Takeda and TiGenix Enter into Licensing Agreement for Ex-U.S. rights to Cx601 for the Treatment of Complex Perianal Fistulas in Patients with Crohn's Disease
(Thomson Reuters ONE) -
PRESS RELEASE
REGULATED INFORMATION
Takeda and TiGenix Enter into Licensing Agreement for Ex-U.S. rights
to Cx601 for the Treatment of Complex Perianal Fistulas
in Patients with Crohn's Disease
Osaka, Japan, July 5, 2016, and Leuven, Belgium, July 5, 2016, 8:00am CEST -
Takeda Pharmaceutical Company Limited (TSE: 4502) ("Takeda") and TiGenix NV
(Euronext Brussels: TIG) ("TiGenix") today announced that the companies have
entered into an exclusive ex-U.S. license, development and commercialization
agreement for Cx601, a suspension of allogeneic adipose-derived stem cells
(eASC) injected intra-lesionally for the treatment of complex perianal fistulas
in patients with Crohn's disease. TiGenix will receive an upfront cash payment
of ?25 million. TiGenix will be eligible to receive additional regulatory and
sales milestone payments for up to a potential total of ?355 million and double
digit royalties on net sales by Takeda. The first anticipated milestone payment
is ?15 million upon obtaining the Marketing Authorization of Cx601 in the
European Economic Area (EEA). In addition, Takeda will make an equity investment
of ?10 million in the share capital of TiGenix within the next 12 months.
Crohn's disease is a chronic inflammatory disease of the gastrointestinal tract.
People living with Crohn's disease often experience complex perianal fistulas
for which there are limited treatment options. Recognizing the debilitating
nature of the disorder and the lack of treatment options, in 2009 the European
Commission granted Cx601 orphan designation for the treatment of complex
perianal fistulas. In March 2016, TiGenix announced that it submitted the
Marketing Authorization Application (MAA) to the European Medicines Agency (EMA)
for Cx601. The filing was based on the 24 week results of the ADMIRE-CD Phase 3
clinical trial. The company also recently announced top-line 52 week data
confirming the efficacy and safety of a single injection of Cx601.
Following Marketing Authorization in the European Union, Takeda will become the
marketing authorization holder and will be responsible for all commercialization
and regulatory activities. Takeda will also be responsible for additional
development activities of Cx601 for the indication of complex perianal fistulas
in Crohn's disease. TiGenix will retain the rights to develop Cx601 in new
indications.
"In Europe approximately one million people suffer from Crohn's disease, with
rising incidence. As a leader in gastroenterology, Takeda aspires to bring
innovative treatments to patients where unmet medical needs exist," said Marc
Princen, President of Europe and Canada, Takeda. "This collaboration and the
addition of Cx601 to our portfolio highlights Takeda's commitment to the
development of treatments to improve the health of people living with
gastroenterological disorders, leveraging our expertise in Inflammatory Bowel
Disease and Crohn's specifically."
"TiGenix is pleased to partner with Takeda, a global pharmaceutical company with
a strong track record and strong leadership position in gastroenterology. This
agreement reduces the investment risks associated with building a pan-European
marketing and selling infrastructure, and helps get this much-needed treatment
option to patients and gives to Cx601 the best partner with the needed
capabilities and resources to secure its commercial success" said Eduardo Bravo,
CEO, TiGenix. "This agreement further provides TiGenix with the financial
strength to move forward with the clinical development of Cx601 in the U.S.,
which represents approximately 50 percent of the world's Crohn's market."
Audio Conference
TiGenix will hold an audio conference on July 5, 2016 at 14.30 CEST/8.30 EDT. To
participate in the conference, please call one of the following numbers ten
minutes prior to commencement:
* Confirmation Code: 1500754
* United Kingdom: +44(0)20 3427 1901 or 0800 279 4977
* United States of America: +1212 444 0481 or 1877 280 2296
* Netherlands: +31(0)20 716 8256 or 0800 020 2576
* Belgium: +32(0)2 400 3463 or 0800 58032
* France: +33(0)1 70 99 42 76 or
0805 631 579
* Spain: +3491 791 7146 or 800 600 526
About Takeda
Takeda Pharmaceutical Company Limited (TSE: 4502) 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, central nervous
system 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's Commitment to Gastroenterology
Takeda is a global leader in gastroenterology. With expertise spanning more than
25 years, the company's dedication to innovation continues to evolve and have a
lasting impact. ENTYVIO® (vedolizumab) demonstrates Takeda's global capabilities
and expansion into the specialty care market in gastroenterology and biologics.
