CAMBRIDGE, Mass., Dec. 4 /PRNewswire-FirstCall/ -- 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.
Media Contact: Investor Contact:
Maria Cantor Catherine Forte
617-768-6690 617-768-6881
SOURCE Genzyme
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Related links:
http://www.genzyme.com/
http://www.prnewswire.com/comp/113803.html /
CONTACT:
Media Contact: Maria Cantor, +1-617-768-6690,
or Investor Contact: Catherine Forte, +1-617-768-6881, both of
Genzyme
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