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Active Biotech and Ipsen announce completion of recruitment of tasquinimod clinical phase III study in prostate cancer Full recruitment triggers a EUR10 million milestone payment to Active Biotech


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© Marketwire 2012
2012-12-10 08:02:18 -

LUND, SWEDEN and PARIS -- (Marketwire) -- 12/10/12 -- Active Biotech (NASDAQ OMX
NORDIC: ACTI) and Ipsen (Euronext: IPN; ADR: IPSEY) today announced that
the
Phase III clinical trial for tasquinimod, a novel compound for the
treatment of
prostate cancer, is successfully enrolled with over 1,200 randomized
patients as
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)
as
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
new
treatment option to patients with mCRPC."



"I am very satisfied by the speed of recruitment of prostate cancer
patients
into this study. We now look forward to the continued development of this
global
trial and the subsequent development of this unique drug also in other
indications", said Tomas Leanderson, President & CEO Active Biotech.





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. The results showed that 6 month progression-free
proportions for
TASQ and placebo groups were 69% and 37%, respectively (p<.0001). The
median
progression free survival was 7.6 months for the tasquinimod group,
compared to
3.3 months for the placebo group (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.
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
ESMO
(European Society for Medical Oncology). The results support an effect of
tasquinimod on both immunomodulation and angiogenesis positioning
tasquinimod as
a potentially unique therapeutic approach with a mechanism of action that
does
not target the androgen receptor pathway.
Also, in October 2012, the independent Data and Safety Monitoring Board
(DSMB
monitoring the ongoing Phase III trial, recommended that the study
continues in
accordance with the protocol since no safety-related issues were noted.
A new Phase II, proof-of-concept clinical trial was initiated and which
aims at
establishing the clinical efficacy of tasquinimod used as maintenance
therapy in
patients with mCRPC who have not progressed after a first-line docetaxel
based
chemotherapy.
Ipsen has also initiated an innovative Phase II proof-of-concept clinical
trial
with tasquinimod, to evaluate the safety and efficacy of tasquinimod in
advanced
or metastatic hepato-cellular, ovarian, renal cell and gastric carcinomas
in
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
phase
are laquinimod, an orally administered small molecule with unique
immunomodulatory properties for the treatment of multiple sclerosis, TASQ
for
prostate cancer and ANYARA primarily for the treatment of renal cell
cancer. In
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 : 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. Ipsen's R&D is
focused
on its innovative and differentiated technological 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 : 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.
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 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 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 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 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 07:30 a.m. CET on December 10,
2012.



Active Biotech and Ipsen announce completion of recruitment:



hugin.info/1002/R/1663501/539478.pdf : hugin.info/1002/R/1663501/539478.pdf



This announcement is distributed by Thomson Reuters on behalf of
Thomson Reuters 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: Active Biotech via Thomson Reuters ONE



[HUG#1663501]




For further information:

Active Biotech
Tomas Leanderson
President & CEO
Tel: +46 46 19 20 95
Email Contact : www2.marketwire.com/mw/emailprcntct?id=A0074A7675B042A3

Active Biotech AB (Corp. Reg. No. 556223-9227)
Box 724, SE-220 07 Lund
Tel: +46 46 19 20 00
Fax: +46 46 19 11 00

Ipsen
Media
Didier Veron
Vice President, Public Affairs and Corporate Communications
Tel.: +33 (0)1 58 33 51 16
Fax: +33 (0)1 58 33 50 58
E-mail: Email Contact : www2.marketwire.com/mw/emailprcntct?id=E2F591C667D0602C

Financial Community
Pierre Kemula
Vice President, Corporate Finance, Treasury and Financial Markets
Tel.: +33 (0)1 58 33 60 08
Fax: +33 (0)1 58 33 50 63
E-mail: Email Contact : www2.marketwire.com/mw/emailprcntct?id=BD12445B0903DB09

Stephane Durant des Aulnois
Investor Relations Manager
Tel.: +33 (0)1 58 33 60 09
Fax: +33 (0)1 58 33 50 63
E-mail: Email Contact : www2.marketwire.com/mw/emailprcntct?id=314FD7A21C2ED9A4



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