DUPIXENT was approved by the FDA for the treatment of moderate-to-severe atopic dermatitis in adults whose disease is not adequately controlled with topical prescription therapies or when those therapies are not advisable. The document discusses DUPIXENT's clinical profile, launch strategy focusing on patients with the highest unmet need, pricing responsibly based on the disease burden and clinical benefits, and plans for working with payers and providing patient support to optimize access and treatment. Regeneron and Sanofi are committed to bringing this breakthrough therapy rapidly to patients and minimizing barriers to treatment.
Presented at the joint International Eczema Council and National Alopecia Areata Foundation Symposium, "Atopic Dermatitis and Alopecia Areata: Comparison and Contrast”, held during the 2019 Annual American Academy of Dermatology meeting in Washington, DC to explore the similarities and differences between these two common but complex skin diseases and the implications from bench to bedside.
Presented at the joint International Eczema Council and National Alopecia Areata Foundation Symposium, "Atopic Dermatitis and Alopecia Areata: Comparison and Contrast”, held during the 2019 Annual American Academy of Dermatology meeting in Washington, DC to explore the similarities and differences between these two common but complex skin diseases and the implications from bench to bedside.
Presented at the joint International Eczema Council and National Alopecia Areata Foundation Symposium, "Atopic Dermatitis and Alopecia Areata: Comparison and Contrast”, held during the 2019 Annual American Academy of Dermatology meeting in Washington, DC to explore the similarities and differences between these two common but complex skin diseases and the implications from bench to bedside.
Presented at the joint International Eczema Council and National Alopecia Areata Foundation Symposium, "Atopic Dermatitis and Alopecia Areata: Comparison and Contrast”, held during the 2019 Annual American Academy of Dermatology meeting in Washington, DC to explore the similarities and differences between these two common but complex skin diseases and the implications from bench to bedside.
hanifin and rajka criteria, entymology, definition of AD, atopy, etiopathogenesis of AD, genetics in AD, filaggrin, epidermal barrier dysfunction, atopic march, hygiene hypothesis, infantile phase of AD, childhood phase of AD, adult phase of AD, pityriasis alba, denne morgan folds, dirty neck appearence, nipple dermatitis, hanifin and rajka criteria, UK refinement of hanifin and rajka criteria, millenium criteria of AD, japanese dermatological association criteria, management of AD, wet wrap therapy,
Summary of updated information about the disease of Atopic dermatitis, aetiology, immunopathogenesis, main clinical features and dianostic criteria, concepts of managemnt of Atopic dermatitis including newest treatment trends.
Making Key Decisions in New Product Planning When “Perfect” Information is No...Anthony Russell
Presentation given at New Product Planning Summit 2021.
Learning Objectives:
* Review the types of decisions typically made in New Product Planning
* Discuss the nature of information available to support decision-making in New Product Planning
* Review the impact and context of decision-making in New Product Planning
* Review potential approaches to assist in New Product Planning decision-making
Psoriasis - A BRIEF OUTLOOK..................................by Vishnu R.Nair...RxVichuZ
My fifth presentation...in slideshare.....
This is a precise insight into the popular disease called PSORIASIS....the reasons...classification....diagnosis...and varying therapies..........
Nevertheless, i do sincerely hope that this presentation helps people who are in research work for this disease..or for students, who have this in their curriculum syllabus, or for simple reading.............
More ppts will come on the way............
Thanks for reading..............do give ur feedback..in my email address rxvichu623@gmail.com.........ur views and suggestions will be warmly acknowledged..........
For further details, contact me in whatsapp or hike at 8086948729 or in my facebook profile at Rx Vichhu
Study well!!
Keep rocking!!!
@rxvichu
:) :)
tofacitinib (Tofacent) is an oral drug used for treating rheumatoid arthritis. It belongs to a class of drugs called Janus kinase (JAK) inhibitors. buy tofacitinib only at $6. Visit our website to know more https://emergencydrug.com/drug/tofacitinib-5mg/
Course director, Anthony J. Mancini, MD, FAAP, FAAD, prepared atopic dermatitis infographics for this CME activity titled "Improving the Care of Young Patients With Atopic Dermatitis: Recognizing the Differences Between Children, Adolescents, and Adults." For the full presentation, monograph, complete CME information, and to apply for credit, please visit us at http://bit.ly/320x7ZG. CME credit will be available until July 9, 2020.
