Takeda Pharmaceutical said today it has agreed to acquire stem cell therapy developer TiGenix for up to €520 million ($632 million) in a deal designed to strengthen the buyer’s late-stage gastroenterology pipeline and presence in the U.S. specialty care market.

The deal builds upon a partnership by the companies, through which TiGenix sold to Takeda ex-U.S. licensing rights to develop and commercialize Cx601 (darvadstrocel), an up-to-€390 million deal signed in July 2016.

Cx601 is a suspension of allogeneic expanded adipose-derived stem cells. Last month, Cx601 became the first allogenic stem cell therapy to receive a positive opinion from the European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP). That recommendation is expected to be the basis for a marketing authorization by the European Commission that is expected in the first half of this year.

Cx601 is expected to be indicated as a treatment of complex perianal fistulas in adults with nonactive/mildly active luminal Crohn’s disease, whose fistulas have shown an inadequate response to at least one conventional or biologic therapy.

In the U.S., Cx601 is the subject of a global, pivotal Phase III trial assessing its effectiveness against complex perianal fistulas in patients with nonactive/mildly active luminal Crohn’s disease. Takeda says it is also exploring regulatory filings of Cx601 in Japan, Canada and emerging markets.

“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,” Andrew Plump, M.D., Ph.D., CMO and CSO, Takeda, said in a statement.

Positive Phase III Results

In 2016, TiGenix trumpeted results from the Phase III ADMIRE-CD study showing a single injection of Cx601 was statistically superior to placebo in achieving combined remission at week 52 in the study’s 212-patient intent to treat (ITT) population, with 54.2% combined remission at week 52 compared to 37.1% in the placebo arm.

In the 204-patient modified ITT population of all patients randomized and treated, with at least one post-baseline efficacy evaluation, Cx601 showed 56.3% remission at week 52 versus 38.6% for placebo, TiGenix said.

Takeda said it 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 €1.78 ($2.15) per share in cash and an equivalent price per American Depositary Share, warrant and convertible bond.

Takeda said it would discuss the financial impact of the deal in its fiscal year 2018 consolidated earnings forecast, which will be announced in May when the company holds its earnings conference for the end of FY2017.

TiGenix would become a wholly owned subsidiary of Takeda following completion of the acquisition, which is expected in the first or second quarter of this year. The deal has won the support of TiGenix’s board of directors, including managing director and CEO Eduardo Bravo.

Also agreeing to tender their shares is TiGenix’s largest shareholders, Grifols Worldwide Operations and its regenerative medicine subsidiary Gri-Cel, which own a combined 14.4% of shares.

In addition to gastroenterology, Takeda’s two other areas of therapeutic focus are oncology and disorders of the central nervous system, an area Takeda signaled its intent to strengthen through an up-to-$1.2 billion Alzheimer's disease treatment collaboration with Denali Therapeutics inked and announced separately today (see separate story).

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