Active Biotech receives tasquinimod milestone payment from Ipsen for 10TASQ10 study
(Thomson Reuters ONE) -
Milestone payment of 12 million euros
under the terms of the agreement
Lund (Sweden) and Paris (France), 9 October 2013. 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)
analysis.
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
www.activebiotech.com 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 www.ipsen.com.
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
Financiers.
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: tomas.leanderson(at)activebiotech.com Hans Kolam, CFO
Active Biotech AB (Corp. Reg. No. Tel: +46 46 19 20 44
556223-9227) E-mail: hans.kolam(at)activebiotech.com
Box 724, SE-220 07 Lund
Tel: +46 46 19 20 00
Fax: +46 46 19 11 00
Ipsen
Media
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 : brigitte.le.guennec(at)ipsen.com
E-mail: didier.veron(at)ipsen.com
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: stephane.durant.des.aulnois(at)ipsen.com
Fax: +33 (0)1 58 33 50 63
E-mail: pierre.kemula(at)ipsen.com
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-
coblentz(at)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 07:30 am CET on October 9, 2013.
Active Biotech receives tasquinimod milestone payment from Ipsen:
http://hugin.info/1002/R/1734299/580839.pdf
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Source: Active Biotech via Thomson Reuters ONE
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