Date: 2017-09-05
Type of information: Validation of a production plant
Compound: manufacturing facility in Madrid
Company: TiGenix (Belgium)
Therapeutic area: Autoimmune diseases - Inflammatory diseases
Type agreement: validation of a production plant
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Details:
- • On September 5, 2017, TiGenix has obtained a license for the commercial production of expanded adipose-derived stem cells (eASCs) at its expanded manufacturing facility in Madrid. The manufacturing license follows an inspection by the Spanish Medicines Agency (AEMPS), and provides production capacity for the potential initial European commercial roll out of Cx601, an investigational stem cell therapy, for the treatment of complex perianal fistulas in patients with Crohn's disease. TiGenix has submitted a marketing authorization (MA) application for Cx601 to the European Medicines Agency (EMA) on the basis of results from its Phase III ADMIRE-CD trial with a decision expected in 2017. Cx601 has been licensed to Takeda for exclusive development and commercialization outside of the U.S.
The expanded facility will also provide sufficient capacity for the manufacturing of other pipeline products under development by TiGenix, including Cx611, currently undergoing a Phase I/II trial in severe sepsis.
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Is general: Yes
