Leuven (BELGIUM) - February 23, 2016, 07:00h 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 that it has successfully obtained the license for commercial production of Cx601, TiGenix's product for the treatment of complex perianal fistulas in Crohn's disease patients.
The issuance of the manufacturing license from the Spanish Medicines Agency (AEMPS) represents a relevant achievement in bringing Cx601 closer to commercial launch.
"We are very pleased with this approval which confirms our state-of-the-art GMP manufacturing capabilities in the stem cell field" said Wilfried Dalemans, Chief Technical Officer. "The commercial GMP license in addition to the current GMP license for clinical manufacturing is a clear recognition of our proven capabilities in the field and sets the stage for gearing-up the manufacturing of Cx601 commercial lots, making TiGenix a leading reference in the development of cell therapy medicinal products once more".
Following the successful completion of its Phase III ADMIRE-CD clinical trial in August, the approval marks a new milestone in TiGenix's mission to bring Cx601 to European patients suffering from complex perianal fistulas, a complication of Crohn's disease for which there is currently no effective treatment.
"This timely and successful achievement fulfils one of the final requirements for our plan to file a Marketing Approval Application for Cx601 at the European Medicines Agency (EMA) in the coming weeks," said Maria Pascual, VP Regulatory Affairs. "In this way our plan remains in line with the expectation to make Cx601 available to European patients in the second half of 2017".
For more information, please contact:
TiGenix
Claudia D'Augusta
Chief Financial Officer
T: +34 91 804 92 64
claudia.daugusta@tigenix.com
About TiGenix
TiGenix NV (Euronext Brussels: TIG) is an advanced biopharmaceutical company focused on developing and commercialising novel therapeutics from its proprietary platforms of allogeneic, or donor-derived, expanded stem cells. Two products from the adipose-derived stem cell technology platform are currently in clinical development. Cx601 is in Phase III for the treatment of complex perianal fistulas in Crohn's disease patients. Cx611 has completed a Phase I sepsis challenge trial and a Phase I/II trial in rheumatoid arthritis. Effective July 31, 2015, TiGenix acquired Coretherapix, whose lead cellular product, AlloCSC-01, is currently in a Phase II clinical trial in acute myocardial infarction (AMI). In addition, the second product candidate from the cardiac stem cell-based platform acquired from Coretherapix, AlloCSC-02, is being developed in a chronic indication. TiGenix also developed ChondroCelect, an autologous cell therapy product for cartilage repair of the knee, which was the first Advanced Therapy Medicinal Product (ATMP) to be approved by the European Medicines Agency (EMA). From June 2014, the marketing and distribution rights of ChondroCelect were exclusively licensed to Sobi for the European Union (except for Finland, where it is distributed by the Finnish Red Cross Blood Service), Norway, Russia, Switzerland and Turkey, and the countries of the Middle East and North Africa. TiGenix is headquartered in Leuven (Belgium) and has operations in Madrid (Spain). For more information, please visit www.tigenix.com.
About Cx601
Cx601 is a suspension of allogeneic expanded adipose-derived stem cells (eASC) injected intra-lesionally. Cx601 is being developed for the treatment of complex perianal fistulas in Crohn's disease patients. Crohn's disease is a chronic inflammatory disease of the intestine and patients can suffer from complex perianal fistulas for which there is currently no effective treatment. In 2009, the European Commission granted Cx601 orphan designation for the treatment of anal fistulas, recognising the debilitating nature of the disease and the lack of treatment options. Based on positive Phase II results, TiGenix sought scientific advice from the European Medicines Agency (EMA) on the future development path of Cx601. TiGenix then initiated a randomised, double-blind, placebo-controlled Phase III trial in Europe and Israel designed to comply with the requirements laid down by the EMA. 'Madrid Network', an organisation within the Autonomous Region of Madrid which helps companies to grow through high-technology innovation, issued a soft loan to help finance this Phase III study. The programme is funded by The Secretary of State for Research, Development and Innovation (Ministry of Economy and Competitiveness) within the framework of the INNTEGRA plan. The study's primary endpoint was combined remission, defined as clinical assessment at week 24 of closure of all treated external openings draining at baseline despite gentle finger compression, and absence of collections >2cm confirmed by MRI. The trial had a first complete analysis of results at 24 weeks, with a follow-up analysis to be performed at 52 weeks post-treatment. Recruitment of the whole sample of patients was completed in the fourth quarter of 2014. Based on the positive Phase III results, TiGenix will submit a Marketing Authorisation Application to the EMA in early 2016. TiGenix is preparing to develop Cx601 for the US market after having reached an agreement with the FDA through a special protocol assessment, or SPA, procedure on its proposed protocol on August 7, 2015.
Forward-looking information
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