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 worldwide. It offers Cerezyme for treating gaucher disease type I; Fabrazyme for treating fabry disease; Aldurazyme for mucopolysaccharidosis I; Myozyme and Lumizyme for pompe disease; Renagel, a calcium and metal-free phosphate binder 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 CK...
500 Kendall Street
Cambridge, MA 02142
Founded in 1981
Key Executives for Genzyme Corporation
Chief Executive Officer and President
Chairman and Chief Executive Officer of Sanofi
Executive Vice President and President of Manufacturing & Corporate Operations
Senior Vice President and President of Personalized Genetic Health
Compensation as of Fiscal Year 2014.
Genzyme Corporation Key Developments
FDA Approves Genzyme's Cerdelga (Eliglustat) Capsules
Aug 19 14
Genzyme announced that the U.S. Food and Drug Administration (FDA) has approved Cerdelga(TM) (eliglustat) capsules, the first-line oral therapy for certain adult Gaucher disease type 1 patients. A small number of adult patients who metabolize Cerdelga more quickly or at an undetermined rate, as detected by an established genetic laboratory test, will not be eligible for Cerdelga treatment. Cerdelga is expected to be available to patients within a month. Genzyme has been researching an oral therapy for Gaucher disease for fifteen years, from early chemistry and preclinical research through clinical development. The Cerdelga clinical development program is the ever conducted in Gaucher disease, with approximately 400 patients treated in 29 countries. The FDA approval was based on efficacy data from two positive Phase 3 studies for Cerdelga: one in patients new to therapy (Trial 1), and the other in patients switching from approved enzyme replacement therapies (Trial 2). The filing also incorporated four years of efficacy data from the Cerdelga Phase 2 study. In Trial 1, improvements were seen across the following endpoints after 9 months on Cerdelga: spleen size, platelet levels, hemoglobin levels, and liver volume. Patients continue to receive Cerdelga in the extension period, and the majority of patients have been on treatment for over eighteen months. Trial 2 met the pre-specified criteria for non-inferiority to an enzyme replacement therapy (imiglucerase), which was a composite endpoint of each of the following parameters: spleen volume, hemoglobin levels, platelet counts, and liver volume. Patients continue to receive Cerdelga in the extension period, and the majority of patients have been on treatment for over two years. The most common adverse reactions (>=10%) are fatigue, headache, nausea, diarrhea, back pain, pain in extremities, and upper abdominal pain. Cerdelga is a specific ceramide analogue inhibitor of glucosylceramide synthase (IC(50) = 10 ng/mL) with broad tissue distribution. It reduces the production of glucosylceramide, the substance that builds up in the cells and tissues of people with Gaucher disease. For more information, visit cerdelga.com.
Genzyme Receives Label Expansion for Lumizyme in United States for Treatment of Pompe Disease
Aug 1 14
Genzyme announced that the U.S. Food and Drug Administration approved a supplement to expand the indication for Lumizyme(R) (alglucosidase alfa). Lumizyme manufactured at the 4000L scale is now indicated for all Pompe patients of any age or phenotype. The approval of this indication is now consistent with that of the rest of the world, where alglucosidase alfa manufactured at the 4000L is the only scale available. Previously, in the United States, Lumizyme had been approved only for patients with late onset Pompe disease. In the United States, alglucosidase alfa is manufactured at two different production scales. Alglucosidase alfa manufactured at the 160L scale (initial pilot scale) has a brand name of Myozyme(R) (alglucosidase alfa) and alglucosidase alfa manufactured at the 4000L (final manufacturing scale) has a brand name of Lumizyme. Based on the biochemical and clinical data provided as part of the submission, FDA concluded that alglucosidase alfa manufactured at both scales in the US (i.e., Lumizyme and Myozyme) are comparable. The overall safety profile of alglucosidase alfa remains unchanged. Specific updates to the Lumizyme product label include: Updated Indication: LUMIZYME(R) (alglucosidase alfa) is a hydrolytic lysosomal glycogen-specific enzyme indicated for patients with Pompe disease (GAA deficiency). Inclusion of safety and efficacy data from infantile-onset studie; Removal of the REMS program. Update to the boxed warning to include infantile-onset specific warning regarding fluid overload. Updated to Pregnancy Category C classification.
Genzyme and Cleveland Clinic Collaborate to Develop New MS Therapeutics
May 5 14
Genzyme has announced new research collaboration with Cleveland Clinic focused on developing new therapeutic approaches to the treatment of multiple sclerosis, or MS. This innovative collaboration aligns the research efforts of both organizations around projects which are designed to develop a deep understanding of the pathogenesis and progression of MS and to address the unmet medical needs in MS, particularly progressive forms of the disease. Initially the collaboration will focus on projects that explore strategies to address neurodegeneration, a hallmark of progressive MS, and novel technologies to better understand the pathology of the disease. The collaboration will be led by a joint steering committee comprised of Genzyme and Cleveland Clinic researchers and span a minimum of 5 years.
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