Press ReleaseSource: Sanofi (EURONEXT: SAN)
(NYSE: SNY)
Sanofi presents R&D strategy and innovative
pipeline
·
Robust pipeline expected to support long-term growth
·
9 planned regulatory submissions over next 18 months
·
At least 10 pivotal phase 3 studies expected to begin over next 12
months
·
R&D model leverages new proprietary technology platforms,
multi-targeting molecules and biologics
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:
- chronic obstructive pulmonary disease and eosinophilic
esophagitis (dupilumab[1]);
- autosomal dominant polycystic kidney disease (ADPKD), a rare
kidney disease (venglustat);
- type 2 diabetes (efpeglenatide, a once-weekly GLP-1
agonist);
- obesity (a GLP-1/GCG dual agonist);
- primary progressive multiple sclerosis (alemtuzumab), and;
- first line NSCLC[2] (cemiplimab).
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).
"We 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 shifts:
- From small molecules to biologics;
- From mono-targeting to multi-targeting compounds; and
- From licensing to proprietary assets.
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
ImmunologySanofi 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.
OncologySanofi 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), with an expected regulatory submission
in Q1 2018. The development program also includes large or untapped
opportunities in immuno-oncology, such as basal cell carcinoma,
cervical cancer, and first line lung cancer.
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.
Multiple SclerosisIn 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 diseases[3].
Sustaining leadership in Rare Disease, Diabetes &
Cardiovascular and Vaccines
Rare DiseaseSanofi'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 hATTR[4] amyloidosis and fitusiran for hemophilia A
and B, with and without inhibitors.
Diabetes & CardiovascularSanofi 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 an oral 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 HCM[5] and is
expected to start a registrational phase 2b/3 study in
2018.
VaccinesSanofi has six key 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 detailsThe event will be 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.
About Sanofi Sanofi is
dedicated to supporting people through their health challenges. We
are a global biopharmaceutical company focused on human health. We
prevent illness with vaccines, provide innovative treatments to
fight pain and ease suffering. We stand by the few who suffer from
rare diseases and the millions with long-term chronic conditions.
With more than 100,000 people in 100 countries, Sanofi is
transforming scientific innovation into healthcare solutions around
the globe. Sanofi, Empowering Life |
Media Relations ContactKyra
ObolenskyTel. : +33 (0)1 53 77 46 46mr@sanofi.com |
Investor Relations ContactGeorge GrofikTel.:
+33 (0)1 53 77 45 45ir@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-inflammation MS,
Neuro, Ophthalmology Oncology Rare Disease |
Diabetes Solutions
Cardiovascular & metabolism Infectious Disease Vaccines
|
Phase 3
R isatuximabAnti-CD38 mAb
+pomalidomide/dexamethasoneRelapsed Refractory Multiple
Myeloma |
patisiran (**)siRNA inhibitor targeting
TTRHereditary ATTR amyloidosis |
GZ402666avalglucosidase alfa Pompe Disease |
fitusiran(9)(**) siRNA targeting Anti-Thrombin
Hemophilia |
sotagliflozin (**)Oral SGLT-1&2
inhibitorType 1 Diabetes |
SAR341402Rapid acting insulinType 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
antagonistOsteoarthritis |
mavacamten(7)(**) Myosin inhibitor
Obstructive Hypertrophic Cardiomyopathy |
Rcemiplimab(4)(**)PD-1 inhibitor mAbAdvanced
CSCC (Skin cancer) |
SAR407899rho kinaseMicrovascular Angina |
R SAR566658 Maytansin-loaded anti-CA6 mAb Triple
Negative Breast Cancer |
Combination ferroquine / OZ439(**) Antimalarial |
R olipudase alfarhASM DeficiencyAcid Sphingomyelinase
Deficiency(6) |
TuberculosisRecombinant subunit vaccine |
OSAR339375(6)miRNA-21Alport Syndrome |
HIV Viral vector prime & rgp120 boost vaccine |
venglustatOral GCS inhibitorGaucher related
Parkinson's Disease |
SP0232(8) mAb(**) Respiratory
syncytial virus Monoclonal antibody |
SAR422459ABCA4 gene therapyStargardt Disease
|
Phase 1
SAR440340(**)Anti-IL33 mAbAsthma |
UshStat® Myosin 7A gene therapy Usher Syndrome
1B |
SAR439794TLR4 agonistPeanut
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 |
SAR439459anti-TGFß mAb Advanced Solid Tumors |
SAR440181(3)(**)Myosin activationDilated
Cardiomyopathy |
O REGN3767(1) Anti LAG-3 mAb Advanced
Cancers |
SAR439859SERDMetastatic Breast Cancer |
Herpes Simplex Virus Type 2 HSV-2 vaccine |
O ALN-TTRsc02(2) Sub-cutaneous siRNA
inhibitor targeting TTRHereditary 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) |
PR5iDTP-HepB-Polio-HibPediatric hexavalent vaccines,
U.S. |
Phase 3
dupilumab(**)Anti-IL4RalphamAbAsthma 6 - 11
years old |
R isatuximabAnti-CD38 mAb1st line Ti (IMROZ)
|
dupilumab(**)Anti-IL4RalphamAbAsthma 12y+ |
R isatuximabAnti-CD38 mAbRelapsing Refractory
Multiple Myeloma (IKEMA) |
dupilumab(**)Anti-IL4RalphamAbNasal Polyposis
|
Aubagio® teriflunomide Relapsing Multiple
Sclerosis - Pediatrics |
Dupixent®(**)Anti-IL4RalphamAbAtopic
Dermatitis 12 - 17 years old |
Sotagliflozin(**)Oral SGLT-1&2
inhibitorType 2 Diabetes |
Dupixent®(**)Anti-IL4Ralpha
mAbAtopic Dermatitis 6 - 11 years old |
Praluent®(**) Anti-PCSK9 mAb CV
events reduction |
Dupixent®(**)Anti-IL4Ralpha mAbAtopic
Dermatitis 6 months - 5 years old |
Fluzone® QIV HD Quadrivalent inactivated
Influenza vaccine - High dose |
R cemiplimab(1)(**)PD-1 inhibitor2nd line
Cervical Cancer |
Men Quad TTAdvanced meningococcalACYW conjugate vaccine |
R cemiplimab(1)(**)PD-1 inhibitor1st line
NSCLC |
Pediatric pentavalent vaccineDTP-Polio-HibJapan |
|
Phase 2
dupilumab(**)Anti-IL4Ralpha mAbEosinophilic
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 VRVgPurified vero rabies vaccine |
R cemiplimab(1)(**)PD-1 inhibitor mAbAdvanced
Basal Cell Carcinoma |
Adacel+Tdap booster |
venglustatOral GCS inhibitorGaucher Disease Type 3 |
Shan 6DTP-HepB-Polio-Hib Pediatric hexavalent
vaccine |
venglustatOral GCS inhibitorFabry 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-TGFß mAb +
PD1 inhibitor mAb Advanced Solid Tumors |
SAR439859SERD + 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
[1] Partnered products: cemiplimab, dupilumab, anti-IL33 mAb
(Regeneron); sotagliflozin (Lexicon); efpeglenatide (Hanmi);
fitusiran, patisiran (Alnylam); mavacamten, MYK-491
(Myokardia).
[2] Non-Small Cell Lung Cancer
[3] The Principia transaction remains subject to customary
regulatory approvals and has not yet closed.
[4]hATTR = Hereditary Transthyretin-Mediated Amyloidosis
[5] HCM= Hypertrophic cardiomyopathy
Attachments:
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