Date: February 27, 2014
Mississauga, ON – February 27, 2014 – Genzyme, a Sanofi company, today announced the Canadian availability of PrLEMTRADA™ (alemtuzumab) for the management of adult patients with relapsing-remitting multiple sclerosis (RRMS), with active disease defined by clinical and imaging features, who have had an inadequate response to interferon beta or other disease-modifying therapies.
LEMTRADA 12 mg has a dosing and administration schedule of two annual treatment courses. The first treatment course of LEMTRADA is administered via intravenous infusion on five consecutive days, and the second course is administered on three consecutive days, 12 months later. LEMTRADA patients require monitoring at regular intervals between treatment courses and for 48 months following the final infusion.
During an extensive, ongoing clinical development program, 80 per cent of RRMS patients who received two treatment courses of LEMTRADA required no further therapy1 and 55 per cent remained relapse-free through the first year of the extension study. Unlike other current disease modifying therapies (DMTs) in which stopping treatment usually results in resumed disease activity, LEMTRADA continues to have a durable effect far beyond the two annual treatment courses. In fact, in more than 70 per cent of clinical trial patients, disability scores improved or remained stable over three years.1
“The approval of LEMTRADA represents an important new treatment option for Canadians living with MS. In clinical trials, LEMTRADA demonstrated impressive effectiveness following two treatment courses for patients with active relapsing MS,” said Dr. Anthony Traboulsee, Associate Professor of Neurology and Medical Director of the UBC Hospital MS Clinic of Vancouver Coastal Health. “Our own experience in treating 35 patients through clinical trials with LEMTRADA has been extremely positive.”
LEMTRADA was approved by Health Canada in December 2013. The approval was based on data from the LEMTRADA clinical development program comparing treatment of LEMTRADA to high-dose subcutaneous interferon beta-1a (Rebif®) – which is dosed three times per week – in patients with RRMS who had active disease. In a controlled Phase 3 clinical study, LEMTRADA was more effective compared to Rebif at reducing both the annualized relapse rates (ARR) and the accumulation of disability was significantly slowed in patients given LEMTRADA vs. Rebif.2
In clinical trials, LEMTRADA demonstrated an ARR reduction of 49.4 per cent when compared with Rebif (p<0.0001), and the proportion of relapse-free patients was significantly (p<0.0001) higher in LEMTRADA patients than Rebif (65.4 per cent and 46.7 per cent, respectively). In addition, the risk of sustained accumulation of disability (SAD) over six months was reduced by 42 per cent in patients who received LEMTRADA versus Rebif (p=0.0084).2 “
The approval and availability of LEMTRADA represents an important advancement for the MS community,” said Dr. Karen Lee, Vice-President, Research, Multiple Sclerosis Society of Canada. “The more treatment options that are available, the more choices Canadians living with MS have to potentially improve their overall quality of life.”
In November 2013, Genzyme’s AUBAGIO® (teriflunomide) 14 mg was approved by Health Canada as monotherapy for the treatment of patients with RRMS to reduce the frequency of clinical exacerbations and to delay the accumulation of physical disability. The approval was based on efficacy data from two Phase III clinical trials – TEMSO (TEriflunomide Multiple Sclerosis Oral) and TOWER (Teriflunomide Oral in people With relapsing remitting multiplE scleRosis). In the TEMSO trial, AUBAGIO 14 mg significantly reduced the annualized relapse rate (p=0.0005) and the time to disability progression (p=0.0279) at two years versus placebo in patients with RRMS. In the TOWER trial, AUBAGIO 14 mg significantly reduced the annualized relapse rate (p=0.0001) and the time to disability progression sustained for 12 weeks (p=0.0442) was statistically significantly reduced versus placebo in patients with RRMS.
“The Canadian approval and availability of LEMTRADA and AUBAGIO represent an important milestone for Genzyme and demonstrate our focus on scientific innovation and commitment to MS patients,” said Peter Brenders, General Manager, Genzyme Canada. “We are proud of our commitment to long-term leadership and partnership with the MS community.”
LEMTRADA is supported by a comprehensive and extensive clinical development program that involved 1,188 patients, resulting in 2,363 patient-years of safety follow-up.
