12 April 2018

TiGenix reports 2017 full year results

 

Leuven (BELGIUM) – April 12, 2018, 7:00h CEST – 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 reported its business and financial highlights for 2017 and post year-end events.

Key business and financial highlights for 2017 and post year-end highlights

  • On March 23, 2018, Alofisel® (darvadstrocel), previously Cx601, received European Commission (EC) approval 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. Alofisel® should be used after conditioning of fistula[i]. This marks the first allogeneic stem cell therapy to receive central marketing authorization approval in Europe.
  • EC approval followed a positive recommendation from the Committee for Human Medicinal Products (CHMP) of the European Medicines Agency (EMA) in conjunction with the Committee for Advanced Therapies (CAT) in December 2017.
  • In January 2018, the Committee for Orphan Medicinal Products (COMP) of the EMA ratified Alofisel®’s orphan drug status in Europe. Alofisel® was first granted orphan drug designation (ODD) in 2009.
  • TiGenix further strengthened its IP protection in 2017 with a global patent license from Mesoblast Limited for the use of adipose-derived mesenchymal stem cells in local treatment of fistulas and the granting of TiGenix’ divisional European patent EP 2944688 in October.
  • The global pivotal Phase III trial to support a future U.S. registration for Cx601 (darvadstrocel) formally launched in Europe and Israel in June 2017. To support this trial, TiGenix opened its U.S. headquarters in Cambridge, MA, in June 2017 and made two key senior appointments.
  • In December 2017, TiGenix announced a strategic focus of its resources and capabilities on its adipose derived stem cell (eASC) platform and product candidates Alofisel®/ Cx601 and Cx611.

TiGenix’ cash position as of December 31, 2017 amounted to EUR 34.1 million. Receipt of marketing authorization for Alofisel® on March 23, 2018 triggered a post year-end milestone payment of EUR 15.0 million from Takeda Pharmaceuticals to TiGenix.

 
Proposed acquisition of TiGenix by Takeda

On January 5, 2018, Takeda announced its intention to acquire 100% of the securities with voting rights or giving access to voting rights of TiGenix not already owned by Takeda or Takeda’s affiliates at a price of EUR 1.78 per share in cash, an equivalent price in cash per American Depositary Share (“ADS”) and a price in cash per warrant based on the strike price and maturity of each warrant, representing an aggregate equity value of approximately EUR 520 million.

On February 15, 2018, Takeda formally notified its intention to launch the tender offer to the Belgian Financial Services and Markets Authority (FSMA). TiGenix expects the tender offer to be launched by Takeda during April 2018.

Completion of the tender offer is subject to the following conditions precedent, as U.S. antitrust clearance and the marketing authorization for Alofisel® in the European Union have already been obtained: (i) the tender into the tender offer, in aggregate, of a number of shares, ADSs and warrants that, together with all shares, ADSs and warrants owned by Takeda and its affiliates, represents or gives access to 85% or more of the voting rights represented or given access to by all of the outstanding shares, ADSs and warrants on a fully diluted basis as of the end of the first acceptance period of the tender offer, and (ii) the absence of a material adverse effect occurring at any time after the date of the initial announcement (i.e. January 5, 2018). Only if those conditions are satisfied (or waived by Takeda, as applicable) by the end of the first acceptance period of the tender offer, will the transaction be consummated.  

Following approval by the FSMA, Takeda will publish a prospectus in which it will set out the full details of the tender offer, and TiGenix will publish a response memorandum, in which it will set out the position of its board of directors on the tender offer.

TiGenix expects that the results of the first acceptance period of the tender offer will be announced by Takeda approximately 24 business days after the launch of the tender offer.

“This has been a truly momentous period for TiGenix. Alofisel® became the first allogeneic stem cell therapy to receive a marketing authorization in Europe, clearing the last hurdle before being able to make this new treatment option for patients suffering this severe and debilitating complication of Crohn’s disease available to the medical community,” “We have also taken significant steps to progress the development of Cx601 for complex perianal fistulas in the U.S., and towards other indications in line with our focus on our eASC platform, which includes Alofisel®/ Cx601 and Cx611, as announced in December.” “We believe the intended takeover bid from Takeda is a positive step for TiGenix’ security holders and reflects the true value of our dedication to patients over the last few years. We believe that TiGenix’ expertise could help Takeda to accelerate its ambition to develop novel stem cell therapies. Takeda is a patient centric company that offers the best capabilities and resources to ensure access to Alofisel®/ Cx601 to patients worldwide.”

Eduardo Bravo

CEO of TiGenix

Investor Conference Call and Webcast

In light of the pending transaction with Takeda, TiGenix will not be hosting a conference call to discuss its 2017 full year results.

 

For more information please contact:

 

 TiGenix                                                           PR Enquiries

 Claudia Jiménez                                               Consilium Strategic Communications

 Senior Director                                                 Chris Gardner, Sukaina Virji, Melissa Gardiner

 Investor Relations and Communications          T: +44 20 3709 5700

 T: +34 91 804 9264                                           tigenix@consilium-comms.com 

 claudia.jimenez@tigenix.com                           

 

 

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, Alofisel®, successfully completed a European Phase III clinical trial for the treatment of complex perianal fistulas - 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 commercialize Alofisel® for complex perianal fistulas outside the U.S. TiGenix’ second adipose-derived product, Cx611, is undergoing a Phase Ib/IIa trial in severe sepsis – a major cause of mortality in the developed world. 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) / Cx601

Alofisel®/ Cx601 is a local administration of allogeneic (or donor derived) expanded adipose-derived stem cells (eASCs) for the treatment of complex perianal fistulas 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 fistulas are a severe and debilitating complication for which there is currently no effective treatment. Alofisel®/ Cx601 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 Alofisel® showing a 44% greater probability of achieving combined remission compared to control (placebo)2. 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 20162. Based on the positive 24 weeks Phase III study results, TiGenix submitted a Marketing Authorization Application to the European Medicines Agency (EMA). Marketing Authorization in Europe was granted in March 2018. 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 randomized, double-blind, placebo-controlled study designed to confirm the efficacy and safety of a single administration of Cx601 for the treatment of complex perianal fistulas 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 commercialize Alofisel®/ Cx601 for complex perianal fistulas in Crohn’s patients outside of the U.S.

 

 

***Please see here PDF for the full report***


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