Genzyme Corporation operates as a global biotechnology company in the United States, European Union, Latin America, and Asia Pacific. The company’s product and service portfolio is focused on rare disorders, renal disease, orthopaedics, organ transplant, and diagnostic and predictive testing.
Segments
The Company operates in five segments: Renal, which develops, manufactures and distributes products that treat patients suffering from renal diseases, including chronic renal failure; Therapeutics, which develops, manufactures and distributes therapeutic products, with an expanding focus on products to treat patients suffering from genetic diseases and other chronic debilitating diseases, including a family of diseases known as lysosomal storage disorders, (LSDs), and other specialty therapeutics, such as Thyrogen; Transplant, which develops, manufactures and distributes therapeutic products that address pre-transplantation, prevention and treatment of acute rejection in organ transplantation, as well as other auto-immune disorders; Biosurgery, which develops, manufactures and distributes biotherapeutics and biomaterial products, with an emphasis on products that meet medical needs in orthopaedics and surgical areas; and Genetics, which provides testing services for the oncology, prenatal and reproductive markets.
Products and Services
Renal
Renagel (sevelamer hydrochloride): Renagel is a non-absorbed, calcium-free, metal-free phosphate binder indicated for the control of serum phosphorus in patients with chronic kidney disease (CKD) on hemodialysis. The company is marketing the product in approximately 50 countries.
The company markets Renagel tablets in the U.S., the European Union and Brazil directly to nephrologists through a sales force. In the U.S., the company's Renagel sales are made to three major wholesalers. These wholesalers distribute Renagel to retail pharmacies, hospitals and other providers of medication to patients. Chugai Pharmaceutical Co., Ltd. and its partner, Kirin Brewery Co., Ltd., have rights to develop and market Renagel in Japan, China and other Pacific Rim countries.
Hectorol (doxercalciferol): The company’s product Hectorol, a line of vitamin D2 pro-hormone products that are indicated for the treatment of secondary hyperparathyroidism in patients with stages 3 and 4 CKD (0.5 mcg and 2.5 mcg capsules) and in patients with stage 5 CKD on dialysis (2.5 mcg capsules and injection). Hectorol provides significant parathyroid hormone (PTH) reductions with minimal impact on calcium and phosphorus levels. Three formulations of the product have been approved for commercial sale in the U.S. is 2.5 mcg capsules and 0.5 mcg capsules. The 2.5 mcg formulation also is approved in Canada, where it is marketed and sold by Shire BioChem, a Canadian subsidiary of Shire plc.
The company markets Hectorol in the U.S. through a direct sales force focused on nephrologists. Its U.S. Hectorol capsule sales are made to three major wholesalers, who then sell and distribute the product to retail pharmacies, hospitals and other providers of medication to patients.
Therapeutics
The company's Therapeutics segment has five therapeutic products on the market and various other therapeutic products in varying stages of development.
Cerezyme (imiglucerase): The company is marketing Cerezyme as an enzyme replacement therapy for the treatment of Gaucher disease, an LSD that is caused by a deficiency in the enzyme glucocerebrosidase, which causes fatty deposits to build up in certain organs and bones to various symptoms, including anemia, spleen and liver enlargement and bone deterioration. Treatment with Cerezyme enzyme replacement therapy represents the safe enzyme replacement therapy approved for treatment of Type 1 Gaucher disease. In the European Union, Cerezyme is also approved for the treatment of patients who exhibit clinically significant, non-neurological manifestations of the disease (Type 3 Gaucher disease).
The company markets Cerezyme directly to physicians, hospitals and treatment centers worldwide through a specialized sales force.
Fabrazyme (agalsidase beta): The company has developed Fabrazyme, a recombinant form of the human enzyme alpha-galactosidase, as a treatment for Fabry disease. Fabry disease is an LSD that is caused by a deficiency of the enzyme alpha-galactosidase A, which leads to the progressive accumulation of lipids within cells of the kidneys, heart and other organs. In agreement with the FDA, the company undertook a number of post-marketing commitments, and has completed a phase 4, multi-national, multi-center, double-blind placebo-controlled study. In 2005, the EMEA approved new labeling for Fabrazyme based on the results from the phase 4 study. Fabrazyme is sold by its existing LSD and Renal sales forces.
Thyrogen (thyrotropin alfa): Thyrogen is an adjunctive diagnostic agent used in the follow-up of patients with well-differentiated thyroid cancer. The company developed this product to allow patients to continue taking their thyroid hormone supplements. This helps patients avoid the debilitating effects of hypothyroidism. Thyrogen is sold to hospitals and doctors’ offices through distributors in the U.S., Brazil and the European Union. The company is pursuing additional indications for Thyrogen. In March 2005, the company received European Union approval for use of Thyrogen in combination with radioiodine in ablation of thyroid tissue.
Myozyme (alglucosidase alfa): The company is marketing Myozyme as a therapy for Pompe disease, a progressive and often fatal muscle disease resulting from an inherited enzyme deficiency. Myozyme is the first treatment approved for Pompe disease and is indicated for all patients with the disorder. The company is conducting a clinical trial of late onset patients.
Aldurazyme (laronidase): The company formed a joint venture with BioMarin Pharmaceutical, Inc. (BioMarin), and BioMarin Genetics, Inc. to develop and market Aldurazyme, a recombinant form of the human enzyme alpha-L-iduronidase, to treat an LSD known as mucopolysaccharidosis I (MPS I). MPS I is a progressive, debilitating, and often life-threatening disease, which encompasses various clinical presentations, classified as ‘Hurler’, ‘Hurler-Scheie’ and ‘Scheie’ syndromes. The company markets Aldurazyme directly to physicians in the U.S. through its LSD sales force.
