Full Press Release Details
Sanofi presents R&D strategy and innovative pipeline
PARIS, FRANCE - 13 December 2017 Sanofi will host an analyst meeting in Paris today to discuss the
company s Research and Development strategy, development pipeline and milestones for 2018. The company will highlight the progress it has made against Sustaining Innovation , a key pillar of its 2020 strategic roadmap, and advancing
a differentiated portfolio addressing unmet needs.
The company s pipeline spans 71 R&D projects, which includes 37 new molecular
entities and novel vaccines. At least 10 pivotal phase 3 studies are expected to start over the next 12 months and will evaluate new treatments for:
Regulatory filings expected in the next 12 months include two investigational cancer drugs (cemiplimab and isatuximab), a novel therapy for
type 1 diabetes (sotagliflozin) and a potential treatment for uncontrolled, persistent asthma (dupilumab).
have seen significant advancement on our ambition to sustain innovation in R&D, with the development of leading technology platforms and proof of concept demonstrated in multiple high-potential projects in late stage trials. We are confident
this portfolio will be the foundation for Sanofi s future long-term growth, said Olivier Brandicourt, MD, Chief Executive Officer at Sanofi.
As a key pillar of the 2020 Roadmap, the new Sanofi R&D model is based on three key strategic
The company has continuously adapted its R&D model in recent years to deliver greater efficiency and excellence in development, resulting
in a major uplift in productivity. Since 2016, consistent with the three key strategic shifts outlined above, Sanofi has placed increasing emphasis on developing proprietary technology platforms, including multi-specific antibodies (bi- & tri-specific), siRNA, trigonal peptides, dual and triple agonists, and PRR-Antibody conjugates. It has also leveraged
external expertise in targeted platforms such as mRNA mixtures and Nanobodies .
We aim to advance multi-targeting therapeutic approaches for core disease pathways that have the potential to attack
more than one disease at a time or bring improved risk benefit in the treatment of a single disease, said Elias Zerhouni, MD, Global Head of R&D at Sanofi. 2018 will be an important year as we expect multiple milestones for
Sanofi s late-stage pipeline, made possible through the prioritization principles we have consistently applied to our early-stage research programs.
Building a competitive position in Specialty Care
Sanofi is strengthening
its specialty care portfolio and has executed launches in its fast-growing immunology franchise. Dupilumab, which we are developing in collaboration with Regeneron, has potential across multiple indications. Phase 3 trials for uncontrolled,
persistent asthma recently demonstrated a potentially clinically important profile among biologic treatments. Submission in this important indication is expected before the end of 2017. Clinical development is underway in nasal polyposis,
eosinophilic esophagitis, food allergies and in pediatric populations in most of these indications. Additionally, phase 3 development for dupilumab is now planned in chronic obstructive pulmonary disease (COPD). Sanofi, in collaboration with
Regeneron, also expects to bring SAR440340, an anti-IL-33 antibody, which has the potential for a broader spectrum of immune modulation, into phase 2 in atopic
dermatitis, asthma and COPD in 2018, alone or in combination with dupilumab.
Sanofi is committed to re-building its position in oncology and has made major progress in the past two
years. This strategy is starting to deliver and we anticipate 14 new proof-of-concept studies to be initiated, four potential proof-of-concept readouts, six phase one starts and three BLA/ MAA submissions in 2018. Cemiplimab is an investigational PD-1 checkpoint inhibitor and the
backbone of our checkpoint immuno-oncology strategy with our partner Regeneron. It is being studied in cutaneous squamous cell carcinoma (CSCC), for which it was granted Breakthrough
Therapy designation by the U.S. Food and Drug Administration (FDA). Topline results show high and durable response rates (overall response rate 46.3%) in a pivotal Phase 2 study in 82 patients with advanced CSCC. This positive data has
resulted in the initiation of a rolling BLA submission, with completed submission expected in Q1 2018. The development program also includes large or untapped opportunities in immuno-oncology, such as basal cell carcinoma, cervical cancer, and first
Isatuximab is a Sanofi investigational antiCD38 monoclonal antibody with a first regulatory submission expected in 2018
for relapsed refractory multiple myeloma (RRMM). Beyond multiple myeloma, and building on the emerging evidence that CD38 inhibition may reverse resistance to PD-L1, isatuximab will be studied in combination
with cemiplimab or other immuno-oncology agents. Sanofi will also present early research programs for its Selective Estrogen Receptor Degrader (SERD) and TGF-beta program to overcome PD-1 resistance.
