- First Results From the TEMSO Phase III Trial to be Presented During theECTRIMS Congress in October 2010
Sanofi-aventis (EURONEXT: SAN and NYSE: SNY) announced today that theinvestigational once-daily oral drug teriflunomide significantly reducedannualized relapse rate (ARR) at 2 years versus placebo in patients withrelapsing multiple sclerosis (RMS), thus achieving the primary endpoint inthe TEMSO phase III trial. Both the 7mg and 14mg doses of teriflunomide werewell tolerated with a similar number of patients reporting eithertreatment-emergent adverse events (TEAEs) or TEAEs leading to treatmentdiscontinuation in the treatment arms versus placebo.
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Effects on other clinical and MRI related outcomes further support theprimary outcome. The safety profile was in line with previous clinicalexperience.
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The TEMSO trial is the first study of a large phase III clinicaldevelopment program to produce results on teriflunomide as monotherapy. Studyfindings from TEMSO will be presented during the platform presentationscheduled for October 15, 2010, starting at 9:15 a.m. CET at the 26th AnnualMeeting of the European Committee for Treatment and Research in MultipleSclerosis (ECTRIMS) in Gothenburg, Sweden. The TEMSO study results areembargoed until this oral presentation.
About Teriflunomide
Teriflunomide is a new oral disease modifier for RMS that blocks de novopyrimidine synthesis thus reducing T- and B-cells proliferation with nocytotoxicity. A comprehensive clinical development program for teriflunomidehas been launched in monotherapy. First Phase II study results of the safetyand efficacy of teriflunomide monotherapy in MS were published in Neurologyin 2006. In addition to the TEMSO trial, two other Phase III trials, TOWERand TENERE, are ongoing in RMS. A Phase III study, TOPIC, is also underway inearly MS or Clinically Isolated Syndrome (CIS). Teriflunomide has also beenevaluated as an adjunct therapy to either interferon 1-beta or glatirameracetate in two Phase II studies. Results of these studies were presentedearlier this year during the American Committee for Treatment and Research inMultiple Sclerosis meeting (ACTRIMS) congress, and the American Academy ofNeurology (AAN) meeting respectively. Phase II studies with teriflunomide(7mg and 14mg) in adjunct with interferon 1-beta demonstrated an improvementin outcomes, with a consistent safety profile in patients treated with theadjunct treatment compared with patients treated with IFN-beta and receivingplacebo. In the other Phase II study, teriflunomide in adjunct to glatirameracetate (GA) was well-tolerated compared to patients receiving GA andplacebo. Although there was a numerical trend for the reduction in number andvolume of gadolinium enhancing T-1 brain MRI lesions in the adjunct armcompared to placebo with GA, the relative effect was not as robust as thatobserved for teriflunomide with IFN-beta.
About TEMSO Study
TEMSO is a 2-year randomized, double-blind, placebo controlled studyincluding 1088 RMS patients worldwide, aged 18-55 years, with an ExpandedDisability Status Scale (EDSS) <= 5.5 and at least one relapse over theprevious year or at least 2 relapses over the preceding 2 years. Patientswere randomized to placebo or teriflunomide, 7mg or 14mg, once daily. Theprimary endpoint was annualized relapse rate defined as the number ofconfirmed relapses per patients-year. The key secondary endpoint was the timeto disability progression measured by EDSS. Safety and tolerabilityevaluations were based on treatment emergent adverse events, physicalexaminations, vital signs and laboratory investigations.
About Multiple Sclerosis
Multiple sclerosis (MS) is a chronic, unpredictable and progressivelydisabling disease. Patients with MS typically are diagnosed at a young ageand they face a lifetime of uncertainty with gradually declining health.Today, over two million people around the world suffer from MS. MS is theresult of damage to myelin, a protective sheath surrounding nerve fibres ofthe central nervous system. When myelin is damaged, this interferes withmessages between the brain and other parts of the body. Multiple sclerosis isa very variable condition and the symptoms depend on which areas of thecentral nervous system have been affected. There is no definite pattern to MSand everyone with MS has a different set of symptoms, which vary from time totime and can change in severity and duration, even in the same person.Management of MS is complex; early intervention in the pathological processis recommended in order to delay disease progression or at least, slow itdown. A complex support system is required for the care of MS patients,including health and social services, as well as various healthcareprofessionals. Although there is no known cure for multiple sclerosis,several therapies are proven to be helpful but there remains an unmet needfor new oral therapies with an acceptable benefit/risk profile.
About sanofi-aventis
Sanofi-aventis, a leading global pharmaceutical company, discovers,develops and distributes therapeutic solutions to improve the lives ofeveryone. Sanofi-aventis 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 thePrivate Securities Litigation Reform Act of 1995, as amended. Forward-lookingstatements are statements that are not historical facts. These statementsinclude projections and estimates and their underlying assumptions,statements regarding plans, objectives, intentions and expectations withrespect to future financial results, events, operations, services, productdevelopment and potential, and statements regarding future performance.Forward-looking statements are generally identified by the words "expects,""anticipates," "believes," "intends," "estimates," "plans" and similarexpressions. Although sanofi-aventis' management believes that theexpectations reflected in such forward-looking statements are reasonable,investors are cautioned that forward-looking information and statements aresubject to various risks and uncertainties, many of which are difficult topredict and generally beyond the control of sanofi-aventis, that could causeactual 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 uncertaintiesinherent in research and development, future clinical data and analysis,including post marketing, decisions by regulatory authorities, such as theFDA or the EMA, regarding whether and when to approve any drug, device orbiological application that may be filed for any such product candidates aswell as their decisions regarding labelling and other matters that couldaffect the availability or commercial potential of such products candidates,the absence of guarantee that the products candidates if approved will becommercially successful, the future approval and commercial success oftherapeutic alternatives, the Group's ability to benefit from external growthopportunities as well as those discussed or identified in the public filingswith the SEC and the AMF made by sanofi-aventis, including those listed under"Risk Factors" and "Cautionary Statement Regarding Forward-LookingStatements" in sanofi-aventis' annual report on Form 20-F for the year endedDecember 31, 2009. Other than as required by applicable law, sanofi-aventisdoes not undertake any obligation to update or revise any forward-lookinginformation or statements.
SOURCE Sanofi-aventis
