Company Overview of Genzyme Corporation
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
Founded in 1981
Key Executives for Genzyme Corporation
Chief Executive Officer and President
Executive Vice President and President of Manufacturing & Corporate Operations
Senior Vice President and President of Personalized Genetic Health
President of Surgical Products
Compensation as of Fiscal Year 2015.
Genzyme Corporation Key Developments
Genzyme Corp. to Pay $32.5 Million to Resolve Wrongful Marketing Allegations
Sep 3 15
Genzyme Corp. will be paying a $32.5 million settlement to resolve allegations that it inappropriately marketed a surgical device. Genzyme adulterated and misbranded surgical device Seprafilm while it was being sold from 2005 and 2010. Genzyme had agreed to enter into deferred prosecution with the government for two years while allegations, filed in the U.S. District Court for the Middle District of Florida, were resolved. The agreement calls for Genzyme to pay the $32.5 million fine and revise its internal compliance program. Given compliance with the mandates, the Justice Department has requested that the case be dismissed at the end of the agreement's term. Genzyme had created a device called Seprafilm, a clear piece of film that can be applied to internal tissues during pelvic and abdominal surgeries to reduce scar tissue formations between organs after surgery. The device was approved by the U.S. Food and Drug Administration for use in patients undergoing open abdominal or pelvic laparotomy, where surgeons make a large incision to conduct surgeries. But the procedure had become less common with the advent of laparoscopic surgery. In response, some Genzyme sales representatives taught surgeons and other medical staff to make the Seprafilm sheets into a liquid that could be squirted through narrow tubes used in a laparoscopic procedure. The device was never approved for such a use, and according to criminal charges, the direction by sales representatives and participation in preparing the liquid form of the device in operating rooms caused Seprafilm to become adulterated. Genzyme also disclosed to the government during its investigation that the company had distributed promotional material for Seprafilm that implied that the device had been proven safe and effective in gynecologic cancer surgeries. Though Genzyme had done a study on 14 patients, the device had not been thoroughly evaluated for such malignancies.
Genzyme Initiates Phase 1/2 Clinical Trial to Evaluate Olipudase Alfa in Pediatric Patients
Jun 15 15
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
Jun 4 15
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.
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