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TiGenix and Takeda announce Alofisel®cid:image001.png@01D3C4E1.49F40190(darvadstrocel) receives approval to treat complex perianal fistulae in Crohn’s disease in Europe

TiGenix
Posted on: 28 Mar 18

·         First allogeneic stem cell therapy (originating from donor stem cells) to receive central marketing authorisation approval in Europe

  • Darvadstrocel offers a new treatment option for patients who do not respond to current available therapies and may be subject to numerous invasive surgeries1

 

High Wycombe, UK, 26 March, 2018, 09:00 BST – TiGenix NV (Euronext Brussels and NASDAQ: TIG) (“TiGenix”) and Takeda Pharmaceutical Company Limited (TSE: 4502) (“Takeda”) today announced that the European Commission (EC) has approved Alofisel (darvadstrocel), previously Cx601, for the treatment of complex perianal fistulae in adult patients with nonactive/mildly active luminal Crohn’s disease, when fistulae have shown an inadequate response to at least one conventional or biologic therapy. Darvadstrocel should be used after conditioning of fistula.2 This marks the first allogeneic stem cell therapy (originating from donor stem cells) to receive central marketing authorisation (MA) approval in Europe.

 

The European approval follows a positive opinion by the European Medicines Agency (EMA) Committee for Medicinal Products for Human Use (CHMP), in conjunction with the Committee for Advanced Therapies (CAT), in December 2017. The recommendation was based on results from TiGenix’s Phase III ADMIRE-CD pivotal trial, which showed that darvadstrocel achieved statistically significant superiority versus the control group in the primary efficacy endpoint of combined remission at 24 weeks,*1 as well as further follow-up data that indicated darvadstrocel maintained long-term remission of treatment refractory complex perianal fistulae in patients with Crohn’s disease over 52 weeks.3

 

“Fistulating perianal Crohn’s disease represents one of the most challenging types of Crohn’s disease. It is challenging not only due to the difficult symptoms of pain and discharge, but particularly due to the major impact that these symptoms have on all aspects of life. This approval is a big step forward for patients with complex perianal fistulae in Crohn’s disease in the UK and has the potential to improve their quality of life,” said Professor Ailsa Hart from St Mark’s Hospital and Imperial College, London. “Alofisel offers a novel and well-tolerated stem cell therapy treatment option for patients who do not respond to currently available therapies, and who have until now had limited treatment options available.”

 

Mr Andrew Williams, Consultant Colorectal Surgeon at Guy's and St. Thomas' NHS Foundation Trust commented: “The availability of Alofisel provides a promising surgical option for those patients with complex Crohn's perianal fistula disease. To date, surgical treatment for this challenging group has been very disappointing, it is hoped that with the adjunct of stem cell therapy, significant improvements can be made in fistula healing rates. The use of a stem cell therapy exemplifies the importance of a strong multidisciplinary gastrointestinal team collaborating to achieve the best results for these patients with complex medical conditions.”

 

“This approval of Alofisel reflects our deep understanding and recognised leadership in the development of allogeneic stem cells and our firm commitment to developing innovative therapies for medical needs," said Dr. María Pascual, VP Regulatory Affairs and Corporate Quality at TiGenix. "We are pleased to offer the medical community an important new treatment option for patients with Crohn’s disease who do not respond to currently available therapies.”

 

 

Darvadstrocel has been licensed to Takeda for the exclusive development and commercialisation outside of the US. Receipt of the MA will trigger a milestone payment from Takeda to TiGenix of €15 million, and initiation of the process of transferring MA from TiGenix to Takeda.

 

“Today’s marketing authorisation, the first for an allogeneic stem cell therapy, represents a positive advancement in the treatment of patients with complex perianal fistulae in Crohn’s disease,” said Dr. Asit Parikh, Head of Takeda’s Gastroenterology Therapeutic Area Unit. “We look forward to bringing this much needed treatment option to patients across Europe in the coming months.”

 

* Combined remission defined as clinical assessment of closure of all treated external openings draining at baseline, despite gentle finger compression, and absence of collections >2cm confirmed by pelvic MRI

 

 

Contacts

 

For TiGenix:

 

Claudia Jiménez

Senior Director

Investor Relations and Communications

T: +34 91 804 9264

claudia.jimenez@tigenix.com

 

For Takeda:

 

Audrey Liechti

Media in UK and Ireland

T: +44 7787 445369

audrey.liechti@takeda.com

 

About Takeda UK Ltd.

 

Takeda UK Ltd., located in High Wycombe, is the UK marketing and sales organisation of Takeda Pharmaceutical Company Limited, Osaka, Japan. Takeda Pharmaceutical Company Limited (TSE: 4502) is a global, research and development-driven pharmaceutical company committed to bringing better health and a brighter future to patients by translating science into life-changing medicines. Takeda focuses its R&D efforts on oncology, gastroenterology and neuroscience therapeutic areas plus vaccines. Takeda conducts R&D both internally and with partners to stay at the leading edge of innovation. Innovative products, especially in oncology and gastroenterology, as well as Takeda’s presence in emerging markets, are currently fueling the growth of Takeda. Around 30,000 Takeda employees are committed to improving quality of life for patients, working with Takeda’s partners in health care in more than 70 countries. Additional information about Takeda UK Ltd. is available through its corporate website, www.takeda.com/en-gb.

 

About TiGenix

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, darvadstrocel, successfully completed a European Phase III clinical trial for the treatment of complex perianal fistulae - a severe, debilitating complication of Crohn’s disease. 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 commercialise darvadstrocel for complex perianal fistulae outside the U.S. 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.

 

 

About Alofisel (darvadstrocel)

Darvadstrocel is a local administration of allogeneic (or donor derived) expanded adipose-derived stem cells (eASCs) for the treatment of complex perianal fistulae in adult Crohn’s disease patients that have previously shown an inadequate response to at least one conventional therapy or biologic therapy. Crohn’s disease is a chronic inflammatory disease of the intestine and complex perianal fistulae are a severe and debilitating complication for which there is currently no effective treatment. Darvadstrocel was granted orphan drug designation by the European Commission in 2009 and by the U.S Food and Drug Administration (FDA) in 2017. TiGenix completed a European Phase III clinical trial (ADMIRE-CD) in August 2015 in which both the primary endpoint and the safety and efficacy profile were met, with patients receiving darvadstrocel showing a 44% greater probability of achieving combined remission compared to control (placebo).1 A follow-up analysis was completed at 52 weeks3 and 104 weeks post-treatment, confirming the sustained efficacy and safety profile of the product. The 24-week results of the Phase III ADMIRE-CD trial were published in The Lancet in July 2016.1 Based on the positive 24 weeks Phase III study results, TiGenix submitted a Marketing Authorisation Application to the European Medicines Agency (EMA). A global Phase III clinical trial (ADMIRE-CD II) intended to support a future U.S. Biologic License Application (BLA) started in 2017, based on a trial protocol that has been agreed with the FDA through a special protocol assessment procedure (SPA) (clinicaltrials.gov; NCT03279081). ADMIRE-CD II is a randomised, double-blind, placebo-controlled study designed to confirm the efficacy and safety of a single administration of darvadstrocel for the treatment of complex perianal fistulae in Crohn's disease patients. In July 2016, TiGenix entered into a licensing agreement with Takeda, a global pharmaceutical company active in gastroenterology, under which Takeda acquired exclusive rights to develop and commercialise darvadstrocel for complex perianal fistulae in Crohn’s patients outside of the U.S.

Editor's Details

Mike Wood
PharmiWeb.com
www.pharmiweb.com
editor@pharmiweb.com

Last updated on: 28/03/2018

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