Osaka, Japan based Takeda launched a voluntary conditional takeover bid for TiGenix last week, citing the licensed cell therapy candidate Cx601 as a major driver.
Takeda said the deal would be “a natural extension of an existing partnership agreement.”
Takeda gained non-US rights to Cx601 - now known as Alofisel - from Belgium-based TiGenix in 2016. The product is an off-the-shelf stem cell therapy intended to treat active luminal Crohn’s disease.
In December last year, the EMA recommended approving Alofisel.
Alofisel is produced in plastic flasks in incubators at a one-litre scale using stem cells taken from healthy volunteers who have undergone liposuction for cosmetic reasons.
It is made at TiGenix’s regulatory approved and recently expanded facility in Madrid, Spain.
A Takeda spokesperson told Biopharma-Reporter: “Until the transaction closes, we will continue to operate as two separate companies and conduct business as usual.
“In the short-term, TiGenix will provide ex-US supply of Cx601 via its own facility. Takeda is setting up internal expertise and resources to provide mid- to long-term supply of Cx601 via multiple sources.”
Even before announcing this acquisition, Takeda had been prepping to takeover European production from 2021 through a purpose built manufacturing facility, though further details had not been disclosed.
The acquisition will also give Takeda the rights to the product in the US.
Last year, TiGenix hired contract manufacturing organisation (CMO) Lonza for clinical supply of darvadstrocel from its site in Maryland.
Takeda told us it is too early to comment on whether Lonza will continue to be contracted post-acquisition. “Once the transaction is finalised, we will review the manufacturing and supply requirements for Cx601 in the US.”