Roche Gets License From Genzyme For EGFR Lung Cancer Assays

Roche Holding AG (ROG.VX) said Tuesday it has obtained a sublicense from Genzyme Corp. (GENZ) to develop a companian diagnostic test involving cancer drug Tarceva.

MAIN FACTS:

- Molecular assay aims to enhance personalized treatment with Tarceva by detecting Epidermal Growth-Factor Receptor activating mutations

- At the same time, Roche and OSI Pharmaceuticals, Inc. have agreed to collaborate

on the development of a PCR-based companion diagnostic test to identify people with non-small cell lung cancer that harbors EGFR activating mutations.

- "The companion diagnostic test will use Roche's proprietary molecular diagnostics technology," said Daniel O'Day, Head of Roche's Diagnostic Division. "The aim is to provide a simple tool that will quickly identify EGFR activating mutations and so enhance physicians' ability to customize the use of Tarceva for people with advanced NSCLC."

- Tarceva has clinically demonstrated a survival benefit in a broad range of patients with advanced NSCLC. However, tumours with EGFR activating mutations have been shown to be particularly sensitive to Tarceva. The identification of patients' EGFR mutation status would allow physicians to personalize treatment.

- Roche has applied to the European Medicines Agency to extend the current label for Tarceva to include the first-line treatment of patients with advanced NSCLC harboring EGFR activating mutations. Tarceva is the only EGFR inhibitor approved by both the U.S. Food and Drug Administration and European Medicines Agency for use in maintenance and second-line treatment settings for the treatment of patients with advanced or metastatic NSCLC with and without EGFR activating mutations.

-Zurich Bureau, Dow Jones Newswires; +41 43 443 8040; zurichdjnews@dowjones.com

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