TiGenix announces final equity payment for cardiac platform acquisition
(Thomson Reuters ONE) -
PRESS RELEASE
regulated information
Leuven (BELGIUM) - June 12, 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 a ?5
million milestone payment in new TiGenix shares to Genetrix in relation to the
cardiac platform acquisition that took place in July 2015.
Under the Coretherapix contribution agreement entered into between TiGenix and
Genetrix on July 29, 2015, Genetrix is entitled to receive a ?5 million
milestone payment upon the study report of the CAREMI trial becoming available.
CAREMI is the first-in-human clinical trial with the primary objective being
safety and evaluating the feasibility of an intracoronary infusion of 35 million
of AlloCSCs in patients with AMI and left ventricular dysfunction treated within
the first week post-AMI. Importantly, the trial is the first cardiac stem cell
study to integrate a highly discriminatory magnetic resonance imaging (MRI)
strategy to select patients at increased risk of heart failure and late adverse
outcomes.
In accordance with the Coretherapix contribution agreement, the ?5 million
milestone payment will be made in new TiGenix shares on the basis of the average
closing share price on Euronext Brussels 90 days prior to the study report
becoming available on June 9, 2017, which will result in the issue of 6,538,329
new ordinary TiGenix shares to Genetrix. The new shares will in principle be
issued by mid-August.
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 a biopharmaceutical company
developing and commercializing novel therapeutics which exploit the anti-
inflammatory properties of allogeneic, or donor-derived, stem cells.
TiGenix's 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 AlloCSC-01
AlloCSC-01 is an intracoronary administration of allogeneic cardiac stem cells
for the treatment of ischemic heart disease. A phase I/II clinical trial
(CAREMI) evaluating AlloCSC-01 in Acute Myocardial Infarction (AMI) met its
primary endpoint with no mortality or major cardiac adverse events (MACE) found
after 30 days of treatment. No mortality or MACE were found at 6 or 12 months
follow-up and there were no immune-related adverse events at 12 months follow-
up. The CAREMI trial has benefitted from the support of the CARE-MI consortium
(Grant Number 242038, http://www.caremiproject.eu/) funded by the Seventh
Framework Programme of the European Commission under the coordination of the
Centro Nacional the Investigaciones Cardiovasculares (CNIC) and the Centro
Nacional de Biotecnología and the participation of research institutions and
companies from nine EU countries.
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
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