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Agreements

Date: 2016-12-21

Type of information: Exercise of an option agreement

Compound: Cx601 (adipose derived allogeneic stem cell therapy)

Company: Takeda Pharmaceutical (Japan) Tigenix (Belgium)

Therapeutic area: Autoimmune diseases - Inflammatory diseases - Digestive diseases

Type agreement:

licensing

development

commercialisation

Action mechanism:

cell therapy. Cx601 is a suspension of expanded allogeneic adult stem cell product derived from human adipose (fat) tissue (expanded Adipose derived Stem Cells or eASCs) that is delivered locally in the fistula through intra-lesional injection.

Disease: complex perianal fistulas in patients with Crohn's disease

Details:

* On July 5, 2016, Takeda Pharmaceutical and TiGenix  announced that the companies have entered into an exclusive ex-U.S. license, development and commercialization agreement for Cx601, a suspension of allogeneic adipose-derived stem cells (eASC) injected intra-lesionally for the treatment of complex perianal fistulas in patients with Crohn's disease. 
In 2009 the European Commission granted Cx601 orphan designation for the treatment of complex perianal fistulas. In March 2016, TiGenix announced that it submitted the Marketing Authorization Application (MAA) to the European Medicines Agency (EMA) for Cx601. The filing was based on the 24 week results of the ADMIRE-CD Phase 3 clinical trial. The company also recently announced top-line 52 week data confirming the efficacy and safety of a single injection of Cx601.
Following Marketing Authorization in the European Union, Takeda will become the marketing authorization holder and will be responsible for all commercialization and regulatory activities. Takeda will also be responsible for additional development activities of Cx601 for the indication of complex perianal fistulas in Crohn's disease. TiGenix will retain the rights to develop Cx601 in new indications. "This agreement further provides TiGenix with the financial strength to move forward with the clinical development of Cx601 in the U.S., which represents approximately 50 percent of the world's Crohn's market" said Eduardo Bravo, CEO, TiGenix.

Financial terms:

TiGenix will receive an upfront cash payment of €25 million. TiGenix will be eligible to receive additional regulatory and sales milestone payments for up to a potential total of €355 million and double digit royalties on net sales by Takeda. The first anticipated milestone payment is €15 million upon obtaining the Marketing Authorization of Cx601 in the European Economic Area (EEA). In addition, Takeda will make an equity investment of €10 million in the share capital of TiGenix within the next 12 months.

Latest news:

* On December 21, 2016, TiGenix announced that it has received a confirmation notification from Takeda stating that the company has decided to exercise its option to develop and commercialize Cx601 in both Japan and Canada.
This decision gives TiGenix the right to receive additional future milestone payments of up to 3,000,000 euros for both countries (1,500,000 individually) in the event of obtaining a marketing approval by the relevant Regulatory Authority, in either or both countries, including an early access program, or conditional approval, allowing patients with Crohn's disease suffering from perianal fistula in these countries to gain access to Cx601. In addition to these approval milestones, TiGenix is eligible to receive price reimbursement milestones for up to 2,000,000 euros for both countries (1,000,000 individually) as well as double-digit royalties on net sales.

Is general: Yes