Genzyme, a Sanofi company, announced today that data on its
relapsing multiple sclerosis treatments, Aubagio®
(teriflunomide) and Lemtrada® (alemtuzumab), will be
featured during the 2015 annual meeting of the Consortium of
Multiple Sclerosis Centers (CMSC) being held in Indianapolis,
Indiana, May 27-30.
“The data to be presented during CMSC provide further insight
into the potential clinical impact of Aubagio and Lemtrada,” said
Bill Sibold, Head of Genzyme’s Multiple Sclerosis business. “For
more than a decade, Genzyme has been dedicated to developing novel
treatments for MS. In addition to the global launches of our two
products, our early stage and clinical research programs in MS aim
to address remaining unmet needs with innovative therapeutic
approaches and underscore our long-term commitment to the MS
community.”
Genzyme’s platform and poster presentations will feature
efficacy and safety information on Aubagio and Lemtrada, while
other company activities will explore the dynamics involved in
treatment decisions. Presentation details along with information
about Genzyme-sponsored activities are as follows.
Lemtrada:
- Durable Effect of Alemtuzumab on MRI
Activity and Brain Atrophy in Relapsing-Remitting Multiple
Sclerosis Patients: 4-Year Follow-up of Care-MS II (platform
#3562)
- Alemtuzumab Improves Sustained
Accumulation of Disability Outcomes Using the SAD-Plus Assessment
in RRMS Patients with Inadequate Efficacy Response to Prior Therapy
(poster #3531)
- Improvements in Quality of Life Are
Maintained in Alemtuzumab-Treated RRMS Patients Who Develop
Autoimmune Adverse Events: Care-MS II (poster #3560)
- Lymphocyte Pharmacodynamics and Safety
of Natalizumab in Patients Previously Treated with Alemtuzumab
(poster #3403)
- Infusion-Associated Reactions in
Patients Receiving Alemtuzumab after Switching from Subcutaneous
Interferon Beta-1a (poster #3543)
Aubagio:
- Teriflunomide Efficacy in Newly
Diagnosed Patients With RMS Enrolled in the TEMSO and TOWER
Studies: a Post Hoc Analysis (poster #3400)
- Consistent Efficacy of Teriflunomide in
Prespecified Subgroup Analyses From a Phase 3 Trial (TOPIC) in
Patients With Early Multiple Sclerosis (poster #3475)
- Efficacy and Safety of Teriflunomide in
Patients Switching From Other Disease-Modifying Therapies (poster
#3392)
- Hair Photography Project: Exploring the
Clinical Course of Hair Thinning Associated With Teriflunomide
(poster #3315)
- Baseline Characteristics of Patients
Enrolled in the Teri-PRO Phase 4 Study in the United States vs
Canada, Europe, and Latin America (poster #3389)
- Investigation of the Effectiveness and
Tolerability of Colesevelam HCl for Accelerated Elimination of
Teriflunomide in Healthy Subjects (poster #3517)
Disease Management:
- Best Practice Recommendations of
Advanced Practice Clinicians for the Care of the Challenging MS
Patient (poster #3657)
Genzyme-sponsored events at CMSC include the following:
Cases in MS: Selecting Appropriate
Treatment Options for PatientsDate: Thursday, May 28 from 7 p.m. –
8 p.m.Location: JW Marriott Indianapolis Grand Ballroom – Exhibit
Hall, Product Theater Area
The Management of Infusions in Patients with
Relapsing MSDate: Friday, May 29, 7 a.m. – 8 a.m.Location: JW
Marriott Indianapolis – White River Ballroom G-J
In addition, Genzyme is a sponsor of the following symposium at
CMSC being presented by the MS Association of America:
Addressing the Science and Emotion of Benefit
and Risk: Working Collaboratively to Improve Shared Decision
MakingDate: Thursday, May 28 from 8 p.m. – 9:15 p.m.Location: JW
Marriott Indianapolis – White River Ballroom C-D
Aubagio® (teriflunomide) U.S. Indication and
Usage
Aubagio is a once-daily, oral therapy indicated in the U.S. for
the treatment of adult patients with relapsing forms of multiple
sclerosis. The recommended dose of Aubagio is 7 mg or 14 mg orally
once-daily.
Important Safety Information About Aubagio for U.S.
Patients
The Aubagio label includes the risk of hepatotoxicity and,
teratogenicity (based on animal data). In the United States, this
information can be found in the boxed warning.
