Ipsen Announces Discontinuation of the Development of Irosustat in Monotherapy
Opportunities for Irosustat in combination with other
hormonal therapies will be further evaluated
Paris (France), 6 June 2011
– Ipsen (Euronext: IPN -
ADR: IPSEY) today announced its decision to
assess the alternative development of Irosustat (BN 83495) in
combination with other hormonal therapies.
This decision is based on the
futility analysis from the
proof-of-concept trial phase II
clinical study carried out in
Europe in monotherapy in endometrial
cancer, and on the phase I/II clinical study results obtained in
metastatic prostate and breast cancers.
The futility analysis of the
European study in patients suffering
from endometrial cancer demonstrates that the primary
endpoint will not be reached (patients on treatment for more
than 6 months without progression)
and that the superiority will
not be demonstrated with Irosustat versus
megestrol acetate in terms of progression free survival (PFS).
Thus, Ipsen has decided to discontinue
the development of Irosustat in
monotherapy. Of note, the treatment was well
tolerated and has shown an inhibition of the steroid sulfatase
associated with a significant reduction
in the levels of some
circulating steroid hormones and with
insome patients, prolonged clinical
partial responses, demonstrating the
clinical interest of sulfatase inhibition.
On the basis of this clinical
safety profile associated with the
reduction of hormonal parameters and
with this potentially encouraging
clinical efficacy signal in monotherapy,
Ipsen will explore options to develop Irosustat in combination with
other hormonal therapies in hormone-dependent cancers. This
perspective comes in line with the recommendation of clinical
expert committees.
About Irosustat
Irosustat is a first-in-class orally
available irreversible steroid sulfatase
(STS) inhibitor. The steroid sulfatase pathway gives
rise to oestrone and dehydroepiandrosterone (DHEA) that in
turn produce oestradiol and
androstenediol (Adiol) that can both
stimulate the growth of hormone-dependent tumors.
This compound has been tested for postmenopausal metastatic breast
cancer as well as in PI/II clinical development for castrate
resistant prostate cancer.
There are three Ipsen sponsored
ongoing clinical studies for which
Ipsen is discontinuing
patient recruitment.
About this phase II European trial in endometrial cancer
The European clinical trial compares
single-agent Irosustat to megestrol
acetate (MA) in post-menopausal women with
histologically confirmed hormone receptor positive endometrial
cancer, presenting with recurrent or advanced disease not eligible
for treatment with surgery The primary
endpoint for the study was the
proportion of patients who have
neither progressed nor died after 6
months of treatment with Irosustat.
Progression free survival (PFS), clinical benefits and
overall survival were evaluated as secondary endpoints.
About Endometrial Cancer
Endometrial cancer, which develops from the inner lining of the
uterus, is the most common cancer found in the female reproductive
system. According to the American Cancer Society, about 40,100 new
cases of endometrial cancer were diagnosed in the United States and
approximately 7,470 women died from this disease
in 2008. There is a strong medical need for new products to be
available in this indication.
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 moreinformation on Ipsen, visit www.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.
For further information
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
Tel.: +33 (0)1 58 33 60 08
Fax: +33 (0)1 58 33 50 63
E-mail: pierre.kemula@ipsen.com
Investor Relations Manager
Tel.: +33 (0)1 58 33 60 09
Fax: +33 (0)1 58 33 50 63
E-mail: stephane.durant.des.aulnois@ipsen.com
Posted: June 2011
