CAMBRIDGE, Mass., Oct. 6 /PRNewswire-FirstCall/ -- Genzyme Corporation
(Nasdaq:
GENZ -
News) announced today that it has entered into a license agreement
with the University of California at Los Angeles (UCLA) Jonsson Cancer Center
to obtain exclusive, worldwide diagnostic rights to its discovery of gene
mutations believed to be associated with drug resistance to Gleevec®
(imatinib mesylate), the current first-line therapy for patients with chronic
myeloid leukemia (CML).
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The molecular hallmark of CML is a mutation known as BCR-ABL. This
mutation is the specific target for Gleevec and is found in 95 percent of
patients with CML. Secondary mutations in the ABL portion of the gene
correlate with treatment failure or relapse in most patients on Gleevec
therapy. Through this license, Genzyme will be the first company to develop
and market a diagnostic test to detect a significant portion of these
secondary BCR-ABL mutations and monitor resistance in CML patients prior to,
and during, treatment with Gleevec. Results from such a test may assist
physicians in predicting patient relapse before it happens and making
appropriate adjustments in treatment.
"Developing diagnostic tests for targeted cancer therapies and making them
available to physicians and their patients is our top priority, and this is
the third such unique test that we intend to develop and launch this year,"
said Mara Aspinall, president of Genzyme Genetics, the business unit of
Genzyme Corp. focused on the research and development of high quality, complex
diagnostic testing services. Genzyme recently launched a test to specifically
identify epidermal growth factor receptor (EGFR) mutations associated with
non-small cell lung cancer.
"This new test is designed to identify those patients who are likely to
respond to Gleevec, as well as those who are likely to develop resistance to
the drug," she added. "Because CML is a chronic disease, requiring ongoing
therapy, the literature suggests that the long-term morbidity and quality of
life should improve for many patients as a result of physicians having access
to this test."
Because of its high efficacy and mild morbidity, Gleevec as a first-line
therapy is considered to have revolutionized long-term survival of patients
with CML. Gleevec was approved by the U.S. Food and Drug Administration in
May 2001 as the first drug in a new class of anti-neoplastic agents for the
treatment of CML. Over 90 percent of patients treated with Gleevec respond
initially to treatment, and many experience a complete remission. Despite
these positive response rates, a subset of patients don't respond to Gleevec
therapy fully or at all, and approximately 4 to 5 percent of successfully
treated patients annually will develop resistance to Gleevec during therapy
with a return of their disease manifestations.
The discovery of the BCR-ABL mutations was made by researchers at UCLA in
2001, who are currently working to determine if the same mutations in patients
with CML may also lead to resistance to newer investigational treatments.
This licensing agreement will result in one of several major new cancer
diagnostic tests Genzyme Genetics plans to launch this year, all of which will
be designed to help identify which patients are likely to respond to targeted
cancer therapies. In addition to the EGFR test, Genzyme also unveiled its
first cancer test to complement treatment for patients with B-cell chronic
lymphocytic leukemia (B-CLL) with drugs such as Campath® (alemtuzumab) in
July. The new test checks for minimal residual disease in patients with B-CLL.
About Chronic Myeloid Leukemia
Chronic myeloid leukemia is also known as chronic myelogenous leukemia.
According to the American Cancer Society, CML is a type of cancer that starts
in blood-forming cells of the bone marrow and then invades the blood. It can
spread to the lymph nodes, spleen, liver, and other parts of the body. In
contrast, other types of non-leukemia cancer can start in these organs and
then spread to the bone marrow (or elsewhere). CML can also change into a
fast-growing acute leukemia that invades almost any organ in the body.
The American Cancer Society estimates that there will be approximately
4,600 new cases of CML diagnosed in 2005. Approximately 25,000 CML patients
are living in remission on therapy in the U.S. today. The average age of
people with CML is around 50 years.
About Genzyme Genetics
Genzyme Genetics is a leading, nationwide provider of high-quality,
complex diagnostic 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 Corporation
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. Founded in 1981, Genzyme has grown from a small start-up to a
diversified enterprise with more than 7,600 employees in locations spanning
the globe and 2004 revenues of $2.2 billion. 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
statements regarding Genzyme's revenue estimate for 2005, the development and
marketing of a diagnostic test to detect secondary BCR-ABL mutations and
monitor resistance in CML patients prior to and during treatment with Gleevec,
the ability of the CML markers test to predict patient relapse, identify
patients who are likely to respond to Gleevec, and identify patients likely to
develop resistance to Gleevec, Genzyme Genetics' expectations regarding long-
term morbidity and quality of life improvements resulting from doctors' access
to a CML marker diagnostic test, as well as Genzyme Genetics' plans to launch
additional cancer diagnostic tests this year. 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, scientific, technical and manufacturing
issues that could prevent the development of a CML markers diagnostic test as
contemplated, the failure of a CML markers diagnostic test to produce
diagnostic results as anticipated, the commercial acceptance of CML markers
diagnostic tests, including the acceptance of a CML test 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 ended June 30, 2005. Genzyme cautions investors not
to place substantial reliance on the forward-looking statements contained in
this press release. Revenue guidance is given as of July 14, 2005 and is not
being updated or reaffirmed. All other statements speak only as of the date of
this press release, and Genzyme undertakes no obligation to update or revise
the statements.
Genzyme® and Campath® are registered trademarks of Genzyme
Corporation. Gleevec® is a registered trademark of Novartis. 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 Contacts: University of California, Los Angeles Contact:
Sally Curley (investors) Kim Irwin (media)
(617) 768-6140 (310) 206-2805
Laura Boscarino (media)
(205) 943-8312
