Drug Development

Takeda hands TiGenix a rare, $434M marketing deal for PhIII stem cell therapy

Belgian biotech TiGenix triggered a rare round of enthusiasm for stem cell research a couple of years back with news its lead off-the-shelf therapy hit the primary endpoint in a Phase III study treating fistulas in Crohn’s disease patients.  They backed it up a year later with even more positive data. And now, a few months after it was filed for approval, Takeda is buying its way in with a small deal to acquire the European rights to Cx601.

That good news made for an excellent opportunity for TiGenix to simultaneously retreat from its personalized cartilage repair therapy ChondroCelect, which never gained market traction.

TiGenix filed Cx601 for European approval back in March, setting up the deal with Takeda that includes a $27.5 million upfront, $16.5 million for an upcoming equity investment and another $390 million in milestones. The first of those milestones will be $11 million – provided European regulators approve the therapy.

Stem cell therapies have offered a series of bitter setbacks over the years. Once seen as a natural and promising way to heal nature’s wounds, a slate of companies tried and failed to develop new treatments with the tech. TiGenix claimed pioneering rights with the OK for ChondroCelect, its autologous (derived from patient cells) approach to knee damage. By the time the company filed for a $58 million IPO late last year, it barely warranted a mention in the F-1.

Marc Princen, President of Takeda EUCan

Marc Princen, President of Takeda EUCan

Citing a tough regulatory environment as well as the lack of reimbursement for its treatment, TiGenix said today it is beginning the process to withdraw the marketing OK, ending a commercialization deal it has in place with Sobi.

For Tigenix, the future will be all about allogeneic (off the shelf) stem cell therapies.

“This collaboration and the addition of Cx601 to our portfolio highlights Takeda’s commitment to the development of treatments to improve the health of people living with gastroenterological disorders, leveraging our expertise in Inflammatory Bowel Disease and Crohn’s specifically,” said Marc Princen, president of Takeda in Europe and Canada.

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