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First-of-Its-Kind Treatment for Relapsing-Remitting Multiple Sclerosis Now Available in Canada

February 27, 2014

MISSISSAUGA, ON, Feb. 27, 2014 /CNW/ – Genzyme, a Sanofi company, today
announced the Canadian availability of (Pr)LEMTRADA(TM) (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 therapy(1) 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(TM) 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(TM) 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(TM) (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.

About Sanofi

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(TM) and AUBAGIO® are registered trademarks of Genzyme
Corporation. All rights reserved.

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References

_______________________

(1) Genzyme. Effect of Genzyme’s LEMTRADA(TM) 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.

SOURCE Genzyme


Source: PR Newswire



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