March 03, 2015 11:29 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: 59
Chief Financial Officer
Executive Vice President and President of Manufacturing & Corporate Operations
Age: 53
Senior Vice President and President of Personalized Genetic Health
Age: 50
Senior Vice President and President of Transplant, Oncology & Multiple Sclerosis
Age: 50
Compensation as of Fiscal Year 2014.

Genzyme Corporation Key Developments

Voyager Therapeutics, Inc. and Genzyme Corporation Announce Strategic Collaboration to Discover, Develop and Commercialize Novel Gene Therapies for Severe CNS Disorders

Voyager Therapeutics, Inc. and Genzyme Corporation have announced a strategic collaboration to discover, develop and commercialize novel gene therapies for severe CNS disorders. The collaboration will leverage Genzyme's long-standing commitment and scientific leadership in the field of adeno-associated virus (AAV) gene therapy and Voyager's AAV product engine to develop breakthrough therapies for patients suffering from severe CNS disorders. The alliance will encompass multiple gene therapy programs, including programs for Parkinson's disease, Friedreich's ataxia and Huntington's disease, as well as other CNS disorders. Each program targets a severe, debilitating disease and has the potential to deliver transformational therapeutic benefit for patients. The collaboration portfolio created will combine programs and intellectual property from both companies. Voyager will drive R&D activities for all programs, working with Genzyme in a highly collaborative way. Genzyme will have the option to license several programs following completion of an initial proof-of-concept human clinical trial. However, Voyager will retain all US rights to its lead product programs in Parkinson's disease (VY-AADC01) and Friedreich's ataxia (VY-FXN01). Voyager will split US profits with Genzyme for the Huntington's disease program (VY-HTT01). In addition, Voyager's lead amyotrophic lateral sclerosis (ALS) program (VY-SOD101) is not part of the collaboration and Voyager retains worldwide rights to this program. Genzyme will make an upfront commitment of $100 million to Voyager, including $65 million in cash, a $30 million equity investment in Voyager and additional in-kind contributions. Voyager is eligible to receive future potential development and sales milestone payments of up to $745 million, as well as tiered royalties on product sales.

First MS Patients in the U.S. Receive Genzyme's Lemtrada Following FDA Approval

Genzyme, a Sanofi company, announced that the first U.S. patients have initiated treatment with Lemtrada(R) (alemtuzumab) in the commercial setting following its November 14(th) FDA approval for the treatment of patients with relapsing forms of multiple sclerosis (MS). Because of its safety profile, the use of Lemtrada should generally be reserved for patients who have had an inadequate response to two or more drugs indicated for the treatment of MS. Lemtrada has a unique dosing and administration schedule of two annual treatment courses. The first treatment course is administered via intravenous infusion on five consecutive days, and the second course is administered on three consecutive days, 12 months later. The FDA approval of Lemtrada was based on two pivotal randomized Phase III open-label rater-blinded studies comparing treatment with Lemtrada to Rebif(R) (high-dose subcutaneous interferon beta-1a) in patients with relapsing remitting MS who were either new to treatment (CARE-MS I) or who had relapsed while on prior therapy (CARE-MS II). In CARE-MS I, Lemtrada was significantly more effective than interferon beta-1a at reducing annualized relapse rates; the difference observed in slowing disability progression did not reach statistical significance. In CARE-MS II, Lemtrada was significantly more effective than interferon beta-1a at reducing annualized relapse rates, and accumulation of disability was significantly slowed in patients given Lemtrada vs. interferon beta-1a. The clinical development program for Lemtrada involved nearly 1,500 patients with more than 6,400 patient-years of safety follow-up. The Lemtrada label includes a boxed warning noting a risk of serious, sometimes fatal autoimmune conditions, serious and life-threatening infusion reactions and also noting Lemtrada may cause an increased risk of malignancies including thyroid cancer, melanoma and lymphoproliferative disorders. The most common side effects of Lemtrada are rash, headache, pyrexia, nasopharyngitis, nausea, urinary tract infection, fatigue, insomnia, upper respiratory tract infection, herpes viral infection, urticaria, pruritus, thyroid gland disorders, fungal infection, arthralgia, pain in extremity, back pain, diarrhea, sinusitis, oropharyngeal pain, paresthesia, dizziness, abdominal pain, flushing, and vomiting. Other serious side effects associated with Lemtrada include autoimmune thyroid disease, autoimmune cytopenias, infections and pneumonitis. Lemtrada is only available through a restricted distribution program, the Lemtrada REMS (Risk Evaluation and Mitigation Strategy). This program has been developed to ensure that access to Lemtrada in the U.S. is only through certified prescribers, healthcare facilities and pharmacies and to also ensure that patients are enrolled in the REMS program. The program is intended to help educate healthcare providers and patients on the serious risks associated with Lemtrada and the appropriate periodic monitoring required to support the detection of these risks for 48 months after the last infusion. The REMS is based on a developmental risk management program that was successfully implemented in the Phase 2 and Phase 3 trials and allowed for early detection and management of some of the serious risks associated with Lemtrada.

