Leuven (BELGIUM) - October 17, 2016, 07:00h CET - TiGenix NV (Euronext Brussels: TIG), an advanced biopharmaceutical company focused on developing and commercializing novel therapeutics from its proprietary platforms of allogeneic expanded stem cells, today announced that Cx601, its lead product candidate being developed for the treatment of complex perianal fistulas in Crohn's disease patients, has been granted Orphan Drug Designation status in Switzerland. This is the second orphan drug designation granted to Cx601.
Developed by TiGenix and recently licensed to Takeda Pharmaceutical Company Limited ("Takeda"), for the exclusive development and commercialization outside the US, Cx601 is 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 that have had an inadequate response to at least one conventional or biologic treatment. Crohn's disease is a chronic inflammatory disease of the gastrointestinal tract. People living with Crohn's disease can experience complex perianal fistulas for which there are limited treatment options.
On September 15, 2016, Takeda received orphan drug status from the Swiss Agency for Therapeutic Products (Swissmedic) regarding the application dossier for Cx601, or eASCs, adipose-derived stem cells for the rare disease anal fistulas. This decision was based on the recognition of the European Commission's Orphan Drug Designation in 2009, as well as the supporting data provided to the agency, which addressed proof of quality, efficacy and safety, as well as the rarity of the disease.
"The preparation and success of this dossier was a great start to our recently formalized partnership with Takeda and speaks to the important medicinal value of Cx601 in an area of high unmet medical need," said Maria Pascual, Vice President Regulatory Affairs and Corporate Quality of TiGenix.
Orphan drug designations are granted to drugs or biologics that are being investigated for the treatment of a rare disease or condition. In Europe, including Switzerland, this applies to diseases affecting fewer than five in 10,000 people. Orphan Drug Designation offers the sponsor incentives, which can include the possibility of a prioritized evaluation by Swissmedic.
Developed by TiGenix and recently licensed to Takeda Pharmaceutical Company Limited ("Takeda"), for the exclusive development and commercialization outside the US, Cx601 is 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 that have had an inadequate response to at least one conventional or biologic treatment. Crohn's disease is a chronic inflammatory disease of the gastrointestinal tract. People living with Crohn's disease can experience complex perianal fistulas for which there are limited treatment options.
On September 15, 2016, Takeda received orphan drug status from the Swiss Agency for Therapeutic Products (Swissmedic) regarding the application dossier for Cx601, or eASCs, adipose-derived stem cells for the rare disease anal fistulas. This decision was based on the recognition of the European Commission's Orphan Drug Designation in 2009, as well as the supporting data provided to the agency, which addressed proof of quality, efficacy and safety, as well as the rarity of the disease.
"The preparation and success of this dossier was a great start to our recently formalized partnership with Takeda and speaks to the important medicinal value of Cx601 in an area of high unmet medical need," said Maria Pascual, Vice President Regulatory Affairs and Corporate Quality of TiGenix.
Orphan drug designations are granted to drugs or biologics that are being investigated for the treatment of a rare disease or condition. In Europe, including Switzerland, this applies to diseases affecting fewer than five in 10,000 people. Orphan Drug Designation offers the sponsor incentives, which can include the possibility of a prioritized evaluation by Swissmedic.