In MS clinical studies with Aubagio, the incidence of serious
adverse events were similar among Aubagio and placebo-treated
patients. Serious events may include decreased white blood cell
count, peripheral neuropathy, hyperkalemia, skin reactions and
increased blood pressure. The most common adverse events associated
with Aubagio in MS patients included increased ALT levels,
alopecia, diarrhea, influenza, nausea and paresthesia.
Teriflunomide is the principal active metabolite of leflunomide,
which is indicated in the U.S. for the treatment of rheumatoid
arthritis. Severe liver injury including fatal liver failure has
been reported in patients treated with leflunomide. ALT should be
monitored monthly for at least 6 months in patients who start
treatment with Aubagio.
Aubagio is contraindicated in patients with severe hepatic
impairment, pregnant women and women of childbearing potential who
are not using reliable contraception and in patients who are taking
leflunomide. Aubagio is not recommended for breast feeding women,
patients with immunodeficiency states, patients with significantly
impaired bone marrow function or significant anemia, leucopenia,
neutropenia or thrombocytopenia, patients with severe active
infection until resolution, patients with severe renal impairment
undergoing dialysis and patients with hypoproteinaemia.
Please click here for full U.S. Prescribing
Information for Aubagio, including boxed warning and
contraindications.
About Aubagio® (teriflunomide)
Aubagio is approved in more than 50 countries, with additional
marketing applications under review by regulatory authorities
globally.
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.
Lemtrada® (alemtuzumab) U.S. Indication and
Usage
Lemtrada is indicated in the United States for the treatment of
patients with relapsing forms of multiple sclerosis (MS). Because
of its safety profile, the use of Lemtrada should generally be
reserved for patients who have had an inadequate response to two or
more drugs indicated for the treatment of MS.
Lemtrada is contraindicated in patients who are infected with
Human Immunodeficiency Virus (HIV) because Lemtrada causes
prolonged reductions of CD4+ lymphocyte counts.
Important Safety Information About Lemtrada for U.S.
Patients
Serious and life-threatening autoimmune conditions such as
immune thrombocytopenia (ITP) and anti-glomerular basement membrane
disease can occur in patients receiving Lemtrada. Monitor complete
blood counts with differential, serum creatinine levels, and
urinalysis with urine cell counts at periodic intervals in patients
who receive Lemtrada. Lemtrada is associated with serious and
life-threatening infusion reactions. Lemtrada can only be
administered in certified healthcare settings that have on-site
access to equipment and personnel trained to manage anaphylaxis and
serious infusion reactions. Lemtrada may be associated with an
increased risk of malignancy, including thyroid cancer, melanoma
and lymphoproliferative disorders. The Lemtrada REMS Program, a
risk management program with frequent monitoring, has been
implemented to help mitigate these serious risks.
The Lemtrada label includes a boxed warning noting a risk of
serious, sometimes fatal autoimmune conditions, serious and
life-threatening infusion reactions and also noting Lemtrada may
cause an increased risk of malignancies including thyroid cancer,
melanoma and lymphoproliferative disorders. Lemtrada is
contraindicated in patients with Human Immunodeficiency Virus (HIV)
infection.
Please click here for full U.S. Prescribing
Information for Lemtrada, including boxed warning and
contraindications.
About Lemtrada® (alemtuzumab)
Lemtrada is approved in more than 40 countries, with additional
marketing applications under review. Lemtrada is supported by a
comprehensive and extensive clinical development program that
involved nearly 1,500 patients worldwide and 5,400 patient-years of
follow-up.
Alemtuzumab is a monoclonal antibody that targets CD52, a
protein abundant on T and B cells. Circulating T and B cells are
thought to be responsible for the damaging inflammatory process in
MS. Although the exact mechanism of action for alemtuzumab is
unknown, it is presumed to deplete circulating T and B lymphocytes
after each treatment course. Lymphocyte counts then increase over
time with a reconstitution of the lymphocyte population that varies
for the different lymphocyte subtypes.
Genzyme holds the worldwide rights to alemtuzumab and has
responsibility for its development and commercialization in
multiple sclerosis. Bayer Healthcare receives contingent payments
based on global sales revenue.
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.com.
Genzyme®, Aubagio® and Lemtrada® are registered
trademarks of Genzyme Corporation. All rights reserved.
About Sanofi
Sanofi, a global 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).
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Genzyme Media RelationsErin Pascal, + 1
617-768-6864erin.pascal@genzyme.comorSanofi Investor
RelationsSébastien Martel, +33 (0) 1 53 77 45
45ir@sanofi.com
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