– 30 Presentations Planned On Marketed
Products and New Data from Company’s MS Pipeline –
Genzyme, a Sanofi company, announced today that new longer-term
data on its relapsing multiple sclerosis treatments,
Aubagio® (teriflunomide) and Lemtrada® (alemtuzumab),
will be featured during the 67th annual meeting of the American
Academy of Neurology (AAN) being held in Washington, D.C. April
18-25. The company will present 30 platform and poster
presentations from its MS franchise, including 19 on Lemtrada, 10
on Aubagio and one pipeline presentation. Key data being presented
at AAN include:
- 12-Year Clinical Efficacy and Safety
Data for Teriflunomide: Results from a Phase 2 Extension Study
(Poster Session – P7.223; April 23; 2:00 – 6:30 p.m. EDT)
- Assessing Comparative Outcomes from
Teriflunomide and Dimethyl Fumarate Studies in Relapsing MS: Use of
“Number Needed to Treat” Analysis (Poster Session – P3.245; April
21; 2:00 – 6:30 p.m. EDT)
- Durable Effect of Alemtuzumab on MRI
Activity in Treatment-Naive Active Relapsing-Remitting Multiple
Sclerosis Patients: 4-Year Follow-up of CARE-MS I (Poster Session –
P7.246; April 23; 2:00 – 6:30 p.m. EDT)
- Durable Effect of Alemtuzumab on MRI
Outcomes in Patients With Relapsing-Remitting Multiple Sclerosis
Who Relapsed on Prior Therapy: 4-Year Follow-up of CARE-MS II
(Poster Session – P7.249; April 23; 2:00 – 6:30 p.m. EDT)
- Alemtuzumab Slows Brain Volume Loss
Over 4 Years Despite Most Relapsing-Remitting Multiple Sclerosis
Patients Not Receiving Treatment for 3 Years (Poster Session –
P7.263; April 23; 2:00 – 6:30 p.m. EDT)
- Characterization of a Next Generation
Anti-CD52 Antibody (Platform Session – S20.006; April 22; 3:15 p.m.
EDT)
Genzyme’s MS R&D pipeline is focused on investigational
treatments to help address unmet needs for relapsing and
progressive forms of MS through research in selective
immunomodulation, neuroprotection and remyelination. The
investigational anti-CD52 antibody GZ402668 is currently in a Phase
1 trial in MS patients, including intravenous and subcutaneous
administration. Genzyme is also developing vatelizumab, an
investigational anti-VLA-2 humanized monoclonal antibody currently
in a Phase 2 trial for relapsing forms of MS.
“The data we’re presenting at AAN this year help address
important scientific questions about Aubagio and Lemtrada over the
long-term, and in comparison with other therapies,” said Bill
Sibold, Head of Genzyme’s Multiple Sclerosis business. “We’re also
very excited to share some additional findings on the next
generation of potential Genzyme MS therapies. Our presence at AAN
demonstrates our long-term commitment to the MS community, and our
continued focus to address unmet needs for people living with
MS.”
The list of Genzyme’s additional presentations at AAN is as
follows, along with information about company-sponsored
activities.
Aubagio:
- Teriflunomide Shows Consistent Clinical
Efficacy on Severe Relapses across Two Phase 3 Trials in Patients
with Relapsing forms of Multiple Sclerosis, TEMSO and TOWER (Poster
Session – P7.212; April 23; 2:00 – 6:30 p.m. EDT)
- Teriflunomide Significantly Increased
Time to First Relapse in TEMSO, TOWER and TOPIC (Poster Session –
P7.279; April 23; 2:00 – 6:30 p.m. EDT)
- Positive MRI Outcomes in Patients with
Early Multiple Sclerosis Treated with Teriflunomide: Subgroup
Analyses from the TOPIC Phase 3 Study (Poster Session – P7.253;
April 23; 2:00 – 6:30 p.m. EDT)
- The Clinical Course of Hair Thinning
Associated with Teriflunomide: Case Series of Patients Who
Participated in a Hair Photography Project (Poster Session –
eP7.016; April 23; 2:00 – 6:30 p.m. EDT)
- How Satisfied with Their Treatment Are
Patients with MS? Psychometric Evaluation of the Treatment
Satisfaction Questionnaire for Medication (TSQM) (Poster Session –
P3.236; April 21; 2:00 – 6:30 p.m. EDT)
- Safety and Efficacy of Teriflunomide in
Patients Switching from Subcutaneous Interferon Beta-1a (Poster
Session – P7.275; April 23; 2:00 – 6:30 p.m. EDT)
- Efficacy of Teriflunomide in
Early-Stage MS: Reanalysis of the TOPIC Study Using 2010 McDonald
Diagnostic Criteria (Poster Session – P7.274; April 23; 2:00 – 6:30
p.m. EDT)
- Pooled Safety Analyses from
Teriflunomide Clinical Studies (Poster Session – P7.268; April 23;
2:00 – 6:30 p.m. EDT)
Lemtrada:
- Durable Effect of Alemtuzumab on
Clinical Outcomes in Treatment-Naive Relapsing-Remitting Multiple
Sclerosis Patients: 4-Year Follow-up of CARE-MS I (Platform Session
– S4.007; April 21; 2:30 p.m. EDT)
- Durable Effect of Alemtuzumab on
Clinical Outcomes in Patients With Relapsing-Remitting Multiple
Sclerosis Who Relapsed on Prior Therapy: 4-Year Follow-up of
CARE-MS II (Poster Session – P7.276; April 23; 2:00 – 6:30 p.m.
