TiGenix: Takeda Exercises its Option to Develop and Commercialize Cx601 in both Japan and Canada
(Thomson Reuters ONE) -
PRESS RELEASE
REGULATED INFORMATION
INSIDE INFORMATION
Takeda Exercises its Option to Develop and Commercialize Cx601 in both Japan and
Canada
Leuven (BELGIUM): December 21, 2016, 22:01h CET - TiGenix NV (Euronext Brussels
and Nasdaq: TIG; the "Company"), 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
received a confirmation notification from Takeda Pharmaceuticals International
AG (Takeda) stating that it has decided to exercise its option to develop and
commercialize Cx601 in both Japan and Canada.
Today TiGenix announces that Takeda has decided to exercise its option to
include both Japan and Canada into the scope of its licensing agreement with
TiGenix whereby Takeda acquired, on July 4, 2016, the exclusive right to develop
and commercialize Cx601 for complex perianal fistulas in Crohn's patients
outside of the U.S. This decision entitles Takeda the right to move forward with
these two countries.
"The decision by our partner Takeda, after its initial assessment of both the
regulatory strategy and commercial potential of Cx601 in these two countries, is
encouraging and comes at an opportune time for us as we are focused on further
developing Cx601 for the U.S. and pursuing the marketing approval of Cx601 in
Europe which we anticipate during 2017," said Eduardo Bravo, CEO of TiGenix.
"This is another excellent example of our partner's dedication to foster
innovative research and drug development for patients where unmet medical needs
exist. Once again, we are fortunate to have found such a partner for Cx601, and
one that is clearly dedicated to the long term success of Cx601," concluded
Eduardo Bravo.
This decision gives TiGenix the right to receive additional future milestone
payments of up to 3,000,000 euros for both countries (1,500,000 individually) in
the event of obtaining a marketing approval by the relevant Regulatory
Authority, in either or both countries, including an early access program, or
conditional approval, allowing patients with Crohn's disease suffering from
perianal fistula in these countries to gain access to Cx601. In addition to
these approval milestones, TiGenix is eligible to receive price reimbursement
milestones for up to 2,000,000 euros for both countries (1,000,000 individually)
as well as double-digit royalties on net sales.
For more information, please contact:
TiGenix
Claudia D'Augusta
Chief Financial Officer
Tf: +34 91804 9264
claudia.daugusta(at)tigenix.com
About TiGenix
TiGenix NV (Euronext Brussels: 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: 21.12.2016 - 22:01 Uhr
Sprache: Deutsch
News-ID 514435
Anzahl Zeichen: 10710
contact information:
Town:
Leuven
Kategorie:
Business News
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