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Product History

1986

Genzyme markets 32 research reagents or diagnostic intermediates (20 manufactured in Kent, U.K.) for use in laboratory analysis.

Introduces InterTest-2, the industry’s first in vitro test kit that uses monoclonal antibodies to measure human interleukin-2.

Hyaluronic acid (HA) and glucocerebrosidase (GCR) enter clinical trials.

1988

U.S. Food and Drug Administration (FDA) approves the marketing of clindamycin phosphate, an antibiotic used to treat serious hospital infections.

1989

Genzyme is allowed to make Ceredase® (alglucerase injection) available to seriously ill patients prior to marketing approval.

IG Labs is first to begin testing for the first cystic fibrosis mutation.

1990

Ceredase becomes available to patients outside the United States on a named-patient basis.

1991

FDA grants marketing approval for Ceredase.

Alcon receives FDA approval to market Provisc®, a Genzyme-developed HA-based opthalmic product.

IG Labs introduces Insight®, a prenatal cytogenetic test.

1992

Israeli Ministry of Health approves Ceredase.

1993

Genzyme Diagnostics begins marketing its direct LDL cholesterol kit.

Begins marketing Predicta erythroproietin ELISA kit for the diagnosis of anemia.

1994

FDA grants marketing approval of Cerezyme.

Ceredase is approved for marketing in Germany, Australia, France, Holland, and the U.K.

1995

Ceredase receives reimbursement approval in Brazil and is approved for marketing in Portugal, Italy, New Zealand, Sweden, and Spain.

1996

Genzyme launches Seprafilm adhesion barrier in Europe.

Ceredase receives marketing approval in Japan.

FDA grants approval to market Seprafilm for use in open abdominal or pelvic surgery.

Genzyme Diagnostics begins marketing N-geneous HDL cholesterol test in the United States.

1997

Marketing approval of Seprafilm in Japan; product co-marketed with Kaken Pharmaceutical Co., Ltd., Tokyo.

Genzyme Genetics introduces Afp4SM, a more accurate biochemical screening test for Downs Syndrome.

FDA issues a biologics license application for Carticel® (autologous cultured chondrocytes) to repair cartilage in the knee — the first for a cell therapy product.

1998

FDA grants U.S. marketing approval for Renagel® (sevelamer hydrochloride) and Thyrogen® (thyrotropin alfa for injection).

FDA grants marketing approval for Synvisc® (hylan G-F 20).

FDA grants marketing approval for Thymoglobulin® (anti-thymocyte globulin).

1999

Thyrogen® approved for use in the 15 member states of the European Union.

FDA approves WelChol (colesevelam hydrochloride) for marketing.

Genzyme receives the European CE Mark for Seprafilm for use in reducing adhesions following cardiac surgery.

Partners Genzyme and Biogen receive Orphan Drug Designation for AVONEX® (interferon beta 1-a) in Japan.

2000

Genzyme Genetics introduces the 87-mutation cystic fibrosis test, the most comprehensive on the market.

Genzyme receives registration approval of Thyrogen in Brazil.

Genzyme granted marketing approval of Renagel Capsules in the European Union.

Genzyme receives marketing approval for Sepramesh Biosurgical Composite for use in hernia repair procedures.

Genzyme obtains rights to develop and commercialize Synpac’s CHO-based enzyme replacement for Pompe disease.

2001

Genzyme launches Fabrazyme® (afgalsidase beta for injection) in the European Union.

With partner Cambridge Antibody Technology, begins phase 1-2 clinical trial of human anti-TGF-beta monoclonal antibody for the treatment of scleroderma.

2002

Genzyme receives approval for Thyrogen in Canada.

European Union approves Synvisc for use in the hip.

Genzyme Oncology begins kidney cancer clinical trial.

2003

Genzyme begins enrolling patients in multiple Pompe Disease studies to support rapid development and approval of Myozyme.

FDA approves Genzyme’s Fabrazyme, the first treatment approved in the United States for people suffering from Fabry disease, with orphan drug status.

Genzyme and partner BioMarin receive FDA approval of Aldurazyme, the first specific treatment approved for people with mucopolysaccharidosis I (MPS I).

Genzyme and Dyax announce joint venture for DX-88 in Hereditary Angioedema.

Europe expands Cerezyme label to include Type 3 Gaucher Disease.

Genzyme files to market Synvisc in Japan.

Genzyme receives extended European label for Thyrogen.

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