Genzyme Receives FDA Approval For New Labeling For Carticel(R)

Genzyme Corporation
(Nasdaq: GENZ) announced today that the U. S. Food and Drug Administration
(FDA) has approved new labeling for Carticel(R) (autologous cultured
chondrocytes) based on the completion of a post-approval commitment study.
This label incorporates safety and efficacy data from the Study of the
Treatment of Articular Repair (STAR) as a result of Genzyme's successful
completion of this final confirmatory, post-marketing study.


"Genzyme has pioneered cartilage repair in the field of orthopaedics
and sports medicine for more than a decade," said Ann Merrifield, president
of Genzyme Biosurgery, the division that manufactures and commercializes
Carticel. "Now, the successful completion of our final FDA post-approval
commitment further confirms Carticel's safety and effectiveness for
patients with troublesome and debilitating cartilage injuries in the knee.
Carticel has already benefited thousands of patients with specific types of
cartilage injuries where there traditionally have been limited treatment
options. With this new data on-label, we hope to provide all appropriate
patients access to therapy."



The STAR study investigated the safety and effectiveness of Carticel in
patients who had an inadequate response to a previous cartilage repair
procedure in the knee. Investigators enrolled patients in 29 clinical
centers in this prospective 4-year study, which achieved all of its
endpoints. The data from the STAR study will be presented at the upcoming
American Orthopaedic Society for Sports Medicine (AOSSM) Meeting on Sunday,
July 15, 2007 in Calgary, Canada.



"Carticel has been established as a unique and valuable tool for
orthopaedic surgeons in the treatment of patients with cartilage injuries
in the knee. Accordingly, it is important that all appropriately indicated
patients have access to this technology," said David Levine, M.D., Vice
President, Clinical Research for Genzyme Biosurgery. "Now that the post-
approval commitments have been completed, we are confident that health
plans that had yet to cover this treatment option will adopt the
appropriate medical policy for Carticel."



A Unique Cell Therapy



Carticel is used by orthopaedic surgeons to treat patients who have
clinically significant articular cartilage lesions on the thigh bone part
of the knee caused by acute or repetitive trauma that has not responded to
a prior cartilage repair procedure. Carticel should only be used in
conjunction with debridement, placement of a periosteal flap and
rehabilitation. The independent contributions of the autologous cultured
chondrocytes and other components of the therapy to outcome are unknown.
Carticel employs a unique process to grow a patient's own cartilage cells
for implantation to correct certain types of damage. The treatment starts
when an orthopaedic surgeon trained in the use of Carticel provides Genzyme
with a biopsy of healthy cartilage taken from a patient's knee in an
arthroscopic procedure. Technicians at Genzyme's cell culture laboratory in
Cambridge, MA use proprietary methods to grow millions of cells from this
biopsy. The cells are then delivered to the hospital, where the surgeon
implants them into the patient's knee defect in a surgical procedure.
















Carticel was the first cell therapy to be approved by the FDA. First
introduced in March of 1995, Carticel received accelerated approval from
the FDA in August of 1997 after the FDA instituted specific cell therapy
guidelines. Under accelerated approval, the FDA required Genzyme to conduct
confirmatory post-marketing studies.



To learn more about Carticel please visit carticel



Cell Therapy Expertise at Genzyme



Genzyme has more than a decade of experience in developing and
manufacturing autologous cell therapy products that have been used to treat
thousands of patients. Epicel(R) (cultured epidermal autografts), a cell
therapy for treating patients with severe burns, is also manufactured by
Genzyme. Together, Carticel and Epicel represent the first such products
ever brought to market in the United States, providing Genzyme with
superior scientific and commercial expertise in this field.



About Carticel



Carticel is for autologous use and is indicated for the repair of
symptomatic, cartilage defects of the femoral condyle (medial, lateral or
trochlea), caused by acute or repetitive trauma, in patients who have had
an inadequate response to a prior arthroscopic or other surgical repair
procedure (e.g., debridement, microfracture, drilling/abrasion
arthroplasty, or osteochondral allograft/autograft). Carticel should only
be used in conjunction with debridement, placement of a periosteal flap and
rehabilitation. The independent contributions of the autologous cultured
chondrocytes and other components of the therapy to outcome are unknown. It
is not indicated for the treatment of cartilage damage associated with
generalized osteoarthritis. It is not recommended for patients whose knee
meniscus has been surgically removed unless the patient has undergone
surgical reconstruction prior to or concurrent with Carticel implantation.



Pre-existing conditions including meniscal tears, joint instability or
malalignment of the joint should be corrected prior to or concurrent with
Carticel implantation. It should not be used in patients with a known
history of hypersensitivity to gentamicin, other aminoglycosides or
materials of bovine origin. Carticel is not routinely tested for
transmissible infectious diseases and may transmit disease to the
healthcare provider handling Carticel. In addition, it should not be used
in patients who have previously had cancer in the bones, cartilage, fat or
muscle of the treated limb. Use in children, patients over age 65, or in
joints other than the knee has not yet been assessed.



The occurrence of a subsequent surgical procedure, primarily
arthroscopy, following Carticel implantation is common. The most common
reactions (>5% of patients), derived from the Study of the Treatment of
Articular Repair (STAR), include arthrofibrosis/joint adhesions, graft
overgrowth, chondromalacia or chondrosis, cartilage injury, graft
complication, meniscal lesion, graft delamination, and osteoarthritis.



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 and 2006 revenues of $3.2 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 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,
orthopedics, 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.


Genzyme Corporation

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