Teriflunomide Successfully Reduces Relapses and is Well Tolerated in Multiple Sclerosis Patients

October 15, 2010

PARIS, October 15, 2010 /PRNewswire-FirstCall/ –

– Phase III TEMSO Study Meets Goals Including Delayed Disability
Progression for Teriflunomide 14mg

Sanofi-aventis (EURONEXT: SAN and NYSE: SNY) announced today the results
from the two year phase III TEMSO study of teriflunomide, a novel oral
disease modifier investigated for the treatment of relapsing multiple
sclerosis (RMS). In this study, both doses of teriflunomide (7 and 14mg)
significantly reduced annualized relapse rate (primary study endpoint) by 31%
vs. placebo (p is less than or equal to 0.0005). The risk of disability
progression (sustained for 12 weeks) was also significantly reduced by 30%
for the 14mg dose (p=0.02) and numerically reduced by 24% for the 7mg dose
(p=0.08). Both doses of teriflunomide were well tolerated with a similar
number of patients reporting either treatment-emergent adverse events (TEAEs)
including serious adverse events or TEAEs leading to treatment
discontinuation in the treatment vs. placebo arms.

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“We are very pleased with the successful results of the TEMSO study which
are an important step forward in multiple sclerosis clinical research,” said

Marc Cluzel, M.D., Ph.D., Executive Vice President, Research & Development,
sanofi-aventis. “These exciting results with teriflunomide represent a new
real hope to delivering an oral therapy to patients who live with this
serious condition and are eager for new treatment options, and more
convenient product forms in-line with our sanofi-aventis commitment to
multiple sclerosis.”

The results of the TEMSO trial are the first study findings from a large
phase III clinical development program on teriflunomide. These results were
presented today during the European Committee for Treatment and Research in
Multiple Sclerosis (ECTRIMS) congress, in Gothenburg, Sweden.

“Multiple sclerosis is a complex disease, and it often has an
unpredictable and highly disabling disease course, therefore leading to
important health care needs in this relatively young patient group “, said
Dr. Paul O’Connor, Director of the MS Clinic at St Michael’s Hospital,
Toronto, Canada and principal investigator of the TEMSO study. “We were very
satisfied to see how TEMSO demonstrated that teriflunomide successfully
reduced relapse rate but also reduced the time to disability progression for
the highest dose with a favorable safety profile for multiple sclerosis
patients with relapses and emerges as a potential new first-line treatment
option in this patient population.”

Teriflunomide also significantly reduced the brain disease activity on a
range of magnetic resonance imaging (MRI) measures including a significant
reduction of the burden of disease (total lesion volume), by 39% (p=0.03) and
67% (p=0.0003) at the 7 and 14mg doses relative to placebo, respectively.

Teriflunomide was well tolerated with no major safety concerns. Adverse
events occurring at a higher rate in the teriflunomide groups were diarrhea,
nausea, alanine transferase increases that were mainly mild and asymptomatic
with no dose effect and mild hair thinning and hair loss which rarely led to
treatment discontinuation. No serious opportunistic infections occurred in
patients treated with teriflunomide.

In addition to the TEMSO results, data on long-term safety of RMS
patients, from eight years of follow-up of the open-label extension of a
phase II study were also presented at the ECTRIMS congress. These data showed
that teriflunomide was well tolerated during eight years of continuous use
with a safety profile consistent with that reported during the first 36
double-blind phase weeks of the study.

About Teriflunomide

Teriflunomide is a new disease modifying drug being investigated for the
treatment of multiple sclerosis with a comprehensive clinical development
program which has been launched in monotherapy. First Phase II study results
of the safety and efficacy of teriflunomide monotherapy in MS were published
in Neurology in 2006. In addition to the TEMSO trial, two other Phase III
trials, TOWER and TENERE, are ongoing in RMS patients. A Phase III study,
TOPIC, is also underway in early MS or CIS (Clinically isolated syndrome).
Teriflunomide has also been evaluated as an adjunct therapy to either
interferon beta or glatiramer acetate in two Phase II studies. Results of
these studies were presented earlier this year during the American Committee
for Treatment and Research in Multiple Sclerosis (ACTRIMS) and American
Academy of Neurology (AAN) meetings respectively. Phase II studies with
teriflunomide (7 and 14mg) in adjunct with IFNbeta demonstrated an
improvement in MRI outcomes, with a consistent safety profile in patients
treated with the adjunct therapy compared to patients treated with IFNbeta
and receiving placebo. In the other Phase II study, teriflunomide in adjunct
to glatiramer acetate (GA) was well-tolerated compared to patients receiving
GA and placebo and showed a numerical trend for the reduction in number and
volume of gadolinium enhancing T-1 brain MRI lesions in the adjunct arm
compared to the placebo with GA arm.

About the TEMSO Study

TEMSO is a 2-year randomized, double-blind, placebo-controlled
multinational study including 1,088 RMS patients aged 18-55 years from 21
countries, with an Expanded Disability Status Scale (EDSS) is less than or
equal to 5.5 and at least one relapse in the previous year or at least 2
relapses in the preceding 2 years. Patients were randomized to placebo or
teriflunomide, 7 or 14mg, once daily and followed for 108 weeks. The primary
endpoint was annualized relapse rate defined as the number of confirmed
relapses per patient-year. The key secondary endpoint was the time to
sustained disability progression measured by the EDSS. Safety and
tolerability evaluations were based on treatment emergent adverse events,
physical examinations, vital signs and laboratory investigations.

About Multiple Sclerosis

Multiple sclerosis (MS) is a chronic, unpredictable and progressively
disabling disease with a substantial burden on patients. MS patients
typically are diagnosed at a young age and they face a lifetime of
uncertainty with gradually declining health. Today, over two million people
around the world suffer from MS. MS is the result of damage to myelin, a
protective sheath surrounding nerve fibres of the central nervous system.
When myelin is damaged, this interferes with messages between the brain and
other parts of the body. Multiple sclerosis is a very variable condition and
the symptoms depend on which areas of the central nervous system have been
affected. There is no definite pattern to MS and everyone with MS has a
different set of symptoms, which vary from time to time and can change in
severity and duration, even in the same person. Management of MS is complex;
early intervention in the pathological process is recommended in order to
delay disease progression or at least, slow it down. A complex support system
is required for the care of MS patients, including health and social
services, as well as various healthcare professionals. Although there is no
known cure for multiple sclerosis, several therapies are proven to be helpful
but there remains an unmet need for new oral therapies with proven efficacy
and good tolerability as well as long term safety.

About sanofi-aventis

Sanofi-aventis, a leading global pharmaceutical company, discovers,
develops and distributes therapeutic solutions to improve the lives of
everyone. Sanofi-aventis is listed in Paris (EURONEXT: SAN) and in New York

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SOURCE Sanofi-aventis

Source: newswire

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