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Sanofi: Sanofi and Regeneron Announce Positive Results from Phase 2b Study of Dupilumab in Patients with Moderate-to-Severe

Sanofi: Sanofi and Regeneron Announce Positive Results from Phase 2b Study of        Dupilumab in Patients with Moderate-to-Severe Atopic Dermatitis      Sanofi and Regeneron Announce Positive Results from Phase 2b Study of        Dupilumab in Patients with Moderate-to-Severe Atopic Dermatitis    - Results from Earlier Clinical Trials Published Today in the New England                             Journal of Medicine -  Paris and Tarrytown,  NY - July  9, 2014 -  Sanofi (EURONEXT: SANand  NYSE:  SNY) and  Regeneron  Pharmaceuticals,  Inc.  (NASDAQ:  REGN)  today  announced  positive  results  from  a  Phase  2b  dose-ranging  study  of  dupilumab,  an  investigational therapy,  in  adult patients  with  moderate-to-severe  atopic  dermatitis (AD), a serious, chronic form of eczema. All doses of dupilumab met the primary endpoint  of a  greater improvement  in Eczema  Area and  Severity  Index (EASI)  scores from  baseline  compared to  placebo. In  addition,  the  companies also announced that  four earlier clinical  studies of dupilumab  in  moderate-to-severe atopic dermatitis were published  today in the New  England  Journal  of  Medicine  (NEJM).  Dupilumab  is  an  investigational  monoclonal  antibody that blocks signaling  of IL-4 and IL-13,  two cytokines that play  a  key role in the pathogenesis of moderate-to-severe atopic dermatitis.  "These clinical data, coupled  with our mid-stage phase  2a results in  asthma  last year, support the growing scientific evidence that the IL4/IL-13  pathway  may be a fundamental driver in allergic diseases," said George D. Yancopoulos, M.D., Ph. D., Chief Scientific Officer of Regeneron and President of Regeneron Laboratories. "Blocking  IL-4/IL-13 signaling  may provide  an important  new  approach to atopic conditions, including  asthma, atopic dermatitis and  nasal  polyposis, where we have ongoing clinical programs."  In the  Phase 2b  trial, all  five subcutaneous  doses of  dupilumab showed  a  dose-dependent improvement in the primary endpoint, the mean percent change in EASI score from baseline  to week 16. The  improvements in EASI score  ranged  from a high of 74 percent for patients in the highest dose group, who received 300 milligrams (mg) weekly, to  a low of 45  percent in patients who  received  the lowest dose of 100 mg monthly, compared to 18 percent for patients in  the  placebo group (p<0.0001 for all doses).  The most common adverse event in the Phase 2b study was nasopharyngitis, which was balanced across dupilumab treatment  groups (18.5 to 23 percent)  compared  to placebo (21 percent).  Injection site reactions were  more frequent in  the  dupilumab group (5  to 9.5 percent)  compared to placebo  (3 percent), as  was  headache (12 to 15 percent) compared to placebo (8 percent).  Dupilumab-treated  patients  showed   highly  statistically  significant   and  dose-dependent improvements in  additional key efficacy  measures compared  to  placebo after 16 weeks of treatment:    o12 percent to 33 percent of dupilumab-treated patients achieved clearing     or near-clearing of skin lesions, as measured by an investigator's global     assessment (IGA) score of 0 or 1, compared to 2 percent with placebo.     (p=0.02 to p<0.0001)        oDupilumab-treated patients experienced a 16.5 percent to 47 percent mean     reduction in itching, as measured by the pruritus numerical-rating scale     (NRS) score, compared to an increase of 5 percent in the placebo group.     (p=0.0005 to p<0.0001)  "Atopic dermatitis is known to have a profoundly negative effect on quality of life  and  people  with  more  severe  forms  of  this  disease  have  limited  therapeutic choices," said Elias Zerhouni, MD, President, Global R&D,  Sanofi.  "These latest results  are consistent with  what was observed  in the  earlier  clinical studies  and  add  to  the  body  of  evidence  that  investigational  dupilumab may have a role to play for patients with moderate-to-severe  atopic  dermatitis. We  are now  able to  select the  optimal doses  for the  phase  3  studies, which we anticipate to begin later this year."  This Phase 2b  double-blind, placebo-controlled,  16-week, dose-ranging  study  randomized 380 patients with  moderate-to-severe atopic dermatitis, who  could  not be  adequately controlled  with  topical medication  or for  whom  topical  treatment was not advisable. Patients were  randomized to receive one of  five  doses of dupilumab (300 mg  weekly, 300 mg every  other week, 300 mg  monthly,  200 mg every other week,  100 mg monthly) or  placebo. Patients in the  study  had approximately 50 percent  of their skin affected  by atopic dermatitis  at  baseline. Within the past year, approximately 35 percent of patients  received  an oral  corticosteroid  and  approximately 20  percent  received  a  systemic  immunosuppressant for AD.  Approximately 60 percent  of patients had  another  allergic condition, including approximately 40  percent of patients who had  a  history of asthma. The follow-up period  of the study is ongoing and  patients  will be followed for 16 weeks after treatment.  The NEJM Dupilumab Moderate-to-Severe Atopic Dermatitis Publication The New  England  Journal of  Medicine  publication includes  data  from  four  placebo-controlled studies, which all  evaluated weekly subcutaneous doses  of  dupilumab. This included a  Phase 2a 12-week monotherapy  study, a Phase  2a,  four-week study of dupilumab in  combination with topical glucocorticoids  and  two Phase 1 four-week monotherapy studies.  In these studies, the most  common  AEs were nasopharyngitis and headache, which occurred with a higher  frequency  in the dupilumab group. Treatment with  dupilumab, either as a monotherapy  or  in  combination,  was  associated  with   improvement  in  skin  lesions   and  substantial improvements  in  pruritus  (itching).  The  full  publication  is  available at  "The New England Journal of Medicine publication brings important attention to moderate-to-severe  atopic  dermatitis,  a  common,  chronic  skin   condition  characterized by severe itching that can have a significant negative impact on a patient's ability to  lead a full  and active life,"  said Lisa Beck,  M.D.,  Department of Dermatology,  University of  Rochester Medical  Center and  lead  author of the NEJM paper. "We are encouraged by the consistent findings across these earlier studies and look forward to further clinical investigation  with  dupilumab."  About the IL-4/IL-13 Pathway and Atopic Dermatitis Moderate-to-severe atopic dermatitis, a serious, chronic form of eczema, is  a  systemic inflammatory disease characterized by an allergic response driven  by  a subset of immune cells called Type 2 helper T cells, or Th2 cells. IL-4 and IL-13 are key cytokines that are  required for the initiation and  maintenance  of this Th2 immune response. Moderate-to-severe forms of atopic dermatitis can be characterized by pronounced cutaneous  dryness, and skin lesions marked  by  redness, infiltration/papulation, crusting/oozing,  and lichenification  (skin  thickening), with  periods  of  lesion  exacerbation  accompanied  by  intense  itching, scratching, and skin  damage that can  lead to secondary  infections.  Moderate-to-severe atopic dermatitis can negatively impact patients' lives and is associated  with a  high burden  to society  in terms  of direct  costs  of  medical care and prescription drugs and loss of productivity.  About Dupilumab Dupilumab, a fully-human monoclonal antibody,  is directed against the  shared  IL-4R alpha  subunit,  which  blocks  signaling  from  both  IL-4  and  IL-13.  Dupilumab was created using Regeneron's pioneering VelocImmune® technology and is being  co-developed with  Sanofi  in atopic  dermatitis, asthma  and  nasal  polyposis. Dupilumab is an  investigational agent under clinical  development  and its safety and  efficacy have not been  fully evaluated by any  regulatory  authority.  About Sanofi  Sanofi, a  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).  About Regeneron Pharmaceuticals, Inc.  Regeneron is  a  leading  science-based  biopharmaceutical  company  based  in  Tarrytown, New  York  that  discovers, invents,  develops,  manufactures,  and  commercializes medicines  for the  treatment of  serious medical  conditions.  Regeneron markets medicines for  eye diseases, colorectal  cancer, and a  rare  inflammatory condition  and has  product candidates  in development  in  other  areas of high  unmet medical need,  including hypercholesterolemia,  oncology,  rheumatoid arthritis, allergic asthma, and atopic dermatitis. For  additional  information about the company, please visit  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  forward-looking 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 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,  2013. Other  than  as  required by applicable law, Sanofi does not undertake any obligation to update or revise any forward-looking information or statements.  Regeneron Forward-Looking Statements  This news release includes forward-looking  statements that involve risks  and  uncertainties  relating  to  future  events  and  the  future  performance  of  Regeneron, and  actual events  or  results may  differ materially  from  these  forward-looking statements. Words such  as "anticipate," "expect,"  "intend,"  "plan," "believe," "seek," "estimate," variations  of such words, and  similar  expressions are intended to identify such forward-looking statements, although not all  forward-looking statements  contain these  identifying words.  These  statements concern, and these risks  and uncertainties include, among  others,  the nature,  timing,  and possible  success  and therapeutic  applications  of  Regeneron's products, product candidates,  and research and clinical  programs  now underway or  planned, including without  limitation dupilumab;  unforeseen  safety issues  resulting  from  the administration  of  products  and  product  candidates in patients,  including serious  complications or  side effects  in  connection with the use of Regeneron's product candidates in clinical  trials,  such as  the  contemplated  Phase  3  study  of  dupilumab  in  patients  with  moderate-to-severe atopic dermatitis;  the likelihood and  timing of  possible  regulatory approval and  commercial launch of  Regeneron's late-stage  product  candidates, including without limitation dupilumab for the treatment of atopic dermatitis; ongoing regulatory obligations and oversight impacting Regeneron's research and  clinical  programs and  business,  including those  relating  to  patient privacy; determinations by regulatory and administrative  governmental  authorities which may  delay or  restrict Regeneron's ability  to continue  to  develop  or  commercialize  Regeneron's   products  and  product   candidates;  competing drugs and  product candidates  that may be  superior to  Regeneron's  products  and  product  candidates;  uncertainty  of  market  acceptance   and  commercial success of Regeneron's products and product candidates; the ability of Regeneron to manufacture and manage supply chains for multiple products and product candidates; coverage and  reimbursement determinations by  third-party  payers, including Medicare and Medicaid; unanticipated expenses; the costs  of  developing, producing, and selling products; the ability of Regeneron to  meet  any of its sales or other financial projections or guidance and changes to the assumptions underlying those  projections or guidance;  the potential for  any  license or  collaboration  agreement, including  Regeneron's  agreements  with  Sanofi and Bayer  HealthCare LLC, to  be cancelled or  terminated without  any  further product success;  and risks associated  with intellectual property  of  other parties  and pending  or  future litigation  relating thereto.  A  more  complete description  of  these and  other  material  risks can  be  found  in  Regeneron's filings with the United States Securities and Exchange Commission, including its Form 10-K for the year ended December 31, 2013 and its Form 10-Q for the quarter ended March 31, 2014. The reader is cautioned not to rely  on  any forward-looking statements made by Regeneron. Regeneron does not undertake any obligation  to update  publicly any  forward-looking statement,  including  without limitation any financial projection  or guidance, whether as a  result  of new information, future events, or otherwise.  Sanofi Contacts:         Investor Relations                          Sébastien Martel Media Relations          Tel.: +33 (0)1 53 77 45 45 Jack Cox    Tel:+33 (0)1 53 77 94 74 Regeneron Contacts:      Investor Relations                          Manisha Narasimhan, Ph.D. Media Relations          Tel: 1 (914) 847-5126 Hala Mirza      Tel: 1 (914) 847-3422  Link to PDF Version  ------------------------------------------------------------------------------  This announcement is distributed by NASDAQ OMX Corporate Solutions on behalf of NASDAQ OMX Corporate Solutions clients. The issuer of this announcement warrants that they are solely responsible for the content, accuracy and originality of the information contained therein. Source: Sanofi via Globenewswire HUG#1819490  
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