EDT)
- Switching to Alemtuzumab From
Subcutaneous Interferon Beta-1a After CARE-MS I Further Improved
MRI Outcomes in Patients With Relapsing-Remitting Multiple
Sclerosis (Poster Session – P7.261; April 23; 2:00 – 6:30 p.m.
EDT)
- Switching to Alemtuzumab From
Subcutaneous Interferon Beta-1a After CARE-MS II Further Improved
MRI Outcomes in Patients With Relapsing-Remitting Multiple
Sclerosis (Poster Session – P7.248; April 23; 2:00 – 6:30 p.m.
EDT)
- Improvement in Disability With
Alemtuzumab Is Associated With Quality of Life Improvement Over 3
Years in Patients Who Relapsed on Prior Therapy (Poster Session –
P3.260; April 21; 2:00 – 6:30 p.m. EDT)
- Durable Effect of Alemtuzumab on
Disability Improvement in Patients With Relapsing-Remitting
Multiple Sclerosis Who Relapsed on a Prior Therapy (Poster Session
– P3.261; April 21; 2:00 – 6:30 p.m. EDT)
- Durable Efficacy of Alemtuzumab in
Patients With Highly Active Relapsing-Remitting Multiple Sclerosis
Who Relapsed on a Prior Therapy (Poster Session – P7.269; April 23;
2:00 – 6:30 p.m. EDT)
- Slowing of Brain Volume Loss in
Patients With Relapsing-Remitting Multiple Sclerosis After
Switching From Subcutaneous Interferon Beta-1a to Alemtuzumab
(Poster Session – P7.264; April 23; 2:00 – 6:30 p.m. EDT)
- Improvement in Clinical Outcomes in
Treatment-Naive Relapsing-Remitting Multiple Sclerosis Patients Who
Switched From Subcutaneous Interferon Beta-1a to Alemtuzumab
(Poster Session – P7.270; April 23; 2:00 – 6:30 p.m. EDT)
- Improvement in Clinical Outcomes
Following Switch From Subcutaneous Interferon Beta-1a to
Alemtuzumab: CARE-MS II Extension Study (Poster Session – P7.278;
April 23; 2:00 – 6:30 p.m. EDT)
- The Efficacy of Alemtuzumab Is
Maintained in Patients Who Develop Thyroid Adverse Events (Poster
Session – P7.272; April 23; 2:00 – 6:30 p.m. EDT)
- Incidence of Infection Decreases Over
Time in Alemtuzumab-Treated Patients With Relapsing-Remitting
Multiple Sclerosis: 4-Year Follow-up of the CARE-MS Studies (Poster
Session – P7.265; April 23; 2:00 – 6:30 p.m. EDT)
- Administration of Alemtuzumab on
Nonconsecutive Days Does Not Impact Infusion-Associated Reactions,
Efficacy, or Lymphocyte Depletion (Poster Session – P7.277; April
23; 2:00 – 6:30 p.m. EDT)
- A Phase 3b/4 Long-Term Study of
Alemtuzumab in Patients With Relapsing-Remitting Multiple
Sclerosis: TOPAZ Study Design (Poster Session – P7.219; April 23;
2:00 – 6:30 p.m. EDT)
- Evaluation of Comprehensive Alemtuzumab
Infusion Guidance in Patients With Relapsing-Remitting Multiple
Sclerosis: EMERALD Study Design (Poster Session – P7.283; April 23;
2:00 – 6:30 p.m. EDT)
- Design of a Non-interventional Study to
Establish Effectiveness, Quality of Life, Cognition, Health-Related
and Work Capacity Data on Alemtuzumab in Multiple Sclerosis
Patients in Germany (TREAT-MS) (Poster Session – P7.281; April 23;
2:00 – 6:30 p.m. EDT)
Abstracts are available on the AAN website.
Genzyme Industry Therapeutic
Update
“Targeting T and B Cells in MS: The Journey From Immunology
to Clinical Outcomes”
Date: Tuesday, April 21 at 7:00 p.m.
Location: Ballroom Salon 6, Marriott Marquis, Washington,
D.C.
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.
For full prescribing information and more information about
Aubagio for U.S. patients, please visit:
http://products.sanofi.us/aubagio/aubagio.pdf.
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.
Some patients in extension trials have been treated for up to 10
years.
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.
Please click here for full U.S. Prescribing
Information for Lemtrada, including boxed warning and
contraindications.
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
comprehensive risk management program with frequent monitoring, is
being implemented to help mitigate these serious risks.
In the U.S., 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.
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 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 not
fully understood, 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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amended. Forward-looking statements are statements that are not
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among other things, the uncertainties inherent in research and
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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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