INTRODUCTION OF PSORIASIS, EPIDEMIOLOGY OF PSORIASIS, CLINICAL FEATURES OF PSORIASIS, PROGNOSIS OF PSORIASIS, HISTOPATHOLOGY OF PSORIASIS, TRIGGERING FACTORS OF PSORIASIS, PATHOGENESIS OF PSORIASIS
hanifin and rajka criteria, entymology, definition of AD, atopy, etiopathogenesis of AD, genetics in AD, filaggrin, epidermal barrier dysfunction, atopic march, hygiene hypothesis, infantile phase of AD, childhood phase of AD, adult phase of AD, pityriasis alba, denne morgan folds, dirty neck appearence, nipple dermatitis, hanifin and rajka criteria, UK refinement of hanifin and rajka criteria, millenium criteria of AD, japanese dermatological association criteria, management of AD, wet wrap therapy,
Summary of updated information about the disease of Atopic dermatitis, aetiology, immunopathogenesis, main clinical features and dianostic criteria, concepts of managemnt of Atopic dermatitis including newest treatment trends.
Making Key Decisions in New Product Planning When “Perfect” Information is No...Anthony Russell
Presentation given at New Product Planning Summit 2021.
Learning Objectives:
* Review the types of decisions typically made in New Product Planning
* Discuss the nature of information available to support decision-making in New Product Planning
* Review the impact and context of decision-making in New Product Planning
* Review potential approaches to assist in New Product Planning decision-making
Psoriasis - A BRIEF OUTLOOK..................................by Vishnu R.Nair...RxVichuZ
My fifth presentation...in slideshare.....
This is a precise insight into the popular disease called PSORIASIS....the reasons...classification....diagnosis...and varying therapies..........
Nevertheless, i do sincerely hope that this presentation helps people who are in research work for this disease..or for students, who have this in their curriculum syllabus, or for simple reading.............
More ppts will come on the way............
Thanks for reading..............do give ur feedback..in my email address rxvichu623@gmail.com.........ur views and suggestions will be warmly acknowledged..........
For further details, contact me in whatsapp or hike at 8086948729 or in my facebook profile at Rx Vichhu
Study well!!
Keep rocking!!!
@rxvichu
:) :)
tofacitinib (Tofacent) is an oral drug used for treating rheumatoid arthritis. It belongs to a class of drugs called Janus kinase (JAK) inhibitors. buy tofacitinib only at $6. Visit our website to know more https://emergencydrug.com/drug/tofacitinib-5mg/
Course director, Anthony J. Mancini, MD, FAAP, FAAD, prepared atopic dermatitis infographics for this CME activity titled "Improving the Care of Young Patients With Atopic Dermatitis: Recognizing the Differences Between Children, Adolescents, and Adults." For the full presentation, monograph, complete CME information, and to apply for credit, please visit us at http://bit.ly/320x7ZG. CME credit will be available until July 9, 2020.
INTRODUCTION OF PSORIASIS, EPIDEMIOLOGY OF PSORIASIS, CLINICAL FEATURES OF PSORIASIS, PROGNOSIS OF PSORIASIS, HISTOPATHOLOGY OF PSORIASIS, TRIGGERING FACTORS OF PSORIASIS, PATHOGENESIS OF PSORIASIS
Lantern Pharma is a clinical stage biotechnology company focused on leveraging artificial intelligence (“A.I.”), machine learning and genomic date to streamline the drug development process and to identify patients who will benefit from their targeted oncology therapies. Their portfolio of therapies consists of compounds that others have tried, but failed, to develop into an approved commercialized drug. Additionally, they develop new compounds with the assistance of their A.I. platform (RADR) and biomarker driven approach. The Company is currently developing four therapeutic programs.
