SAN ----- Genzyme’s Multiple Sclerosis Franchise
Post# of 29735
Posted On: 09/26/2013 7:27:24 AM
SAN ----- Genzyme’s Multiple Sclerosis Franchise Featured at ECTRIMS
- 18 Platform and Poster Presentations Provide Deeper Insight Into the Clinical Development Programs for Aubagio® and Lemtrada™ -
Genzyme, a Sanofi company (EURONEXT: SAN and NYSE: SNY) announced today that new data from its Aubagio® (teriflunomide) and Lemtrada™ (alemtuzumab) clinical development programs will be presented during the 29th Congress of the European Committee for Research and Treatment in Multiple Sclerosis (ECTRIMS) and the 18th Annual Conference of Rehabilitation in MS (RIMS) to be held in Copenhagen, Denmark, October 2-5.
“The recent European Commission approvals of Aubagio and Lemtrada make this year’s ECTRIMS particularly significant for Genzyme’s MS Franchise,” said Genzyme CEO and President David Meeker. “As we prepare to launch both products, we look forward to presenting these new data, which highlight the unique potential of our products to treat a broad spectrum of relapsing remitting MS patients and reflect our strong commitment to the MS community.”
Presentations at ECTRIMS/RIMS featuring Aubagio and Lemtrada are as follows.
Aubagio:
Oral Platform Presentation
TOPIC Main Outcomes: Efficacy and Safety of Once-Daily Oral Teriflunomide in Patients with Clinically Isolated Syndrome (Parallel Session 3 – 99; October 3; 12:00 p.m. CEST)
Poster Presentations
Immune Response to Neoantigen and Recall Antigens in Healthy Subjects Receiving Teriflunomide (Poster Session I – P622; October 3; 3:45 p.m. CEST)
Teriflunomide: No Effects on Sperm DNA (Poster Session II – P1187; October 4; 3:30 p.m. CEST)
Long-Term Safety and Efficacy of Teriflunomide in Patients with Relapsing Forms of Multiple Sclerosis in the TEMSO Extension Trial (Poster Session I – P544; October 3; 3:45 p.m. CEST)
Pooled Efficacy Data From Two Phase 3 Placebo-Controlled Trials of Oral, Once-Daily Teriflunomide (Poster Session I – P618; October 3; 3:45 p.m. CEST)
Updated Pregnancy Outcomes from the Teriflunomide Clinical Development Programme: Retrospective Analysis of the Teriflunomide Clinical Trial Database (Poster Session I – P541; October 3; 3:45 p.m. CEST)
Pooled Safety Data from Three Placebo-Controlled Teriflunomide Studies (Poster Session I – P633; October 3; 3:45 p.m. CEST)
Teriflunomide Reduces Relapse-Related Sequelae, Severe Relapses, Hospitalisations and Corticosteroid Use: Pooled Data from the Phase 3 TEMSO and TOWER Studies (Poster Session II – P1095; October 4; 3:30 p.m. CEST)
Impact of Severe Relapses on Disability, Fatigue, and Health-Related Quality of Life Outcomes: A Pooled Dataset of the Phase 3 TEMSO and TOWER Studies (Poster Session II – P1093; October 4; 3:30 p.m. CEST)
Lemtrada:
Poster Presentations
Alemtuzumab Improves EDSS via Effects on Functional Systems: CARE-MS II (Poster Session I – P649; October 3; 3:45 p.m. CEST)
Reduction of Disability with Alemtuzumab in Relapsing-Remitting Multiple Sclerosis Patients Who Participated in CARE-MS II: Three-Year Follow-Up (Poster Session I – P592; October 3; 3:45 p.m. CEST)
Infection Risk with Alemtuzumab in Patients with Relapsing-Remitting Multiple Sclerosis: Pooled Results from the CARE-MS I and CARE-MS II Trials (Poster Session I – P603; October 3; 3:45 p.m. CEST)
Lymphocyte Subset Dynamics Following Alemtuzumab Treatment in the CARE-MS II study (Poster Session I – P531; October 3; 3:45 p.m. CEST)
Adverse Event Profile of Alemtuzumab in Active Relapsing-Remitting Multiple Sclerosis Patients Who Participated in the CARE-MS Studies: Three-Year Follow-Up (Poster Session II – P1053; October 4; 3:30 p.m. CEST)
Lymphocyte Counts and Efficacy Outcomes After Alemtuzumab in Relapsing-Remitting Multiple Sclerosis Patients: The CARE-MS Studies (Poster Session I – P515; October 3; 3:45 p.m. CEST)
Preservation of Lymphocyte Migratory Ability Following Anti-CD52 Therapy (Poster Session II – P1207; October 4; 3:30 p.m. CEST)
Detection, Incidence, and Management of Glomerulonephritis in the Alemtuzumab Clinical Development Program (Poster Session I – P597; October 3: 3:45 p.m. CEST)
Immunogenicity of Alemtuzumab Does Not Impact Safety and Efficacy in Relapsing-Remitting Multiple Sclerosis Patients in the CARE-MS I Study (Poster Session I – P523; October 3; 3:45 p.m. CEST)
Abstracts are available on the ECTRIMS/RIMS website.