In multiple sclerosis (MS), Sanofi plans to build on the proven long-term clinical profile of Lemtrada (alemtuzumab) by initiating a Phase 3 study in 2018 for alemtuzumab in patients with primary progressive multiple sclerosis (PPMS). Consistent
with Sanofi s rigorous prioritization methodology, the company will deprioritize GLD-52 in this indication in favor of alemtuzumab. In addition, Sanofi, in collaboration with Principia, will be developing
a novel Bruton s tyrosine kinase (BTK) inhibitor, designed to access the brain and spinal cord by crossing the blood-brain barrier and impact immune cell and brain cell signaling. It is currently being studied in MS with potential applications
in other central nervous system diseases3.
Sustaining leadership in Rare Disease,
Diabetes & Cardiovascular and Vaccines
Sanofi s Rare Disease pipeline is structured with the goal of sustaining innovation in lysosomal storage disorders, while also expanding
strategically into related conditions. Clinical development programs include venglustat, an oral inhibitor of glucosylceramide synthase, in Fabry Disease, Gaucher Disease Type 3, GBA Parkinson s Disease and autosomal dominant polycystic kidney
disease (ADKPD). Late-stage/pivotal programs include olipudase, a first-in-class enzyme replacement therapy (ERT) for the
non-neurological manifestations of acid sphingomyelinase deficiency (ASMD), and avalglucosidase alfa, a novel ERT for Pompe disease. Finally, through a strategic collaboration with Alnylam, we are advancing
the development of patisiran for hATTR4 amyloidosis and fitusiran for hemophilia A and B, with and without inhibitors.
Diabetes & Cardiovascular
Sanofi is committed to sustaining a leadership position in diabetes and expanding into adjacent
co-morbidities. Its late-stage diabetes pipeline includes sotagliflozin, an investigational SGLT-1/2 inhibitor being developed in collaboration with Lexicon, and
efpeglenatide, a once-weekly GLP-1 being developed in collaboration with Hanmi, both of which potentially offer unique patient advantages. Additionally, Sanofi is leveraging its novel peptide incretin platform
to develop breakthrough assets for diabetes, obesity and non-alcoholic steatohepatitis (NASH). The lead compound is a dual agonist of GLP-1/GCG which has shown highly
competitive weight loss in the clinic and is expected to enter phase 3 in obesity in 2018. A phase 2 study in NASH is also due to start in 2018.
In cardiovascular, Sanofi continues to work in collaboration with Myokardia on therapeutic options for genetic forms of cardiomyopathy. The
lead compound is mavacamten, an oral modulator of cardiac myosin, which is in phase 2 for HCM5 and is expected to start a registrational phase 2b/3 study in 2018.
vaccine projects currently in development, and priority disease areas include influenza, meningitis and respiratory syncytial virus (RSV). RSV is the leading cause of infant viral mortality and represents a new potential category for Sanofi.
The company is taking a complementary dual approach to RSV with a monoclonal antibody in phase 2, in collaboration with MedImmune, and a vaccine in phase 1.
webcast live on Sanofi s website at 8:30 am CET/2:30 am EST. The webcast details and full presentation will be made available on Sanofi s Investor Relations webpage and an Appendix compiling all Sanofi studies registered on
clinicaltrials.gov will also be published.
