SMC Says Yes to Lemtrada®▼ (alemtuzumab) 12mg IV, a New Treatment for Adults with Active Relapsing Remitting-Multiple

 SMC Says Yes to Lemtrada®▼ (alemtuzumab) 12mg IV, a New Treatment for Adults           with Active Relapsing Remitting-Multiple Sclerosis (RRMS)    PR Newswire    OXFORD, England, July 7, 2014  OXFORD, England, July 7, 2014 /PRNewswire/ --  " Scotland has one of the highest rates of multiple sclerosis in the world, and the approval of Lemtrada in Scotland is an important step forward for people with active RRMS who remain in need of new treatment options. MS treatments have come a long way in the past twenty years and the availability of Lemtrada provides an opportunity for neurologists to offer a new therapy to people with multiple sclerosis, " commented Dr. Belinda Weller, Consultant Neurologist, Western General Hospital, Edinburgh.  The Scottish Medicines Consortium (SMC) today published its advice that Lemtradahas been accepted for use within NHS Scotland for the treatment of adult patients with relapsing-remitting multiple sclerosis (RRMS), with active disease defined by clinical or imaging features. ^[1]   (Logo: http://photos.prnewswire.com/prnh/20140703/694633 )  " RRMS accounts for eighty-five percent of all initial diagnoses in MS. We are pleased that after many years in development, Lemtrada is now available to patients in Scotland. This provides people with MS with an important and innovative treatment option to consider in partnership with their MS specialists, " said Amy Bowen, Director of Service Development at the MS Trust.  There are approximately 10,000 people living with MS in Scotland. ^[2] The majority of people with RRMS experience approximately one or two relapses per year. ^[3] Around half of all relapses may leave people with lingering problems and disability may accumulate over time. ^[ ^3 ^] ^, ^[4]  Lemtrada is the second of Genzyme's treatments for MS to receive approval for use from the SMC and become available for use within NHS Scotland. ^[ ^1 ^] Lemtrada has also been approved by NICE and is available for NHS patients in England & Wales. ^[5]  " We are thrilled by today ' s news that the SMC has approved Lemtrada for NHS use for people with RRMS. At Genzyme, patients at the heart of everything we do and this final milestone brings a treatment option to people with MS that could really reshape the management of their condition. We are also immensely proud of our association with Lemtrada as a home-grown product, developed and pioneered in Cambridge by a team of UK scientists. This reminds us of the UK ' s position at the forefront of science-led medicine, the importance of industry collaboration which brings global expertise in clinical development and our joint commitment to MS patients, " commented Brendan Martin, General Manager for Genzyme UK and Ireland.  About Lemtrada (alemtuzumab)   Lemtrada is a humanised monoclonal antibody therapy which selectively targets CD52, a protein abundant on T and B cells. Treatment with alemtuzumab results in the depletion of circulating T and B cells thought to be responsible for the damaging inflammatory process in MS. Alemtuzumab has transient impact on other immune cells. The reduction in the level of circulating T and B cells by alemtuzumab and subsequent repopulation may reduce the potential for relapse, which ultimately delays disease progression. Patients treated with Lemtrada had reduced annualised relapse rate compared to patients treated with subcutaneous beta-interferon injected three times per week, and treatment experienced patients were less likely to experience accumulation of their disability. Lemtrada is administered in two short treatment courses. The first treatment course includes one infusion per day for five days (course one). A year later a second course is administered one infusion per day for three days (course two). ^[6] Lemtrada had been in clinical development for MS for more than 10 years and is supported by an extensive multicentre, multi-country clinical programme. ^[7] ^, ^[8] ^, ^[9] Lemtrada was developed as part of research at the University of Cambridge and more than 1,500 patients received Lemtrada treatment as part of these clinical trials. ^[ ^7 ^] ^, ^[ ^8 ^] ^, ^[ ^9 ^]  EU Indication and Usage   Lemtrada is indicated in the European Union for the treatment of adult patients with relapsing remitting multiple sclerosis with active disease defined by clinical or imaging features. ^[ ^6 ^]  Genzyme have introduced a risk management plan to ensure that Lemtrada is used as safely as possible. Based on this plan, safety information