Genzyme Introduces New Genetic Test To Complement Lung Cancer Portfolio

Main Category: Lung Cancer
Also Included In: Genetics
Article Date: 05 Dec 2006 - 0:00 PDT

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Genzyme Corporation (Nasdaq: GENZ) announced today the commercial availability of a new laboratory test to help identify non-small cell lung cancer (NSCLC) patients who may not respond to targeted therapies. Genzyme's KRAS Mutation Analysis will help identify NSCLC patients who test positive for specific KRAS mutations. Mutations in the KRAS gene have been associated with resistance to certain drugs currently used in treating this deadly form of cancer, including the tyrosine kinase inhibitors (TKIs) Tarceva(R) (erlotinib) and IRESSA(R) (gefitinib).

"Between 15 and 30 percent of tumors from NSCLC patients have mutations in the KRAS gene and clinical studies show that this information plays an important role in making treatment decisions," said Mara Aspinall, president of Genzyme Genetics, the business unit of Genzyme Corp. focused on the research, development and provision of complex testing services. "Genzyme Genetics is currently the only national commercial laboratory in the U.S. to offer this new test. We believe this test will provide physicians and their patients with critical information to help determine how best to move forward with their treatment."

Aspinall went on to state that Genzyme believes that effective cancer treatment is improved by personalized medicine -- directing specific therapies at the patients most likely to benefit from them -- and that this important convergence of diagnostics and therapeutics is a priority for the company.

Recent clinical studies have shown that mutations in the KRAS gene are found more frequently in patients who show limited clinical response or who have a shorter time to disease progression with TKI treatment. A retrospective study published in a 2005 Journal of Clinical Oncology demonstrated a decrease in time to disease progression and in overall survival in KRAS mutation- positive patients when treated with Tarceva plus chemotherapy, versus chemotherapy treatment alone. Conversely, with TKI treatment, NSCLC patients with mutations in the epidermal growth factor receptor (EGFR) gene have shown improved response rates, and longer time to disease progression.

A Growing Lung Cancer Testing Portfolio

In addition to the new KRAS Mutation Analysis, Genzyme Genetics offers two other tests in its portfolio that help identify NSCLC patients likely to respond to TKI therapies:

- EGFR by FISH (fluorescence in-situ hybridization) was launched earlier this year and detects amplification of the EGFR gene.

- EGFR Mutation Analysis Assay detects the presence of EGFR mutations in patients with NSCLC.

Genzyme holds exclusive, worldwide diagnostic rights to the discovery of EGFR gene mutations in NSCLC tumors. Researchers are now investigating the presence of the same EGFR mutations in other tumor types to determine if mutation testing can help bring effective, targeted therapies to patients suffering from other cancers.

TKI therapies, such as Tarceva (erlotinib) and IRESSA (gefitinib), are currently used in NSCLC patients who are refractory, or have failed, one or more chemotherapy regimens. Refractory patients make up approximately 30 percent of the total NSCLC patient population. Clinical studies of Tarceva and IRESSA in the first-line setting are ongoing.

About Lung Cancer

According to the American Cancer Society, lung cancer is the leading cause of cancer death for both men and women. An estimated 162,460 people in the United States will die of lung cancer this year, which is more than the number of those who die each year from colon, breast, and prostate cancers combined. In 2006, there will be an estimated 174,470 new cases of lung cancer in the United States.

About Genzyme Genetics

Genzyme Genetics is a leading, nationwide provider of high-quality, complex testing services for physicians and their patients. With CLIA- certified laboratories and counseling facilities located across the U.S., Genzyme Genetics offers extensive diagnostic testing services, supported by innovative technology and a commitment to quality service and trusted information. Genzyme Genetics is a business unit of Genzyme Corporation.

About Genzyme

One of the world's leading biotechnology companies, Genzyme is dedicated to making a major positive impact on the lives of people with serious diseases. This year marks the 25th anniversary of Genzyme's founding. Since 1981, the company has grown from a small start-up to a diversified enterprise with more than 8,500 employees in locations spanning the globe and 2005 revenues of $2.7 billion. Genzyme has been selected by FORTUNE as one of the "100 Best Companies to Work for" in the United States.

With many established products and services helping patients in more than 80 countries, Genzyme is a leader in the effort to develop and apply the most advanced technologies in the life sciences. The company's products and services are focused on rare inherited disorders, kidney disease, orthopaedics, cancer, transplant and immune diseases, and diagnostic testing. Genzyme's commitment to innovation continues today with a substantial development program focused on these fields, as well as heart disease and other areas of unmet medical need.

This press release contains forward-looking statements, including the statements regarding the ability of KRAS Mutation Analysis to help identify patients who may not respond to targeted therapy for the treatment of NSCLC, to identify patients who test positive for specific KRAS mutations and to provide physicians and patients with critical information regarding treatment, the potential improvement in cancer treatment through personalized medicine, and the ability of EGFR by FISH and EGFR Mutation Analysis Assay to identify patients likely to respond to TKI therapies. These statements are subject to risks and uncertainties that could cause actual results to differ materially from those projected in these forward-looking statements. These risks and uncertainties include, among others, the failure of KRAS Mutation Analysis, EGFR by FISH and EGFR Mutation Analysis Assay to produce diagnostic results as anticipated, the inability for physicians to personalize therapy and improve cancer treatment as expected notwithstanding physicians' access to KRAS Mutation Analysis, the continued availability of KRAS Mutation Analysis, EGFR by FISH and EGFR Mutation Analysis Assay resulting from the lack of commercial acceptance of these tests, including the acceptance of the tests at price levels that are economically viable for Genzyme Genetics, and the risks and uncertainties described in reports filed by Genzyme with the Securities and Exchange Commission under the Securities Exchange Act of 1934, as amended, including without limitation the information under the heading "Factors Affecting Future Operating Results" in the Management's Discussion and Analysis of Financial Condition and Results of Operations section of the Genzyme Quarterly Report on Form 10-Q for the quarter ending September 30, 2006. Genzyme cautions investors not to place substantial reliance on the forward-looking statements contained in this press release. These statements speak only as of the date of this press release, and Genzyme undertakes no obligation to update or revise the statements.

Tarceva(R) is a registered trademark of OSI Pharmaceuticals, Inc. IRESSA(R) is a registered trademark of AstraZeneca UK Limited. Genzyme(R) is a registered trademark of Genzyme Corporation. All rights reserved.

Genzyme's press releases and other company information are available at http://www.genzyme.com/ and by calling Genzyme's investor information line at 1-800-905-4369 within the United States or 1-703-797-1866 outside the United States.

Genzyme
http://www.genzyme.com/

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