approved in 75 countries. Fabrazyme is administered by intravenous infusion. Aldurazyme Aldurazyme (laronidase) is an enzyme replacement therapy used to treat Mucopolysaccharidosis Type 1 (MPS I). MPS I occurs in approximately 1 in 85,000 newborns worldwide, but the incidence and patient severity vary among regions. The principal markets for Aldurazyme are the U.S., Europe and Latin America. Multiple Sclerosis (MS) Aubagio Aubagio (teriflunomide) is a small molecule immunomodulatory agent with anti-inflammatory properties, reversibly inhibits dihydroorotate dehydrogenase, a mitochondrial enzyme involved in de novo pyrimidine synthesis. The exact mechanism by which teriflunomide exerts its therapeutic effect in MS is unknown but might involve a reduction in various activated lymphocytes in the CNS. Aubagio has shown significant efficacy across key measures of MS disease activity, including slowing the progression of physical disability, reducing relapses, and reducing the number of brain lesions as detected by MRI. Aubagio is the first and only oral MS therapy to slow the progression of disability in two Phase III trials (TEMSO and TOWER) and is the only oral therapy shown to prevent or delay a second clinical attack in patients who have experienced initial neurological symptoms suggestive of MS (TOPIC trial). Ongoing development efforts include the TeriKIDS study to assess the safety and efficacy of teriflunomide in children (10-17 years old), global post-marketing registries for pregnancy, and a post-approval study that will evaluate long-term safety in the marketed population using data from selected national health registries in Europe. Aubagio was approved in the U.S. in 2013 and is approved in approximately 60 countries around the world, including the E.U. and Brazil, with additional marketing applications under review by regulatory authorities globally. As of December 31, 2015, approximately 48,000 people have been treated with Aubagio worldwide. Lemtrada Lemtrada (alemtuzumab) is a humanized monoclonal antibody targeting the CD52 antigen. Alemtuzumab was developed to treat patients with relapsing forms of MS. In 2013, Lemtrada was granted marketing authorization in the E.U. for treatment of adult patients with relapsing forms of MS with active disease defined by clinical or imaging features. Since then, Lemtrada has been approved by regulatory authorities in various countries in the world, including Brazil. In 2014, the U.S. FDA approved Lemtrada for the treatment of patients with relapsing forms of MS. Lemtrada is available in the U.S. through a restricted program called the LEMTRADA Risk Evaluation and Mitigation Strategy (REMS) Program. Lemtrada is approved in approximately 45 countries. Additional marketing applications for Lemtrada are under review by regulatory agencies around the world. Oncology The company has a portfolio of 10 marketed products in Oncology, and diversified its presence beyond chemotherapy (Taxotere, Jevtana, and Eloxatin) with Thymoglobulin and Mozobil and with an angiogenesis inhibitor, Zaltrap, launched in 2012 in the United States and in 2013 in the E.U. Jevtana Jevtana (cabazitaxel), a cytotoxic agent, is a semisynthetic taxane promoting tubulin assembly and stabilizing microtubules, approved in combination with prednisone for the treatment of patients with hormone-refractory metastatic prostate cancer previously treated with a docetaxel-containing treatment regimen. Jevtana was the result of a 14-year research and development program to address the significant unmet medical need after taxane-based treatment progression. Jevtana was launched in the U.S. in 2010 and this therapy is now covered by Centers for Medicare and Medicaid Services (CMS), and by most of the private insurance companies that pay for oncology care. In 2011, Jevtana received marketing authorization from the European Commission. In 2014, the Japanese Health Authority (Pharmaceuticals and Medical Devices Agency, or PMDA) granted marketing authorization for Jevtana, which is approved in approximately 80 countries. The company has initiated a development program with Jevtana.
sanofi-adr (SNY:New York)
54, Rue La Boétie
Phone: 33 1 53 77 40 00
Fax: 33 1 53 77 42 96www.sanofi.com
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