Takeda bids €520m for TiGenix

Japanese Pharma major Takeda had announced its intention to take over Belgian adipose stem cell therapy specialist Tigenix, which has already exclusively licenced its lead product darvadstrocel (Cx601) to treat Crohn’s disease. In December darvadstrocel received a recommendation from the European Medicines Agency to market the product in Europe  in patients with complex perianal fistulas, one of the most disabling manifestations of Crohn's disease.


In an offer agreed by TiGenix Board of Directors, Takeda offered 1.78  per share and an equivalent price per American Depositary Share (ADS) totaling €520m in cash on a fully diluted basis. 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.

For Takeda, The take-over would be  a pretty good business: under the exclusive licence agreement for Cx601 the company acquired in July 2016, Tigenix would retain the US rights and all rights to market Cx601 in other indications. Besides a €25m upfront payment, an equity investment of €10m and the €15m milestone for European market approval in store, Tigenix would be eligible to receive sales milestone payments for up to €355m (totaling €405m) plus double digit royalties on net sales by Takeda. And that’s without the US, the largest market for the treatment and further indications that could potentially be treated with TiGenix adipose stem-cell derived therapy, such as sepsis, which affects 24 million people annually in the world.

A pivotal Phase III trial for US registration has initiated in 2017 with Cx601 for the treatment of complex perianal fistulas in patients with non-active/mildly active luminal Crohn’s disease. Takeda is also exploring the steps required for regulatory filing of Cx601 for patients in Japan, Canada and emerging markets.

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. 


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