LUND, SWEDEN and PARIS--(Marketwire - December 10, 2012) - Active Biotech (NASDAQ OMX
NORDIC: ACTI) and Ipsen (Euronext: IPN; ADR: IPSEY) today announced that
Phase III clinical trial for tasquinimod, a novel compound for the
prostate cancer, is successfully enrolled with over 1,200 randomized
planned in the clinical protocol. This achievement triggers a EUR10 million
milestone payment from Ipsen to Active Biotech.
This study is a global, pivotal, randomized,
double-blind, placebo-controlled Phase III clinical trial of tasquinimod in
patients with metastatic castrate
resistant prostate cancer (mCRPC). The aim of the study is to confirm
tasquinimod's efficacy, with radiological Progression Free Survival (PFS)
primary endpoint and overall survival (OS) as secondary endpoint. The study
recruited patients in more than 250 centers all over the word.
Marc de Garidel, Chairman and Chief Executive Officer of Ipsen, said:
"The on-schedule recruitment of tasquinimod phase III clinical trial
highlights Active Biotech's commitment and the growing interest from the
medical community for an innovative and differentiated mode of action."
Marc de Garidel added: "We now
look forward to confirming the encouraging phase II results and bringing a
treatment option to patients with mCRPC."
"I am very satisfied by the speed of recruitment of prostate cancer
into this study. We now look forward to the continued development of this
trial and the subsequent development of this unique drug also in other
indications", said Tomas Leanderson, President & CEO Active Biotech.
Tasquinimod has a pleiotropic mode of action which includes
anti-angiogenic and anti-metastatic activity. Today the development of
tasquinimod is principally focused on the treatment of prostate cancer.
It was announced in December 2009 that the primary endpoint of the Phase II
clinical study, to show a higher fraction of patients with no disease
progression during the six-month period of treatment using tasquinimod, had
met. Phase II results were published in Journal of Clinical Oncology in
September 2011. The results showed that 6 month progression-free
TASQ and placebo groups were 69% and 37%, respectively (p<.0001). The
progression free survival was 7.6 months for the tasquinimod group,
3.3 months for the placebo group (p=0.0042).
Analysis of up to three years safety data from the Phase II study,
the EAU February 2012, show that treatment side effects were mild to
5% of AEs grade 3-4), manageable and less frequent after two months of
The adverse events observed included gastrointestinal disorders, primarily
observed initially during treatment, fatigue and musculoskeletal pain.
In June, 2012, overall survival (OS) data was presented at ASCO (American
Society of Clinical Oncology).
In October, 2012, biomarker data were presented at the scientific congress
(European Society for Medical Oncology). The results support an effect of
tasquinimod on both immunomodulation and angiogenesis positioning
a potentially unique therapeutic approach with a mechanism of action that
not target the androgen receptor pathway.
Also, in October 2012, the independent Data and Safety Monitoring Board
monitoring the ongoing Phase III trial, recommended that the study
accordance with the protocol since no safety-related issues were noted.
A new Phase II, proof-of-concept clinical trial was initiated and which
establishing the clinical efficacy of tasquinimod used as maintenance
patients with mCRPC who have not progressed after a first-line docetaxel
Ipsen has also initiated an innovative Phase II proof-of-concept clinical
with tasquinimod, to evaluate the safety and efficacy of tasquinimod in
or metastatic hepato-cellular, ovarian, renal cell and gastric carcinomas
patients who have progressed after standard therapies.
About Active Biotech
Active Biotech AB (NASDAQ OMX NORDIC: ACTI) is a biotechnology company with
focus on autoimmune/inflammatory diseases and cancer. Projects in pivotal
are laquinimod, an orally administered small molecule with unique
immunomodulatory properties for the treatment of multiple sclerosis, TASQ
prostate cancer and ANYARA primarily for the treatment of renal cell
addition, laquinimod is in Phase II development for Crohn's and Lupus. The
company also has one additional project in clinical development, the orally
administered compound 57-57 for Systemic Sclerosis. Please visit
www.activebiotech.com for more information.
Ipsen is a global specialty-driven pharmaceutical company with total sales
exceeding EUR1.1 billion in 2011. Ipsen's ambition is to become a leader in
specialty healthcare solutions for targeted debilitating diseases. Its
development strategy is supported by four franchises: neurology /
endocrinology / Somatuline®, uro-oncology / Decapeptyl® and
Moreover, the Group has an active policy of partnerships. Ipsen's R&D is
on its innovative and differentiated technological platforms, peptides and
toxins. In 2011, R&D expenditure totaled more than EUR250 million, above
Group sales. The Group has total worldwide staff of close to 4,500
Ipsen's shares are traded on segment A of Euronext Paris (stock code: IPN,
code: FR0010259150) and eligible to the "Service de Règlement
The Group is part of the SBF 120 index. Ipsen has implemented a Sponsored
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 Statement
The forward-looking statements, objectives and targets contained herein are
based on the Group's management strategy, current views and assumptions.
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
macroeconomic conditions based on the information available today.
Moreover, the targets described in this document were prepared without
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
promising product in early development phase or clinical trial may end up
being launched on the market or reaching its commercial targets, notably
regulatory or competition reasons. The Group must face or might face
from Generics that might translate into a loss of market share.
Furthermore, the Research and Development process involves several stages
of which involves the substantial risk that the Group may fail to achieve
objectives and be forced to abandon its efforts with regards to a product
which it has invested significant sums. Therefore, the Group cannot be
that favorable results obtained during pre-clinical trials will be
subsequently during clinical trials, or that the results of clinical trials
be sufficient to demonstrate the safe and effective nature of the product
concerned. The Group also depends on third parties to develop and market
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
will fulfill their obligations. It might be unable to obtain any benefit
those agreements. A default by any of the Group's partners could generate
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
any forward looking statements, targets or estimates contained in this
release to reflect any change in events, conditions, assumptions or
circumstances on which any such statements are based, unless so required by
The Group's business is subject to the risk factors outlined in its
documents filed with the French Autorité des Marchés Financiers.
Active Biotech is obligated to publish the information contained in this
release in accordance with the Swedish Securities Market Act. This
was provided to the media for publication 07:30 a.m. CET on December 10,
Active Biotech and Ipsen announce completion of recruitment:
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Source: Active Biotech via Thomson Reuters ONE