has been included in the Summary of Product Characteristics (SmPC) and the Patient Information Leaflet for Lemtrada, including the appropriate precautions to be followed by healthcare professionals and patients. ^[ ^6 ^]  For full prescribing information about Lemtrada, the Summary of Product Characteristics can be found here: http://www.medicines.org.uk/emc/medicine/28917/SPC/LEMTRADA+12+mg+concentrate+for+solution+for+infusion/  About Genzyme, a Sanofi Company   Genzyme has pioneered the development and delivery of transformative therapies for patients affected by rare and debilitating diseases for over 30 years. We accomplish our goals through world-class research and with the compassion and commitment of our employees. With a focus on rare diseases and multiple sclerosis, we are dedicated to making a positive impact on the lives of the patients and families we serve. That goal guides and inspires us every day. Genzyme's portfolio of transformative therapies, which are marketed in countries around the world, represents ground-breaking and life-saving advances in medicine. As a Sanofi company, Genzyme benefits from the reach and resources of one of the world's largest pharmaceutical companies, with a shared commitment to improving the lives of patients.  About Genzyme in the UK   Genzyme is a significant force in the UK biotechnology sector focused on improving the lives of patients with rare genetic diseases and multiple sclerosis. First established in the UK in 1981, Genzyme employs 450 people at two sites. Genzyme Therapeutics in Oxford is the company's UK commercial base marketing products for the treatment of patients with chronic debilitating diseases. These include genetic diseases such as lysosomal storage disorders (LSDs) - characterised by a lack of enzymes essential to healthy biological processes - and multiple sclerosis - a complex neurological disease affecting the central nervous system. Our portfolio also includes a therapy which aids in the management of thyroid cancer.  Genzyme's manufacturing facility in Haverhill, Suffolk, now integrated with Sanofi's PharmaOperations Unit, has undergone a dramatic building programme since its purchase in 1982 and now employs 380 people at a site with two large-scale manufacturing plants, a pilot plant, a development centre, warehouse and other associated facilities. The Haverhill facility manufactures the active ingredients in therapies for patients undergoing renal dialysis and is a major global distribution centre for Genzyme's products for genetic diseases. Learn more at http://www.genzyme.co.uk  Genzyme ^®  is a registered trademark. All rights reserved   References   1. SMC guidance. alemtuzumab, 12mg, concentrate for solution for infusion (Lemtrada®) http://www.scottishmedicines.org.uk   2. Scottish Public Health Authority. Multiple sclerosis: key points. Available online at www.scotpho.org.uk/health-wellbeing-and-disease/multiple-sclerosis/key-points [Accessed December 2013]  3. Multiple Sclerosis Trust. Types of MS. http://www.mstrust.org.uk/atoz/types.jsp [Accessed October 2013]   4. MS Society UK. Relapsing-Remitting MS (RRMS). http://www.mssociety.org.uk/what-is-ms/types-of-ms/relapsing-remitting-rrms [Accessed January 2014]   5. National Institute for Health and Care Excellence. Final appraisal determination (FAD). Alemtuzumab for treating relapsing-remitting multiple sclerosis. March 2014  6. Summary of Product Characteristics: Lemtrada. Electronic Medicines Compendium (eMC) http://www.medicines.org.uk/emc/medicine/28917/SPC/LEMTRADA+12+mg+concentrate+for+solution+for+infusion/ [Last accessed May 2014]  7. Cohen et al. Alemtuzumab versus interferon beta 1a as first-line treatment for patients with relapsing-remitting multiple sclerosis: a RCT phase III trial. The Lancet 2012; 380: 1069-1078  8. Coles et al. Alemtuzumab for patients with relapsing multiple sclerosis after disease-modifying therapy: a RCT phase III trial. The Lancet 2012; 380: 1829-1839  9. Coles, A.J. Alemtuzumab more effective than interferon b-1a at 5-year follow-up of CAMMS223 Clinical Trial. Neurology 2012; 78: 1069-1078    Contacts:  Genzyme Media Relations (UK & Ireland) Henry Featherstone - Genzyme Mob: +44(0)7718-695-969 Email: henry.featherstone@genzyme.com  Genzyme Media Relations (UK & Ireland) Lisa Henry - Weber Shandwick Tel: +44(0)20-7067-0808 Mob: +44(0)7785-458-203 Email: lhenry@webershandwick.com  Genzyme Media Relations (UK & Ireland) Samantha Gale - Weber Shandwick Tel: +44(0)20-7067-0709 Mob: +44(0)7880-056-198 Email: sgale@webershandwick.com   
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