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Sanofi Launches 'Once Daily' Oral, Teriflunomide 14 mg Tablet 'Aubagio' - for Treatment of Multiple Sclerosis in India

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(Eds: Disclaimer: The following press release comes to you under an arrangement with PR Newswire. PTI takes no editorial responsibility for the same.) MUMBAI, December 5, 2018/PRNewswire/ -- - AubagioŽ (Teriflunomide, 14 mg) offers patients diagnosed with Multiple Sclerosis the efficacy and convenience of once-a-day oral treatment - Over 200,000 people in India are living with Multiple Sclerosis[1] Sanofi Genzyme, the specialty care global business unit of Sanofi, brings to India - AubagioŽ (Teriflunomide, 14 mg), from its international Multiple Sclerosis (MS) portfolio. Multiple Sclerosis is a chronic debilitating disease of the nervous system with varied symptoms like weakness in the limbs, poor vision, fatigue or slurred speech. (Logo: ) (Photo: ) AubagioŽ (Teriflunomide, 14 mg) is the first original 'once-daily' oral 'disease modifying therapy' (DMT) for Multiple Sclerosis to be approved in India. It offers an effective, safe and a convenient option that is indicated as a first-line treatment for relapsing forms of Multiple Sclerosis that must be taken once a day, with or without food. Commenting on the launch, N. Rajaram, Managing Director, Sanofi India, said, "There are around two lakh people living with this disease in India. There are increasing numbers of cases being detected due to greater awareness and access to better diagnostic facilities. Millions of patients depend on us for their healthcare needs, and as a health journey partner, we understand the many challenges that people with Multiple Sclerosis face." He added, "For over a decade Sanofi has invested in developing and delivering novel therapeutic solutions for treatment of Multiple Sclerosis around the world; and with that, we have now brought our original research product to India. This product has the potential to offer an efficacious and convenient treatment regimen of just once a day oral tablet, vis-ŕ-vis common treatment options that are injectables. With AubagioŽ (Teriflunomide, 14 mg), we reiterate Sanofi Genzyme's commitment to improve and empower the lives of people with debilitating diseases in India." Dr. Shalini Menon, Head - Medical Affairs, India & South Asia, Sanofi, said, "AubagioŽ (Teriflunomide, 14 mg) is a differentiated disease modifying therapy, that blocks the enzyme involved in multiplication of overactive immune cells. When taken daily, AubagioŽ (Teriflunomide, 14 mg) reduces the number of overactive immune cells that cause the disease flare-ups, while still allowing normal immune cell activity to occur. It is important to note that AubagioŽ (Teriflunomide, 14 mg) has demonstrated consistent efficacy in reducing the frequency of relapses, delaying the accumulation of physical disability and, arresting further decrease in brain volume. In addition, given its convenience as an oral medicine, AubagioŽ (Teriflunomide, 14 mg) encourages people with Multiple Sclerosis to continue with long-term treatment." First approved by the US FDA in 2012, AubagioŽ (Teriflunomide, 14 mg) has a strong global presence today with approvals in more than 81 countries.[3]It has been extensively studied in more than 5,500 patients with up to 13 years of clinical and follow-up studies with proven clinical efficacy, safety and tolerability outcomes.[3] Globally, more than 85,000 patients with Multiple Sclerosis are benefitting from the use of AubagioŽ [3]. About Multiple Sclerosis: Multiple Sclerosis is an autoimmune, debilitating disease of the nervous system that affects the spinal cord and brain. In Multiple Sclerosis, there is progressive damage to the sheath that protects nerve cells, impairing communication between the brain and the nervous system. Signs and symptoms vary from one person to another and may include: weakness and numbness in the limbs, poor vision, tingling and pain in parts of the body, unsteady gait, lack of coordination, fatigue or slurred speech. Most people develop a 'relapsing-remitting' form of Multiple Sclerosis where symptoms ('relapses') may last for days or weeks and then improve completely or partially. This is then followed by a period of remission that could last for months or even years.[2]Multiple Sclerosis is a common cause of disability that usually affects young persons during their most productive years but only 45% of all patients are correctly diagnosed.[4] Research shows across the world, over 2.3 million people are living with Multiple Sclerosis.[5] About AubagioŽ (Teriflunomide, 14 mg) AubagioŽ (Teriflunomide, 14 mg) is an innovator product with almost 13 years of proven clinical efficacy, safety and tolerability data, and is a best in class medication for relapsing and remitting Multiple Sclerosis. It is a differentiated Disease-Modifying Therapy (DMT), which works by blocking the enzyme needed for immune cells to keep multiplying at an overactive rate. When taken daily, AubagioŽ reduces the number of overactive immune cells [that causes the disease flare-ups, while still allowing normal immune cell activity to occur]. Unlike other medicines, AubagioŽ is India's first innovator 'once-daily' oral pill to treat Multiple Sclerosis in India. It can be taken any time of the day, with or without food. This ensures patient adherence and convenience, both of which are missing in currently available Multiple Sclerosis therapies. About Sanofi Sanofi is dedicated to supporting people through their health challenges. We are a global biopharmaceutical company focused on human health. We prevent illness with vaccines, provide innovative treatments to fight pain and ease suffering. We stand by the few who suffer from rare diseases and the millions with long-term chronic conditions. With more than 100,000 people in 100 countries, Sanofi is transforming scientific innovation into healthcare solutions around the globe. Sanofi Genzyme, the specialty care global business unit of Sanofi, is focused on rare diseases, multiple sclerosis, and immunology. It focuses on developing specialty treatments for debilitating diseases that are often difficult to diagnose and treat, providing hope to patients and their families. Sanofi Genzyme is recognized as one of the industry's most generous in-kind givers and 2018 marks the 20th year of Sanofi Genzyme’s charitable access program in India. Through this program, known as INCAP (INdia Charitable Access Program), Sanofi Genzyme is currently providing free Enzyme Replacement Therapy to patients with Lysosomal Storage Disorders (LSDs) in India. [1] Accessed on July 4, 2018 (This was in the context of - Currently, in almost 90% cases , Multiple Sclerosis treatment is driven by injectables) [2] Mayo Clinic. Multiple Sclerosis. Available at: on May 24, 2018. [3] Genzyme data on File [4] Genzyme data on File (As per market research done in 2015) [5] Source: Sanofi Genzyme PWR PWR

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