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Sanofi and BioNTech Announce Cancer Immunotherapy Collaboration and License Agreement

Paris, France and Mainz, Germany - November 3, 2015 - Sanofi and BioNTech A.G. today announced that they have entered into a multiyear exclusive collaboration and license agreement. This research collaboration between Sanofi and BioNTech will leverage the scientific expertise of the two organizations to discover and develop up tofive cancer immunotherapies, each consisting of a mixture of synthetic messenger RNAs (mRNAs).

Sanofi  and  BioNTech  have  agreed  to  $60  million  in  upfront  and  near-term  milestone  payments, payable to BioNTech under the terms of the agreement. Further, BioNTech could receive over $300 million in development, regulatory and commercial milestones and other payments per product. If commercialized successfully, BioNTech would also beeligible for tiered royalties on net sales up to double digits. In addition, BioNTech has the optionto co-develop and co-commercialize two of the five mRNA therapeutics products with Sanofi in the European Union and the United States. Complementing Sanofi’s global oncology footprint and scientific expertise, BioNTech will combine the  use  of  its  proprietary  mRNA  technology  platform with  its  extensive  capabilities  in  developing immune-stimulating  pharmaceuticals.  As  part  of  this effort,  BioNTech  will  utilize  its  mRNA formulation technology, which  enables targeted mRNA delivery  in  vivo,  to generate  novel  cancer immunotherapies.  BioNTech  will  also  supply  part  of  the mRNA  material needed for  development activities from its in-house GMP manufacturing unit.
“Immunotherapy  has  shown  promise  as  an  avenue  to  develop  potentially  curative  treatments  for people with cancer, and Sanofi has strategically launched a number of inter-company collaborations in  this  area  in recent  months,”  said  Elias  Zerhouni,  President,  Global  R&D  at  Sanofi.  “Our collaboration with BioNTech has the potential to lay the foundation for a unique therapeutic modality in immuno-oncology.”

“The  collaboration  with  Sanofi  is  groundbreaking:  through  using  our  broad  suite  of  mRNA technologies  and  extensive  tumor  immunology  understanding,  it  will  allow  us  to  develop  a completely  new  class  of  cancer  immune-therapeutics  with  Sanofi,  which  we  believe  will  have  a profound and deep impact on the treatment of cancer,”said Ugur Sahin, CEO of BioNTech.  “This alliance is in line with our strategy to collaborate with companies that share our passion and drive to develop  and  commercialize  truly  innovative  and  disruptive  immunotherapies  for  the  treatment  of cancer.”

 

About Sanofi
Sanofi,  a  global  healthcare  leader,  discovers,  develops  and  distributes  therapeutic  solutions focused  on  patients'  needs.  Sanofi  has  core  strengths  in  diabetes  solutions,  human  vaccines, innovative drugs, consumer healthcare, emerging markets, animal health and Genzyme. Sanofi is listed in Paris (EURONEXT: SAN) and in New York (NYSE: SNY). 


About BioNTech AG
BioNTech  AG  is  an  immunotherapy  leader  with  bench-to-market  capabilities,  developing  truly personalized,  well-tolerated  &  potent  treatments  for  cancer  and  other  diseases.  Established  by clinicians and scientists, the Group is pioneering disruptive technologies ranging from individualized mRNA  based  medicines  through  innovative  Chimeric  Antigen  Receptors  /T-cell  Receptor-based products  and  novel  antibody  checkpoint  immunomodulators.  BioNTech’s  clinical  programs  are supported  by  an  in-house  molecular  diagnostics  unit whose  products  include  MammaTyper®,  a molecular in-vitro diagnostic kit marketed under CEand IVD marking in Europe and certain other countries. Founded in 2008, BioNTech is privately held and shareholders include the MIG Fonds, Salvia,  and  the  Strüngmann  Family  Office,  with  the  Strüngmann  Family  Office  as  the  majority shareholder. Information about BioNTech is available at www.biontech.de


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 forwardlooking 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, 2014. 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
jack.cox@sanofi.com
Investor Relations
Sébastien Martel
Tel: +33 (0)1 53 77 45 45
ir@sanofi.com
Sanofi Global R&D Communications
Amy BA, Ph.D.
Tel: +1 (617) 665-4851
amy.ba@sanofi.com
Contacts BioNTech AG:
Media Relations
Regina Jehle
Tel: +49 (0) 6131 9084 1273
Regina.Jehle@biontech.de
Hume Brophy (for BioNTech AG)
Mary Clark, Eva Haas, Hollie Vile
Tel: +44 20 3440 5657
biontech@humebrophy.com