CAMBRIDGE, Mass.--(BUSINESS WIRE)--Genzyme,
a Sanofi company (EURONEXT: SAN and NYSE: SNY), today reported top-line
results from TENERE, a Phase III clinical trial comparing the
effectiveness, safety and tolerability of once-daily oral teriflunomide
to interferon beta-1a (Rebif®), an approved injectable
therapy, in people with relapsing forms of multiple sclerosis (RMS). The
TENERE trial, which included 324 patients, is the second completed study
of five efficacy studies of teriflunomide in MS, making the clinical
program one of the largest and broadest of any multiple sclerosis agent
under development.
No statistical superiority was observed between the Rebif and
teriflunomide arms (7mg and 14mg) on risk of treatment failure, the
primary composite endpoint of the study. Risk of treatment failure was
defined as the occurrence of a confirmed relapse or permanent treatment
discontinuation for any cause, whichever came first. In the study, 48.6
percent of patients receiving 7mg of oral teriflunomide (n=109) and 37.8
percent of patients receiving 14 mg of oral teriflunomide (n=111)
reached the primary endpoint, versus 42.3 percent of patients receiving
interferon beta 1-a (n=104).
The teriflunomide 14 mg daily dose (0.259) and Rebif (0.216) were not
distinguishable on the endpoint of estimated annual relapse rate. The
rate was higher in the 7mg arm (0.410). The percentage of patients
experiencing any treatment emergent adverse events was similar across
all arms of the study. The rate of permanent treatment discontinuation
in the study due to a treatment emergent adverse event was higher in the
Rebif arm (21.8 percent vs. 8.2 percent in the 7mg teriflunomide arm and
10.9 percent in the 14 mg teriflunomide arm).
Both the 7mg and 14mg doses of teriflunomide were safe and generally
well tolerated. Most adverse events observed in the teriflunomide arms
were mild in severity, including nasopharyngitis, diarrhea, hair
thinning, and back pain. These occurred with a higher incidence than in
the Rebif arm. The most common adverse events observed in the Rebif arm
were increases in alanine aminotransferase levels, headache and flu-like
symptoms. These occurred with a higher incidence than in the
teriflunomide arms. There were no deaths in the trial.
Genzyme anticipates presenting detailed TENERE study findings at a
forthcoming medical meeting. The company will also include the results
in its application with the EMA for marketing authorization in the
European Union, along with results from its successful Phase III TEMSO
trial. The company expects to file an application for marketing
authorization with the EMA in the first quarter of 2012. The U.S. FDA
application for teriflunomide was accepted for review by the U.S. FDA in
October 2011.
About the TENERE Trial
TENERE was a two-year, randomized, rater-blinded comparator study that
included 324 people with RMS from 53 centers in 13 countries. Trial
participants were 18 years of age or older, with an Expanded Disability
Status Scale (EDSS) of 5.5 or less at the initial screening visit. Trial
participants were randomized to receive oral teriflunomide, 7 mg or 14
mg, once daily, or interferon beta-1a (Rebif® 44mcg tiw new
formulation) and were followed for 48 weeks. The primary endpoint was
risk of failure as defined by the first occurrence of relapse or
permanent study treatment discontinuation for any cause, whichever came
first. Secondary outcome measures included annualized relapse rate,
subject-reported fatigue as assessed by the Fatigue Impact Scale (FIS),
and subject satisfaction as assessed by the Treatment Satisfaction
Questionnaire for Medication (TSQM). Safety and tolerability evaluations
were based on adverse events, physical examinations, vital signs and
laboratory investigations. A long-term extension of TENERE is ongoing.
About Teriflunomide
Teriflunomide is an immunomodulatory, disease-modifying oral drug with
anti-inflammatory properties, and is under investigation for the
treatment of MS. Teriflunomide blocks the proliferation and functioning
of activated T and B lymphocytes – which are thought to be especially
damaging in MS – by selectively and reversibly inhibiting a critical
mitochondrial enzyme. Slowly dividing or resting lymphocytes are
unaffected by teriflunomide, leaving the immune system’s response to
infection uncompromised.
Teriflunomide is being studied in a large clinical program that is
expected to include more than 4,000 trial participants in 36 countries.
Five efficacy clinical trials are either completed or underway with
teriflunomide, making the clinical program one of the largest and
broadest of any MS agent under development. In addition to the TEMSO and
TENERE trials, the Phase III, placebo-controlled trial TOWER is ongoing
in people with RMS. Another Phase III study, TOPIC, is underway in early
MS or CIS (clinically isolated syndrome). Teriflunomide is also being
evaluated as an adjunct 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.
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, rare
diseases, consumer healthcare, emerging markets and animal health.
Sanofi is listed in Paris (EURONEXT: SAN) and in New York (NYSE: SNY).
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