Designed and developed specifically to target the gastrointestinal (GI) tract,
ENTYVIO was launched in 2014 for the treatment of adults with moderate to severe
ulcerative colitis and Crohn's disease. TAKECAB® (vonoprazan fumarate) is
Takeda's potassium-competitive acid blocker and was launched in Japan in
2015. Takeda also markets motility agent AMITIZA® (lubiprostone), which
originally launched in 2006 for the treatment of chronic idiopathic
constipation, and received subsequent approval to treat irritable bowel syndrome
with constipation and opioid-induced constipation. Preceding these notable
launches, Takeda pioneered gastroenterological breakthroughs in proton pump
inhibitors beginning in the 1990's with lansoprazole. Through specialized and
strategic in-house development, external partnerships, in-licensing and
acquisitions, Takeda currently has a number of promising early stage GI assets
in development, and remains committed to delivering innovative, therapeutic
options for patients with gastrointestinal and liver diseases.
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 Cx601
Cx601 is a suspension of allogeneic expanded adipose-derived stem cells (eASC)
injected intra-lesionally. Cx601 is being developed for the treatment of complex
perianal fistulas in Crohn's disease patients. 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
fistulas, recognizing the debilitating nature of the disease and the lack of
treatment options. Based on positive Phase II results, TiGenix sought scientific
advice from the European Medicines Agency (EMA) on the future development path
of Cx601. TiGenix then initiated a randomized, double-blind, placebo-controlled
Phase III trial in Europe and Israel designed to comply with the requirements
laid down by the EMA (the ADMIRE-CD trial). 'Madrid Network', an organization
within the Autonomous Region of Madrid which helps companies to grow through
high-technology innovation, issued a soft loan to help finance this Phase III
study. The program is 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 ADMIRE-CD trial, the results of which
were reported in August 2015, Cx601 achieved statistically significant
superiority (p<0.025) on the primary endpoint with 49.5% combined remission at
week 24 compared to 34.3% in the placebo arm in the ITT population. These
results translate into a relative risk of 1.44, meaning that patients receiving
Cx601 had a 44% greater probability of achieving combined remission than placebo
patients. 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 ADMIRE-CD trial has completed a follow-up analysis at 52 weeks post-
treatment. Based on the positive 24 week Phase III results, TiGenix has
submitted a Marketing Authorization Application to the EMA in early 2016.
TiGenix is preparing to develop Cx601 for the US market after having reached an
agreement with the FDA through a special protocol assessment, or SPA, procedure
on its proposed protocol on August 7, 2015.
Takeda's Forward-Looking Statements
This press release contains "forward-looking statements." Forward-looking
statements include all statements other than statements of historical fact,
including plans, strategies and expectations for the future, statements
regarding the expected timing of filings and approvals relating to the
transaction, the expected timing of the completion of the transaction, the
ability to complete the transaction or to satisfy the various closing
conditions, future revenues and profitability from or growth or any assumptions
underlying any of the foregoing. Statements made in the future tense, and words
such as "anticipate," "expect," "project," "continue," "believe," "plan,"
"estimate," "pro forma," "intend," "potential," "target," "forecast,"
"guidance," "outlook," "seek," "assume," "will," "may," "should," and similar
expressions are intended to qualify as forward-looking statements. Forward-
looking statements are based on estimates and assumptions made by management
that are believed to be reasonable, though they are inherently uncertain and
difficult to predict. Investors and security holders are cautioned not to place
undue reliance on these forward-looking statements.
Forward-looking statements involve risks and uncertainties that could cause
actual results or experience to differ materially from that expressed or implied
by the forward-looking statements. Some of these risks and uncertainties
include, but are not limited to: required regulatory approvals for the
transaction may not be obtained in a timely manner, if at all; the conditions to
closing of the transaction may not be satisfied; competitive pressures and
developments; applicable laws and regulations; the success or failure of product
development programs; actions of regulatory authorities and the timing thereof;
changes in exchange rates; and claims or concerns regarding the safety or
efficacy of marketed products or product candidates in development.
The forward-looking statements contained in this press release speak only as of
the date of this press release, and neither Tigenix nor Takeda undertakes any
obligation to revise or update any forward-looking statements to reflect new
information, future events or circumstances after the date of the forward-
looking statement. If one or more of these statements is updated or corrected,
investors and others should not conclude that additional updates or corrections
will be made.
TiGenix's Forward-Looking Statements
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.
###
CONTACTS:
For TiGenix:
Claudia D'Augusta
Chief Financial Officer
claudia.daugusta(at)tigenix.com
+34 91 804 92 64
For Takeda:
Tsuyoshi Tada
Media in Japan
tsuyoshi.tada(at)takeda.com
+81 33 278 2417
Elissa Johnsen
Media outside of Japan
elissa.johnsen(at)takeda.com
+1 224 554 3185
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#2025563]
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Datum: 05.07.2016 - 08:02 Uhr
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