bioMérieux and GlaxoSmithKline Enter into Alliance to Develop Molecular Theranostic Test for Cancer Treatment Selection

Regulatory News:

bioMérieux (Paris: BIM) and GlaxoSmithKline (GSK) have signed an agreement to develop a novel molecular test for cancer. In this new collaboration, the two companies will develop a theranostic test to aid oncologists in choosing the appropriate treatment for metastatic melanoma (skin cancer).

The new assay is intended to detect mutations (beyond the conventional V600E form) in the B-Raf gene. The assay will be used to test phase II and III metastatic melanoma patients to select those eligible for treatment with GSK's B-Raf or MEK inhibitor compounds. Mutations in the B-Raf gene are also found in thyroid, ovarian and colon cancers.

"We are very pleased to expand our relationship with the oncology unit of GSK, a leading innovator in oncology therapeutics, to develop a companion test that could drive personalized treatment,” said Richard Ding, bioMérieux’s Corporate Vice President for Theranostics. "What makes this test unique is that it targets a critical part of a tumor growth factor signalling pathway and can be applied to a number of drug candidates in development. This collaboration also reinforces our theranostics pipeline,” he added.

bioMérieux and GSK will bring complementary expertise to the project. GSK will bring its extensive experience in oncology and clinical evaluation. Global R&D teams from bioMérieux will develop and seek regulatory approval of the test. An in vitro diagnostic kit will be commercialized worldwide, leveraging resources from bioMérieux and the collaboration. GSK and bioMérieux have a separate, ongoing collaboration to develop a test for breast cancer patient stratification since November 2009.

Each year in the United States there are 68,000 cases of melanoma of which about 15% are metastatic¹. Of the 59,000 cases of melanoma in Europe each year, the percentage of patients with metastatic melanoma varies widely across the region, ranging from 10-70%². Colorectal cancer is diagnosed in 150,000 patients in the United States¹ each year and in about 260,000 in Europe². Metastatic colon cancer affects about 30,000 patients¹ a year in the U.S. and over 50,000 in Europe².

1) National Cancer Institute- http://seer.cancer.gov/faststats/selections.php?#Output
2) Cancer Incidence and Mortality in Europe, 2004, P. Boyle and J. Ferlay, Annals of Oncology Volume 16, Issue 3

About Theranostics

A theranostic is a diagnostic test that helps clinicians make the right therapeutic decision for the right patients, enabling a more personalized approach to medicine.

bioMérieux is partnering with pharmaceutical companies, biotech companies and payors to develop theranostic tests which:

• empower physicians with high-medical value testing for science-driven treatment decisions;
• improve patient outcomes and patient safety by identifying patients who won’t respond to a drug or who will experience an adverse event;
• increase the efficiency of drug development, helping pharmaceutical companies by pinpointing those patients most likely to benefit from the new drug;
• positively impact health economics, helping physicians select optimal and cost effective therapy.

bioMérieux’s theranostics strategy focuses on infectious diseases and cancer. The Company has made a sustained investment in high medical value biomarkers through in-house R&D programs, research collaborations and the aggressive pursuit of licensing opportunities. With distribution in over 150 countries, bioMérieux has the experience of bringing hundreds of diagnostics to global markets over the past 45 years.

bioMérieux has a dedicated theranostics division based in Cambridge, Massachusetts (U.S.) and backed by an extensive global network. It also has a subsidiary, bioTheranostics, specialized in molecular diagnostic oncology tests, with two assays on the market: CancerTYPE ID^®, for identifying metastatic cancers of uncertain or unknown origin, and Breast Cancer Index^SM, for predicting breast cancer recurrence risk. Other information can be found at: www.biotheranostics.com.

Theranostics development leverages bioMerieux's unique hybrid business strategy: bioTheranostics’ high complexity CLIA* lab, allied with bioMerieux's global IVD business, supports aggressive development timelines while ensuring test availability wherever the drug is sold.

* Clinical Laboratory Improvement Amendments

About bioMérieux

Advancing diagnostics to improve public health

A world leader in the field of in vitro diagnostics for over 45 years, bioMérieux is present in more than 150 countries through 39 subsidiaries and a large network of distributors. In 2009, revenues reached €1.223 billion with 85% 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 cancer screening and monitoring and cardiovascular emergencies. They are also used for detecting microorganisms in agri-food, pharmaceutical and cosmetic products.

bioMérieux is listed on the NYSE Euronext Paris market (Symbol: BIM – ISIN: FR0010096479).
Other information can be found at www.biomerieux.com.