TiGenix Submits Day 120 Responses to European Medicines Agency for Cx601 Marketing Authorization
(Thomson Reuters ONE) -
PRESS RELEASE
TiGenix Submits Day 120 Responses to European Medicines Agency for Cx601
Marketing Authorization
Leuven (BELGIUM) - December 22, 2016, 22:01h CET - TiGenix NV (Euronext Brussels
and Nasdaq: TIG), an advanced biopharmaceutical company focused on developing
and commercializing novel therapeutics from its proprietary platforms of
allogeneic expanded stem cells, today announced that it has submitted its
responses to the European Medicines Agency's (EMA) Day 120 List of Questions for
Cx601, its lead product candidate being developed for the treatment of complex
perianal fistulas in patients with Crohn's disease.
TiGenix has submitted its responses to the Day 120 List of Questions issued by
the Committee for Medicinal Products for Human Use (CHMP) of the European
Medicines Agency (EMA) as part of the centralized review process of the
Marketing Authorization Application (MAA) of Cx601 for the treatment of perianal
fistula in Crohn's disease patients, licensed to Takeda Pharmaceuticals
International AG ("Takeda") for its exclusive development and commercialization
outside the US.
TiGenix expects to receive the EMA Day 180 List of Outstanding Issues in
February 2017 and anticipates a decision from the EMA on Cx601 Marketing
Approval during 2017 which, if approved, would trigger the payment by Takeda to
TiGenix of Euro 15 million.
"We are pleased with the comprehensive set of answers and additional analyses
that our team provided and remain confident that the follow-up analysis of Cx601
52-week data appropriately addresses the questions posed by the EMA," said Dr.
Maria Pascual, Vice President Regulatory Affairs and Corporate Quality of
TiGenix. "The submission of the Day 120 responses restarts the clock and brings
us one step closer to being able, together with our partner Takeda, to provide
this very much needed treatment to patients with Crohn's disease suffering from
such a debilitating disease," concluded Dr. Pascual.
For more information, please contact:
TiGenix
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 focused on developing and commercializing novel therapeutics from its
proprietary platforms of allogeneic, or donor-derived, expanded stem cells. Our
lead product candidate from the adipose-derived stem cell technology platform is
Cx601, which is in registration with the European Medicines Agency for the
treatment of complex perianal fistulas in Crohn's disease patients. Our adipose-
derived stem cell product candidate Cx611 has completed a Phase I sepsis
challenge trial and a Phase I/II trial in rheumatoid arthritis. Effective July
31, 2015, TiGenix acquired Coretherapix, whose lead cellular product candidate,
AlloCSC-01, is currently in a Phase II clinical trial in Acute Myocardial
Infarction (AMI). In addition, the second product candidate from the cardiac
stem cell-based platform acquired from Coretherapix, AlloCSC-02, is being
developed in a chronic indication. On July 4, 2016, TiGenix entered into a
licensing agreement with Takeda, a large pharmaceutical company active in
gastroenterology, under which Takeda acquired the exclusive right to
commercialize Cx601 for complex perianal fistulas outside the United States.
TiGenix is headquartered in Leuven (Belgium) and has operations in Madrid
(Spain).
About Cx601
Cx601 is a suspension of allogeneic expanded adipose-derived stem cells (eASC)
locally injected. Cx601 is an investigational agent being developed for the
treatment of complex perianal fistulas in Crohn's disease patients with
inadequate response to at least one conventional or biologic therapy including
antibiotics, immunosuppressants, or anti-TNF agents. Crohn's disease is a
chronic inflammatory disease of the intestine and patients can suffer from
complex perianal fistulas for which there is currently no effective treatment.
In 2009, the European Commission granted Cx601 orphan designation for the
treatment of anal fistulas, recognizing the debilitating nature of the disease
and the lack of treatment options. Cx601 has met the primary end-point in the
Phase III ADMIRE-CD study in Crohn's disease patients with complex perianal
fistula, a randomized, double-blind, placebo-controlled trial run in Europe and
Israel and designed to comply with the requirements laid down by the EMA.
'Madrid Network' issued a soft loan to help finance this Phase III study, which
was funded by the Secretary of State for Research, Development and Innovation
(Ministry of Economy and Competitiveness) within the framework of the INNTEGRA
plan. The study's primary endpoint was combined remission, defined as clinical
assessment at week 24 of closure of all treated external openings draining at
baseline despite gentle finger compression, and absence of collections >2cm
confirmed by MRI. In the ITT population (n=212), Cx601 achieved statistically
significant superiority (p=0.024) on the primary endpoint with 50% combined
remission at week 24 compared to 34% in the placebo arm. Efficacy results were
robust and consistent across all statistical populations. Treatment emergent
adverse events (non-serious and serious) and discontinuations due to adverse
events were comparable between Cx601 and placebo arms. The 24-weeks results have
been published by The Lancet, one of the most highly regarded and well known
medical journals in the world. The Phase III study has completed a follow-up
analysis at 52 weeks confirming its sustained efficacy and safety profile. Top
line follow-up data showed that in the ITT population Cx601 achieved statistical
superiority (p=0.012) with 54% combined remission at week 52 compared to 37% in
the placebo arm. The 52-week data also showed a higher rate of sustained closure
in those patients treated with Cx601 and in combined remission at week 24
(75.0%) compared to patients in the placebo group (55.9%). Based on the positive
24-weeks Phase III study results, TiGenix has submitted a Marketing
Authorization Application to the EMA in early 2016. TiGenix is preparing to
develop Cx601 in the U.S. after having reached an agreement with the FDA through
a special protocol assessment procedure (SPA) in 2015. On July 4, 2016 TiGenix
entered into a licensing agreement with Takeda, a pharmaceutical company leader
in gastroenterology, whereby Takeda acquired an exclusive right to 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
recognized 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
applicable 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: 22.12.2016 - 22:01 Uhr
Sprache: Deutsch
News-ID 514648
Anzahl Zeichen: 9969
contact information:
Town:
Leuven
Kategorie:
Business News
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