bioMerieux and Ipsen Sign Theragnostics Agreement to Develop Companion Test for New Breast Cancer Treatment
Regulatory News:
bioMerieux and Ipsen (Paris:IPN) announce today that they have
signed an agreement by which bioMerieux will develop a companion test
for a new breast cancer drug undergoing clinical evaluation by Ipsen.
The development will be co-funded by bioMerieux and Ipsen.
Ipsen is developing a novel breast cancer therapy, BN 83495,
targeting the steroid sulfatase enzyme (STS). The new drug, designed
to block this marker found in hormone-dependent breast cancer in
postmenopausal women, is currently in phase I clinical development.
bioMerieux will devise a companion assay to determine the patients
best suited to benefit from the new STS inhibitor treatment. The assay
is intended for both the clinical development of the Ipsen drug as
well as a diagnostic test, potentially for future commercialization.
The test will be developed on bioMerieux's NucliSENS EasyQ(R)
molecular diagnostics platform, using the company's proprietary
NASBA(R) amplification technology.
"bioMerieux is very pleased to sign an important theragnostics
partnership with Ipsen and bring a high medical value test to help
advance cancer treatment options and improve patient prognosis,"
declared Stephane Bancel, Chief Executive Officer of bioMerieux. "By
teaming our expertise with that of biopharmaceutical companies,
bioMerieux's goal is to contribute towards making the best medicine
available to the right patients, while optimizing health costs," he
added.
Jean-Luc Belingard, Chairman and CEO of the Ipsen Group stated:
"This innovative collaboration with bioMerieux is designed to help
Ipsen accelerate the time-to-market of its potent steroid sulphatase
inhibitor compound BN 83495, bringing, as soon as possible, its
therapeutic benefits to those breast cancer patients showing
potentially responsive clinical profiles".
bioMerieux has a dedicated theragnostics division based in
Cambridge, Massachusetts, in the U.S. The company's scientists partner
with pharmaceutical companies to develop innovative tests to be
associated with specific therapies, focusing in particular on cancer,
cardiovascular and infectious diseases.
Breast cancer is the most prevalent form of cancer worldwide with
1.1 million new cases diagnosed each year and responsible for some
502,000 deaths annually(1).
About Theragnostics
Theragnostics is the association of a diagnostic test with a
therapy. A strategic focus at bioMerieux, theragnostics is part of an
emerging trend in healthcare management.
There are three key applications:
-- identifying patients who respond to treatment (efficacy
tests);
-- identifying patients for whom treatment would cause harmful
side-effects;
-- monitoring the response to a treatment and determining the
most effective, non-toxic drug dosage.
bioMerieux has a dedicated theragnostics division based in the
U.S. in Cambridge, Massachusetts, and backed by an extensive global
network. The company is well-positioned for development in this field
with 45,000 instruments installed worldwide and diagnostic platforms
ranging from immunoassays to molecular biology and automated
microbiology culturing systems.
About Steroid Sulphatase and Ipsen's BN 83495
The development of tumour marker tests is aimed at determining the
molecular signature of tumours thus guiding a rational choice of
treatment for defined patient groups. The pivotal role of the
cytoplasmic enzyme STS (steroid sulphatase) in supporting steroids
synthesis as well as breast tumour growth is now under investigation.
Increased STS expression in breast tumours is thus hypothesised to
have prognostic significance; Ipsen is conducting clinical studies to
investigate the therapeutic benefit of BN 83495, a potent STS
inhibitor, in breast cancer patients. A phase I clinical trial with BN
83495 in patients with breast cancer has been completed and the
results demonstrated the inhibition of the sulphatase enzyme at the
dosages tested in tumour biopsies.
About bioMerieux
Advancing Diagnostics to Improve Public Health
A world leader in the field of in vitro diagnostics for over 40
years, bioMerieux is present in more than 150 countries through 35
subsidiaries and a large network of distributors. In 2006, revenues
reached EUR 1.037 billion with 83% of sales outside of France.
bioMerieux provides diagnostic solutions (reagents, instruments,
software), which determine the source of disease and contamination to
improve patient health and ensure consumer safety. Our products are
used for diagnosing infectious diseases and providing high medical
value results for cardiovascular emergencies and cancer screening and
monitoring. They are also used for detecting microorganisms in
agri-food, pharmaceutical and cosmetic products. bioMerieux is listed
on Eurolist by Euronext. For more information, visit
www.bioMerieux.com.
About Ipsen
Ipsen is an innovation driven international specialty
pharmaceutical group with over 20 products on the market and a total
worldwide staff of nearly 4,000. The company's development strategy is
based on a combination of products in targeted therapeutic areas
(oncology, endocrinology and neuromuscular disorders) which are growth
drivers, and primary care products which contribute significantly to
its research financing. This strategy is also supported by an active
policy of partnerships. The location of its four Research and
Development centres (Paris, Boston, Barcelona, London) gives the Group
a competitive edge in gaining access to leading university research
teams and highly qualified personnel. In 2006, R&D expenditure was EUR
178.3 million, i.e. 20.7% of consolidated sales, which amounted to EUR
861.7 million while total revenues amounted to EUR 945.3 million (in
IFRS). 700 people in R&D are dedicated to the discovery and
development of innovative drugs for patient care. Ipsen's shares are
traded on Segment A of Eurolist by Euronext(TM) (stock code: IPN, ISIN
code: FR0010259150). Ipsen' s shares are eligible to the "Service de
Reglement Differe" ("SRD") and the Group is part of the SBF 250 index.
For more information on Ipsen, visit our website at www.ipsen.com.
Forward-looking statements
The forward-looking statements and targets contained herein are
based on Ipsen's management's 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 Research and Development
process involves several stages at each of which there is a
substantial risk that the Group will fail to achieve its objectives
and be forced to abandon its efforts in respect of 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. Ipsen 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. Ipsen's business is subject to the risk
factors outlined in its information documents filed with the French
Autorite des marches Financiers.
(1) WHO 2007