Leuven (BELGIUM): December 21, 2016, 22:01h CET - TiGenix NV (Euronext Brussels and Nasdaq: TIG; the "Company"), an advanced biopharmaceutical company focused on developing and commercializing novel therapeutics from its proprietary platforms of allogeneic expanded stem cells, today announced that it has received a confirmation notification from Takeda Pharmaceuticals International AG (Takeda) stating that it has decided to exercise its option to develop and commercialize Cx601 in both Japan and Canada.
Today TiGenix announces that Takeda has decided to exercise its option to include both Japan and Canada into the scope of its licensing agreement with TiGenix whereby Takeda acquired, on July 4, 2016, the exclusive right to develop and commercialize Cx601 for complex perianal fistulas in Crohn's patients outside of the U.S. This decision entitles Takeda the right to move forward with these two countries.
"The decision by our partner Takeda, after its initial assessment of both the regulatory strategy and commercial potential of Cx601 in these two countries, is encouraging and comes at an opportune time for us as we are focused on further developing Cx601 for the U.S. and pursuing the marketing approval of Cx601 in Europe which we anticipate during 2017," said Eduardo Bravo, CEO of TiGenix. "This is another excellent example of our partner's dedication to foster innovative research and drug development for patients where unmet medical needs exist. Once again, we are fortunate to have found such a partner for Cx601, and one that is clearly dedicated to the long term success of Cx601," concluded Eduardo Bravo.
This decision gives TiGenix the right to receive additional future milestone payments of up to 3,000,000 euros for both countries (1,500,000 individually) in the event of obtaining a marketing approval by the relevant Regulatory Authority, in either or both countries, including an early access program, or conditional approval, allowing patients with Crohn's disease suffering from perianal fistula in these countries to gain access to Cx601. In addition to these approval milestones, TiGenix is eligible to receive price reimbursement milestones for up to 2,000,000 euros for both countries (1,000,000 individually) as well as double-digit royalties on net sales.
For more information, please contact:
TiGenix
Claudia D'Augusta
Chief Financial Officer
Tf: +34 91804 9264
claudia.daugusta@tigenix.com
Today TiGenix announces that Takeda has decided to exercise its option to include both Japan and Canada into the scope of its licensing agreement with TiGenix whereby Takeda acquired, on July 4, 2016, the exclusive right to develop and commercialize Cx601 for complex perianal fistulas in Crohn's patients outside of the U.S. This decision entitles Takeda the right to move forward with these two countries.
"The decision by our partner Takeda, after its initial assessment of both the regulatory strategy and commercial potential of Cx601 in these two countries, is encouraging and comes at an opportune time for us as we are focused on further developing Cx601 for the U.S. and pursuing the marketing approval of Cx601 in Europe which we anticipate during 2017," said Eduardo Bravo, CEO of TiGenix. "This is another excellent example of our partner's dedication to foster innovative research and drug development for patients where unmet medical needs exist. Once again, we are fortunate to have found such a partner for Cx601, and one that is clearly dedicated to the long term success of Cx601," concluded Eduardo Bravo.
This decision gives TiGenix the right to receive additional future milestone payments of up to 3,000,000 euros for both countries (1,500,000 individually) in the event of obtaining a marketing approval by the relevant Regulatory Authority, in either or both countries, including an early access program, or conditional approval, allowing patients with Crohn's disease suffering from perianal fistula in these countries to gain access to Cx601. In addition to these approval milestones, TiGenix is eligible to receive price reimbursement milestones for up to 2,000,000 euros for both countries (1,000,000 individually) as well as double-digit royalties on net sales.
For more information, please contact:
TiGenix
Claudia D'Augusta
Chief Financial Officer
Tf: +34 91804 9264
claudia.daugusta@tigenix.com
