ThromboGenics and BioInvent Announce Results from Phase IIb Venous Thromboembolism Prevention Study with TB-402
LEUVEN, Belgium and LUND, Sweden, June 5, 2012 /PRNewswire/ --
- All further development of TB-402 will be stopped
ThromboGenics NV (Euronext Brussels: THR) and co-development partner BioInvent International (OMXS: BINV) announce today the results from a Phase IIb trial comparing TB-402, a long acting anticoagulant, against rivaroxaban (Xarelto®; 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, ThromboGenics and BioInvent 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.
Dr. Patrik De Haes, CEO of ThromboGenics, 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."
Svein Mathisen, CEO of BioInvent, also 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. 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.'’
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) including macular hole. 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 €375 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 http://www.thrombogenics.com
About BioInvent International
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, Roche 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 http://www.bioinvent.com.
Important information about forward-looking statements
Certain statements in this press release may be considered "forward-looking". Such forward-looking statements are based on current expectations, and, accordingly, entail and are influenced by various risks and uncertainties. The Company therefore cannot provide any assurance that such forward-looking statements will materialize and does not assume an obligation to update or revise any forward-looking statement, whether as a result of new information, future events or any other reason. Additional information concerning risks and uncertainties affecting the business and other factors that could cause actual results to differ materially from any forward-looking statement is contained in the Company's Annual Report.
This press release does not constitute an offer or invitation for the sale or purchase of securities or assets of ThromboGenics in any jurisdiction. No securities of ThromboGenics may be offered or sold within the United States without registration under the U.S. Securities Act of 1933, as amended, or in compliance with an exemption therefrom, and in accordance with any applicable U.S. state securities laws.
For further information please contact:
Dr. Patrik De Haes, CEO
Chris Buyse, CFO
Citigate Dewe Rogerson
David Dible/ Nina Enegren/ Sita Shah
The Trout Group
Todd James, Director
Simon Harnest, Associate