Transplant
This business segment includes three marketed products, as well as product candidates in the research and development stages that the company acquired through its acquisition of SangStat Medical Corporation (SangStat), and its acquisition of AnorMED in 2006.
Thymoglobulin (anti-thymocyte globulin, rabbit): Thymoglobulin is an immunosuppressive polyclonal antibody that suppresses certain types of immune cells responsible for acute organ rejection in transplant patients. The company markets Thymoglobulin in the U.S. for the treatment of acute rejection of renal transplants. In Canada, the company has marketed Thymoglobulin for both the prevention and treatment of acute rejection of renal transplants.
In the European Union, Thymoglobulin has an approved label which allows the company to market it for various approved uses including the prevention and treatment of rejection in solid organ transplants, the prevention and treatment of graft versus host disease, and the treatment of aplastic anemia, a disease that affects the production of mature, functional blood cells. Thymoglobulin also has a similarly label in various Asian and Latin American countries. The company has filed for marketing approval of Thymoglobulin in Japan and the UK. The company sells Thymoglobulin in 47 countries through a direct sales force or through distributors to transplant centers for use by transplant surgeons, nephrologists, hematologists and oncologists.
The company completed enrollment in a phase 2 trial of Thymoglobulin in liver transplantation to prevent rejection and delay of the introduction of calcineurin inhibitors in patients with renal dysfunction prior to liver transplant. The company intends to conduct phase 2 clinical trials beginning in 2007 in North America and Europe for the treatment of immune mediated bone marrow failure associated with myelodysplastic syndromes.
Lymphoglobuline (anti-thymocyte-globuline, equine): The company markets Lymphoglobuline, another immunosuppressive polyclonal antibody, in Latin America, the European Union, and certain Asia Pacific countries for the treatment of aplastic anemia and for the prevention and treatment of graft rejection. This product is sold through its sales force in Europe and through distributors elsewhere.
Biosurgery
Synvisc (hylan G-F 20): Synvisc is a biomaterial derived from hyaluronan used to treat the pain associated with osteoarthritis of the knee. Synvisc is sold commercially in approximately 60 countries, both directly and through marketing and distribution arrangements.
The company is investing in research and clinical trials to expand the use of Synvisc to additional joints and through approaches. In the European Union and Canada, Synvisc is approved for the treatment of pain associated with osteoarthritis of the hip, and in the European Union, the company launched Synvisc for the treatment of pain associated with osteoarthritis of the ankle and shoulder.
In December 2006, the company completed a pivotal trial evaluating a single-injection regimen of Synvisc.
Sepra Products: The Sepra family of products is aimed primarily at preventing adhesions (internal scar tissue) following various surgical procedures in areas of the body such as the abdomen and pelvis. These products are produced from biomaterials derived from hyaluronan. The company markets the Sepra products primarily through a direct sales force in the U.S., France and Australia, and primarily through distribution arrangements in Japan and the rest of the world.
Seprafilm, the first marketed product and by sales volume of the Sepra family, is the FDA-approved product clinically proven to reduce the incidence, extent and severity of postsurgical adhesions in both the abdomen and pelvis. During 2005, the company launched Sepramesh IP, a product for hernia repair to replace Sepramesh.
Genetics
The company develops and provides reproductive testing services primarily in the U.S. and Japan. In the U.S., the company also offers diagnostic services for oncology and genetic counseling services focused on pre-natal and post-natal care, reproductive and fertility medicine. It offers various types of testing—the most significant are cytogenetic testing, molecular genetic (DNA) testing, immunohistochemistry testing, flow cytometry testing and biochemical testing. These services are promoted through a direct sales force in the U.S., with testing performed in its nine clinical laboratories located throughout the U.S. The company services the Japanese market through a direct sales force and distributors, with testing primarily performed in its clinical laboratory in Santa Fe, New Mexico.
Significant Events
In February 2007, the company agreed with Dyax Corp. to terminate its participation and interest in Dyax-Genzyme LLC.
Competition
Renal
The company's Renagel competes with Fresenius Medical Care; and Shire plc.
The company's Hectorol competes with Abbott Laboratories, Inc.; Amgen, Inc.; Pharmaceuticals, a division of F. Hoffman-LaRoche, Ltd.; and Teva Pharmaceuticals Industries, Ltd.
Therapeutics
The company's Cerezyme competes with Zavesca, a small molecule oral therapy developed by CellTech Group plc which is marketed by Teva Pharmaceuticals Industries, Ltd. in Israel and Actelion, Ltd. in the United States and the European Union. Other competitors include Shire; Protalix Biotherapeutics, Ltd.; and Amicus Therapeutics, Inc.
The company's Fabrazyme competes with Shire, Transkaryotic Therapies, Inc., and Amicus Therapeutics, Inc.
Transplant
The company's Thymoglobulin and Lymphoglobuline competes with Novartis AG; Pfizer, Inc.; Ortho Biotech; Fresenius Biotech GmbH; and the Roche Group.
Biosurgery
The company's Synvisc competes with Seikagaku Kogyo; Smith & Nephew Orthopaedics; Kaken Pharmaceutical Co.; Fidia S.p.A.; Sanofi-Aventis; Anika Therapeutics, Inc.; Johnson & Johnson; Ferring Pharmaceuticals; and Q-Med AB.
The company's Sepra products competes with Innovata plc; Baxter; Gynecare Worldwide, a division of Ethicon, Inc.; Johnson & Johnson company; Interceed; FzioMed, Inc.; Confluent Surgical, Inc.; MAST Biosurgery AG; and U.S. Life Medical Sciences, Inc.
Genetics
The company's competitors in the Genetics segments include Diagnostics and Laboratory Corporation of America Holdings (LabCorp).
History
Genzyme Corporation was founded in 1981.
