LUND, SWEDEN and PARIS--(Marketwire - May 18, 2012) - Active Biotech (NASDAQ OMX
NORDIC: ACTI) and Ipsen (Euronext: IPN; ADR: IPSEY) will present
tasquinimod
(TASQ), their prostate cancer drug candidate, at the scientific conference
"2012
ASCO Annual Meeting" to be held in Chicago (USA) on 1-5 June 2012.
The
presentation will provide overall survival (OS) data from the tasquinimod
Phase
II study in chemotherapy-naïve metastatic castrate resistant prostate
cancer
(CRPC).
The poster "Tasquinimod and survival in men with metastatic castration-
resistant
prostate cancer: Results of long-term follow-up of a randomized phase
II
placebo-controlled trial" A.J. Armstrong, M. Häggman, W.M.
Stadler, J.R.
Gingrich, V.J. Assikis, J. Polikoff, S.R. Denmeade, D. J. George, C.
Andreou,
W.R. Clark, P. Sieber, R. Agajanian, L. Belkoff, J-E. Damber, Ö.
Nordle, G.
Forsberg, M. A. Carducci, R. Pili. will be presented on June 4 at 08:00 am
CDT
(3:00 pm CET).
The abstract released today, based on 97 events, shows that overall
survival
after tasquinimod treatment is longer than previously reported in this
patient
population. Median time to death was 34.2 vs. 30.2 months (tasquinimod
vs
placebo). A preliminary subgroup analysis using the PCWG2 (Prostate
Cancer
Clinical Trials Working Group 2) defined criteria showed that median time
to
death in the bone-metastatic subgroup was 34.2 vs. 25.6 months (tasquinimod
vs
placebo). The impact of the cross-over design and the imbalance among groups
in
favor of placebo will be discussed in the presentation.
For more detailed information, please see www.asco.org.
A global, pivotal, randomized, double-blind, placebo-controlled Phase III
study
of tasquinimod in patients with metastatic CRPC is ongoing. The aim of the
study
is to confirm tasquinimod's efficacy on the disease, with
radiological
Progression Free Survival (PFS) as the primary endpoint and overall survival
as
secondary endpoint. The study will include about 1,200 patients in more
than
250 clinics. Recruitment is proceeding according to plan with top line
results
expected by the end of 2013.
About tasquinimod
Tasquinimod has a pleiotropic mode of action which includes
immunomodulatory,
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 been met. Phase
II
results were published in Journal of Clinical Oncology in September 2011. It
was
concluded that tasquinimod significantly slowed disease progression and
improved
Progression Free Survival (PFS) in chemonaïve patients with metastatic
castrate-resistant prostate cancer (CRPC), alongside an acceptable side
effect profile.
Six month progression free proportion of patients for tasquinimod and
placebo
treatment groups were 69% and 37%, respectively (p < 0.0001), with a median
PFS of
7.6 vs. 3.3 months (p=0.0042). Analysis of up to three years safety data
from
the Phase II study, presented at the EAU February 2012, show that treatment
side
effects were mild to moderate (~ 5% of AEs grade 3-4), manageable and
less
frequent after two months of therapy. The adverse events observed
included
gastrointestinal disorders, primarily observed initially during
treatment,
fatigue and musculoskeletal pain.
Active Biotech AB (NASDAQ OMX NORDIC: ACTI) is a biotechnology company
with
focus on autoimmune/inflammatory diseases and cancer. Projects in or
entering
pivotal phase are laquinimod, an orally administered small molecule with
unique
immunomodulatory properties for the treatment of multiple sclerosis,
tasquinimod
for prostate cancer as well as ANYARA for use in cancer targeted
therapy,
primarily of renal cell cancer. In addition, laquinimod is in Phase
II
development for Crohn's and Lupus. Further projects in clinical
development
comprise the two orally administered compounds, 57-57 for Systemic Sclerosis
and
RhuDex(®) for rheumatoid arthritis. Please visit
http://www.activebiotech.com
for more information.
About Ipsen
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 /
Dysport®,
endocrinology / Somatuline®, uro-oncology / Decapeptyl® and
hemophilia.
Moreover, the Group has an active policy of partnerships. R&D is focused
on
innovative and differentiated technological patient-driven platforms,
peptides
and toxins. In 2011, R&D expenditure totaled more than EUR250 million, above
21%
of Group sales. The Group has total worldwide staff of close to 4,500
employees.
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.
Forward Looking Statement
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. 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 Generics that might translate into loose of market shares. Furthermore,
the Research and Development process involves several stages each
of which involve 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 favorable 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. 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 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 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 08:30 a.m. CET on May 18, 2012.
Active Biotech and Ipsen to present Tasquinimod Phase II OS data:
http://hugin.info/1002/R/1612953/513587.pdf
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Source: Active Biotech via Thomson Reuters ONE
[HUG#1612953]
