TiGenix reconfirms its strategic focus on its allogeneic stem cell platforms
(Thomson Reuters ONE) -
REGULATED INFORMATION
PRESS RELEASE
TiGenix reconfirms its strategic focus on its allogeneic stem cell platforms
Leuven (BELGUIM) - July 5, 2016, 8:00h CEST - TiGenix NV (Euronext Brussels:
TIG), an advanced biopharmaceutical company focused on the development and
commercialization of novel therapeutics based on its proprietary platforms of
allogeneic expanded stem cells, today announced the initiation of the withdrawal
of the Marketing Authorization for ChondroCelect® due to commercial reasons.
This decision is in line with TiGenix's strategy to concentrate its resources
and capabilities on its allogeneic stem cell platforms, its upcoming Cx601 Phase
III US trial and its other clinical stage assets.
Due to the regulatory environment around autologous chondrocyte-based cell
therapy products in Europe leading to a difficult competitive landscape for
ChondroCelect, together with the lack of reimbursement in key European
countries, TiGenix has been prompted to initiate the withdrawal process of the
Marketing Authorization for ChondroCelect® for commercial reasons. Consequently,
TiGenix has come to an agreement with Sobi for the early termination of their
existing commercial relationship and will also terminate its manufacturing
agreement with PharmaCell.
"TiGenix continues to be committed to bring novel therapeutics based on our
proprietary allogeneic stem cell platforms to patients with high unmet medical
need, as was evidenced by the recently announced licensing agreement with Takeda
Pharmaceutical for the ex-US rights to commercialize Cx601 for the treatment of
perianal fistula in Crohn's disease," said Eduardo Bravo, CEO of TiGenix. "To
deliver shareholder value we need to focus all our efforts and internal
resources on the upcoming Cx601 Phase III US trial while advancing with our
other clinical stage assets, namely AlloCSC-01 in acute myocardial infarction
and Cx611 in severe sepsis."
TiGenix will be working with the regulatory agencies on this withdrawal, and is
in the process of notifying healthcare professionals and remind them of the
availability of therapeutic alternatives for patients with cartilage lesions of
the knee.
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: 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 visit www.tigenix.com.
About ChondroCelect
ChondroCelect, indicated for cartilage repair in the knee, was the first
approved cell-based product in Europe that successfully completed the entire
development track from research through clinical development to European
approval through the centralised procedure. ChondroCelect received Marketing
Authorization in October 2009 as the first Advanced Therapy Medicinal Product.
ChondroCelect is a cell-based medicinal product for use in autologous
chondrocyte implantation in which cells are taken from the patient's own knee,
multiplied to reach a large quantity, and then re-implanted at the site of the
defect. ChondroCelect is indicated for the repair of single symptomatic
cartilage defects of the femoral condyle of the knee (International Cartilage
Repair Society grade III or IV) in adults.
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 GlobeNewswire on behalf of
GlobeNewswire clients. The owner of this announcement warrants that:
(i) the releases contained herein are protected by copyright and
other applicable laws; and
(ii) they are solely responsible for the content, accuracy and
originality of the information contained therein.
Source: TiGenix via GlobeNewswire
[HUG#2025567]
Unternehmensinformation / Kurzprofil:
Datum: 05.07.2016 - 08:02 Uhr
Sprache: Deutsch
News-ID 481477
Anzahl Zeichen: 8134
contact information:
Town:
Leuven
Kategorie:
Business News
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