Regulatory News:
Active Biotech (NASDAQ STOCKHOLM:ACTI) and Ipsen (Euronext: IPN;
ADR: IPSEY) today announced top line results of the 10TASQ10 study.
While the study showed that tasquinimod reduced the risk of
radiographic cancer progression or death compared to placebo (rPFS,
HR=0.69, CI 95%: 0.60 – 0.80) in patients with metastatic
castration resistant prostate cancer (mCRPC) who have not received
chemotherapy, tasquinimod did not extend overall survival (OS,
HR=1.09, CI 95%: 0.94 – 1.28).
Efficacy results together with preliminary safety data do not
support positive benefit risk balance in this population. Therefore
the companies have decided to discontinue all studies in prostate
cancer. Full results will be presented at an upcoming scientific
conference.
Marc de Garidel, Chairman and Chief Executive Officer of
Ipsen stated: “We are disappointed for prostate cancer
patients. Ipsen remains strongly committed to oncology. We are
grateful to the clinicians, caregivers, patients and their families
who were involved in this study."
Professor Tomas Leanderson, President and Chief Executive
Officer of Active Biotech stated: “The outcome of the
10TASQ10 study is a major disappointment based on the promising
phase II results. However, the data at hand is unambiguous and
cannot motivate further development of tasquinimod in this patient
population. I want to thank the clinicians, caregivers, patients
and their families who were involved in this study."
Ipsen and Active Biotech are in communication with trial
investigators, ethics committees and the relevant regulatory
authorities, to provide them with updated and current information
in compliance with local regulations. The companies are working
with trial investigators and local regulatory authorities to ensure
that patients who participated in the tasquinimod trials are
transitioned to appropriate therapies so that trial participants
receive appropriate care.
About tasquinimod
Tasquinimod is a novel oral immunotherapy that targets the tumor
microenvironment by binding to S100A9 and modulating regulatory
myeloid cell functions, exerting immunomodulatory, anti-angiogenic
and anti-metastatic properties. Today the development of
tasquinimod principally has been focused on the treatment of
prostate cancer, but early clinical studies in other cancer
indications are performed.
About the 10TASQ10 trial
The 10TASQ10 trial is a randomized, double-blind,
placebo-controlled, global Phase III clinical trial evaluating
tasquinimod in patients with metastatic castration resistant
prostate cancer (mCRPC) who have not yet received chemotherapy. The
aim of the 10TASQ10 study is to confirm tasquinimod’s efficacy,
with radiological Progression Free Survival (rPFS) as primary
endpoint and overall survival (OS) as key secondary endpoint. The
Phase III 10TASQ10 trial met its enrollment target in December 2012
with more than 1,200 randomized patients as planned in the clinical
protocol.
About Active Biotech
Active Biotech AB (publ) (Nasdaq Stockholm: ACTI) is a
biotechnology company with focus on neurodegenerative diseases and
cancer. Projects in pivotal phase are laquinimod, an orally
administered small molecule with unique immunomodulatory properties
for the treatment of multiple sclerosis, and tasquinimod, an oral
immunomodulatory, anti-metastatic substance for the treatment of
prostate cancer. The objective of the preclinical ISI project is to
produce new, patentable chemical compounds for treatment of
diseases in the company’s focus areas. Please visit
www.activebiotech.com for more information.
About Ipsen
Ipsen is a global specialty-driven biotechnological group with
total sales exceeding €1.2 billion in 2014. Ipsen sells more than
20 drugs in more than 115 countries, with a direct commercial
presence in 30 countries. Ipsen’s ambition is to become a leader in
specialty healthcare solutions for targeted debilitating diseases.
Its development strategy is supported by 3 franchises: neurology,
endocrinology and urology-oncology. Ipsen’s commitment to oncology
is exemplified through its growing portfolio of key therapies
improving the care of patients suffering from prostate cancer,
bladder cancer or neuro-endocrine tumors. Ipsen also has a
significant presence in primary care. Moreover, the Group has an
active policy of partnerships. Ipsen's R&D is focused on its
innovative and differentiated technological platforms, peptides and
toxins, located in the heart of the leading biotechnological and
life sciences hubs (Les Ulis, France; Slough/Oxford, UK; Cambridge,
US). In 2014, R&D expenditure totaled close to €187 million,
representing about 15% of Group sales. The Group has more than
4,500 employees worldwide. Ipsen’s shares are traded on segment A
of Euronext Paris (stock code: IPN, ISIN code: FR0010259150) and
eligible to the “Service de Règlement Différé” (“SRD”). The Group
is part of the SBF 120 index. Ipsen has implemented a Sponsored
Level I American Depositary Receipt (ADR) program, which trade on
the over-the-counter market in the United States under the symbol
IPSEY. For more information on Ipsen, visit www.ipsen.com.
