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Europeiske legemiddelmyndigheter/EU kommisjonen godkjenner Aubagio® (teriflunomide), en gang daglig, oral behandling for pasienter med MS03-09-2013
Sanofi (EURONEXT: SAN and NYSE: SNY) og Genzyme kunngjorde i dag at de europeiske legemiddelmyndigheter/EU kommisjonen har gitt markedsføringstillatelse for Aubagio® (teriflunomide) 14 mg, en gang daglig, oral behandling for behandling av voksne pasienter med relapserende - remitterende multippel sklerose (RRMS).

Det faktum at Aubagio 14 mg har vist en positiv effekt på sykdomsprogresjon i to fase III-studier viser viktigheten av dette nye behandlingsalternativet for pasienter med relapserende-remitterende MS" sier Professor Ludwig Kappos, MD, Chair of Neurology, University Hospital, Basel, Switzerland. "Som et nytt en-gang daglig, oralt behandlingsalternativ med en god dokumentert sikkerhetsprofil og toleranse, kan Aubagio være et godt alternativ for pasienter som ikke er fornøyd med de tradisjonelle injeksjonsbehandlinger."

Den europeiske godkjennelsen av Aubagio er basert på data fra fase III-studiene TEMSO (TEriflunomide Multiple Sclerosis Oral) og TOWER (Teriflunomide Oral in people With relapsing remitting multiplE scleRosis). I disse studiene, som gikk over 2 år, reduserte Aubagio signifikant den årlige attakkrate, samt sykdomsprogresjon sammenlignet med placebo.

Med Aubagios effekt, sikkerhet og praktiske dosering kan medikamentet bli et godt behandlingsalternativ for pasienter,” sier Genzyme CEO og President, David Meeker, M.D. “Dagens godkjennelse av Aubagio er steg fremover for Genzyme i arbeidet for å utvikle nye viktige behandlinger som kan adressere de forskjellige behov innen MS.”
 
Multippel sklerose rammer mer en 2,1 millioner mennesker i verden. Det er rundt 630,000 mennesker som har MS i Europa.

Utviklingen av Aubagio er et resultat av mer enn ti års arbeid i Sanofis forskning- og utviklings organisasjon.

EU-indikasjon og dosering

Aubagio (teriflunomide) 14 mg er en tablett som tas en gang daglig og er indisert for behandling av voksne pasienter med relapserende- remitterende multippel sklerose.

Fakta Om Aubagio® (teriflunomide)

Aubagio er et immunmodulerende medikament med anti-inflammatoriske egenskaper. Selv om den eksakte virkningsmekanisme ikke er fullstendig kjent, ansees det å involvere en reduksjon av antall aktiverte lymfocytter i sentralnervesystemet.. Aubagio understøttes av et av de største kliniske forskningsprogram innen MS, med mer enn 5000 studiedeltagere i 36 land. Noen pasienter har i forlengelsesstudier vært behandlet i opptil 10 år. 

Viktig sikkerhetsinformasjon om Aubagio

Aubagio produktmerking inkluderer risiko for levertoksisitet og teratogenisitet. (basert på dyrestudier). I kliniske MS studier har forekomsten av alvorlige bivirkninger på Aubagio vært på linje med placebo. De vanligste bivirkninger assosiert med Aubagio hos MS pasienter inkluderer forhøyede ALT nivåer, hårtynning, diare, influensa, kvalme og parestesier. Teriflunomide er en aktiv metabolitt av leflunomide, som er indisert for behandling av rheumatoid artritt. Alvorlig leverskade inkludert fatal leversvikt har vært rapportert hos pasienter behandlet med leflunomide.

Leflunomide har omtrent 2.1 millioner pasientårs erfaring innen rheumatorid artritt siden lansering.

Aubagio er kontraindisert for pasienter med alvorlig nedsatt leverfunksjon, gravide kvinner og fruktbare kvinner som ikke benytter pålitelig prevensjon, ammende kvinner, pasienter med immunsvikt, pasienter med signifikant nedsatt benmargsfunksjon eller signifikant anemi, leukopeni, neutropenia eller trombocytopeni, pasienter med alvorlig aktiv infeksjon, pasienter med alvorlig nedsatt nyrefunksjon som undergår dialyse, og pasienter med hypoproteinemi.

For med fullstendig informasjon om Aubagio vennligst se følgende web-side:
http://ec.europa.eu/health/documents/community-register/html/alfregister.htm

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. .

Genzyme® and Aubagio® are registered trademarks of Genzyme Corporation, a Sanofi company.

About Sanofi

Sanofi, an integrated global 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).

Sanofi 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 forwardlooking 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 3/3 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, 2012. Other than as required by applicable law, Sanofi does not undertake any obligation to update or revise any forward-looking information or statements.

Contacts:

Sanofi Media Relations
Jack Cox
Tel: +33 (0) 1 53 77 46 46
E-mail: mr@sanofi.com

Sanofi Investor Relations
Sebastien Martel 
Tel: +33 (0) 1 53 77 45 45
E-mail: ir@sanofi.com  

Genzyme Media Relations
Erin Walsh 
Tel: 617-768-6881
E-mail: Erin.Walsh@genzyme.com  

Sanofi Investor Relations
Kristen Galfetti
Tel: +1 908 981 5560
E-mail: ir@sanofi.com  
Genzyme Corporate


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