| Media Relations Contact Kyra Obolensky Tel. : +33 (0)1 53 77 46 46 mr@sanofi.com | Investor Relations Contact George Grofik Tel.: +33 (0)1 53 77 45 45 ir@sanofi.com | |||||
| 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 of new products, including future clinical trial results and analysis of clinical data (including post-marketing data), 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. There are additional risks that may cause actual results to differ materially from those contemplated by the forward-looking statements, such as the lack of commercial success of certain product candidates once approved, pricing pressures, both in the United States and abroad, including pharmaceutical reimbursement and pricing, the future approval and commercial success of therapeutic alternatives, risks associated with intellectual property and any related pending or future litigation and the ultimate outcome of such litigation, changes in applicable laws or regulations, the impact of cost containment initiatives and subsequent changes thereto, as well as those risks and uncertainties 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, 2016. Other than as required by applicable law, Sanofi does not undertake any obligation to update or revise any forward-looking information or statements. |
Appendix 1: R&D Pipeline New Molecular Entities (*) R : Registration Study (other than Phase 3) O :
Opt-in rights products for which rights have not been exercised yet Immuno-inflammatioavbn MS, Neuro, Ophthalmology Oncology Rare Diseases Diabetes Solutions Cardiovascular & metabolism Infectious Disease Vaccines Phase 3 R isatuximab Anti-CD38
mAb +pomalidomide/dexamethasone Relapsed Refractory Multiple Myeloma patisiran () siRNA inhibitor targeting TTR Hereditary ATTR amyloidosis GZ402666 avalglucosidase alfa Pompe Disease fitusiran(9)() siRNA targeting Anti-Thrombin Hemophilia
sotagliflozin () Oral SGLT-1&2 inhibitor Type 1 Diabetes SAR341402 Rapid acting insulin Type 1 & Type 2 Diabetes efpeglenatide() Long-acting GLP-1 receptor agonist Type 2 Diabetes Phase 2 SAR156597 IL4/IL13 Bi-specific mAb Systemic
Scleroderma SAR425899 GLP-1R/GCG dual agonist Obesity/Overweight in T2D GZ389988 TRKA antagonist Osteoarthritis mavacamten(7)() Myosin inhibitor Obstructive Hypertrophic Cardiomyopathy R cemiplimab(4)() PD-1 inhibitor mAb Advanced CSCC (Skin
cancer) SAR407899 rho kinase Microvascular Angina R SAR566658 Maytansin-loaded anti-CA6 mAb Triple Negative Breast Cancer Combination ferroquine / OZ439(**) Antimalarial R olipudase alfa rhASM Deficiency Acid Sphingomyelinase Deficiency(6)
Tuberculosis Recombinant subunit vaccine O SAR339375(6) miRNA-21 Alport Syndrome HIV Viral vector prime & rgp120 boost vaccine venglustat Oral GCS inhibitor Gaucher related Parkinson s Disease SP0232(8) mAb(**) Respiratory syncytial virus
Monoclonal antibody SAR422459 ABCA4 gene therapy Stargardt Disease
Phase 1 SAR440340(**) Anti-IL33 mAb Asthma UshStat Myosin 7A gene therapy Usher Syndrome 1B SAR439794 TLR4 agonist
Peanut Allergy SAR228810 Anti-protofibrillar AB mAb Alzheimer s Disease SAR408701 Maytansin-loaded anti-CEACAM5 mAb Solid Tumors SAR438335 GLP-1/GIP dual agonist Type 2 Diabetes SAR439459 anti-TGFb mAb Advanced Solid Tumors SAR440181(3)(**)
Myosin activation Dilated Cardiomyopathy O REGN3767(1) Anti LAG-3 mAb Advanced Cancers SAR439859 SERD Metastatic Breast Cancer Herpes Simplex Virus Type 2 HSV-2 vaccine O ALN-TTRsc02(2) Sub-cutaneous siRNA inhibitor targeting TTR Hereditary ATTR