Ipsen Forward Looking Statements
The forward-looking statements, objectives and targets contained
herein are based on the Group’s management strategy, current views
and assumptions. Such statements involve known and unknown risks
and uncertainties that may cause actual results, performance or
events to differ materially from those anticipated herein. All of
the above risks could affect the Group’s future ability to achieve
its financial targets, which were set assuming reasonable
macroeconomic conditions based on the information available today.
Use of the words "believes," "anticipates" and "expects" and
similar expressions are intended to identify forward-looking
statements, including the Group’s expectations regarding future
events, including regulatory filings and determinations. Moreover,
the targets described in this document were prepared without taking
into account external growth assumptions and potential future
acquisitions, which may alter these parameters. These objectives
are based on data and assumptions regarded as reasonable by the
Group. These targets depend on conditions or facts likely to happen
in the future, and not exclusively on historical data. Actual
results may depart significantly from these targets given the
occurrence of certain risks and uncertainties, notably the fact
that a promising product in early development phase or clinical
trial may end up never being launched on the market or reaching its
commercial targets, notably for regulatory or competition reasons.
The Group must face or might face competition from generic products
that might translate into a loss of market share. Furthermore, the
Research and Development process involves several stages each of
which involves the substantial risk that the Group may fail to
achieve its objectives and be forced to abandon its efforts with
regards to a product in which it has invested significant sums.
Therefore, the Group cannot be certain that favourable results
obtained during pre-clinical trials will be confirmed subsequently
during clinical trials, or that the results of clinical trials will
be sufficient to demonstrate the safe and effective nature of the
product concerned. There can be no guarantees a product will
receive the necessary regulatory approvals or that the product will
prove to be commercially successful. If underlying assumptions
prove inaccurate or risks or uncertainties materialize, actual
results may differ materially from those set forth in the
forward-looking statements. Other risks and uncertainties include
but are not limited to, general industry conditions and
competition; general economic factors, including interest rate and
currency exchange rate fluctuations; the impact of pharmaceutical
industry regulation and health care legislation; global trends
toward health care cost containment; technological advances, new
products and patents attained by competitors; challenges inherent
in new product development, including obtaining regulatory
approval; the Group's ability to accurately predict future market
conditions; manufacturing difficulties or delays; financial
instability of international economies and sovereign risk;
dependence on the effectiveness of the Group’s patents and other
protections for innovative products; and the exposure to
litigation, including patent litigation, and/or regulatory actions.
The Group also depends on third parties to develop and market some
of its products which could potentially generate substantial
royalties; these partners could behave in such ways which could
cause damage to the Group’s activities and financial results. The
Group cannot be certain that its partners will fulfill their
obligations. It might be unable to obtain any benefit from those
agreements. A default by any of the Group’s partners could generate
lower revenues than expected. Such situations could have a negative
impact on the Group’s business, financial position or performance.
The Group expressly disclaims any obligation or undertaking to
update or revise any forward looking statements, targets or
estimates contained in this press release to reflect any change in
events, conditions, assumptions or circumstances on which any such
statements are based, unless so required by applicable law. The
Group’s business is subject to the risk factors outlined in its
registration documents filed with the French Autorité des Marchés
Financiers.
Active Biotech's Safe Harbor Statement in Accordance with the
Swedish Securities Market Act:
This press release contains certain forward-looking statements.
Such forward-looking statements involve known and unknown risks,
uncertainties and other important factors that could cause the
actual results, performance or achievements of the company, or
industry results, to differ materially from any future results,
performance or achievement implied by the forward-looking
statements. The company does not undertake any obligation to update
or publicly release any revisions to forward-looking statements to
reflect events, circumstances or changes in expectations after the
date of this press release.
Active Biotech is obligated to publish the information contained
in this press release in accordance with the Swedish Securities
Market Act. This information was provided to the media for
publication 7:00 am. CET on 16 April 2015.
Active BiotechTomas Leanderson, President & CEOTel:
+46 46 19 20 95E-mail:
tomas.leanderson@activebiotech.comorHans
Kolam, CFOTel: +46 46 19 20 44E-mail:
hans.kolam@activebiotech.comorIpsenMediaDidier
VéronSenior Vice-Président, Public Affairsand CommunicationTel.:
+33 (0)1 58 33 51 16Fax: +33 (0)1 58 33 50 58E-mail:
didier.veron@ipsen.comorBrigitte Le GuennecCorporate External
Communication ManagerTel.: +33 (0)1 58 33 51 17Fax: +33 (0)1 58 33
50 58E-mail : brigitte.le.guennec@ipsen.comorFinancial
CommunityStéphane Durant des AulnoisVice-Président, Investor
RelationsTel.: +33 (0)1 58 33 60 09Fax: +33 (0)1 58 33 50 63E-mail:
stephane.durant.des.aulnois@ipsen.comorThomas Peny-Coblentz,
CFAInvestor Relations Deputy DirectorTel.: +33 (0)1 58 33 56 36Fax:
+33 (0)1 58 33 50 63E-mail: thomas.peny-coblentz@ipsen.com
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