Genzyme in the UK

Company Info

Lemtrada®▼ (alemtuzumab) 12mg IV, a new treatment for adults with active relapsing remitting multiple sclerosis (RRMS), is recommended by NICE and now available in England

Date: May 28, 2014

"I am delighted that our work has led to the decision from NICE to make Lemtrada available on the NHS. This development concludes a journey that began in 1991 and now provides an opportunity for neurologists to offer a new therapy for people with multiple sclerosis early in the course of their illness” commented Alastair Compston, Professor of Neurology and Head of the Department of Clinical Neurosciences, University of Cambridge.

Dr. Alasdair Coles, Senior Lecturer, Department of Clinical Neurosciences, University of Cambridge added “We are delighted that NICE has supported the EU decision to make Lemtrada available to anyone with active relapsing remitting multiple sclerosis, without the restrictions invoked on previous drug approvals. This represents a significant change in the way therapies for multiple sclerosis are approved. We are pleased that we are able to offer patients the choice of this new treatment option.’’

Oxford, UK – The National Institute for Health and Care Excellence (NICE), has announced today the final approval of Lemtrada as an option for treating adults with active RRMS, within its marketing authorisation. Patients with RRMS will now be able to access this new treatment on the NHS.

“RRMS accounts for eighty-five percent of all initial diagnoses in MS. We are delighted that after many years in development, Lemtrada is now available on the NHS. This provides people with MS with an important treatment option to consider in partnership with their MS specialists.” said Amy Bowen, Director of Service Development at the MS Trust.

Approximately 100,000 people in the UK have MS and about 2,500 people are newly diagnosed with it each year.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 symptoms may worsen over time.4

Lemtrada is the second of Genzyme’s treatments for MS to receive approval for use from NICE and become available on the NHS.1

“We are thrilled by today’s news that NICE has approved Lemtrada for NHS use for people with RRMS. At Genzyme, we put 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 fewer relapses compared to patients treated with a beta-interferon injected multiple times per week, and treatment experienced patients were less likely to experience worsening 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). Lemtrada had been in clinical development for MS for more than 10 years and is supported by an extensive multicentre, multi-country clinical programme. , , 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.6, 7, 8

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. 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.5

For full prescribing information about Lemtrada, the Summary of Product Characteristics

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 Pharma Operations 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 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). Alemtuzumab for treating relapsing–remitting multiple sclerosis. March 2014
  2. 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]
  3. Multiple Sclerosis Trust. Types of MS. http://www.mstrust.org.uk/atoz/types.jsp [Accessed May 2014]
  4. MS Society UK. Relapsing remitting MS. http://www.mssociety.org.uk/what-is-ms/types-of-ms/relapsing-remitting-rrms [Accessed March 2014]
  5. Genzyme. Alemtuzumab Summary of Product Characteristics (SmPC) December 2013
  6. 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
  7. 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
  8. Coles, A.J. Alemtuzumab more effective than interferon b-1a at 5-year follow-up of CAMMS223 Clinical Trial. Neurology 2012; 78: 1069-1078
  9. EPAR Summary for the public. Lemtrada (alemtuzumab) European Medicines Agency. http://www.ema.europa.eu/docs/en_GB/document_library/EPAR_-_Summary_for_the_public/human/003718/WC500150523.pdf [Last accessed May 2014]

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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

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