Takeda has launched a takeover bid for Belgian biotech TiGenix, which has completed late-stage testing of a stem cell therapy for Crohn’s disease-related complications.
The Japanese pharma company says it intends to buy voting-right shares in TiGenix at €1.78 per share, in cash, and the deal will go ahead if it can secure at least an 85% stake in the biotech.
TiGenix’ board is backing the takeover deal, which values the company at €520m (around $630m), and two major shareholders – Gri-Cel and Grifols – have already said they will tender their shares.
Takeda’s bid comes shortly after TiGenix’ CX-601 (darvadstrocel), an allogeneic (donor) stem cell therapy for Crohn’s patients with perianal fistulas, was recommended for approval by the EU Committee for Medicinal Products for Human Use (CHMP) and is expected to be approved in the coming weeks.
Takeda is already partnering with TiGenix on the therapy, paying €25m upfront for rights to it outside the US in 2016, plus milestones of up to €355m and double-digit royalties. Buying the biotech will give it total geographic ownership, including the US which is considered a larger market opportunity for CX601 than Europe but is a little further back in development, as well as additional indications such as sepsis.
Around a quarter of patients with Crohn’s develop fistulas – abnormal channels connecting the bowel to another organ or the outside surface of the body. Perianal fistulas are the most common type but are still fairly rare, with patients currently managed by antibiotics, immunosuppressant drugs and TNF blockers. CX601 has been classed as an orphan treatment for treating people who don’t respond to drug therapy.
In a pivotal phase III trial, the therapy was associated with a higher rate of complete remission of fistulas than placebo (50% versus 34%) after 24 weeks, and maintained long-term remission for more than a year with a lower rate of relapse than in the control group.
“We believe that TiGenix’s expertise would help accelerate Takeda’s ambition to develop novel stem cell therapies,” said Eduardo Bravo, the Belgian company’s chief executive, adding that its partner “offers the best capabilities and resources to ensure access to Cx601 to patients worldwide.”
Takeda is already a player in inflammatory bowel diseases with its Entyvio (vedolizumab) product for ulcerative colitis and Crohn’s disease, one of its key growth products.