Active Biotech receives tasquinimod milestone payment from Ipsen for 10TASQ10 study

October 9, 2013 07:36 (CEST)

Milestone payment of 12 million euros under the terms of the agreement

LUND, Sweden and PARIS, Oct. 9, 2013 (GLOBE NEWSWIRE) --

Active  Biotech (NASDAQ OMX NORDIC:  
ACTI) and Ipsen (Euronext: IPN; ADR: IPSEY) today announced that Active
Biotech,  under the terms of  the co-development and commercialization agreement
on the novel candidate drug tasquinimod, has received a milestone payment of 12
million euros from Ipsen.

About the agreement
In  2011, Active Biotech and Ipsen entered into  a broad partnership for the co-
development  and  commercialization  of  tasquinimod.  Under  the  terms  of the
agreement,  Active Biotech has  granted Ipsen exclusive  rights to commercialize
tasquinimod  worldwide,  except  for  North  and  South America and Japan, where
Active  Biotech has retained all commercial and marketing rights. Both companies
co-develop  tasquinimod  for  the  treatment  of  metastatic  castrate-resistant
prostate cancer (mCRPC) and Ipsen is developing tasquinimod also in other cancer
indications.  Active Biotech is responsible for conducting and funding the Phase
III 10TASQ10 pivotal clinical trial and will receive up to EUR 200M (whereof EUR
25M upfront   and  EUR 32M  in  milestones  have  been  received  so  far)  upon
achievement  of  clinical,  regulatory  and  commercial milestones. In addition,
Ipsen will pay Active Biotech tiered double-digit royalties on all sales of TASQ
in Ipsen's territories.

About tasquinimod
Tasquinimod is a novel small molecule that targets the tumor microenvironment by
binding  to S100A9  and modulating  regulatory myeloid  cell functions, exerting
immunomodulatory,  anti-angiogenic  and  anti-metastatic properties. Tasquinimod
may  also suppress the tumor hypoxic response, contributing to its effect on the
tumor  microenvironment.  Today  the  development  of tasquinimod is principally
focused  on  the  treatment  of  prostate  cancer, but clinical studies in other
cancer  indications are performed.  The ongoing 10TASQ10 trial  is a randomized,
double-blind,  placebo-controlled,  global  Phase  III clinical trial evaluating
tasquinimod  in  patients  with  metastatic  castrate-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
1,245 randomized  patients  as  planned  in  the  clinical  protocol.  The study
recruited  patients  in  37 countries  covering  more  than  200 centers. Active
Biotech  and Ipsen plan  to conduct the  primary PFS analysis  for the 10TASQ10
trial  in 2014, at  the same  time as  the first  interim overall  survival (OS)

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, tasquinimod
for prostate cancer and ANYARA primarily for the treatment of renal cell cancer.
In  addition, laquinimod is also in Phase  II development for Crohn's and Lupus.
The  company also has one additional project in clinical development, the orally
administered  compound paquinimod  (57-57) for systemic  sclerosis. Please visit for more information.

About Ipsen
Ipsen  is  a  global  specialty-driven  pharmaceutical  company with total sales
exceeding  €1.2  billion  in  2012. 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
uro-oncology.  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 2012, R&D  expenditure totaled  close to €250 million,
representing  more  than  20% of  Group  sales.  The  Group  has close to 4,900
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

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  fulfil 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

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.

For further information:

Active Biotech

Tomas Leanderson, President & CEO
Tel: +46 46 19 20 95
E-mail:  Hans Kolam, CFO
Active   Biotech   AB   (Corp.   Reg.   No. Tel: +46 46 19 20 44
556223-9227)                                E-mail:
Box 724, SE-220 07 Lund
Tel: +46 46 19 20 00
Fax: +46 46 19 11 00


Didier Véron
Senior    Vice-Président,   Public Brigitte Le Guennec
Affairs                            Media and Public Relations Officer
and Communication                  Tel: +33 (0)1 58 33 51 17
Tel: +33 (0)1 58 33 51 16          Fax: +33 (0)1 58 33 50 58
Fax: +33 (0)1 58 33 50 58          E-mail :

Financial Community
Pierre Kemula                      Stéphane Durant des Aulnois
Vice President, Corporate Finance, Investor Relations Officer
Treasury and                       Tel: +33 (0)1 58 33 60 09
Financial Markets                  Fax: +33 (0)1 58 33 50 63
Tel: +33 (0)1 58 33 60 08          E-mail:
Fax: +33 (0)1 58 33 50 63

Thomas Peny-Coblentz
Investor Relations Manager
Tel: +33 (0)1 58 33 56 36
Fax: +33 (0)1 58 33 50 63
E-mail:               thomas.peny-

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 am CET on October 9, 2013.

Active Biotech receives tasquinimod milestone payment from Ipsen: