Sanofi and Regeneron Announce Business Authorization Appliance for Dupixent® (dupilumab) Accustomed for Assay by the EMA
Paris, France, and Tarrytown, N.Y. – December 8, 2016 – Sanofi and Regeneron Pharmaceuticals, Inc. today appear that the European Medicines Agency (EMA) has accustomed for assay the Business Authorization Appliance (MAA) for Dupixent® (dupilumab) for the assay of adults with moderate-to-severe atopic dermatitis (AD) who are candidates for systemic therapy. The investigational biologic assay Dupixent inhibits signaling of IL-4 and IL-13, two key cytokines appropriate for the blazon 2 (including Th2) allowed response, which is believed to be a above disciplinarian in the pathogenesis of the disease.
The MAA for Dupixent contains abstracts from three Phase 3 cardinal studies in the all-around LIBERTY AD affairs that included added than 2,500 patients. The cold of the studies was to appraise Dupixent as monotherapy (SOLO 1 and SOLO 2) and in accessory administering with contemporary corticosteroids (CHRONOS), in developed patients with moderate-to-severe AD whose ache is not abundantly controlled with contemporary decree therapies.
A biologics authorization appliance (BLA) for Dupixent was accustomed for Priority Assay by the U.S. Food and Drug Administering (FDA) in September 2016. Per the Decree Drug User Fee Act (PDUFA), the ambition FDA activity date is March 29, 2017. The European Medicines Agency (EMA) and FDA accept conditionally accustomed Dupixent as the barter name for dupilumab.
Dupixent is currently beneath analytic development and its assurance and adeptness accept not been absolutely evaluated by any authoritative authority. In accession to AD in adults, Dupixent is actuality advised in pediatric AD, asthma, nasal polyposis and eosinophilic esophagitis. If approved, Dupixent would be commercialized by Regeneron and Sanofi Genzyme, the specialty affliction all-around business assemblage of Sanofi.
About Sanofi Sanofi, a all-around healthcare leader, discovers, develops and distributes ameliorative solutions focused on patients’ needs. Sanofi is organized into bristles all-around business units: Diabetes and Cardiovascular, General Medicines and Emerging Markets, Sanofi Genzyme, Sanofi Pasteur and Merial. Sanofi is listed in Paris (EURONEXT: SAN) and in New York (NYSE: SNY).
Sanofi Genzyme focuses on developing specialty treatments for debilitating diseases that are about difficult to analyze and treat, accouterment achievement to patients and their families.
About Regeneron Pharmaceuticals, Inc.Regeneron (NASDAQ: REGN) is a arch science-based biopharmaceutical aggregation that discovers, invents, develops, articles and commercializes medicines for the assay of austere medical conditions. Regeneron commercializes medicines for eye diseases, aerial LDL cholesterol and a attenuate anarchic action and has artefact candidates in development in added areas of aerial unmet medical need, including rheumatoid arthritis, atopic dermatitis, asthma, pain, blight and communicable diseases. For added advice about the company, amuse appointment www.regeneron.com or chase @Regeneron on Twitter.
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Regeneron Forward-Looking Statements and Use of Digital Media This account absolution includes advanced statements that absorb risks and uncertainties apropos to approaching contest and the approaching achievement of Regeneron Pharmaceuticals, Inc. (“Regeneron” or the “Company”), and absolute contest or after-effects may alter materially from these advanced statements. Words such as “anticipate,” “expect,” “intend,” “plan,” “believe,” “seek,” “estimate,” variations of such words, and agnate expressions are advised to analyze such advanced statements, although not all advanced statements accommodate these anecdotic words. These statements concern, and these risks and uncertainties include, amid others, the nature, timing, and attainable success and ameliorative applications of Regeneron’s products, artefact candidates, and assay and analytic programs now underway or planned, including after limitation Dupixent® (dupilumab); the likelihood, timing, and ambit of attainable authoritative approval and bartering barrage of Regeneron’s late-stage artefact candidates and new break for marketed products, such as Dupixent for the assay of developed patients with moderate-to-severe atopic dermatitis who are candidates for systemic assay (including attainable authoritative approval of Dupixent by the European Medicines Agency and the U.S. Food and Drug Administering discussed in this account release) and added abeyant indications; abrupt assurance issues and attainable accountability consistent from the administering of articles and artefact candidates in patients, including after limitation Dupixent; austere complications or ancillary furnishings in affiliation with the use of Regeneron’s articles and artefact candidates (such as Dupixent) in analytic trials; advantage and acceding determinations by third-party payers, including Medicare, Medicaid, and pharmacy account administering companies; advancing authoritative obligations and blank impacting Regeneron’s marketed products, assay and analytic programs, and business, including those apropos to the enrollment, completion, and affair of the accordant endpoints of post-approval studies; determinations by authoritative and authoritative authoritative authorities which may adjournment or bind Regeneron’s adeptness to abide to advance or commercialize Regeneron’s articles and artefact candidates, such as Dupixent; aggressive drugs and artefact candidates that may be above to Regeneron’s articles and artefact candidates; ambiguity of bazaar accepting and bartering success of Regeneron’s articles and artefact candidates and the appulse of studies (whether conducted by Regeneron or others and whether allowable or voluntary) on the bartering success of Regeneron’s articles and artefact candidates; the adeptness of Regeneron to accomplish and administer accumulation chains for assorted articles and artefact candidates; hasty expenses; the costs of developing, producing, and affairs products; the adeptness of Regeneron to accommodated any of its sales or added banking projections or advice and changes to the assumptions basal those projections or guidance; the abeyant for any authorization or accord agreement, including Regeneron’s agreements with Sanofi and Bayer HealthCare LLC (or their corresponding affiliated companies, as applicable), to be annulled or concluded after any added artefact success; and risks associated with bookish acreage of added parties and awaiting or approaching action apropos thereto. A added complete description of these and added actual risks can be begin in Regeneron’s filings with the United States Securities and Exchange Commission, including its Form 10-K for the year concluded December 31, 2015 and its Form 10-Q for the annual aeon concluded September 30, 2016. Any advanced statements are fabricated based on management’s accepted behavior and judgment, and the clairvoyant is cautioned not to await on any advanced statements fabricated by Regeneron. Regeneron does not undertake any obligation to amend about any advanced statement, including after limitation any banking bump or guidance, whether as a aftereffect of new information, approaching events, or otherwise.
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