TiGenix : business update & financial highlights for Q1 of 2013
(Thomson Reuters ONE) -
Regulated information
May 14, 2013
TiGenix Business Update &
Financial Highlights for Q1 of 2013
· ChondroCelect Sales up 55% over Q1 2012
· Cx611 Phase IIa delivers positive results in refractory RA
· Cx601 Phase III enrollment on schedule
Leuven (BELGIUM) - May 14, 2013 -TiGenix NV (Euronext Brussels: TIG), the
European leader in cell therapy, gives an update of its business activities and
provides the financial highlights for the first quarter ending March 31, 2013.
Business highlights
* ChondroCelect:
* TiGenix obtained reimbursement in Spain for ChondroCelect
* ChondroCelect sales benefit from continued uptake in Belgium and in the
Netherlands
* Progress development pipeline
* Positive Cx611 Phase IIa study results in refractory rheumatoid
arthritis
* Cx601 ADMIRE-CD Phase III trial enrollment on plan
* Corporate:
* TiGenix successfully renews GMP license for stem cell manufacturing
facility in Madrid
* Partnering discussion for Cx601 on-going
* Transfer of corporate development responsibilities to CEO complete
Financial highlights
o ChondroCelect sales for the first three months of 2013 amounted to EUR
1.04 million, up 55% compared to the same period of last year
o EUR 6.8 million cash on hand
"With the sustained ramp-up of ChondroCelect sales, driven by increased uptake
and additional reimbursement approvals in new markets, we are moving in the
right direction to make ChondroCelect a cash flow positive asset in 2014," said
Eduardo Bravo, CEO of TiGenix. "Sales growth is expected to increase in H2 2013
as a result of the anticipated development of the private insurance market in
the UK and the launch of ChondroCelect in Spain. On the partnering front, we are
still fully engaged in discussions to co-develop Cx601 with a number of parties.
And after the positive results of our Phase IIa trial with Cx611 in refractory
RA, we have added another high-value clinical asset to our development portfolio
and to our business development efforts."
Business update
ChondroCelect sales up 55% compared with Q1 2012
ChondroCelect sales for the first quarter of 2013 amounted to EUR 1.04 million,
up 55% compared with the same period last year, and 19% compared with the
previous quarter, reflecting the continued uptake in Belgium and the
Netherlands.
ChondroCelect obtains national reimbursement in Spain
Following a positive decision by the Spanish health authorities, ChondroCelect
has gained full market access in one of the largest European pharma markets.
Discussions are on track to obtain or expand reimbursement in France, Germany,
and the UK.
Cx611 Phase IIa reports positive results in refractory rheumatoid arthritis
On April 22, the Company announced positive results of its 6-month Phase IIa
study of Cx611 in refractory rheumatoid arthritis (RA).
The multicenter, randomized, single-blind, placebo-controlled Phase IIa trial
enrolled 53 patients with active refractory rheumatoid arthritis (mean time
since diagnosis 15 years), who failed to respond to at least two biologics
(actual patients enrolled had a mean previous treatment with 3 or more disease-
modifying antirheumatic drugs and with 3 or more biologics). The study results
reaffirmed the safety profile of Cx611 in this patient population, and suggested
a positive impact on outcomes in refractory RA patients, who showed a clear
improvement at three months and a sustained benefit over six months. Five
patients out of 46 were in remission (DAS28 CRP<2,6) after three months, which
is notable in this patient population.
As a first in class product with a novel and different mechanism of action, the
safety and activity of Cx611 in a patient population that has failed all
available treatment options make it an attractive candidate for further
development in RA.
Patient enrollment on plan in ADMIRE-CD Phase III trial (Cx601) in complex
perianal fistulas
Patient enrollment in the ADMIRE-CD trial, the Company's pivotal Phase III
clinical trial with Cx601, is progressing on plan. Cx601 is an adipose derived
allogeneic stem cell suspension for the treatment of complex perianal fistulas
in Crohn's disease patients. ADMIRE-CD is a multicenter, randomized, double-
blind, placebo-controlled Phase III trial that will enroll approximately 278
patients at 55 centers across 7 European countries and Israel. Final results of
the trial are expected in H2 2014, and, if positive, will allow the Company to
file for marketing authorization with the European Medicines Agency.
Manufacturing authorization renewed for stem cell production facility
In January, Spanish health authorities renewed TiGenix's manufacturing
authorization for stem cell products at its manufacturing facility in Madrid,
Spain. At its GMP facility in Madrid, the Company manufactures high-quality,
clinical grade allogeneic stem cell products to fuel its key clinical programs.
Partnering discussion for lead program Cx601 on-going and starting for Cx611
TiGenix keeps advancing its discussions with a number of parties regarding the
commercial rights to Cx601 to maximize the value of its lead program. Closing of
a partnering deal is expected to take place before the end of the year. After
the positive results of the phase IIa study with Cx611 in RA, several pharma
companies have expressed an interest to explore licensing opportunities for this
compound.
Transfer of corporate development responsibilities to CEO complete
Gil Beyen, co-founder of TiGenix, has assumed the role of CEO at Erytech, Lyon,
France. Over the past year Mr Beyen has gradually transferred all his corporate
development responsibilities to Eduardo Bravo. The transition complete and
effective May 13, Mr Beyen stepped down as Managing Director and as a member of
the Executive Committee, but remains as a valuable member of TiGenix's board of
Directors.
Cash position of EUR 6.8 million on March 31, 2013
On March 31, the Company had a cash position of EUR 6.8 million. Net cash used
during the first three months of 2013 was EUR 1.4 million per month, in line
with management's expectations. During the month of April the company received
EUR 1 million, the last tranche of the Madrid Network soft loan granted to
support the Cx601 Phase III trial.
Outlook next 12 months
· Reimbursement decisions in major European countries for ChondroCelect
· Finalize recruitment of Cx601 phase III trial in complex perianal
fistula in Crohn's patients
· Partnering agreement for Cx601
· Start of next clinical trial with Cx611
For more information:
Eduardo Bravo Claudia D'Augusta
Chief Executive Officer Chief Financial Officer
eduardo.bravo(at)tigenix.com claudia.daugusta(at)tigenix.com
Hans Herklots
hans.herklots(at)tigenix.com
+32 16 39 60 97
About TiGenix
TiGenix NV (Euronext Brussels: TIG) is a leading European cell therapy
company with a marketed cell therapy product for cartilage repair,
ChondroCelect®, and a strong pipeline with clinical stage allogeneic adult stem
cell programs for the treatment of autoimmune and inflammatory
diseases. TiGenix is based out of Leuven (Belgium) and has operations in Madrid
(Spain), and Sittard-Geleen (the Netherlands). For more information please
visit www.tigenix.com.
Forward-looking information
This document 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 TiGenix' 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 document. TiGenix disclaims any obligation to update any
such forward-looking statement, forecast or estimates to reflect any change in
TiGenix' 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 Thomson Reuters on behalf of
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(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 Thomson Reuters ONE
[HUG#1701308]
Unternehmensinformation / Kurzprofil:
Datum: 14.05.2013 - 07:01 Uhr
Sprache: Deutsch
News-ID 259452
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contact information:
Town:
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