A New Standard in Patient Support
As LEMTRADA patients require monitoring at regular intervals between treatment courses and for 48 months following the final infusion, Genzyme is providing every patient with a unique, comprehensive and free patient support program. The MS One to One™ program will offer comprehensive support services, including: counseling, pre-treatment testing, coordination of infusion appointment and location, post-treatment monitoring at the patient’s preferred location (lab, infusion centre or in-home), delivery of test results directly to patient’s healthcare provider, patient education and compliance services, as well as reimbursement navigation and other financial assistance. Staffed by dedicated MS nurses and highly trained representatives, MS One to One™ can provide support for individuals living with MS who are receiving Genzyme MS therapies, their health care providers, family and loved ones. Please consult your healthcare provider for more information.
The most common side effects of LEMTRADA are infusion-associated reactions (headache, rash, pyrexia, nausea, urticaria, pruritus, insomnia, chills and flushing) and infections (nasopharyngitis, urinary tract and upper respiratory tract). Serious infections and autoimmune conditions, including thyroid disease, cytopenias, and kidney disease can occur in patients receiving LEMTRADA. A comprehensive risk management program incorporating education and monitoring will support early detection and management of these identified risks.
About MS in Canada
With 100,000 Canadians living with MS and three people newly diagnosed every day,3 Canada has the highest rate of MS in the world.4 As most people are diagnosed with relapsing MS in their 20s and 30s,5 MS is the most common neurological disease affecting young adults in Canada.3
As a debilitating disease, MS symptoms can include: blurred or loss of vision, poor coordination, slurred speech, extreme fatigue, diminished mobility of the arms or legs, problems with memory and concentration, and bladder and bowel dysfunction.5
About LEMTRADA™ (alemtuzumab)
Alemtuzumab is a monoclonal antibody that 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 minimal impact on other immune cells. The acute anti-inflammatory effect of alemtuzumab is immediately followed by the onset of a distinctive pattern of T and B cell repopulation that continues over time, altering the immune system in a way that potentially reduces MS disease activity.
About AUBAGIO® (Teriflunomide)
AUBAGIO is an immunomodulator with anti-inflammatory properties. Although the exact mechanism of action for AUBAGIO is not fully understood, it may involve a reduction in the number of activated lymphocytes in the central nervous system (CNS). AUBAGIO is supported by one of the largest clinical programs of any MS therapy, with more than 5,000 trial participants in 36 countries. Some patients in extension trials have been treated for up to 10 years.
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 groundbreaking 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. Learn more at www.genzyme.ca.
Sanofi, a global and diversified healthcare leader, discovers, develops and distributes therapeutic solutions focused on patients' needs. Sanofi has core strengths in the field of healthcare with seven growth platforms: diabetes solutions, human vaccines, innovative drugs, consumer healthcare, emerging markets, animal health and the new Genzyme. Sanofi is listed in Paris (EURONEXT: SAN) and in New York (NYSE: SNY).
Genzyme®, LEMTRADA™ and AUBAGIO® are registered trademarks of Genzyme Corporation. All rights reserved.
Director Government Affairs and Market Access, Genzyme Canada
Account Coordinator, Cohn & Wolfe
1 Genzyme. Effect of Genzyme’s LEMTRADA™ Maintained in Patients Beyond Two-Year Pivotal MS Studies. Available at: http://news.genzyme.com/press-release/effect-genzymes-lemtrada-maintained-patients-beyond-two-year-pivotal-ms-studies. Accessed on February 7, 2014.
2 Coles AJ et al. Alemtuzumab for patients with relapsing multiple sclerosis after disease-modifying therapy: a randomised controlled phase 3 trial. The Lancet. 2012 Nov 24;380(9856):1829-39. Available at:www.thelancet.com/journals/lancet/article/PIIS0140-6736%2812%2961768-1/fulltext.
Accessed on February 6, 2014.
3 Multiple Sclerosis Society of Canada. About MS. Available at: http://mssociety.ca/en/information/default.htm. Accessed on January 24, 2014.
4 MS-UK. Ethnic groups, geographical regions and MS. Available at: www.ms-uk.org/ethnicgroups. Accessed on January 24, 2014.
5 Genzyme. Multiple Sclerosis (MS) infographic.