60 Degrees Pharmaceuticals (60P) is a growth-oriented biotechnology company with a goal of using cutting-edge biological science and applied research to further develop and commercialize new therapies for the prevention and treatment of infectious diseases. 60P has successfully achieved regulatory approval of ARAKODA® (tafenoquine), a malaria preventative treatment that has been on the market since late 2019. Currently, 60P’s pipeline includes development programs for Tafenoquine and Celgosivir targeting COVID-19, fungal, tick-borne, and other viral diseases.
Virios Therapeutics Inc is a development-stage biotechnology company. It is focused on advancing novel antiviral therapies to treat diseases associated with a viral triggered abnormal immune response such as fibromyalgia.
Virios Therapeutics is a clinical-stage biotechnology company focused on advancing novel, dual mechanism antiviral therapies to treat conditions associated with virally triggered or maintained immune responses, such as Fibromyalgia (“FM”). Immune responses related to the activation of tissue resident Herpes Simplex Virus-1 (“HSV-1”) have been postulated as a potential root cause triggering and/or sustaining chronic illnesses such as FM, irritable bowel disease (“IBS”), and chronic fatigue syndrome, all of which can be characterized by waxing and waning symptom flare-ups with no obvious etiology. Virios’ lead development candidate (“IMC-1”) is a novel, proprietary, fixed dose combination of famciclovir and celecoxib designed to synergistically suppress HSV-1 replication, with the end goal of reducing virally promoted disease symptoms.
NVBDCP.pptx Nation vector borne disease control programSapna Thakur
NVBDCP was launched in 2003-2004 . Vector-Borne Disease: Disease that results from an infection transmitted to humans and other animals by blood-feeding arthropods, such as mosquitoes, ticks, and fleas. Examples of vector-borne diseases include Dengue fever, West Nile Virus, Lyme disease, and malaria.
Knee anatomy and clinical tests 2024.pdfvimalpl1234
This includes all relevant anatomy and clinical tests compiled from standard textbooks, Campbell,netter etc..It is comprehensive and best suited for orthopaedicians and orthopaedic residents.
These lecture slides, by Dr Sidra Arshad, offer a quick overview of physiological basis of a normal electrocardiogram.
Learning objectives:
1. Define an electrocardiogram (ECG) and electrocardiography
2. Describe how dipoles generated by the heart produce the waveforms of the ECG
3. Describe the components of a normal electrocardiogram of a typical bipolar leads (limb II)
4. Differentiate between intervals and segments
5. Enlist some common indications for obtaining an ECG
Study Resources:
1. Chapter 11, Guyton and Hall Textbook of Medical Physiology, 14th edition
2. Chapter 9, Human Physiology - From Cells to Systems, Lauralee Sherwood, 9th edition
3. Chapter 29, Ganong’s Review of Medical Physiology, 26th edition
4. Electrocardiogram, StatPearls - https://www.ncbi.nlm.nih.gov/books/NBK549803/
5. ECG in Medical Practice by ABM Abdullah, 4th edition
6. ECG Basics, http://www.nataliescasebook.com/tag/e-c-g-basics
ARTIFICIAL INTELLIGENCE IN HEALTHCARE.pdfAnujkumaranit
Artificial intelligence (AI) refers to the simulation of human intelligence processes by machines, especially computer systems. It encompasses tasks such as learning, reasoning, problem-solving, perception, and language understanding. AI technologies are revolutionizing various fields, from healthcare to finance, by enabling machines to perform tasks that typically require human intelligence.
Explore natural remedies for syphilis treatment in Singapore. Discover alternative therapies, herbal remedies, and lifestyle changes that may complement conventional treatments. Learn about holistic approaches to managing syphilis symptoms and supporting overall health.
New Drug Discovery and Development .....NEHA GUPTA
The "New Drug Discovery and Development" process involves the identification, design, testing, and manufacturing of novel pharmaceutical compounds with the aim of introducing new and improved treatments for various medical conditions. This comprehensive endeavor encompasses various stages, including target identification, preclinical studies, clinical trials, regulatory approval, and post-market surveillance. It involves multidisciplinary collaboration among scientists, researchers, clinicians, regulatory experts, and pharmaceutical companies to bring innovative therapies to market and address unmet medical needs.