Genzyme-Sponsored Symposium
“The Challenges of Disease Management in MS: Navigating the Changing Landscape”
When: Friday, October 4; 6:00 – 7:00 p.m. CEST
Location: Hall A, Bella Center
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 Lemtrada™ (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, rebalancing the immune system in a way that potentially reduces MS disease activity.
Genzyme holds the worldwide rights to alemtuzumab and has primary responsibility for its development and commercialization in multiple sclerosis. Bayer HealthCare holds the right to co-promote alemtuzumab in MS in the United States. Upon commercialization, Bayer will receive 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® and Aubagio® are registered trademarks of Genzyme Corporation, a Sanofi company.
LemtradaTM is a trademark of Genzyme Corporation, a Sanofi company.
About Sanofi
Sanofi, an integrated 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).
Genzyme Media Relations
Erin Walsh, +1 617-945-3628
erin.walsh@genzyme.com
or
Sanofi Investor Relations
Kristen Galfetti, +1 908-981-5560
ir@sanofi.com
- 18 Platform and Poster Presentations Provide Deeper Insight Into the Clinical Development Programs for Aubagio® and Lemtrada™ -
Genzyme, a Sanofi company (EURONEXT: SAN and NYSE: SNY) announced today that new data from its Aubagio® (teriflunomide) and Lemtrada™ (alemtuzumab) clinical development programs will be presented during the 29th Congress of the European Committee for Research and Treatment in Multiple Sclerosis (ECTRIMS) and the 18th Annual Conference of Rehabilitation in MS (RIMS) to be held in Copenhagen, Denmark, October 2-5.
“The recent European Commission approvals of Aubagio and Lemtrada make this year’s ECTRIMS particularly significant for Genzyme’s MS Franchise,” said Genzyme CEO and President David Meeker. “As we prepare to launch both products, we look forward to presenting these new data, which highlight the unique potential of our products to treat a broad spectrum of relapsing remitting MS patients and reflect our strong commitment to the MS community.”
Presentations at ECTRIMS/RIMS featuring Aubagio and Lemtrada are as follows.
