TiGenix obtains commercial production license for expanded manufacturing facility
(Thomson Reuters ONE) -
PRESS RELEASE
TiGenix obtains commercial production license for expanded manufacturing
facility
- Provides capacity for potential European commercial roll out of
investigational stem cell therapy, Cx601
- Expanded facility also secures manufacturing for other pipeline products
Leuven (BELGIUM) - September 05, 2017, 7:00h CEST - TiGenix NV (Euronext
Brussels and NASDAQ: TIG), an advanced biopharmaceutical company exploiting the
anti-inflammatory properties of allogeneic, or donor-derived, stem cells to
develop novel therapies for serious medical conditions, announces today that it
has obtained a license for the commercial production of expanded adipose-derived
stem cells (eASCs) at its expanded manufacturing facility in Madrid.
The manufacturing license follows an inspection by the Spanish Medicines Agency
(AEMPS), and provides production capacity for the potential initial European
commercial roll out of Cx601, an investigational stem cell therapy, for the
treatment of complex perianal fistulas in patients with Crohn's disease. The
expanded facility will also provide sufficient capacity for the manufacturing of
other pipeline products under development by TiGenix, including Cx611, currently
undergoing a Phase I/II trial in severe sepsis.
TiGenix has submitted a marketing authorization (MA) application for Cx601 to
the European Medicines Agency (EMA) on the basis of results from its Phase III
ADMIRE-CD trial with a decision expected in 2017. An MA would allow Cx601 to be
marketed in all 28 member states of the EU plus Norway, Iceland and
Lichtenstein. Cx601 has been licensed to Takeda for exclusive development and
commercialization outside of the U.S.
"We are very pleased with this approval for our expanded facility, which
confirms our state-of-the-art GMP manufacturing capabilities in the stem cell
field," said Wilfried Dalemans, Chief Technical Officer at TiGenix. "We have now
significantly increased our manufacturing capacity, a key step in the
preparation for commercialization of Cx601 in Europe and in the further
development of our pipeline."
For more information
Claudia D'Augusta
Chief Financial Officer
T: +34 91 804 92 64
claudia.daugusta(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). 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. TiGenix completed a European
Phase III clinical trial (ADMIRE-CD) in August 2015. The 24-week data were
published in the Lancet and showed both the primary endpoint and the safety and
efficacy profile were met.[1] A follow-up analysis was completed at 52 weeks and
104 weeks post-treatment, confirming the sustained efficacy and safety profile
of the product.[2] 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 Authorization Application to
the European Medicines Agency (EMA) and a decision is expected in 2017. A global
Phase III clinical trial 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 Food and Drug Administration (FDA) through a special protocol
assessment procedure (SPA). 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.
About Cx611
Cx611 is an intravenous administration of allogeneic expanded adipose-derived
stem cells (eASCs) for the treatment of severe sepsis. Sepsis is a life-
threatening complication of infection leading to systemic inflammation and organ
failure and is the leading cause of death in the developed world. In May 2015,
TiGenix completed a Phase I sepsis challenge trial (CELLULA) that demonstrated a
favorable safety and tolerability profile for Cx611. Based on the results of
this study, TiGenix launched a Phase I/II clinical trial (SEPCELL) in 2016
evaluating Cx611 for the treatment of severe sepsis secondary to community-
acquired pneumonia (sCAP) in patients who require mechanical ventilation and/or
vasopressors. The first patient was dosed in January 2017 and data is expected
in 2019. The trial has received funding from the European Union's Horizon 2020
research and innovation programme under grant agreement No 681031 and is being
carried out through the SEPCELL consortium, which gathers six partners from four
European countries. See www.sepcell.eu for more information.
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.
References
--------------------------------------------------------------------------------
[1] 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.
[2] Panés, 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.
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: 05.09.2017 - 07:00 Uhr
Sprache: Deutsch
News-ID 558644
Anzahl Zeichen: 10569
contact information:
Town:
Leuven
Kategorie:
Business News
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