Active Biotech and Ipsen enter into a broad partnership for the co-development and commercialization of TASQ in uro-oncology
Apr 18, 2011 07:31 (CEST)
* Ipsen's Uro-Oncology pipeline strengthened, with a phase III product for the
treatment of castrate-resistant prostate cancer
* A potential companion drug for Ipsen's Decapeptyl(®)
* A drug with a unique mechanism of action targeting angiogenesis and
immunomodulation
Lund (Sweden) and Paris (France), April 18 2011 - Active Biotech AB (NASDAQ OMX
NORDIC: ACTI) and Ipsen (Euronext: IPN; ADR: IPSEY) announced today that they
have entered into a broad partnership to co-develop and commercialize Active
Biotech's investigational compound Tasquinimod "TASQ". A global Phase III trial
of TASQ in men with metastatic castrate-resistant prostate cancer (CRPC) was
recently initiated by Active Biotech and patient recruitment is ongoing.
Marc de Garidel, Chairman and Chief Executive Officer of Ipsen stated: "This new
partnership will broaden the scope of our uro-oncology franchise. Subject to the
success of the ongoing phase III clinical trial for the treatment of metastatic
castrate-resistant prostate cancer and following market approval, TASQ will
perfectly fit in our current portfolio, alongside the sustained-release
formulations of Decapeptyl. We continue to fulfill Ipsen's commitment to offer
physicians and patients a comprehensive range of complementary medical solutions
for the treatment of prostate cancer. We are excited to work with Active Biotech
as this partnership leverages our longstanding and recognized expertise in this
severely debilitating disease."
"We are excited to initiate the development of TASQ with Ipsen, who has a proven
track record and strong R&D capabilities within prostate cancer. We consider
Ipsen an ideal partner for Active Biotech and with this partnership a powerful
development and commercialization strategy for TASQ has been secured. "said
Tomas Leanderson, President & CEO of Active Biotech.
About the agreement
Under the terms of the agreement, Active Biotech granted Ipsen exclusive rights
to commercialize TASQ worldwide, except for North and South America and Japan
where Active Biotech retains all commercial and marketing rights. Both companies
will co-develop TASQ for the treatment of castrate-resistant prostate cancer,
with the possibility to develop TASQ in other cancer indications.
Active Biotech is responsible for conducting and funding the Phase III pivotal
clinical trial and will receive up to €200 million consisting of an upfront
payment of €25 million and additional payments contingent upon achievement of
clinical, regulatory and commercial milestones. In addition, Ipsen will pay
Active Biotech progressive double-digit royalties on its net sales and will
conduct and fund a European supportive study in prostate cancer patients out of
its R&D budget. Eventual costs to develop TASQ in future other cancer
indications will be shared.
About TASQ
TASQ (tasquinimod, ABR-215050) binds to a molecule called S100A9 which is
expressed in the white blood cells involved in the regulation of immune
responses. S100A9 interacts with two known pro-inflammatory receptors (Toll like
receptor 4 (TLR4) and receptor of advanced glycation end products (RAGE)) and
this interaction is inhibited by TASQ (Björk et al PLoS Biology, April 2009).
The development of TASQ is currently focused on the treatment of prostate
cancer. TASQ is an antiangiogenic compound, meaning that it cuts off the supply
of nutrients to the tumor. Up-regulation of thrombospondin-1 (TSP1) has been
identified as one important component in order to understand and explain the
anti-angiogenic mechanism of TASQ treatment of prostate cancer (Olsson et al,
Mol Cancer May 2010).
The previously concluded clinical trial was a 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 the fraction of patients
with disease progression during the six-month period was 31% for patients
treated with TASQ compared with 66% for placebo-treated patients. 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.
