Takeda and TiGenix announce that Swissmedic has accepted for review the file on Cx601 for the treatment of complex perianal fistulas in Crohn's disease patients
(Thomson Reuters ONE) -
PRESS RELEASE
Takeda and TiGenix announce that Swissmedic has accepted for review the file on
Cx601 for the treatment of complex perianal fistulas in Crohn's disease patients
Pfäffikon, SZ, June 20, 2017, and Leuven, Belgium, June 20, 2017 - Takeda Pharma
AG (TSE: 4502) ("Takeda") and TiGenix NV (Euronext Brussels and Nasdaq: TIG)
("TiGenix") today announced that the Swiss Agency for Therapeutic Products
(Swissmedic) has accepted for review the file on investigational compound Cx601
to treat complex perianal fistulas in patients with Crohn's disease.
Filing follows Swissmedic granting orphan drug status for Cx601 in September
2016,[1] which recognizes the rare and debilitating nature of the disease. The
marketing authorization application (MAA) for Cx601 is already under review for
the same indication by the Committee for Medicinal Products for Human Use (CHMP)
of the European Medicines Agency (EMA).
Cx601 is a suspension of allogeneic expanded adipose-derived stem cells (eASC)
locally administered for the treatment of complex perianal fistulas in patients
with Crohn's disease, who have had an inadequate response to at least one
conventional or biologic therapy.[2] The Swissmedic filing submission included
the Phase III ADMIRE-CD trial data for Cx601. The ADMIRE-CD trial is a
randomized, double-blind, controlled, Phase III trial designed to investigate
the efficacy and safety of investigational compound Cx601.(2) 24- and 52-week
data were included in the Swissmedic filing submission. The 24-week data were
published in the Lancet and showed both the primary endpoint and the safety and
efficacy profile were met.[3]
"Cx601 may have the potential to offer an alternative treatment option to
current therapies, which are often associated with complications and a high
failure rate for a disease that is difficult to treat and often leads to pain,
swelling, infection and incontinence." said Julie Puype, General Manager, Takeda
Pharma Switzerland. "The submission to Swissmedic is a key milestone in the
commercialization of Cx601 and reflects Takeda's continued commitment to
delivering innovative, therapeutic options for patients with gastrointestinal
diseases."
"Complications from Crohn's disease, such as complex perianal fistulas, can have
a severe impact on the lives of those affected." said Dr. María Pascual, VP of
Regulatory Affairs and Corporate QA at TiGenix. "This submission by our partner
Takeda reflects our joined continued efforts to make Cx601 available to patients
and physicians beyond the European Union."
Crohn's disease is a chronic inflammatory disease of the gastrointestinal tract,
which is thought to affect an estimated 6,100 people in Switzerland[4] and up to
1.6 million people in Europe.[5] Complex perianal fistulas are a complication
for people living with Crohn's disease. Despite modern medical and surgical
advancements, they remain challenging for clinicians to treat[6] and are
considered one of the most disabling manifestations of Crohn's disease.[7]
Takeda's Commitment to Gastroenterology
More than 70 million people worldwide are impacted by gastrointestinal (GI)
diseases,[8] which can be complex, debilitating and life-changing. Takeda is
driven to improving the lives of patients with GI diseases through innovative
medicines, dedicated patient disease management support and the evolution of the
healthcare environment. Takeda is leading in gastroenterology through the
delivery of innovative medicines in areas associated with high unmet needs, such
as inflammatory bowel disease, GI acid-related diseases and GI motility
diseases. Our GI research & development team is also exploring solutions in
celiac disease and nonalcoholic steatohepatitis (NASH), as well as scientific
advancements through microbiome therapies. With more than 25 years of experience
in this area, our broad approach to treating many diseases that impact the GI
system and our global network of collaborators, Takeda aims to advance how
patients manage their disease.
About Takeda Pharmaceutical Company
Takeda Pharmaceutical Company Limited is a global, R&D-driven pharmaceutical
company committed to bringing better health and a brighter future to patients by
translating science into life-changing medicines. Takeda focuses its research
efforts on oncology, gastroenterology and central nervous system therapeutic
areas. It also has specific development programs in specialty cardiovascular
diseases as well as late-stage candidates for vaccines. Takeda conducts R&D both
internally and with partners to stay at the leading edge of innovation. New
innovative products, especially in oncology and gastroenterology, as well as its
presence in emerging markets, fuel the growth of Takeda. More than 30,000 Takeda
employees are committed to improving quality of life for patients, working with
our partners in health care in more than 70 countries. For more information,
visit http://www.takeda.com/news.
Takeda in Switzerland
The headquarters in Glattpark, near Zurich, look after Takeda's activities in
Europe and in Canada. The branch for the Swiss market is located in Pfäffikon
SZ. In total, nearly 500 employees work for Takeda in both locations. You can
find more information about Takeda Pharma AG at http://www.takeda.ch.
