Full Description

Genzyme Corporation (Genzyme) is a biotechnology company. The Company’s product and service portfolio is focused on rare disorders, renal diseases, orthopaedics, cancer, transplant and immune disease, and diagnostic and predictive testing. Genzyme operates in four segments: Genetic Diseases, Cardiometabolic and Renal, Biosurgery and Hematologic Oncology. Genetic Diseases unit develops, manufactures and distributes therapeutic products, with a 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). Cardiometabolic and Renal segment develops, manufactures and distributes products that treat patients suffering from renal diseases, including chronic renal failure and endocrine and cardiovascular diseases. Biosurgery develops, manufactures and distributes biotherapeutics and biomaterial-based products, with a focus on products that meet medical needs in the orthopaedics and broader surgical areas. Hematologic Oncology develops, manufactures and distributes products for the treatment of cancer.

Its transplant business unit develops, manufactures and distributes therapeutic products that address pre-transplantation, prevention and treatment of graft rejection in organ transplantation and other hematologic and auto-immune disorders. The Company’s genetics business unit provides testing services for the oncology, prenatal and reproductive markets. Genzyme also reports the activities of its diagnostic products, bulk pharmaceuticals and immune mediated disease business units under the caption Other.

Genetic Diseases

The Genetic Diseases unit derives all of its revenue from sales of Cerezyme, Fabrazyme, Myozyme and Aldurazyme. Cerezyme, Fabrazyme, Myozyme and Aldurazyme are each aimed at treating LSDs with patient populations of less than 10,000 worldwide. The Company markets 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 leading to a variety of symptoms, including anemia, spleen and liver enlargement and bone deterioration.

The Company has developed Fabrazyme, a recombinant form of the human enzyme alpha-galactosidase, as a treatment for Fabry disease. The Company is marketing Myozyme as a therapy for Pompe disease. Myozyme targets the underlying cause of Pompe disease by replacing the enzyme that is absent or deficient. Aldurazyme is a recombinant form of the human enzyme alpha-L-iduronidase, to treat LSD known as MPS I.

Cardiometabolic and Renal

The unit derives all of its revenue from sales of Renagel/Renvela (including sales of bulk sevelamer), Hectorol and Thyrogen. Renagel and Renvela are non-absorbed, calcium-free, metal-free phosphate binders indicated for the control of serum phosphorus in patients with chronic kidney disease (CKD) on dialysis. Genzyme markets Renagel in over 60 countries. The Company markets its sevelamer therapies in the United States, Europe, Canada, Latin America and Australia directly to nephrologists through a sales force. The wholesalers distribute Renagel/Renvela to retail pharmacies, hospitals and other providers of medication to patients. Chugai Pharmaceutical Co., Ltd. and its partner, Kyowa Hakko Kirin Co., Ltd., have rights to develop and market Renagel in Japan, China and other Pacific Rim countries. During the year ended December 31, 2008, the Company’s sales of Renagel/Renvela (including sales of bulk sevelamer), totaled 15% of its total revenue in 2008.

Hectorol is 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 microgram and 2.5 microgram capsules) and in patients with stage 5 CKD on dialysis (2.5 microgram capsules and injection). Hectorol provides 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 United States, a 2.5 microgram capsule, a 0.5 microgram capsule and an intravenous (IV) formulation.

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 while they are being screened for residual or recurring thyroid cancer. Thyrogen helps patients avoid the morbidities associated with hypothyroidism, thus increasing the likelihood that they will seek follow-up care. This will ultimately increase the likelihood of early detection of any recurrent disease, which can improve the success rate of subsequent treatment. In October 2008, the Company received marketing approval in Japan. In December 2007, it received The United States Food and Drug Administration (FDA) approval to market Thyrogen as an adjunctive treatment for ablation or destruction of thyroid remnants in patients who have undergone removal of their thyroid for the treatment of well-differentiated thyroid cancer.

Biosurgery

The Biosurgery unit derives all of its revenue from sales of Synvisc, the Sepra line of products, Carticel and Matrix-induced Autologous Chondrocyte Implantation (MACI). Synvisc is a biomaterial-based product derived from hyaluronan used to treat the pain associated with osteoarthritis of the knee. Synvisc is sold commercially in over 60 countries, both directly and through marketing and distribution arrangements. Synvisc is approved for the treatment of pain associated with osteoarthritis of the hip in 24 countries outside of the United States, and in the European Union, Hong Kong, Israel and Malaysia, Synvisc is approved for the treatment of pain associated with osteoarthritis of the hip, ankle and shoulder.

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. The Company markets the Sepra products primarily through a direct sales force in the United States, France and Australia, and primarily through distribution arrangements in Japan and the rest of the world. Its Sepramesh IP hernia mesh product is marketed by Davol, Inc., a subsidiary of C.R. Bard, Inc., under a license agreement.

Hematologic Oncology

The Hematologic Oncology unit derives all of its revenue from sales and royalties received on sales of Campath and clofarabine. This unit also includes Mozobil, which received marketing approval in the United States in December 2008. Clofarabine is marketed under the name Clolar in North and South America and as Evoltra elsewhere in world. Campath (alemtuzumab) is indicated as a single agent for the treatment of B-cell chronic lymphocytic leukemia (B-CLL). In September 2007, the FDA approved a supplemental biologics license application (sBLA) for Campath and approved expanded labeling for Campath to include first-line treatment of B-CLL. In December 2007, the Company also received European approval of an expanded indication. Campath is marketed by Bayer HealthCare Pharmaceuticals Inc. (Bayer) in the United States as Campath and outside the United States as MabCampath. The product is sold commercially in over 60 countries.

Clolar is indicated in the United States for the treatment of pediatric patients 1 to 21 years old with relapsed or refractory acute lymphoblastic leukemia (ALL) after at least two prior regimens. Clofarabine has approval in 27 European countries and Israel for the treatment of pediatric ALL patients who have relapsed or are refractory after receiving at least two prior regimens and where there is no other treatment option anticipated to result in a durable response.

The Company is developing the intravenous formulation of Clolar for indications, including first-line and relapsed or refractory acute myeloid leukemia (AML) in adults. It is also developing an oral formulation of Clolar and has initiated clinical trials for the treatment of myelodysplastic syndrome (MDS). Mozobil is indicated in the United States in combination with granulocyte-colony stimulating factor (G-CSF) to mobilize hematopoietic stem cells to the peripheral blood for collection and subsequent autologous transplantation in patients with non-Hodgkin's lymphoma (NHL) and multiple myeloma (MM).

In December 2008, the Company received marketing approval for Mozobil in the United States. Mozobil has been granted orphan drug status in the United States for use to improve the yield of progenitor cells in the apheresis product for subsequent stem cell transplantation following myelosuppressive or myeloablative chemotherapy. Genzyme markest Mozobil in the United States primarily through a direct sales force focused on hematologists/oncologists and transplant specialists.