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TiGenix strengthens European IP protection around lead development program Cx601

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, today announced that it has further strengthened its IP protection around the company’s lead product Cx601, intended for the treatment of complex perianal fistulas in patients with Crohn’s disease.
The use of Cx601 in treating fistulas is protected by European patent EP 2292737 entitled “Use of adipose tissue-derived stromal stem cells in treating fistula”. The validity of this patent has been found undisputed in an opposition proceeding before the European Patent Office (EPO) Opposition Division. In addition, the EPO has also granted TiGenix the divisional European patent EP 2944688 entitled “Use of adipose tissue-derived stromal stem cells in treating fistula”, protecting pharmaceutical compositions comprising Cx601. These two events provide increased patent protection for the company’s lead product.
“The successful outcome of the proceeding against our base Cx601 patent and the granting of the new European patent further strengthens TiGenix’ intellectual property portfolio in the use of expanded adipose-derived stem cells (eASCs) in treating fistulas,” said Wilfried Dalemans, Chief Technical Officer at TiGenix. “This patent protection supplements the Orphan Drug Designation for Cx601, which grants the product 10 years of market exclusivity following marketing approval in Europe.”
Complex perianal fistulas are considered one of the most disabling complications of Crohn’s disease and can cause intense pain, infection and incontinence. Despite modern and surgical advancements, they currently remain challenging for clinicians to treat and have a significant negative impact patient quality of life. Cx601, an allogeneic adipose stem cell derived preparation, has been developed to treat such fistulas.
Cx601 is under review 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. TiGenix has submitted a Marketing Authorization (MA) Application to the EMA, wherefore a CHMP opinion is expected to be received in 2017. Cx601 has been licensed to Takeda for the exclusive development and commercialization outside of the U.S. in the submitted indication.
Cx601 has been granted Orphan Drug status in Europe, Switzerland and in the U.S. TiGenix has a comprehensive patent portfolio protecting its stem cell therapy product candidates, including a granted patent for treating fistulas with Cx601 in the U.S.