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

Paris (ots/PRNewswire) - Sanofi-aventis 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 and in New
York .

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Email:philippe.barquet@sanofi-aventis.com .