The ongoing clinical trial (funded by Active Biotech) is a global, randomized,
double-blind, placebo-controlled Phase III trial in patients with metastatic
CRPC. The aim of the study is to confirm TASQ's effect on the disease, with
radiological progression-free survival (PFS) as the primary endpoint and overall
survival as the secondary endpoint. The study will include about 1,200 patients
in more than 250 clinics (www.clinicaltrials.gov)
About Prostate Cancer
Prostate cancer is the most common cancer form among men. Its occurrence is
strongly age-related and it is very rare before the age of 50. Prostate cancer
has highly varying degrees of severity. Despite a relatively good prognosis,
prostate cancer is the second most common cause of cancer death among men.
Every year about 220,000 new cases are diagnosed in the US alone (American
Cancer Society 2010) and 226 000 new cases for European G5 (Datamonitor 2010).
The global market for drugs used in the treatment of prostate cancer was
estimated at USD 5.4 billion for 2009 (GlobalData 2010).
About Ipsen's pipeline in uro-oncology
Ipsen's pipeline in uro-oncology contains Decapeptyl(®). The active substance in
Decapeptyl® is triptorelin, a decapeptide analogue of GnRH (Gonadotrophin
Releasing Hormone), a hormone secreted by the hypothalamus, which initially
stimulates the release of pituitary gonadotrophins (hormones produced by the
pituitary gland), which in turn control hormonal secretions by the testes and
ovaries. Decapeptyl(®) contains a formulation that was initially developed and
continues to be used mainly in the treatment of advanced metastatic prostate
cancer. Additional indications have been subsequently developed.
Decapeptyl(®) is available in monthly or quarterly sustained-release
formulations, as well as a daily formulation. In addition, Ipsen and its partner
Debiopharm submitted a marketing authorization application for 6-month
triptorelin 22.5 mg in Europe in September 2008. Ipsen and Debiopharm announced
the completion of the European decentralized registration procedure for the 6-
month sustained-release formulation of Decapeptyl(®). This formulation is
therefore available in some countries of the European market since 2010.
Decapeptyl(®) was initially launched in France in 1986. At 31 December 2010,
Decapeptyl(®) had marketing authorizations in over 60 countries, including 21 in
Europe.
About Ipsen
Ipsen is a global biopharmaceutical group, with sales exceeding €1.1 billion in
2010. The Group has total worldwide staff of more than 4,400 employees, of which
more than 900 contribute to the discovery and development of innovative drugs
for patient care. Ipsen's development strategy is based on fast growing
specialty care drugs in oncology, endocrinology, neurology and hematology and on
primary care drugs. This strategy is supported by an active policy of
partnerships. Ipsen's research & development (R&D) centers and its peptide &
protein engineering platform give the Group a strong competitive edge. In 2010,
R&D expenditure totaled more than €220 million, above 20% of Group sales.
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, visitwww.ipsen.com
About Active Biotech
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, TASQ for
prostate cancer and 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 SLE and Systemic Sclerosis as well as
RhuDexTM for RA. Please visitwww.activebiotech.comfor more information.
For further information:
Active Biotech
Tomas Leanderson Göran Forsberg
President & CEO VP Investor Relations & Business Development
Tel: +46 (0)46 19 20 95 Tel: +46 (0)46 19 11 54
tomas.leanderson@activebiotech.comgoran.forsberg@activebiotech.com
Ipsen
Media
Didier Véron
Director, 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
Investor Relations Officer Investor Relations Manager
Tel.: +33 (0)1 58 33 60 08 Tel.: +33 (0)1 58 33 60 09
Fax: +33 (0)1 58 33 50 63 Fax: +33 (0)1 58 33 50 63
E-mail:pierre.kemula@ipsen.comE-mail:stephane.durant.des.aulnois@ipsen.com
Ipsen's 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. 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. Notably, future currency fluctuations may
negatively impact the profitability of the Group and its ability to reach its
objectives. Actual results may depart significantly from these targets given the
occurrence of certain risks and uncertainties. The Group does not commit nor
gives any guarantee that it will meet the targets mentioned above. 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'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.
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 on April 18, 2011, at 07.30 CET.
Active Biotech and Ipsen enter into a broad partnership:
http://hugin.info/1002/R/1507162/442019pdf
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Source: Active Biotech via Thomson Reuters ONE
[HUG#1507162]