Acute scrotum is a general term referring to an emergency condition affecting the contents or the wall of the scrotum.
There are a number of conditions that present acutely, predominantly with pain and/or swelling
A careful and detailed history and examination, and in some cases, investigations allow differentiation between these diagnoses. A prompt diagnosis is essential as the patient may require urgent surgical intervention
Testicular torsion refers to twisting of the spermatic cord, causing ischaemia of the testicle.
Testicular torsion results from inadequate fixation of the testis to the tunica vaginalis producing ischemia from reduced arterial inflow and venous outflow obstruction.
The prevalence of testicular torsion in adult patients hospitalized with acute scrotal pain is approximately 25 to 50 percent
Ethanol (CH3CH2OH), or beverage alcohol, is a two-carbon alcohol
that is rapidly distributed in the body and brain. Ethanol alters many
neurochemical systems and has rewarding and addictive properties. It
is the oldest recreational drug and likely contributes to more morbidity,
mortality, and public health costs than all illicit drugs combined. The
5th edition of the Diagnostic and Statistical Manual of Mental Disorders
(DSM-5) integrates alcohol abuse and alcohol dependence into a single
disorder called alcohol use disorder (AUD), with mild, moderate,
and severe subclassifications (American Psychiatric Association, 2013).
In the DSM-5, all types of substance abuse and dependence have been
combined into a single substance use disorder (SUD) on a continuum
from mild to severe. A diagnosis of AUD requires that at least two of
the 11 DSM-5 behaviors be present within a 12-month period (mild
AUD: 2–3 criteria; moderate AUD: 4–5 criteria; severe AUD: 6–11 criteria).
The four main behavioral effects of AUD are impaired control over
drinking, negative social consequences, risky use, and altered physiological
effects (tolerance, withdrawal). This chapter presents an overview
of the prevalence and harmful consequences of AUD in the U.S.,
the systemic nature of the disease, neurocircuitry and stages of AUD,
comorbidities, fetal alcohol spectrum disorders, genetic risk factors, and
pharmacotherapies for AUD.
TEST BANK for Operations Management, 14th Edition by William J. Stevenson, Ve...kevinkariuki227
TEST BANK for Operations Management, 14th Edition by William J. Stevenson, Verified Chapters 1 - 19, Complete Newest Version.pdf
TEST BANK for Operations Management, 14th Edition by William J. Stevenson, Verified Chapters 1 - 19, Complete Newest Version.pdf
Pulmonary Thromboembolism - etilogy, types, medical- Surgical and nursing man...VarunMahajani
Disruption of blood supply to lung alveoli due to blockage of one or more pulmonary blood vessels is called as Pulmonary thromboembolism. In this presentation we will discuss its causes, types and its management in depth.
Ozempic: Preoperative Management of Patients on GLP-1 Receptor Agonists Saeid Safari
Preoperative Management of Patients on GLP-1 Receptor Agonists like Ozempic and Semiglutide
ASA GUIDELINE
NYSORA Guideline
2 Case Reports of Gastric Ultrasound
Title: Sense of Taste
Presenter: Dr. Faiza, Assistant Professor of Physiology
Qualifications:
MBBS (Best Graduate, AIMC Lahore)
FCPS Physiology
ICMT, CHPE, DHPE (STMU)
MPH (GC University, Faisalabad)
MBA (Virtual University of Pakistan)
Learning Objectives:
Describe the structure and function of taste buds.
Describe the relationship between the taste threshold and taste index of common substances.
Explain the chemical basis and signal transduction of taste perception for each type of primary taste sensation.
Recognize different abnormalities of taste perception and their causes.
