Significantly reduced relapse rate and risk of sustained
accumulation of disability in patients taking oral teriflunomide once
daily
CAMBRIDGE, Mass.--(BUSINESS WIRE)--Genzyme,
a Sanofi company (EURONEXT: SAN and NYSE: SNY), announced today top-line
results from the TOWER (Teriflunomide Oral
in people With relapsing remitting multiplE
scleRosis) trial that assessed the efficacy
and safety of once-daily, oral teriflunomide in patients with relapsing
forms of multiple sclerosis (MS). In the study, patients receiving
teriflunomide 14 mg had a statistically significant reduction in
annualized relapse rate and risk of sustained accumulation of
disability. Analysis of the full TOWER data is ongoing and results will
be presented at a forthcoming scientific meeting.
“These encouraging results are consistent with the results on relapse
rate and disability that were observed in the TEMSO study and highlight
the promise of teriflunomide as a potential new treatment for many
patients with relapsing MS”
This double-blind, multi-center trial enrolled 1,169 patients and
compared once-daily treatment with either 7 mg or 14 mg oral
teriflunomide against placebo. Results from the primary and secondary
endpoints for the proposed 14 mg commercial dose include the following:
-
A 36.3 percent reduction in annualized relapse rate, the primary
endpoint of the trial, was observed in patients who received
teriflunomide compared to placebo (p<0.0001)
-
A 31.5 percent reduction in the risk of 12-week sustained accumulation
of disability, the main secondary endpoint, as measured by the
Expanded Disability Status Scale (EDSS) was observed with
teriflunomide compared to placebo (p=0.0442)
“These encouraging results are consistent with the results on relapse
rate and disability that were observed in the TEMSO study and highlight
the promise of teriflunomide as a potential new treatment for many
patients with relapsing MS,” said Genzyme President and CEO, David
Meeker, M.D.
A 22.3 percent reduction in annualized relapse rate was observed in
patients treated with teriflunomide 7 mg compared to placebo (p=0.02);
there was no statistically significant difference observed between
teriflunomide 7 mg and placebo for the risk of 12-week sustained
accumulation of disability.
Patients who completed the trial were followed for a period between 48
and 173 weeks. The average duration of teriflunomide exposure in TOWER
was 18 months. Adverse events observed in the trial were consistent with
previous clinical trials with teriflunomide in MS. The most common types
of adverse events reported more frequently in the teriflunomide arms
were headache, ALT (Alanine transaminase) elevations, hair thinning,
diarrhea, nausea and neutropenia. There was one death from a respiratory
infection in the placebo arm and three deaths in the teriflunomide arms
from a motor vehicle accident, suicide and sepsis.
Marketing applications for teriflunomide for the treatment of relapsing
forms of MS are under review by the U.S. Food & Drug Administration
(FDA), European Medicines Agency (EMA) and other regulatory authorities.
About Teriflunomide
Teriflunomide, a once-daily, oral tablet, is an immunomodulator with a
unique mechanism of action. Although the mechanism of action for
teriflunomide is not fully understood, research supports that
teriflunomide inhibits the proliferation of stimulated T and B
lymphocytes in the periphery thought to be responsible for the damaging
inflammatory process in MS, while generally maintaining normal immune
function.
Teriflunomide is being studied in a large clinical program that is
expected to include more than 5,000 trial participants in 36 countries.
Five efficacy clinical trials are either completed or underway with
teriflunomide, making the clinical program one of the largest of any MS
agent under development. Teriflunomide has been studied in three
multi-center Phase III studies in patients with relapsing MS, including
the completed TEMSO and TENERE trials and the TOWER trial. Another Phase
III study, TOPIC, is underway in early MS or CIS (clinically isolated
syndrome). Teriflunomide is also being evaluated as an adjunctive
therapy to interferon-β in the Phase III TERACLES trial. With up to 10
years of continuous use in a Phase II extension, teriflunomide has the
longest clinical experience of any investigational oral MS therapy.
*AUBAGIO™ is the proprietary name submitted to health authorities for
the company’s investigational MS agent teriflunomide.
About the TOWER Trial
TOWER is a Phase III, multi-center double-blind parallel-group
placebo-controlled study of the efficacy and safety of teriflunomide in
patients with relapsing MS followed by an open-label extension period.
The TOWER study included patients ages 18 to 55. The primary endpoint
was the annualized relapse rate, defined as the number of confirmed
relapses per patient-year. The key secondary endpoint was time to
disability progression confirmed for a minimum of 12-weeks. Safety
variables were defined as adverse events reported by the patients or
noted by the investigator during the study period.
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.
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).
Forward Looking Statements
This press release contains forward-looking statements as defined in
the Private Securities Litigation Reform Act of 1995, as amended.
Forward-looking statements are statements that are not historical facts.
These statements include projections and estimates and their underlying
assumptions, statements regarding plans, objectives, intentions and
expectations with respect to future financial results, events,
operations, services, product development and potential, and statements
regarding future performance. Forward-looking statements are generally
identified by the words “expects”, “anticipates”, “believes”, “intends”,
“estimates”, “plans” and similar expressions. Although Sanofi’s
management believes that the expectations reflected in such
forward-looking statements are reasonable, investors are cautioned that
forward-looking information and statements are subject to various risks
and uncertainties, many of which are difficult to predict and generally
beyond the control of Sanofi, that could cause actual results and
developments to differ materially from those expressed in, or implied or
projected by, the forward-looking information and statements. These
risks and uncertainties include among other things, the uncertainties
inherent in research and development, future clinical data and analysis,
including post marketing, decisions by regulatory authorities, such as
the FDA or the EMA, regarding whether and when to approve any drug,
device or biological application that may be filed for any such product
candidates as well as their decisions regarding labelling and other
matters that could affect the availability or commercial potential of
such product candidates, the absence of guarantee that the product
candidates if approved will be commercially successful, the future
approval and commercial success of therapeutic alternatives, the Group’s
ability to benefit from external growth opportunities, trends in
exchange rates and prevailing interest rates, the impact of cost
containment policies and subsequent changes thereto, the average number
of shares outstanding as well as those discussed or identified in the
public filings with the SEC and the AMF made by Sanofi, including those
listed under “Risk Factors” and “Cautionary Statement Regarding
Forward-Looking Statements” in Sanofi’s annual report on Form 20-F for
the year ended December 31, 2011. Other than as required by applicable
law, Sanofi does not undertake any obligation to update or revise any
forward-looking information or statements.
Genzyme® is a registered trademark. All
rights reserved.