Genzyme Announces Publication Of Study Showing Impact Of Cerezyme On Bone Health For Patients With Type 1 Gaucher Disease

Genzyme Corporation (Nasdaq:
GENZ) announced today that a research study published in the January issue
of the Journal of Bone and Mineral Research demonstrates that long-term use
of Cerezyme(R) (imiglucerase for injection) significantly improves bone
mineral density in patients with Type 1 Gaucher disease in a dose-dependent
manner.


Cerezyme, an enzyme replacement therapy, is the standard of care for
patients with Type 1 Gaucher disease. Patients with Gaucher disease are at
increased risk for developing bone complications, including osteopenia,
osteoporosis and fractures. To evaluate the effect of long-term Cerezyme
use on bone mineral density, the investigators conducted the largest-ever
retrospective analysis of more than 500 patients participating in the
International Collaborative Gaucher Group (ICGG) Gaucher Registry. The ICGG
Gaucher Registry has been sponsored by Genzyme since 1991 and is overseen
by an international board of scientific advisors.



The study compared the outcomes of 342 patients with Type 1 Gaucher
disease who received treatment with Cerezyme to 160 patients who did not
receive treatment. Both the treated and untreated patients had bone mineral
density values significantly below normal at baseline. The patients who
received Cerezyme were dosed at a range from 15-60 units per kilogram of
body weight administered every two weeks. Bone mineral density was assessed
by dual energy x-ray absorptiometry (DXA) of the lumbar spine.



The analysis found that patients receiving Cerezyme experienced a
significant increase in bone mineral density over time when compared with
patients who were not treated. Furthermore, the improvements in bone
mineral density were found to be dose-dependent, with those patients
receiving higher doses of Cerezyme achieving greater increases in bone
mineral density. On average, the patients receiving Cerezyme at 60 units
per kilogram biweekly achieved scores that approached those in the general
population, whereas the untreated patients experienced no improvement or
declining bone mineral density over the same period.



The investigators found that achieving normal (age- and sex-adjusted)
bone mineral density scores may require eight years or more of sustained
treatment with Cerezyme, longer than is required to reach normal values for
other disease parameters, such as hematological parameters or reductions in
liver and spleen volume. They conclude that a normal bone mineral density
score should be a therapeutic goal for patients with Type 1 Gaucher
disease.



About Cerezyme



Cerezyme (imiglucerase for injection) is indicated for long-term enzyme
replacement therapy for pediatric and adult patients with a confirmed
diagnosis of Type 1 Gaucher disease that results in one or more of the
following conditions: anemia, thrombocytopenia, bone disease, hepatomegaly,
or splenomegaly. Important Safety Information: Adverse reactions related to
Cerezyme administration have been reported in less than 15% of patients.
Each of the following events occurred in less than 2% of the total patient
population. Reported adverse events include nausea, vomiting, abdominal
pain, diarrhea, rash, fatigue, headache, fever, dizziness, chills,
backache, and tachycardia. Adverse events associated with the route of
administration include discomfort, pruritus, burning, swelling, and sterile
abscess at the site of venipuncture. Symptoms suggestive of
hypersensitivity include anaphylactoid reaction, pruritus, flushing,
urticaria, angioedema, chest discomfort, dyspnea, coughing, cyanosis, and
hypotension. Approximately 15% of patients have developed IgG antibodies;
periodic monitoring is suggested. Side effects should be reported promptly
to Genzyme Medical Affairs. Cerezyme is available
by prescription only.
















Please see full prescribing information available on cerezyme.



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 9,000 employees in locations
spanning the globe. 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.



Genzyme(R) and Cerezyme(R) are registered trademarks of Genzyme
Corporation. All rights reserved.


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