Genzyme and Isis Pharmaceuticals, Inc. Present Kynamro Clinical Data at the American Heart Association

Genzyme and Isis Pharmaceuticals Inc. announced that new two-year data from a phase 3 long-term extension study of KYNAMRO ® (mipomersen sodium) injection was presented at a scientific session at the annual American Heart Association meeting in Chicago, IL. In the study, a retrospective analysis showed that patients treated with KYNAMRO for a mean of two years had a significant reduction in Major Adverse Cardiovascular Events (MACE) compared to two years prior to therapy. This retrospective analysis included 104 patients who enrolled in the long-term extension study of KYNAMRO after having completed one of the KYNAMRO phase 3 blinded, randomized, placebo-controlled 6-month trials in patients with homozygous and heterozygous FH. All patients who completed at least two years of treatment with KYNAMRO were included in the analysis. The rate of MACE in patients treated with KYNAMRO for two years were adjudicated by an independent committee and compared to the rate of MACE in the same patients based on their medical history prior to treatment with KYNAMRO. In this analysis, MACE were identified in 62% of patients during two years prior to KYNAMRO treatment, and 9% of patients during a mean of 24.4 months after initiation of treatment with KYNAMRO. MACE were defined as myocardial infarction (MI), stroke, unstable angina (UA) and revascularization procedures (PCI/CABG). The safety and effectiveness of KYNAMRO have not been established in patients with hypercholesterolemia who do not have HoFH. The effect of KYNAMRO on cardiovascular morbidity and mortality has not been determined. Because of the risk of hepatotoxicity, KYNAMRO is available only through a Risk Evaluation and Mitigation Strategy (REMS) called the KYNAMRO REMS. The goals of the KYNAMRO REMS are: to educate prescribers about the risk of hepatotoxicity associated with the use of KYNAMRO, and the need to monitor patients during treatment with KYNAMRO as per product labeling. To restrict access to therapy with KYNAMRO to patients with a clinical or laboratory diagnosis consistent with homozygous familial hypercholesterolemia (HoFH). KYNAMRO can cause elevations in transaminases. In the KYNAMRO clinical trial in patients with HoFH, 4 (12%) of the 34 patients treated with KYNAMRO compared with 0% of the 17 patients treated with placebo had at least one elevation in alanine aminotransferase (ALT) =3x upper limit of normal (ULN). There were no concomitant clinically meaningful elevations of total bilirubin, international normalized ratio (INR) or partial thromboplastin time (PTT). KYNAMRO also increases hepatic fat, with or without concomitant increases in transaminases. In the trials in patients with heterozygous familial hypercholesterolemia (HeFH) and hyperlipidemia, the median absolute increase in hepatic fat was 10% after 26 weeks of treatment, from 0% at baseline, measured by magnetic resonance imaging (MRI). Hepatic steatosis is a risk factor for advanced liver disease; including steatohepatitis and cirrhosis. Measure ALT, AST, alkaline phosphatase, and total bilirubin before initiating treatment and then ALT, AST regularly as recommended. During treatment, withhold the dose of KYNAMRO if the ALT or AST are =3x ULN. Discontinue KYNAMRO for clinically significant liver toxicity. Because of the risk of hepatotoxicity, KYNAMRO is available only through a restricted program under a Risk Evaluation and Mitigation Strategy (REMS) called the KYNAMRO REMS.

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