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Active Biotech's and Ipsen's Tasquinimod shows encouraging overall survival improvement in castrate resistant prostate cancer

    


                  Phase II Overall Survival data presented at
                          the 2012 ASCO Annual Meeting

Lund  (Sweden)  and  Paris  (France),  June  4, 2012. Active Biotech (NASDAQ OMX
NORDIC:  ACTI) and  Ipsen (Euronext:  IPN; ADR:  IPSEY) today  presented overall
survival  (OS) data  from the  tasquinimod Phase  II study in chemotherapy-na¯ve
metastatic   castrate   resistant  prostate  cancer  (CRPC)  at  the  scientific
conference "2012 ASCO Annual Meeting" held in Chicago (USA).

Today at 08:00 am CDT (3:00 pm CET) Dr. Andrew J. Armstrong from the Duke Cancer
Institute   (Durham,  NC)  presented  "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*" in a poster discussion
session.

The  intention-to-treat analysis  showed median  overall survival  times (OS) of
33.4 vs.  30.4 months  (p=  0.49, HR  0.87, 95% CI  0.59-1.29, ITT)  in favor of
tasquinimod,  longer than previously reported in this metastatic prostate cancer
population.  A stronger trend for survival  benefit is observed in patients with
bone  metastases; median  OS was  34.2 vs. 27.1 months  (p=0.19, HR 0.73, 95% CI
0.46-1.17). This  phase II  clinical trial  was designed  to test the safety and
efficacy of tasquinimod. Noteworthy, 41 (61%) patients crossed-over from placebo
to  tasquinimod (mean  time to  cross-over approx.  5 months). Also,  there were
imbalances in baseline prognostic factor in favor of the placebo arm. These were
addressed  with a  multivariate analysis  of known  CRPC prognostic  factors. It
demonstrated  a statistically  significant OS  advantage for tasquinimod treated
patients  with  a  hazard  ratio  (HR)  of  0.64 (95%  CI 0.42-0.97, p=0.034), a
decrease  of  approximately  40% in  the  instantaneous  risk  of event (death),
accompanied   by  improvement  in  progression-free  survival  (HR  0.52, 95% CI
0.35-0.78, p=0.001).

"Men  with  metastatic  CRPC  in  this  trial  were  unexpectedly  found to have
prolonged  survival  times  beyond  that  previously  reported  in  this patient
population, despite a high fraction of patients with liver and lung metastases."
says  principal author Andrew Armstrong, MD ScM, Assistant Professor of Medicine
and Surgery at Duke University and the Duke Prostate Center. "We also found that
despite  initial  imbalances  in  baseline  characteristics, the improvements in
progression-free  survival with  tasquinimod may  translate into improvements in
overall  survival, and, if confirmed in the ongoing phase 3 trial, suggests that
tasquinimod  may have  an important  role in  the future  treatment of  men with
CRPC."

Tomas Leanderson, President and CEO of Active Biotech, said: "These data further
increase our strong confidence in tasquinimod as a valuable asset to address the
huge  medical  need  for  hundreds  of  thousands  of men with limited treatment
options today".

Claude Bertrand, Executive Vice-President R&D, Chief Scientific Officer of Ipsen
said: "We are thrilled with Tasquinimod's phase II results as they underline the
activity  of the compound. With its  differentiated mechanism of action, we look
forward  to completing the  ongoing phase III  and replicating these interesting
results  to propose an  alternative treatment that  does not target the androgen
receptor pathway to progressing patients."

For  more detailed  information, please  see www.asco.org.   The presentation is
available on Active Biotech's web site www.activebiotech.com.



*  A.J. Armstrong,  M. H¤ggman,  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, –. Nordle,  G. Forsberg, M. A. Carducci, R.
Pili.



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.

About Phase II

A  global, pivotal,  clinical trial  2:1 randomized, placebo controlled, double-
blind Phase II trial investigating up to 1 mg/day of TASQ versus placebo in 206
asymptomatic   patients  with  metastatic  castrate  resistant   prostate cancer
(CRPC).  The primary endpoint, patients with  disease progression at six months,
was  reached. The results  showed that 6 month  progression-free proportions for
TASQ  and placebo  groups were  69% and 37%, respectively  (p<0.0001).The median
progression  free survival was  7.6 months for the  TASQ group, compared to 3.3
months  for the placebo group  (p=0.0042). TASQ treatment also  had an effect on
biomarkers  relevant  for  prostate  cancer  progression  and was generally well
tolerated.  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.

About Phase III

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 approximately 600
patients recruited so far. Top line results expected by the end of 2013.

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 www.activebiotech.com for more
information.

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.

About Ipsen
Ipsen  is  a  global  specialty-driven  pharmaceutical  company with total sales
exceeding  ¢‚¬1.1  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 ¢‚¬250 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 R¨glement 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.



For further information:

Active Biotech

Tomas Leanderson, President & CEO
Tel: +46 46 19 20 95
tomas.leanderson@activebiotech.com

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 Véron

 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: didier.veron@ipsen.com


 Financial Community
 Pierre Kemula                    Stéphane Durant des Aulnois

 Vice     President,     Investor Investor Relations Manager
 Relations                        Tel.: +33 (0)1 58 33 60 09
 Tel.: +33 (0)1 58 33 60 08       Fax: +33 (0)1 58 33 50 63
 Fax: +33 (0)1 58 33 50 63        E-mail: stephane.durant.des.aulnois@ipsen.com
 E-mail: pierre.kemula@ipsen.com


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 3:00 pm. CET on June 4, 2012.



Active Biotech¢€™s and Ipsen¢€™s Tasquinimod shows encouraging OS: 
http://hugin.info/1002/R/1617049/515852.pdf



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     originality of the information contained therein. 
    
Source: Active Biotech via Thomson Reuters ONE
[HUG#1617049] 
  

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