Leuven (BELGIUM) - March 2, 2016, 19:00h CET - TiGenix NV (Euronext Brussels: TIG), an advanced biopharmaceutical company focused on developing and commercialising novel therapeutics from its proprietary platforms of allogeneic expanded stem cells, announced today the submission of a centralized Marketing Authorization Application (MAA) to the European Medicines Agency (EMA) for Cx601 for the treatment of complex perianal fistulas in adult patients with Crohn’s disease.
TiGenix has submitted a European MAA for its lead product Cx601, consisting of a suspension of allogeneic expanded adipose-derived stem cells (eASC), following the positive results from the pivotal ADMIRE-CD Phase III study in Crohn’s disease patients suffering from complex perianal fistulas.
A complex perianal fistula consists of abnormal tracts between the rectum and the skin surface near the anus, and is commonly associated with Crohn’s disease. It is a serious clinical condition leading to pain, discharge and that can cause severe incontinence. Complex perianal fistulas are associated with depression and may constitute a risk for anorectal carcinoma. Up to 120,000 adult Crohn’s disease patients in Europe and the United States may eventually benefit from Cx601 in an indication for which there is no alternative satisfactory treatment.
“The submission of this application to the EMA represents another important achievement in TiGenix efforts to bring Cx601 to those Crohn’s disease patients who currently lack an effective treatment for this serious and debilitating condition,” said María Pascual, VP Regulatory Affairs of TiGenix. “Meeting this milestone brings us one step closer to fulfilling our ultimate goal of making our therapy available to European patients in the second half of 2017.”
“The EMA filing is the culmination of the milestones set by TiGenix over the last eight months,” said Eduardo Bravo CEO. “This achievement follows the completion of the ADMIRE-CD trial in August, the recently granted license to manufacture Cx601 commercially in Europe and the agreement from the FDA through a Special Protocol Assessment (SPA) on our proposal to conduct a Phase III pivotal trial in the United States. Our capacity to execute timely on these objectives reassures us about our ultimate goal of launching Cx601 in the coming years at both sides of the Atlantic.”
As recently announced, the results of the ADMIRE-CD have been accepted for oral presentation at the upcoming Annual Congress of European Crohn’s and Colitis Organisation (ECCO) in Amsterdam on 17th and 18th March 2016. The acceptance of the abstract confirms the relevance of the results and positions Cx601 as a truly innovative treatment for complex perianal fistulas in Crohn’s disease patients, a severe, debilitating and difficult to treat condition.
For more information, please contact:
TiGenix
Claudia D’Augusta
Chief Financial Officer
T: +34 91 804 92 64
claudia.daugusta@tigenix.com
