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]

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" 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

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:

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

Genzyme ^®  is a registered trademark. All rights reserved 


1. SMC guidance. alemtuzumab, 12mg, concentrate for solution for infusion

2. Scottish Public Health Authority. Multiple sclerosis: key points. Available
online at
[Accessed December 2013]

3. Multiple Sclerosis Trust. Types of MS. [Accessed October 2013] 

4. MS Society UK. Relapsing-Remitting MS (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)
[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:

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


Genzyme Media Relations (UK & Ireland) Henry Featherstone - Genzyme Mob:
+44(0)7718-695-969 Email:

Genzyme Media Relations (UK & Ireland) Lisa Henry - Weber Shandwick Tel:
+44(0)20-7067-0808 Mob: +44(0)7785-458-203 Email:

Genzyme Media Relations (UK & Ireland) Samantha Gale - Weber Shandwick Tel:
+44(0)20-7067-0709 Mob: +44(0)7880-056-198 Email: 
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