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NICE Says Yes to Aubagio® (teriflunomide), a New Once Daily First-line Oral Treatment Available for People with an Active Relapsing Remitting form of MS

OXFORD, England, January 22, 2014 /PRNewswire/ --


"MS treatments have come a long way in recent years and we're moving into a new era where people with MS and their clinicians have more choice and a new alternative to injections.  Having Aubagio available as an effective, simple, oral treatment option, which only needs to be taken once daily, is an exciting development for people with MS," commented Amy Bowen, Director of Service Development at the MS Trust.

A new once daily, oral treatment, Aubagio® (teriflunomide) will now be available on the NHS for people with a relapsing form of multiple sclerosis (RRMS). This does not include patients with highly active or rapidly evolving severe relapsing-remitting MS.  Following today's National Institute for Health and Care Excellence (NICE) approval, adult patients with RRMS[1] will be able to have access to treatment with Aubagio. RRMS accounts for eighty-five percent of all initial diagnoses in MS,[2] and is a condition that has, until now, been limited to initial treatment options that are injectable.

Today's decision is welcomed by the MS community; in the UK alone, approximately 100,000 people are living with MS.[3]The availability of Aubagio offers an alternative to adult patients who find it a burden and inconvenience to have to administer regular injections.

Aubagio® was granted marketing authorisation based on efficacy and safety data from two clinical trials.[4],[5] This, coupled with the fact that Aubagio® is a convenient, once-daily, oral treatment, has led to comments on NICE's positive approval today by Dr Benjamin Turner, Clinical Neurologist at Barts Health NHS Trust:. "This is good news for people with MS and is a significant milestone in improving the care of MS patients in the UK."

The NICE approval of Aubagio represents an alternative first line treatment for people with MS who have previously had to undergo regular injections. Aubagio® is the first medicine in Genzyme's pipeline of MS therapies to become available to patients in the UK

"This is a very exciting time and the launch of Aubagio represents an important milestone for Genzyme as we provide new options to the MS community. Our commitment to improving the lives of people with MS goes beyond advancing treatment options, and we have a patient support programme underway to further support patients in adherence," said Brendan Martin, General Manager for Genzyme UK and Ireland.

Additional resources available: see contact details below

About Aubagio®(teriflunomide)

Aubagio is an immunomodulator with anti-inflammatory properties. The exact mechanism by which teriflunomide exerts its therapeutic effect in MS is not fully understood, but this is mediated by a reduced number of lymphocytes.[6]  Aubagio is supported by an extensive multicentre, multi-country clinical programme, with more than 2,700 trial participants.[7] Some patients in extension trials have been treated for up to 8.5 years.[8]

EU Indication and Usage

Aubagio® (teriflunomide 14 mg) is a once-daily, oral therapy indicated in the European Union for the treatment of adult patients with relapsing remitting multiple sclerosis.[8]

Genzyme has introduced a risk management plan to ensure that Aubagio is used as safely as possible. Based on this plan, safety information has been included in the Summary of Product Characteristics (SPC) and the Patient Information Leaflet for Aubagio, including the appropriate precautions to be followed, as described in Educational Materials to be used by healthcare professionals and patients.[6]

For full prescribing information about Aubagio, the Summary of Product Characteristics can be found here: http://www.medicines.org.uk/emc/medicine/28533/SPC/AUBAGIO+14+mg+film-coated+tablets/

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 welfare of patients with rare inherited and neurological diseases. 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 illnesses, 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 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. Genzyme's Haverhill facility manufactures the active ingredients in Genzyme's therapies for patients undergoing renal dialysis and is a major global distribution centre for the company's products for genetic illnesses. Learn more at http://www.genzyme.co.uk

Genzyme® is a registered trademark.  All rights reserved

References

1. National Institute for Health and Care Excellence. Final appraisal determination (FAD). Teriflunomide for treating relapsing-remitting multiple sclerosis. November 2013

2. MS Society. Relapsing Remitting (RRMS). http://www.mssociety.org.uk/what-is-ms/types-of-ms/relapsing-remitting-rrms  [Accessed January 2014]

3. NICE Proposed Health Technology Appraisal. Alemtuzumab, dimethyl fumarate, laquinimod and teriflunomide for the treatment of relapsing forms of multiple sclerosis. Draft scope. http://www.nice.org.uk/nicemedia/live/14061/63485/63485.pdf  [Accessed October 2013]

4. Miller AE et al. Teriflunomide Efficacy and Safety in Patients with Relapsing Multiple Sclerosis: Results From TOWER, a Second Pivotal Phase 3 Placebo-Controlled Study. Presented at the American Academy of Neurology (AAN) annual meeting, San Diego, 2013; S01.004.

5. O'Connor P et al. Randomized Trial of Oral Teriflunomide for Relapsing Multiple Sclerosis. N Engl J Med. 2011;365:1293-303

6. Aubagio Summary of Product Characteristics November 2013  

7. EPAR Summary for the public. Aubagio (teriflunomide). European Medicines Agency. http://www.ema.europa.eu/docs/en_GB/document_library/EPAR_-_Summary_for_the_public/human/002514/WC500148685.pdf. [Accessed December 2013]

8. Confavreux C et al. Teriflunomide Multiple Sclerosis Trial Group. Long-term follow-up of a phase 2 study of oral teriflunomide in relapsing multiple sclerosis: safety and efficacy results up to 8.5 years. Mult Scler J 2012 Sep;18(9):1278-1289.

Contacts:

Genzyme Media Relations (UK & Ireland)
Henry Featherstone - Genzyme
Tel: +44(0)7718 695 969
Email: [email protected]

Genzyme Media Relations (UK & Ireland)
Rosie Ireland - Weber Shandwick
Tel: +44(0)20-7067-0190
Mob: +44(0)7590-228701
Email: [email protected]

Genzyme Media Relations (UK & Ireland)
Samantha Gale - Weber Shandwick
Tel: +44(0)20-7067-0709
Mob: +44(0)7880-056198
Email: [email protected]


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