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) - May 31, 2017, 07:00h 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 announces that it
will submit responses to the Cx601 Marketing Authorization Application Day 180
List of Outstanding Issues (LoOI) during the month of August.
The submission of the responses to the Committee for Medicinal Products for
Human Use (CHMP) Day 180 LoOI is part of the standard regulatory procedure,
under which on the so called Day 181 the European Medicines Agency (EMA)
continues the review of a file following a clock stop. The Day 181 for the Cx601
file falls within the first week of September, which may trigger a CHMP opinion
in October. TiGenix is confident in its ability to provide detailed and
clarifying responses to the CHMP and remains on track to receive a Marketing
Authorization (MA) decision for Cx601 in 2017.
"This submission represents another important step forward in working towards a
European approval decision for Cx601 during 2017," said Dr. María Pascual, VP of
Regulatory Affairs and Corporate QA of TiGenix. "In parallel, we have advanced
the preparations for the start of a global Phase III clinical trial intended to
support a future US Biologics License Application (BLA) with first submissions
to regulatory bodies performed. We look forward to providing updates on this
dual path over the coming months."
Cx601 has been developed for the treatment of complex perianal fistulas in
Crohn's disease patients as a first indication. The Company submitted a
Marketing Authorization (MA) Application to the EMA, which is supported by
positive 24 and 52 week Phase III data and is now expecting a decision on the
European approval of the Product. Cx601 has been licensed to Takeda
Pharmaceuticals International AG (Takeda) for the exclusive development and
commercialization outside of the US. Receipt of the MA in Europe will trigger a
milestone payment from Takeda to TiGenix of Euro 15 million as well as the
European launch of Cx601, preparations for which are already underway at Takeda.
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) is expected to start 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 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). A follow-up analysis was completed at 52 weeks 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. 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) is expected to start 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.
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.
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: 31.05.2017 - 07:00 Uhr
Sprache: Deutsch
News-ID 545343
Anzahl Zeichen: 9007
contact information:
Town:
Leuven
Kategorie:
Business News
Diese Pressemitteilung wurde bisher 243 mal aufgerufen.
Die Pressemitteilung mit dem Titel:
"TiGenix provides regulatory update on Cx601 EU Marketing Authorization Application procedure"
steht unter der journalistisch-redaktionellen Verantwortung von
TiGenix (Nachricht senden)
Beachten Sie bitte die weiteren Informationen zum Haftungsauschluß (gemäß TMG - TeleMedianGesetz) und dem Datenschutz (gemäß der DSGVO).
