TiGenix provides regulatory update on Cx601 EU Marketing Authorization Application procedure
(Thomson Reuters ONE) -
PRESS RELEASE
TiGenix provides regulatory update on Cx601 EU Marketing Authorization
Application procedure
Leuven (BELGIUM) - October 31, 2017, 7:00h CET - 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 announces that it
provided an Oral Explanation of its responses to the Cx601 Marketing
Authorization (MA) Application Day 180 List of Outstanding Issues (LoOI) during
the meeting of the Committee for Advanced Therapies (CAT) of the European
Medicines Agency (EMA) on October 30, 2017.
An Oral Explanation is part of the MA Application procedure for many novel
orphan drugs. TiGenix is confident it provided detailed and clarifying responses
to the CAT, which may lead to an opinion by the EMA's Committee for Medicinal
Products for Human Use (CHMP) at its meeting on 11(th) - 14(th) December 2017.
The CAT is the EMA's specialised scientific committee for advanced therapy
medicinal products (ATMP) such as gene or cell therapies. The committee's main
responsibility is to prepare a draft opinion on each ATMP application submitted
to the EMA, before the CHMP adopts a final opinion on the marketing
authorisation of the medicine concerned. Prior to any adoption of a CAT opinion,
MA applicants are normally invited to the CAT plenary meeting to explain
positions made in the responses to the Day 180 LoOI.
TiGenix has submitted an MA Application 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. The application was supported by positive 24
and 52 week Phase III data from the ADMIRE-CD trial. Cx601 has been licensed to
Takeda for the exclusive development and commercialization outside of the U.S.
For more information
Claudia Jiménez
Senior Director, Investor Relations and Communications
Tel: +34918049264
Claudia.jimenez(at)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, expanded 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.
About Cx601
Cx601 is a local administration of allogeneic (or donor derived) expanded
adipose-derived stem cells (eASCs) for the treatment of complex perianal
fistulas in Crohn's disease patients that have previously failed conventional
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. 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 Cx601 showing a
44% greater probability of achieving combined remission compared to control
(placebo)(ii). A follow-up analysis was completed at 52 weeks and 104 weeks
post-treatment, confirming the sustained efficacy and safety profile of the
product[i]. The 24-week results of the Phase III ADMIRE-CD trial were published
in The Lancet in July 2016[ii]. Based on the positive 24 weeks Phase III study
results, TiGenix submitted a Marketing Authorization Application to the European
Medicines Agency (EMA) and a CHMP opinion is expected in 2017. 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 Cx601 for complex perianal fistulas in Crohn's patients outside of
the U.S.
Forward-looking information
This press release may contain forward-looking statements and estimates with
respect to the anticipated future performance of TiGenix and the market in which
it operates. Certain of these statements, forecasts and estimates can be
recognised by the use of words such as, without limitation, "believes",
"anticipates", "expects", "intends", "plans", "seeks", "estimates", "may",
"will" and "continue" and similar expressions. They include all matters that are
not historical facts. Such statements, forecasts and estimates are based on
various assumptions and assessments of known and unknown risks, uncertainties
and other factors, which were deemed reasonable when made but may or may not
prove to be correct. Actual events are difficult to predict and may depend upon
factors that are beyond the Company's control. Therefore, actual results, the
financial condition, performance or achievements of TiGenix, or industry
results, may turn out to be materially different from any future results,
performance or achievements expressed or implied by such statements, forecasts
and estimates. Given these uncertainties, no representations are made as to the
accuracy or fairness of such forward-looking statements, forecasts and
estimates. Furthermore, forward-looking statements, forecasts and estimates only
speak as of the date of the publication of this press release. TiGenix disclaims
any obligation to update any such forward-looking statement, forecast or
estimates to reflect any change in the Company's expectations with regard
thereto, or any change in events, conditions or circumstances on which any such
statement, forecast or estimate is based, except to the extent required by
Belgian law.
--------------------------------------------------------------------------------
[i] Panes, J. et al. OP009 Long-term efficacy and safety of Cx601, allogeneic
expanded adipose-derived mesenchymal stem cells, for complex perianal fistulas
in Crohn's disease: 52-week results of a phase III randomised controlled trial.
J Crohn's Colitis. 2017; 11: S5-S5.
[ii] Panés J, García-Olmo D, Van Assche G et al., Expanded allogeneic adipose-
derived mesenchymal stem cells (Cx601) for complex perianal fistulas in Crohn's
disease: a phase 3 randomized, double-blind controlled trial. The Lancet.
2016; 388(10051):1281-90.
This announcement is distributed by Nasdaq Corporate Solutions on behalf of Nasdaq Corporate Solutions clients.
The issuer of this announcement warrants that they are solely responsible for the content, accuracy and originality of the information contained therein.
Source: TiGenix via GlobeNewswire
Unternehmensinformation / Kurzprofil:
Datum: 31.10.2017 - 07:01 Uhr
Sprache: Deutsch
News-ID 565895
Anzahl Zeichen: 9623
contact information:
Town:
Leuven
Kategorie:
Business News
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