Key Topics:
Significance of Taste Sensation:
Differentiation between pleasant and harmful food
Influence on behavior
Selection of food based on metabolic needs
Receptors of Taste:
Taste buds on the tongue
Influence of sense of smell, texture of food, and pain stimulation (e.g., by pepper)
Primary and Secondary Taste Sensations:
Primary taste sensations: Sweet, Sour, Salty, Bitter, Umami
Chemical basis and signal transduction mechanisms for each taste
Taste Threshold and Index:
Taste threshold values for Sweet (sucrose), Salty (NaCl), Sour (HCl), and Bitter (Quinine)
Taste index relationship: Inversely proportional to taste threshold
Taste Blindness:
Inability to taste certain substances, particularly thiourea compounds
Example: Phenylthiocarbamide
Structure and Function of Taste Buds:
Composition: Epithelial cells, Sustentacular/Supporting cells, Taste cells, Basal cells
Features: Taste pores, Taste hairs/microvilli, and Taste nerve fibers
Location of Taste Buds:
Found in papillae of the tongue (Fungiform, Circumvallate, Foliate)
Also present on the palate, tonsillar pillars, epiglottis, and proximal esophagus
Mechanism of Taste Stimulation:
Interaction of taste substances with receptors on microvilli
Signal transduction pathways for Umami, Sweet, Bitter, Sour, and Salty tastes
Taste Sensitivity and Adaptation:
Decrease in sensitivity with age
Rapid adaptation of taste sensation
Role of Saliva in Taste:
Dissolution of tastants to reach receptors
Washing away the stimulus
Taste Preferences and Aversions:
Mechanisms behind taste preference and aversion
Influence of receptors and neural pathways
Impact of Sensory Nerve Damage:
Degeneration of taste buds if the sensory nerve fiber is cut
Abnormalities of Taste Detection:
Conditions: Ageusia, Hypogeusia, Dysgeusia (parageusia)
Causes: Nerve damage, neurological disorders, infections, poor oral hygiene, adverse drug effects, deficiencies, aging, tobacco use, altered neurotransmitter levels
Neurotransmitters and Taste Threshold:
Effects of serotonin (5-HT) and norepinephrine (NE) on taste sensitivity
Supertasters:
25% of the population with heightened sensitivity to taste, especially bitterness
Increased number of fungiform papillae
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2. 2
Sanofi Forward Looking Statements
This presentation 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, Sanofi’s ability to benefit from external growth opportunities and/or obtain regulatory
clearances, risks associated with intellectual property and any related pending or future litigation and the ultimate outcome of such litigation, trends in
exchange rates and prevailing interest rates, volatile economic conditions, the impact of cost containment initiatives 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, 2016. Other than as required by applicable law, Sanofi does not undertake any obligation to update or revise any
forward-looking information or statements.
3. 3
Regeneron Forward Looking Statements
This presentation includes forward-looking statements that involve risks and uncertainties relating to future events and the future performance of
Regeneron Pharmaceuticals, Inc. ("Regeneron" or the "Company"), 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 Dupixent® (dupilumab)
Injection; the likelihood, timing, and scope of possible regulatory approval and commercial launch of Regeneron's late-stage product candidates and
new indications for marketed products, such as Dupixent for the treatment of uncontrolled moderate-to-severe atopic dermatitis in jurisdictions outside
the United States and other potential indications; unforeseen safety issues and possible liability resulting from the administration of products and product
candidates in patients, including without limitation Dupixent; serious complications or side effects in connection with the use of Regeneron's products
and product candidates (such as Dupixent) in clinical trials; coverage and reimbursement determinations by third-party payers, including Medicare,
Medicaid, and pharmacy benefit management companies; ongoing regulatory obligations and oversight impacting Regeneron's marketed products,
research and clinical programs, and business, including those relating to the enrollment, completion, and meeting of the relevant endpoints of post-
approval studies; 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, such as Dupixent; 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 and the impact of studies (whether conducted by Regeneron or others and whether mandated or voluntary) on the 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; 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, Bayer, and Teva Pharmaceutical Industries Ltd. (or their respective affiliated
companies, as applicable), 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, including without limitation the patent litigation relating to Praluent® (alirocumab) Injection, the
permanent injunction granted by the United States District Court for the District of Delaware that, if upheld on appeal, would prohibit Regeneron and
Sanofi from marketing, selling, or manufacturing Praluent in the United States, the outcome of any appeals regarding such injunction, the ultimate
outcome of such litigation, and the impact any of the foregoing may have on Regeneron’s business, prospects, operating results, and financial condition.
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, 2016. Any forward-looking statements are made based on management's
current beliefs and judgment, and 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.
