bioMérieux and Ipsen Sign Theragnostics Agreement to Develop Companion Test for New Breast Cancer Treatment

17 September, 2007

bioMérieux and Ipsen announce today that they have signed an agreement by which bioMérieux will develop a companion test for a new breast cancer drug undergoing clinical evaluation by Ipsen. The development will be co-funded by bioMérieux 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.

bioMérieux 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 bioMérieux’s NucliSENS EasyQ® molecular diagnostics platform, using the company’s proprietary NASBA® amplification technology.

“bioMérieux 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 Stéphane Bancel, Chief Executive Officer of bioMérieux. “By teaming our expertise with that of biopharmaceutical companies, bioMérieux’s goal is to contribute towards making the best medicine available to the right patients, while optimizing health costs,” he added.

Jean-Luc Bélingard, Chairman and CEO of the Ipsen Group stated: “This innovative collaboration with bioMérieux 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”.

bioMérieux 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 .

About Theragnostics
Theragnostics is the association of a diagnostic test with a therapy. A strategic focus at bioMérieux, 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.

bioMérieux 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 bioMérieux
Advancing Diagnostics to Improve Public Health
A world leader in the field of in vitro diagnostics for over 40 years, bioMérieux is present in more than 150 countries through 35 subsidiaries and a large network of distributors. In 2006, revenues reached €1.037 billion with 83% of sales outside of France.

bioMérieux 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. bioMérieux is listed on Eurolist by Euronext. For more information, visit http://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 €178.3 million, i.e. 20.7% of consolidated sales, which amounted to €861.7 million while total revenues amounted to €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 EuronextTM (stock code: IPN, ISIN code: FR0010259150). Ipsen’ s shares are eligible to the “Service de Règlement Différé” (“SRD”) and the Group is part of the SBF 250 index. For more information on Ipsen, visit our website at http://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 Autorité des marchés Financiers.

For further information:
Ipsen
Didier Véron, Director, Public Affairs and Corporate Communications
Tel.: +33 (0)1 44 30 42 38 - Fax: +33 (0)1 44 30 42 04
E-mail: didier.veron@ipsen.com

David Schilansky, Investor Relations Officer
Tel.: +33 (0)1 44 30 43 31 - Fax: +33 (0)1 44 30 43 21
E-mail: david.schilansky@ipsen.com

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