â Â Â Â Â Â Â Â Â Â Sten Westerberg
President & CEOÂ Â Â Â Â Â Â Â Â Â Â Â Â Â Â Â Â Â Â Â Â Â Â Â Â Â Â Â Â Â Â Â Â Â Â Â Â Â Â Â Â Â Â Â Â Â Â Â Â Vice President, Investor Relations
Mobile: +46 (0)708 97 82 13Â Â Â Â Â Â Â Â Â Â Â Â Â Â Â Â Â Â Â Â Â Â Â Â Â Â Â Â Â Â Â Â Â Â Mobile: +46 (0)768 68 50 09
E-mail: [email protected]Â Â Â Â Â Â Â Â Â Â Â Â Â Â Â Â Â E-mail: [email protected]

College Hill (media enquiries)Â Â Â Â Â Â Â Â Â Â Â Â Â Â Â Â Â Â Â Â Â Â Â Â Â Â Â Â Â Â Â Â The Trout Group
Melanie Toyne Sewell Â Â Â Â Â Â Â Â Â Â Â Â Â Â Â Â Â Â Â Â Â Â Â Â Â Â Â Â Â Â Â Â Â Â Â Â Â Â Â Â Â Â Christine Yang
Phone: +44 (0)20 7866 7856Â Â Â Â Â Â Â Â Â Â Â Â Â Â Â Â Â Â Â Â Â Â Â Â Â Â Â Â Â Â Â Â Â Vice President
Rebecca Skye DietrichÂ Â Â Â Â Â Â Â Â Â Â Â Â Â Â Â Â Â Â Â Â Â Â Â Â Â Â Â Â Â Â Â Â Â Â Â Â Â Â Â Â Tel: +1Â 646Â 378 2929
Tel: +1 (857)Â 241 0795Â Â Â Â Â Â Â Â Â Â Â Â Â Â Â Â Â Â Â Â Â Â Â Â Â Â Â Â Â Â Â Â Â Â Â Â Â Â Â Â Â Â E-mail: [email protected]
E-mail: [email protected]

ThromboGenics NV
Dr Patrik De HaesÂ Â Â Â Â Â Â Â Â Â Â Â Â Â Â Â Â Â Â Â Â Â Â Â Â Â Â Â Â Â Â Â Â Â Â Â Â Â Â Â Â Â Â Â Â Â Â Â Chris Buyse
CEOÂ Â Â Â Â Â Â Â Â Â Â Â Â Â Â Â Â Â Â Â Â Â Â Â Â Â Â Â Â Â Â Â Â Â Â Â Â Â Â Â Â Â Â Â Â Â Â Â Â Â Â Â Â Â Â Â Â Â Â Â Â Â Â Â Â Â Â CFO
Tel: +32 16 75 13 10Â Â Â Â Â Â Â Â Â Â Â Â Â Â Â Â Â Â Â Â Â Â Â Â Â Â Â Â Â Â Â Â Â Â Â Â Â Â Â Â Â Â Â Â Â Tel: +32 16 75 13 10
E-mail: patrik,[email protected]Â (https://mce_host/patrik,[email protected]) Â Â Â Â Â Â Â Â Â E-mail: [email protected]

Citigate Dewe RogersonÂ Â Â Â Â Â Â Â Â Â Â Â Â Â Â Â Â Â Â Â Â Â Â Â Â Â Â Â Â Â Â Â Â Â Â Â Â Â The Trout Group
David Dible / Nina Enegren / Sita ShahÂ Â Â Â Â Â Â Â Â Â Â Â Â Â Â Â Â Todd james, Director
Tel: +44 20 7638 9571Â Â Â Â Â Â Â Â Â Â Â Â Â Â Â Â Â Â Â Â Â Â Â Â Â Â Â Â Â Â Â Â Â Â Â Â Â Â Â Â Â Simon Harnest, Associate
E-mail: [email protected]Â Â Â Â Â Â Â Â Â Â Â Â Â Â Â Â Â Â Â Â Â Â Â Tel: +1Â 646Â 378 2929
Â Â Â Â Â Â Â Â Â Â Â Â Â Â Â Â Â Â Â Â Â Â Â Â Â Â Â Â Â Â Â Â Â Â Â Â Â Â Â Â Â Â Â Â Â Â Â Â Â Â Â Â Â Â Â Â Â Â Â Â Â Â Â Â Â Â Â Â Â Â Â Â Â Â Â E-mail: [email protected]

BioInvent International AB (publ)Â Â Â Â Â Â Â Â Â Â Â Â Â Â Â Â Â Â Â Â Â Â ThromboGenics NV
Co. reg. No. 556537-7263,Â Â Â Â Â Â Â Â Â Â Â Â Â Â Â Â Â Â Â Â Â Â Â Â Â Â Â Â Â Â Â Â Â Â Â Â Gaston Geenslaan 1
Visiting address: Sölvegatan 41Â Â Â Â Â Â Â Â Â Â Â Â Â Â Â Â Â Â Â Â Â Â Â Â Â Â B-3001 Heverlee
Mailing address: SE-223 70 LUNDÂ Â Â Â Â Â Â Â Â Â Â Â Â Â Â Â Â Â Â Â Â Â Â Belgium
Phone: +46 (0)46 286 85 50Â Â Â Â Â Â Â Â Â Â Â Â Â Â Â Â Â Â Â Â Â Â Â Â Â Â Â Â Â Â Â Â Â Â Phone: +32 (0)16 75 13 10
[email protected]Â Â Â Â Â Â Â Â Â Â Â Â Â Â Â Â Â Â Â Â Â Â Â Â Â Â Â Â Â Â Â Â Â Â Â Â Â Â Â Â Â Â Â Â www.thrombogenics.com
www.bioinvent.com

Legal disclaimer
The press release contains statements about the future, consisting of subjective assumptions and forecasts for future scenarios. Predictions for the future only apply as the date they are made and are, by their very nature, in the same was 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 5 June, 2012.