Genzyme in the UK

Company Info

Aubagio® (teriflunomide), 14 mg tablet, a once-daily oral treatment for people with active relapsing-remitting multiple sclerosis is now available in the Republic of Ireland

Date: August 11, 2014

“This is an exciting development for the MS community in Ireland who face daily challenges from their debilitating disease. The availability of Aubagio, as the first oral, once-daily, first-line medicine for the treatment of relapsing-remitting MS, offers an alternative to repeated injections which for many patients can be a real burden on top of their symptoms,” commented Ava Battles, Chief Executive MS Society Ireland.

Oxford, UK – Genzyme, a Sanofi Company, today welcomes the decision to make Aubagio available in the Republic of Ireland for the treatment of adults with active relapsing-remitting multiple sclerosis (RRMS).1

Aubagio’s availability in Ireland marks an important step in improving the standard of care available to people with MS. “Having been involved in the clinical trials for Aubagio, I am delighted to see this new treatment option now available for physicians in Ireland to consider with their patients. Multiple sclerosis as a disease and living with its effects has a huge impact on people with MS and those around them. New treatments which try to reduce that impact, such as the availability of a once-daily oral medication like Aubagio, are welcome.” commented Dr Benjamin Turner, Consultant Neurologist at Barts Health NHS Trust, London.

RRMS affects about eighty-five percent of those diagnosed with MS.2 Approximately 250 people are diagnosed with MS every year in Ireland, with 8,000 in total directly affected by the disease.3 The majority of people with RRMS experience approximately one or two relapses per year.4 Around half of all relapses may leave people with lingering problems and disability may accumulate over time.2,4

Aubagio is one of two products in Genzyme’s pipeline of MS therapies and is the first to be made available to patients in Ireland.5 “This is a very exciting time and the launch of Aubagio in Ireland represents an important milestone for Genzyme as we provide new options to a wider 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,” said Brendan Martin, General Manager for Genzyme UK and Ireland.

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. Aubagio is supported by an extensive multicentre, multi-country clinical programme, with more than 2,700 trial participants. Some patients in extension trials have been treated for up to 8.5 years.

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.6

Genzyme has introduced a risk management plan to ensure that Aubagio (teriflunomide) 14 mg 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.7

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 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.

About Genzyme in Ireland

Genzyme is a significant force in the Irish biotechnology sector focused on improving the lives of patients with rare genetic diseases and multiple sclerosis. 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.

Established in 2001, Genzyme Ireland is situated on a 37-acre site in Waterford. This multi- phased biopharmaceutical facility has had a capital investment of over €400 million and employs over 500 personnel. It is a state-of-the-art facility for finishing of biopharmaceuticals and employs a high level of automation, including manufacturing execution systems. Learn more at www.genzyme.ie.

Genzyme® is a registered trademark. All rights reserved.

Contacts

Genzyme Media Relations (UK & Ireland)
Jenny Harte – Genzyme
Tel: 01865 405 200
Email: Jenny.Harte@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: 020 7067 0709
Mob: 07880 056 198
Email: sgale@webershandwick.com

References

  1. HSE Reimbursement of Aubagio (teriflunomide 14mg) for treatment of RRMS in Republic of Ireland. Genzyme data on file
  2. MS Society UK. Relapsing-Remitting MS (RRMS). http://www.mssociety.org.uk/what-is-ms/types-of-ms/relapsing-remitting-rrms [Last Accessed August 2014]
  3. MS Ireland. Multiple Sclerosis & MS Ireland Media Fact Sheet. http://msreadathon.ie/uploads/File/MS%20and%20MS%20Ireland%20Fact%20Sheet%20-%20Media.pdf [Accessed August 2014]
  4. Multiple Sclerosis Trust. Types of MS. http://www.mstrust.org.uk/atoz/types.jsp [Last Accessed August 2014]
  5. HSE Reimbursement of Lemtrada (alemtuzumab) 12mg IV for treatment of RRMS in Republic of Ireland. Genzyme data on file
  6. Summary of Product Characteristics: Aubagio http://www.medicines.org.uk/emc/medicine/28533/SPC/AUBAGIO+14+mg+film-coated+tablets/ [Last accessed August 2014]
  7. EPAR Summary for the public. Aubagio (teriflunomide). European Medicines Agency. Available online at http://www.ema.europa.eu/docs/en_GB/document_library/EPAR_-_Summary_for_the_public/human/002514/WC500148685.pdf [Last Accessed August 2014]
  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

Highlight

  • Sanofi-aventis to Acquire Genzyme for $74.00 in Cash per Share Plus Contingent Value Right

    Sanofi-aventis and Genzyme Corporation announced that they have entered into a definitive agreement under which sanofi-aventis is to acquire Genzyme for $74.00 per share in cash, or approximately $20.1 billion. Read the full corporate press release.

Contact Info:

Genzyme Therapeutics Ltd
4620 Kingsgate
Cascade Way
Oxford Business Park South
Oxford
OX4 2SU
Tel: +01865 405200
Fax: +01865 774172
Email

Contact Info:

Genzyme Ltd, Haverhill Operations
12 Rookwood Way
Haverhill
Suffolk
CB9 8PU
Tel: +01440 703522
Fax: +01440 716269

'