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July 27, 2015 9:37 PM ET

Biotechnology

Company Overview of Genzyme Corporation

Company Overview

Genzyme Corporation, a biotechnology company, engages in the discovery and development of products and services primarily in the areas of rare genetic diseases, multiple sclerosis, cardiovascular diseases, and endocrinology. It offers Cerezyme to treat gaucher disease type I; Fabrazyme to treat fabry disease; Aldurazyme for mucopolysaccharidosis I; Myozyme and Lumizyme for pompe disease; Renagel that reduces phosphorous levels in chronic kidney disease (CKD) patients who are on dialysis; Renvela for use in dialysis patients and patients with earlier stage CKD; Hectorol, a vitamin D2 treatment for secondary hyperparathyroidism in CKD patients; Thyrogen to use in thyroid cancer follow-up; Leuk...

500 Kendall Street

Cambridge, MA 02142

United States

Founded in 1981

10,100 Employees

Phone:

617-252-7500

Fax:

617-252-7600

Key Executives for Genzyme Corporation

Chief Executive Officer and President
Age: 60
Chief Financial Officer
Executive Vice President and President of Manufacturing & Corporate Operations
Age: 54
Senior Vice President and President of Personalized Genetic Health
Age: 51
President of Surgical Products
Age: 66
Compensation as of Fiscal Year 2015.

Genzyme Corporation Key Developments

Genzyme Initiates Phase 1/2 Clinical Trial to Evaluate Olipudase Alfa in Pediatric Patients

Genzyme announced that the first pediatric patient has begun treatment in a Phase 1/2 clinical trial focused on evaluating the investigational therapy olipudase alfa. Olipudase alfa is an enzyme replacement therapy being studied for the treatment of nonneurological manifestations of acid sphingomyelinase deficiency (ASMD), also known as Niemann-Pick disease type B, as opposed to type A, which is characterized by neurological involvement. ASMD is a serious and life-threatening disorder caused by insufficient activity of the enzyme acid sphingomyelinase (ASM) resulting in toxic accumulation of sphingomyelin. There are currently no approved treatment options for patients with Niemann-Pick disease type B. The Phase 1/2 trial is a multi-national, multi-center, open label, ascending dose trial to evaluate the safety, tolerability and pharmacokinetics of olipudase alfa administered intravenously once every 2 weeks for 52 weeks in pediatric patients with ASMD. Twelve pediatric patients will be enrolled into 3 age cohorts: an adolescent cohort (12 to <18 years of age); a child cohort (6 to <12 years of age); and an infant/early child cohort (birth to <6 years of age). The primary objective of the Phase1/2 trial is to assess the safety and tolerability of olipudase alfa. Upon completion of the 52-week trial, patients will have the option to enroll into an extension study. Genzyme is preparing for enrollment to begin in a Phase 2/3 trial involving adult patients with ASMD in the second half of 2015.

Food and Drug Administration Grants Breakthrough Therapy Designation for Genzyme's Olipudase Alfa

Genzyme announced that the U.S. Food and Drug Administration (FDA) has granted Breakthrough Therapy designation to olipudase alfa. This enzyme replacement therapy is being investigated for the treatment of patients with nonneurological manifestations of acid sphingomyelinase deficiency (ASMD), also known as Niemann-Pick disease type B, as opposed to type A which is characterized by neurological involvement. ASMD is a serious and life-threatening disorder caused by insufficient activity of the enzyme acid sphingomyelinase (ASM), which results in toxic accumulation of sphingomyelin. There are currently no approved treatment options for patients with Niemann-Pick disease type B. Breakthrough Therapy designation is intended to expedite the development and review of investigational new drugs that target serious or life-threatening conditions. The criteria for granting Breakthrough Therapy designation are preliminary clinical evidence of substantial improvement on a clinically significant endpoint over available therapies. The Breakthrough Therapy designation is distinct from the FDA's other mechanisms to expedite drug development and review, and will allow for a close collaboration between Genzyme and the FDA on the olipudase alfa development program. Olipudase alfa is being developed by Genzyme to potentially address the fundamental defect underlying the disease. Supplementing the defective or deficient native enzyme with olipudase alfa allows for the breakdown of sphingomyelin, whose accumulation is responsible for the clinical manifestation of ASMD. The Breakthrough Therapy designation is supported by data from a completed Phase 1b study of olipudase alfa. Findings in five adult patients with nonneuronopathic ASMD were presented at the Lysosomal Disease Network's WORLD Symposium in February 2015. The data presented on the repeat-dose safety, pharmacodynamics, and exploratory efficacy of olipudase alfa support its continued development for the investigational use in nonneurological manifestations of ASMD.

Ablynx Enters into an Exclusive Research Collaboration with Genzyme

Ablynx announced that it has entered into an exclusive research collaboration with Genzyme to investigate Nanobodies® against a target that plays an important role in multiple sclerosis (MS) and specifically aligns with Genzyme's early-stage MS research programs involving neuroprotection and CNS repair. The neurodegeneration observed in MS is not directly targeted by existing treatments. Genzyme's research efforts aim to address this unmet need by targeting the underlying causes of MS disease progression and by developing treatments to protect neurons and promote repair of CNS damage. Under the terms of the agreement, Genzyme will have the right to perform in vitro and in vivo research with Ablynx's Nanobodies in MS-relevant models in return for an exclusivity fee. Upon completion of these studies, Genzyme will have the option to negotiate a license agreement. Ablynx has already generated potent Nanobodies against the specific target of interest and confirmed their activity in pre-clinical models.

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