Publication date: 16/11/2017
TiGenix NV (Euronext Brussels and NASDAQ: TIG), an advanced biopharmaceutical company focused on exploiting the anti-inflammatory properties of allogeneic, or donor-derived, stem cells to develop novel therapies for serious medical conditions, announces today that the European Medicines Agency's (EMA) Committee for Human Medicinal Products (CHMP) has approved the company's proposed trade name Alofisel for its proprietary investigational compound Cx601, a treatment for complex perianal fistulas in patients with Crohn's disease.
The trade name Alofisel, a registered trademark owned by TiGenix, will be used from now onwards in the ongoing centralized drug approval process of Cx601 with the EMA, covering all 28 member states of the EU, plus Norway, Iceland and Lichtenstein, as well as from the time of launch following marketing authorization.
TiGenix has also received approval from the United States Adopted Names (USAN) Council and the International Nonproprietary Names (INN) Expert Group at the World Health Organization (WHO) for the use of the nonproprietary name darvadstrocel for Cx601. Darvadstrocel will be included in the forthcoming list of recommended INNs published by the WHO. INNs are simple, informative and unique nonproprietary names for drugs based on pharmacological and/or chemical relationships to allow for clear identification and communication among health professionals.
TiGenix has submitted a Marketing Authorization (MA) Application for Alofisel to the EMA for the treatment of complex perianal fistulas in adult patients with non-active/mildly active luminal Crohn's disease, when fistulas have shown an inadequate response to at least one conventional or biologic therapy. A CHMP opinion is expected in 2017.
TiGenix NV (Euronext Brussels and NASDAQ: TIG) is an advanced biopharmaceutical company developing novel therapies for serious medical conditions by exploiting the anti-inflammatory properties of allogeneic, or donor-derived, stem cells.
TiGenix lead product, Cx601, has successfully completed a European Phase III clinical trial for the treatment of complex perianal fistulas - a severe, debilitating complication of Crohn's disease. Cx601 has been filed for regulatory approval in Europe and a global Phase III trial intended to support a future U.S. Biologic License Application (BLA) started in 2017. TiGenix has entered into a licensing agreement with Takeda, a global pharmaceutical company active in gastroenterology, under which Takeda acquired the exclusive right to develop and commercialize Cx601 for complex perianal fistulas outside the U.S. TiGenix' second adipose-derived product, Cx611, is undergoing a Phase I/II trial in severe sepsis - a major cause of mortality in the developed world. Finally, AlloCSC-01, targeting acute ischemic heart disease, has demonstrated positive results in a Phase I/II trial in acute myocardial infarction (AMI). TiGenix is headquartered in Leuven (Belgium) and has operations in Madrid (Spain) and Cambridge, MA (USA). For more information, please visit http://www.tigenix.com.