Takeda Pharmaceutical is aiming to expand its gastroenterology pipeline with the acquisition of biopharma TiGenix in a deal worth €520 million.
Takeda said the deal is a “natural extension” of its existing partnership agreement with TiGenix and will bring new treatment options to patients with gastrointestinal disorders.
Andrew Plump, Chief Medical and Scientific Officer, Takeda, said: “Limited treatment options exist today and I believe we can be most effective in serving this population by working in collaboration with partners whose unique skill sets allow us to more efficiently explore innovative approaches, including stem cell therapies.”
In July 2016, Takeda and TiGenix entered into an exclusive ex-US license, development and commercialisation agreement for Cx601 – the leading investigational therapy in TiGenix’s pipeline.
Cx601 is a suspension of allogeneic expanded adipose-derived stem cells (eASC) locally administered for the treatment of complex perianal fistulas in patients with non-active/mildly active luminal Crohn’s disease, who have had an inadequate response to at least one conventional or biologic therapy.
In December 2017, the CHMP of the EMA adopted a positive opinion recommending a marketing authorisation for Cx601 in this indication, the first allogeneic stem cell therapy to achieve this.
A decision from the EMA on the marketing authorization for Cx601 is expected in the first half of 2018.
A global, pivotal Phase III trial investigating Cx601 for the treatment of complex perianal fistulas in patients with non-active/mildly active luminal Crohn’s disease has been initiated for US registration.
Takeda intends to work with the FDA to facilitate the development and potential approval of Cx601.
It is also exploring the steps required for regulatory filing of Cx601 for patients in Japan, Canada and emerging markets.