Amyloidosis Respiratory syncytial virus Infants Vaccines O ALN-GO1(2) Investigational RNAi therapeutic Primary Hyperoxaluria Type 1 (PH1) Regeneron product for which Sanofi has opt-in right Alnylam product for which Sanofi has opt-in right Also
known as MYK491 Also known as SAR439684 and REGN2810 Also known as Niemann Pick type B Regulus product for which Sanofi has opt-in right Also known as SAR439152 and as MYK461 Also known as MEDI8897 Currently on clinical hold pending outcome of FDA
discussion Expected to resume around year-end (*) data related to all studies published in clinicaltrials.gov (**) Partnered and/or in collaboration Sanofi may have limited or shared rights on some of these products
Appendix 2: R&D Pipeline Additional Indications (*) R : Registration Study (other than Phase 3) O :
Opt-in rights products for which rights have not been exercised yet Immuno-inflammation MS, Neuro, Ophthalmology Oncology Rare Disease Diabetes Solutions Cardiovascular & metabolism Infectious Disease Vaccines Registration VaxiGrip QIV IM
Quadrivalent inactivated influenza vaccine (6-35 months) PR5i DTP-HepB-Polio-Hib Pediatric hexavalent vaccines, U.S. Phase 3 dupilumab() Anti-IL4R mAb Asthma 6 11 years old R isatuximab Anti-CD38 mAb 1st line Ti (IMROZ) dupilumab()
Anti-IL4R mAb Asthma 12y+ R isatuximab Anti-CD38 mAb Relapsing Refractory Multiple Myeloma (IKEMA) dupilumab() Anti-IL4R mAb Nasal Polyposis Aubagio teriflunomide Relapsing Multiple Sclerosis - Pediatrics Dupixent ()
Anti-IL4R mAb Atopic Dermatitis 12 17 years old Sotagliflozin() Oral SGLT-1&2 inhibitor Type 2 Diabetes Dupixent () Anti-IL4R mAb Atopic Dermatitis 6 11 years old Praluent (**) Anti-PCSK9 mAb CV events
reduction Dupixent () Anti-IL4R mAb Atopic Dermatitis 6 months 5 years old Fluzone QIV HD Quadrivalent inactivated Influenza vaccine - High dose R cemiplimab(1)() PD-1 inhibitor 2nd line Cervical Cancer Men Quad TT Advanced
meningococcal ACYW conjugate vaccine R cemiplimab(1)(**) PD-1 inhibitor 1st line NSCLC Pediatric pentavalent vaccine DTP-Polio-Hib Japan
Phase 2 dupilumab() Anti-IL4R mAb Eosinophilic Esophagitis sotaglifozin() (SAR439954) SGLT 1 & 2 inhibitor
Worsening Heart Failure sarilumab() Anti-IL6R mAb Polyarticular Juvenile Idiopathic Arthritis mavacamten(4)() Myosin inhibitor Non-Obstructive Hypertrophic Cardiomyopathy sarilumab(**) Anti-IL6R mAb Systemic Juvenile Arthritis Rabies VRVg
Purified vero rabies vaccine R cemiplimab(1)(**) PD-1 inhibitor mAb Advanced Basal Cell Carcinoma Adacel+ Tdap booster venglustat Oral GCS inhibitor Gaucher Disease Type 3 Shan 6 DTP-HepB-Polio-Hib Pediatric hexavalent vaccine venglustat Oral GCS
inhibitor Fabry Disease Phase 1 isatuximab + cemiplimab(1)() Anti-CD38 mAb + PD1 inhibitor mAb Relapsing Refractory Multiple Myeloma isatuximab Anti-CD38 mAb + CyBord(2) Newly Diagnosed Multiple Myeloma SAR439459 + cemiplimab(1)() Anti-TGFb mAb
+ PD1 inhibitor mAb Advanced Solid Tumors SAR439859 SERD + Palbociclib Metastatic Breast Cancer O cemiplimab(1)(**) + REGN3767(3) PD1 inhibitor mAb + anti LAG-3 mAb Advanced Cancers Also known as SAR439684 and REGN2810 Cyclophosmamide + bortezomib
(Velcade) + dexamethasone Regeneron product for which Sanofi has opt-in right Also known as SAR439152 and as MYK461 (*) data related to all studies published in clinicaltrials.gov (**) Partnered and/or in collaboration Sanofi may have limited
or shared rights on some of these products