Takeda Pharmaceutical has announced its intention to acquire TiGenix, a biopharma company developing novel stem cell therapies for serious medical conditions, and the total value of the deal is estimated to approximately 520 million euro.
As a result Takeda has entered into an offer and support agreement with TiGenix which provides for a recommended potential voluntary public takeover bid for TiGenix. The Takeda agreement has the unanimous support of the TiGenix board of directors (including its CEO). The acquisition is a natural extension of an existing partnership agreement between Takeda and TiGenix, which aims to bring new treatment options to patients with gastrointestinal disorders.
”This is a very important business deal which demonstrates the increasing interest in companies that, like Idogen, develops cell therapies,” commented Lars Hedbys, CEO of Swedish company Idogen.
First allogenic stem cell therapy to achieve marketing authorization
In July 2016, Takeda and TiGenix entered into an ex-U.S. license, development and commercialization 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 authorization 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.
Exploring stem cell therapies
“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. I have had the opportunity to work alongside the TiGenix team throughout our collaboration and know that we have shared goals and varied, but complementary expertise. I am thrilled at the prospect of welcoming them as part of our organization,” said Andrew Plump, Chief Medical and Scientific Officer, Takeda.
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 U.S. registration. In the U.S., Takeda intends to work with the U.S. FDA to facilitate the development and potential approval of Cx601. Takeda is also exploring the steps required for regulatory filing of Cx601 for patients in Japan, Canada and emerging markets.
Through the potential voluntary public takeover bid, Takeda intends to acquire 100% of the securities with voting rights or giving access to voting rights of TiGenix not already owned by Takeda or its affiliates at an acquisition price of EUR 1.78 per share in cash and an equivalent price per American Depositary Share, warrant and convertible bond, representing a transaction value of approximately EUR 520 million on a fully diluted basis. The bid will be subject to certain conditions precedent as further described below. Subject to its fiduciary duties and review of the final bid prospectus, the bid is unanimously supported by TiGenix’s board of directors (including its CEO). Takeda and TiGenix entered into an offer and support agreement confirming TiGenix’s support and the terms and conditions of the bid set forth in this press release. Gri-Cel S.A., holding 32,238,178 TiGenix shares, and its affiliate Grifols Worldwide Operations Ltd., holding 7,189,800 TiGenix shares in the form of American Depositary Shares, have irrevocably confirmed that they will tender their shares and American Depositary Shares into the potential public takeover bid.