About TiGenix
TiGenix NV (Euronext Brussels and NASDAQ: TIG) is an advanced biopharmaceutical
company developing novel therapies for serious medical conditions by exploiting
the anti-inflammatory properties of allogeneic, or donor-derived, expanded stem
cells.
TiGenix' 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 Cx601
Cx601 is a local administration of allogeneic expanded adipose-derived stem
cells (eASCs) for the treatment of complex perianal fistulas in Crohn's disease
patients that have previously failed conventional therapy. Crohn's disease is a
chronic inflammatory disease of the intestine and complex perianal fistulas are
a severe and debilitating complication for which there is currently no effective
treatment. Cx601 was granted orphan drug designation by the European Commission
in 2009. TiGenix completed a European Phase III clinical trial (ADMIRE-CD) in
August. The 24-week data were published in the Lancet and showed both the
primary endpoint and the safety and efficacy profile were met.(3) A follow-up
analysis was completed at 52 weeks and 104 weeks post-treatment, confirming the
sustained efficacy and safety profile of the product. The 24-week results of the
Phase III ADMIRE-CD trial were published in The Lancet in July 2016.(3) Based on
the positive 24 weeks Phase III study results, TiGenix submitted a Marketing
Authorization Application to the European Medicines Agency (EMA) and a decision
is expected in 2017. A global Phase III clinical trial intended to support a
future U.S. Biologic License Application (BLA) is expected to start in 2017,
based on a trial protocol that has been agreed with the Food and Drug
Administration (FDA) through a special protocol assessment procedure (SPA). In
July 2016, TiGenix entered into a licensing agreement with Takeda, a global
pharmaceutical company active in gastroenterology, under which Takeda acquired
exclusive rights to develop and 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
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.
-Ends-
CONTACTS:
For TiGenix:
Claudia D'Augusta
Chief Financial Officer
claudia.daugusta(at)tigenix.com
+34 91 804 9264
For Takeda:
Anita Geiger
Swiss Media
Anita.geiger(at)takeda.com
+41 79 583 5573
Luke Willats
Media outside Switzerland
Luke.willats(at)takeda.com
+41 44 555 1145
References
--------------------------------------------------------------------------------
[1] Swissmedic. About us - Swissmedic - Tasks - Patients and Users. Orphan drugs
(medicinal products for rare diseases) Available at
https://www.swissmedic.ch/ueber/00131/03915/index.html?lang=en. Accessed May
30, 2017.
[2] Clinicaltrials.gov. Adipose Derived Mesenchymal Stem Cells for Induction of
Remission in Perianal Fistulizing Crohn's Disease (ADMIRE-CD). Available at:
https://clinicaltrials.gov/ct2/show/NCT01541579? term=cx601&rank=2. Published
February 2012. Accessed May 30, 2017.
[3] Panés J, García-Olmo D, Van Assche G et al., Expanded allogeneic adipose-
derived mesenchymal stem cells (Cx601) for complex perianal fistulas in Crohn's
disease: a phase 3 randomized, double-blind controlled trial. The Lancet.
2016; 388(10051):1281-90.
[4] Juillerat, P, Pittet V, Bulliard JL, et al., Prevalence of Inflammatory
Bowel Disease in the Canton of Vaud (Switzerland): A population-based cohort
study. J Crohn's Colitis. 2008; 2(2): 131-141.
[5] Burisch J, Jess T, Martinato, M, et al., on behalf of ECCO - EpiCom. The
burden of inflammatory bowel disease in Europe. J Crohn's Colitis.
2013; 7: 322-337.
[6] Geltzeiler C, Wieghard N and Tsikitis V. Recent developments in the surgical
management of perianal fistula for Crohn's disease. Ann Gastroenterol.
2014; 27(4): 320-330.
[7] Marzo M, Felice C, Pugliese D, et al., Management of perianal fistulas in
Crohn's disease: An up-to-date review. World J Gastroenterol.
2015; 21(5): 1394-1395.
[8] Digestive Health. University of Miami Hospital. Available at:
http://umiamihospital.com/service-lines/digestive-health. Accessed May 30, 2017.
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: 20.06.2017 - 07:00 Uhr
Sprache: Deutsch
News-ID 548709
Anzahl Zeichen: 14403
contact information:
Town:
Leuven
Kategorie:
Business News
Diese Pressemitteilung wurde bisher 196 mal aufgerufen.
Die Pressemitteilung mit dem Titel:
"Takeda and TiGenix announce that Swissmedic has accepted for review the file on Cx601 for the treatment of complex perianal fistulas in Crohn's disease patients"
steht unter der journalistisch-redaktionellen Verantwortung von
TiGenix (Nachricht senden)
Beachten Sie bitte die weiteren Informationen zum Haftungsauschluß (gemäß TMG - TeleMedianGesetz) und dem Datenschutz (gemäß der DSGVO).