4. 4
Agenda
Opening remarks – DUPIXENT®, a breakthrough innovation
● Olivier Brandicourt – Chief Executive Officer, Sanofi
● Leonard S. Schleifer, MD, PhD – Founder, President and Chief Executive Officer, Regeneron
Q&A Session
● George D. Yancopoulos, MD, PhD – Founding Scientist, President and Chief Scientific Officer,
Regeneron
● Elias Zerhouni, MD – President, Global Research & Development, Sanofi
● Bill Sibold – Global Head Multiple Sclerosis, Oncology & Immunology, Sanofi Genzyme
● Robert Terifay – Executive Vice President, Commercial, Regeneron
5. 5
DUPIXENT®: A Breakthrough Treatment for Moderate-to-
Severe Atopic Dermatitis (AD)
● A key new product launch for
Regeneron and Sanofi
● Important addition to Sanofi Genzyme
specialty care business
● Science driving innovation:
First biologic therapy for AD
approved in the US
● Excited to bring product rapidly to
market to help address high unmet need
● Kevzara™ (sarilumab) BLA resubmitted
6. 6
Il-4/IL-13 Considered Common Drivers in the Following
Diseases(1)
Il-4/IL-13 signaling is
considered to be
central to many Type-2
mediated allergic
diseases
IL-4/
IL-13
Atopic
Dermatitis
Asthma
Nasal
Polyps
Eosinophilic
Esophagitis
(1) Dupilumab is under clinical development in asthma, nasal polyps and
eosinophilic esophagitis and its safety and efficacy in these indications
have not been fully evaluated by any Regulatory Authority
7. 7
● Moderate-to-severe form of AD can be a debilitating, life-altering condition that impacts
people’s day-to-day functioning
● Characterized by intense itching and recurrent eczematous lesions
● Multifactorial etiology involving immune-mediated inflammation, skin-barrier defect, genetic
factors and environmental triggers
● Although it often starts in infancy, it is also prevalent in adults
AD is a Chronic, Inflammatory Skin Disease,
Characterized by Intractable Pruritus
8. 8
DUPIXENT®: The First FDA Approved Biologic for Adults
with Uncontrolled Moderate-to-Severe AD
DUPIXENT® INDICATIONS AND USAGE
DUPIXENT® is indicated for the treatment of adult patients with moderate-to-severe atopic dermatitis
whose disease is not adequately controlled with topical prescription therapies or when those therapies
are not advisable. DUPIXENT® can be used with or without topical corticosteroids.
DUPIXENT® WARNINGS AND PRECAUTIONS
Hypersensitivity: Hypersensitivity reactions, including generalized urticaria and serum sickness or
serum sickness-like reactions, were reported in subjects who received DUPIXENT®. If a systemic
hypersensitivity reaction occurs, discontinue DUPIXENT® immediately and initiate appropriate therapy.
Conjunctivitis and Keratitis: Conjunctivitis and keratitis occurred more frequently in subjects who
received DUPIXENT®. Conjunctivitis was the most frequently reported eye disorder. Patients should
report new onset or worsening eye symptoms to their healthcare provider.
Comorbid Asthma: Safety and efficacy of DUPIXENT® have not been established in the treatment of
asthma. Advise patients with comorbid asthma not to adjust or stop their asthma treatment without
consultation with their physicians.
Parasitic (Helminth) Infections: Patients with known helminth infections were excluded from
participation in clinical studies. It is unknown if DUPIXENT® will influence the immune response against
helminth infections
9. 9
U.S. Launch Focused on Patients with the Highest Unmet
Medical Need
Patient
Focus at Launch
Moderate-to-severe AD
patients intolerant to or
inadequate response
to an existing therapy
(Topical prescription therapies and
Oral/systemic steroids or
Immuno-suppressants)
Around 300,000
adult patients
in the U.S.
