Du är här


TiGenix: TiGenix obtains commercial production license for Cx601

Leuven (BELGIUM) - February 23, 2016, 07:00h CET - TiGenix NV (Euronext
Brussels: TIG), an advanced biopharmaceutical company focused on developing
and commercialising novel therapeutics from its proprietary platforms of
allogeneic expanded stem cells, announced today that it has successfully
obtained the license for commercial production of Cx601, TiGenix's product
for the treatment of complex perianal fistulas in Crohn's disease patients.

The issuance of the manufacturing license from the Spanish Medicines Agency
(AEMPS) represents a relevant achievement in bringing Cx601 closer to
commercial launch.

"We are very pleased with this approval which confirms our state-of-the-art
GMP manufacturing capabilities in the stem cell field" said Wilfried
Dalemans, Chief Technical Officer. "The commercial GMP license in addition to
the current GMP license for clinical manufacturing is a clear recognition of
our proven capabilities in the field and sets the stage for gearing-up the
manufacturing of Cx601 commercial lots, making TiGenix a leading reference in
the development of cell therapy medicinal products once more".

Following the successful completion of its Phase III ADMIRE-CD clinical trial
in August, the approval marks a new milestone in TiGenix's mission to bring
Cx601 to European patients suffering from complex perianal fistulas, a
complication of Crohn's disease for which there is currently no effective

"This timely and successful achievement fulfils one of the final requirements
for our plan to file a Marketing Approval Application for Cx601 at the
European Medicines Agency (EMA) in the coming weeks," said Maria Pascual, VP
Regulatory Affairs. "In this way our plan remains in line with the
expectation to make Cx601 available to European patients in the second half
of 2017".

For more information, please contact:

Claudia D'Augusta
Chief Financial Officer
T: +34 91 804 92 64

About TiGenix

TiGenix NV (Euronext Brussels: TIG) is an advanced biopharmaceutical company
focused on developing and commercialising novel therapeutics from its
proprietary platforms of allogeneic, or donor-derived, expanded stem cells.
Two products from the adipose-derived stem cell technology platform are
currently in clinical development. Cx601 is in Phase III for the treatment of
complex perianal fistulas in Crohn's disease patients. 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, 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. TiGenix also
developed ChondroCelect, an autologous cell therapy product for cartilage
repair of the knee, which was the first Advanced Therapy Medicinal Product
(ATMP) to be approved by the European Medicines Agency (EMA). From June 2014,
the marketing and distribution rights of ChondroCelect were exclusively
licensed to Sobi for the European Union (except for Finland, where it is
distributed by the Finnish Red Cross Blood Service), Norway, Russia,
Switzerland and Turkey, and the countries of the Middle East and North
Africa. TiGenix is headquartered in Leuven (Belgium) and has operations in
Madrid (Spain). For more information, please visitwww.tigenix.com.

About Cx601

Cx601 is a suspension of allogeneic expanded adipose-derived stem cells (eASC)
injected intra-lesionally. Cx601 is being developed for the treatment of
complex perianal fistulas in Crohn's disease patients. 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, recognising the debilitating nature of
the disease and the lack of treatment options. Based on positive Phase II
results, TiGenix sought scientific advice from the European Medicines Agency
(EMA) on the future development path of Cx601. TiGenix then initiated a
randomised, double-blind, placebo-controlled Phase III trial in Europe and
Israel designed to comply with the requirements laid down by the EMA. 'Madrid
Network', an organisation within the Autonomous Region of Madrid which helps
companies to grow through high-technology innovation, issued a soft loan to
help finance this Phase III study. The programme is 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. The trial had a first complete analysis of results at 24 weeks, with
a follow-up analysis to be performed at 52 weeks post-treatment. Recruitment
of the whole sample of patients was completed in the fourth quarter of 2014.
Based on the positive Phase III results, TiGenix will submit a Marketing
Authorisation Application to the EMA in early 2016. TiGenix is preparing to
develop Cx601 for the US market after having reached an agreement with the
FDA through a special protocol assessment, or SPA, procedure on its proposed
protocol on August 7, 2015.

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 OMX Corporate Solutions on behalf of NASDAQ OMX 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


Författare WKR

Tala om vad ni tycker

Tala om vad ni tycker

Ni är just nu inne på en betaversion av nya aktiespararna. Lämna gärna feedback på vad ni tycker i formuläret nedan.