Aubagio:
Oral Platform Presentation
TOPIC Main Outcomes: Efficacy and Safety of Once-Daily Oral Teriflunomide in Patients with Clinically Isolated Syndrome (Parallel Session 3 – 99; October 3; 12:00 p.m. CEST)
Poster Presentations
Immune Response to Neoantigen and Recall Antigens in Healthy Subjects Receiving Teriflunomide (Poster Session I – P622; October 3; 3:45 p.m. CEST)
Teriflunomide: No Effects on Sperm DNA (Poster Session II – P1187; October 4; 3:30 p.m. CEST)
Long-Term Safety and Efficacy of Teriflunomide in Patients with Relapsing Forms of Multiple Sclerosis in the TEMSO Extension Trial (Poster Session I – P544; October 3; 3:45 p.m. CEST)
Pooled Efficacy Data From Two Phase 3 Placebo-Controlled Trials of Oral, Once-Daily Teriflunomide (Poster Session I – P618; October 3; 3:45 p.m. CEST)
Updated Pregnancy Outcomes from the Teriflunomide Clinical Development Programme: Retrospective Analysis of the Teriflunomide Clinical Trial Database (Poster Session I – P541; October 3; 3:45 p.m. CEST)
Pooled Safety Data from Three Placebo-Controlled Teriflunomide Studies (Poster Session I – P633; October 3; 3:45 p.m. CEST)
Teriflunomide Reduces Relapse-Related Sequelae, Severe Relapses, Hospitalisations and Corticosteroid Use: Pooled Data from the Phase 3 TEMSO and TOWER Studies (Poster Session II – P1095; October 4; 3:30 p.m. CEST)
Impact of Severe Relapses on Disability, Fatigue, and Health-Related Quality of Life Outcomes: A Pooled Dataset of the Phase 3 TEMSO and TOWER Studies (Poster Session II – P1093; October 4; 3:30 p.m. CEST)
Lemtrada:
Poster Presentations
Alemtuzumab Improves EDSS via Effects on Functional Systems: CARE-MS II (Poster Session I – P649; October 3; 3:45 p.m. CEST)
Reduction of Disability with Alemtuzumab in Relapsing-Remitting Multiple Sclerosis Patients Who Participated in CARE-MS II: Three-Year Follow-Up (Poster Session I – P592; October 3; 3:45 p.m. CEST)
Infection Risk with Alemtuzumab in Patients with Relapsing-Remitting Multiple Sclerosis: Pooled Results from the CARE-MS I and CARE-MS II Trials (Poster Session I – P603; October 3; 3:45 p.m. CEST)
Lymphocyte Subset Dynamics Following Alemtuzumab Treatment in the CARE-MS II study (Poster Session I – P531; October 3; 3:45 p.m. CEST)
Adverse Event Profile of Alemtuzumab in Active Relapsing-Remitting Multiple Sclerosis Patients Who Participated in the CARE-MS Studies: Three-Year Follow-Up (Poster Session II – P1053; October 4; 3:30 p.m. CEST)
Lymphocyte Counts and Efficacy Outcomes After Alemtuzumab in Relapsing-Remitting Multiple Sclerosis Patients: The CARE-MS Studies (Poster Session I – P515; October 3; 3:45 p.m. CEST)
Preservation of Lymphocyte Migratory Ability Following Anti-CD52 Therapy (Poster Session II – P1207; October 4; 3:30 p.m. CEST)
Detection, Incidence, and Management of Glomerulonephritis in the Alemtuzumab Clinical Development Program (Poster Session I – P597; October 3: 3:45 p.m. CEST)
Immunogenicity of Alemtuzumab Does Not Impact Safety and Efficacy in Relapsing-Remitting Multiple Sclerosis Patients in the CARE-MS I Study (Poster Session I – P523; October 3; 3:45 p.m. CEST)
Abstracts are available on the ECTRIMS/RIMS website.
Genzyme-Sponsored Symposium
“The Challenges of Disease Management in MS: Navigating the Changing Landscape”
When: Friday, October 4; 6:00 – 7:00 p.m. CEST
Location: Hall A, Bella Center
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 Lemtrada™ (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, rebalancing the immune system in a way that potentially reduces MS disease activity.
Genzyme holds the worldwide rights to alemtuzumab and has primary responsibility for its development and commercialization in multiple sclerosis. Bayer HealthCare holds the right to co-promote alemtuzumab in MS in the United States. Upon commercialization, Bayer will receive 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® and Aubagio® are registered trademarks of Genzyme Corporation, a Sanofi company.
LemtradaTM is a trademark of Genzyme Corporation, a Sanofi company.
About Sanofi
Sanofi, an integrated 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).
Genzyme Media Relations
Erin Walsh, +1 617-945-3628
erin.walsh@genzyme.com
or
Sanofi Investor Relations
Kristen Galfetti, +1 908-981-5560
ir@sanofi.com
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