Genzyme Genetics and Moffitt Cancer Center Announce Growing Interest in Recently Launched Prognostic Test for Non-Small Cell Lung Cancer

September 16, 2009

ERCC1 Analysis Guides Patient Treatment Decisions

WESTBOROUGH, Mass.–Genzyme Genetics, a business unit of Genzyme Corporation, announced strong sales of ERCC1 Analysis, the first test for selecting chemotherapy for Non-Small Cell Lung Cancer (NSCLC), a cancer that will affect an estimated 219,000 people in the United States in 2009. Genzyme Corporation launched this test on May 1, 2009 and has sold XX tests. In November of 2007, Genzyme Corporation obtained exclusive rights to this lung cancer test from Moffitt Cancer Center.  

Several studies1-6 have shown that evaluating the expression levels of excision repair cross-complementation group 1 (ERCC1) may help physicians identify patients that may benefit from platinum-based chemotherapy - currently considered the standard of care in advanced NSCLC. Specifically, low expression levels of ERCC1 have been related to a better response and survival benefit from adjuvant cisplatin-based chemotherapy.

"We are very pleased that many medical oncologists have begun utilizing this lung cancer test to better identify chemotherapy for non small cell lung cancer patients," said Jarett Rieger, Director of the Office of Technology Management and Licensing at Moffitt. "This test is an example of personalized medicine emanating from Moffitt Cancer Center, and as a result of our licensing partnership with Genyzme this test can now benefit lung cancer patients."

According to a 5-year retrospective study (n= 389) published in the New England Journal of Medicine, overall survival was significantly longer for patients with ERCC1-negative tumors who had received adjuvant cisplatin chemotherapy when compared to the control group treated by surgery alone (56 months vs 42 months, respectively). Among patients with ERCC1-positive tumors, there was no significant difference in survival between the adjuvant chemotherapy group and the control group (50 months vs 55 months respectively).

To learn more about Genzyme Genetics ERCC1 Analysis, please visit the www.genzymegenetics.com/ercc1

About Genzyme Genetics

Genzyme Genetics is driven by its commitment to patients and offers a broad array of testing services for pathology, oncology, reproductive and genetic medicine. Twenty years of testing expertise utilizing sophisticated technologies has made Genzyme Genetics a leading worldwide provider of high-quality testing services for physicians and their patients. With an extensive network of laboratories across the United States and operations in Europe and Japan, Genzyme Genetics assists thousands of clinicians in providing the best care possible to patients. As a division of Genzyme Corporation, Genzyme Genetics contributes its resources and strengths to one of the world’s leading biotechnology companies. For more information, please visit www.genzymegenetics.com

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. Since 1981, the company has grown from a small start-up to a diversified enterprise with more than 10,000 employees in locations spanning the globe and 2007 revenues of $3.8 billion. In 2007, Genzyme was chosen to receive the National Medal of Technology, the highest honor awarded by the President of the United States for technological innovation.

With many established products and services helping patients in nearly 90 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 diagnostic testing. Genzyme's commitment to innovation continues today with a substantial development program focused on these fields, as well as immune disease, infectious disease, and other areas of unmet medical need.

About H. Lee Moffitt Cancer Center & Research Institute

Located in Tampa, Florida, Moffitt Cancer Center  is an NCI Comprehensive Cancer Center - a designation that recognizes Moffitt’s excellence in research and contributions to clinical trials, prevention and cancer control. Moffitt currently has 15 affiliates in Florida, one in Georgia and two in Puerto Rico. Additionally, Moffitt is a member of the National Comprehensive Cancer Network, a prestigious alliance of the country’s leading cancer centers, and is listed in U.S. News & World Report as one of “America’s Best Hospitals” for cancer. Moffitt’s sole mission is to contribute to the prevention and cure of cancer.

1) Vilmar A, et al. Excision repair cross-complementation group 1 (ERCC1) in platinum-based treatment of non-small cell lung cancer with special emphasis on carboplatin: A

review of current literature. Lung Cancer (2008), doi:10.1016/j.lungcan.2008.08.006.

2) Fujii T, et al. ERCC1 predicts the response of cisplatin-based neoadjuvant chemotherapy in non-small-cell lung cancer. Lung Cancer 2007; 08:025.

3) Lord RV, et al. Low ERCC1 expression correlates with prolonged survival after cisplatin plus gemcitabine chemotherapy in non small cell lung cancer. Clin Cancer Res 2002;

8:2286—91.

4) Olaussen K, et al. DNA repair by ERCC1 in non-small-cell lung cancer and cisplatin-based adjuvant chemotherapy. N Engl J Med 2006; 355:983–91.

5) Hwang IG, et al. ERCC1 expression as a predictive marker in stage IIIA, N2 positive non-small lung cancer patients treated with neoadjuvant concurrent chemoradiotherapy

followed by surgery. J Thorac Oncol 2007; 2:S367.

6) Reed E. ERCC1 measurements in clinical oncology. N Engl J Med 2006; 355:1054-5.

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