Genzyme Licenses Exclusive Rights to Chronic Myeloid Leukemia Markers

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Genzyme Licenses Exclusive Rights to Chronic Myeloid Leukemia Markers

Thursday October 6, 9:01 am ET

University of California at Los Angeles Grants Rights to Develop Diagnostic

Test

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).

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.