● BSA affected: 86.5%
● EASI score: 51.5
● Pruritus NRS: 7
● AD duration: 48 years
● BSA affected: 2.5%
● EASI score: 3.1
● Pruritus NRS: 1.6
Pictures from Phase 3 clinical trial provided for illustrative purposes
only to show how the clinical parameters above may correlate to the
clinical presentation of a patient.(1,2)
(1) Images are taken from same patient at baseline (left) and at 16 weeks
(right). Results were not representative of all patients and individual
results did vary. In phase 3 clinical trials, the percentage of patients
achieving an IGA score of 0 or 1 ranged from 36%-38%.
(2) The most common side effects in clinical trials included injection site
reactions, eye and eyelid inflammation, including redness, swelling and
itching, and cold sores in mouth or on lips
IGA: Investigator Global Assessment
BSA: Body Surface Area
EASI: Eczema Area and Severity Index
NRS: Numerical Rating Scale
IGA 4 IGA 1
10. 10
Target Physicians who Treat AD Patients and
Have Experience Prescribing Biologics
Physician
Focus at Launch
Dermatologists
(i.e. Psoriasis)
Allergists/Immunologists
Up to 7,000 doctors
in the U.S.
11. 11
A Commitment to Responsible Pricing: Valuing a
Breakthrough Therapy for Moderate-to-Severe AD
Breakthrough,
First-in-Class Therapy
Disease Burden/Treatment
Landscape
Cost-Effectiveness
Analyses
Physician, Patient, Payer & Other
Stakeholder Feedback
Ensuring Continued
Investment in Biopharma
Innovation
RESPONSIBLE
PRICING FOR
DUPIXENT®
Clinical &
QoL Benefit
QoL: Quality of Life
Careful consideration of several clinical and economic value
measures in pricing DUPIXENT®
Qualitative measures
Quantitative measures
Comparable Biologic
Pricing
12. 12
WAC = Wholesale Acquisition Cost
(1) Moderate-to-severe AD compared with moderate to severe psoriasis. As measured by the Dermatology Life Quality Index (DLQI) , a scale where a higher number means a
worse impact on quality of life. DLQI data derived from 11 published clinical studies of psoriasis treatments in patients with moderate to severe psoriasis, data on file.
Moderate-to-severe AD DLQI data derived from Phase 3 SOLO 1 and SOLO 2 studies clinical studies report, data on file.
(2) Yearly maintenance treatment cost based on WAC prices in the U.S. (not reflective of discounts or rebates) and excludes one-time loading dose(s).
(3) Annual treatment costs for Dupixent in AD compare favorably with biologic treatments for psoriasis including adalimumab, etanercept, ixekizumab, secukinumab and
ustekinumab. The chart represents a comparison of list prices and is not intended to imply a comparison of safety or efficacy.
DUPIXENT® WAC is Lower than Biologics Used to Treat
Psoriasis(1)
0
5
10
15
20
25
30
BaselineMeanDLQIScore
11.5 - 13
Moderate-to-Severe
Atopic Dermatitis
14.5 - 16
Moderate-to-Severe
Psoriasis
Humira
Enbrel
Stelara
Dupixent
Psoriasis Biologic
Treatments
AD is at Least as Burdensome a
Disease as Psoriasis(1)
Yet DUPIXENT® WAC is
Lower than Psoriasis Biologics(2,3)
(in USD)
$30,000
$80,000
$70,000
$50,000
$10,000
$60,000
$40,000
$90,000
$20,000
$0
~$41,000
~$83,000
$37,000
13. 13
Working Alongside Payers to Provide Appropriate Access
For Patients
Provide Patient Access
● Consultation with PBMs
Aligned view on the burden of disease, the
unmet need that exists and the right patient
for treatment
● Early Formulary Coverage Expected(1)
for a large population of patients within days
● Appropriate Utilization Management
Criteria
Expect physician attestation, specialist-only
prescription, and no step-edits through
systemic immunosuppressant therapies
Payer Discussions
(1) Individual plans may vary
14. 14
Comprehensive Support to Optimize Patient Access and
Minimize Barriers to Treatment
Patient Support & Coverage Patient Access
● $0 Copay
Program for
eligible patients
● Patient
Assistance
Program
● Education and personalized
nurse support
● Benefits Investigation
● Prior Authorization
Assistance
● Appeals
Support
DUPIXENT® expected to be commercially available in the U.S. later this week