- The document presents information on Praluent (alirocumab), the first PCSK9 inhibitor therapy approved in the US for treatment of adults with heterozygous familial hypercholesterolemia or clinical atherosclerotic cardiovascular disease who require additional lowering of LDL cholesterol.
- Praluent demonstrated robust and durable LDL-C reduction of over 52 weeks in clinical trials in patients on maximally tolerated statin therapy, with 57-83% of patients achieving sufficient LDL-C reduction with the 75 mg starting dose.
- The Committee for Medicinal Products for Human Use adopted a positive opinion for Praluent in Europe, and approval is expected in late September 2015. The OD
1. A Case report of Heart Failure
2. Discussion on Heart Failure
3. Role of Peptides in Heart Failure
4. Importance of 30 days in heart failure
5. Role of ENTRESTO in Stable Heart Failure patient (PARADIGM-HF study)(HFrEF)
6. Biomarkers in Heart Failure
7. Role of ARNI in Hospitalized Heart Failure patient (PIONEER-HF study)
8. Role of ARNI in HFpEF (PARAMOUNT Trial)
9. Safety and usefulness of ACEI/ARB/ARNI
10. Role of SGPL2 inhibitors in HF with/without DM
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
Javed Butler, MD, MPH, MBA, discusses heart failure in this CME activity titled, "New Frontiers in Managing Heart Failure: Are SGLT2 Inhibitors the Next Leap Forward in Optimizing Patient Care?" For the full presentation, downloadable infographics, monograph, complete CME information, and to apply for credit, please visit us at http://bit.ly/2JG2v9l. CME credit will be available until May 29, 2020.
Viagra Promotion Strategy Mod 23rd April 09Siddharth Soni
Got an opportunity some time back to present a promotion strategy for the wonder drug VIAGRA in India. So here's what I presented.
Did it get implemented? No! I heard that Pfizer works like a bureaucracy... Can't say anything about the veracity of the claim but if it's true, by any chance, then they need to pop the same drug that they prescribe :).
1. A Case report of Heart Failure
2. Discussion on Heart Failure
3. Role of Peptides in Heart Failure
4. Importance of 30 days in heart failure
5. Role of ENTRESTO in Stable Heart Failure patient (PARADIGM-HF study)(HFrEF)
6. Biomarkers in Heart Failure
7. Role of ARNI in Hospitalized Heart Failure patient (PIONEER-HF study)
8. Role of ARNI in HFpEF (PARAMOUNT Trial)
9. Safety and usefulness of ACEI/ARB/ARNI
10. Role of SGPL2 inhibitors in HF with/without DM
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
Javed Butler, MD, MPH, MBA, discusses heart failure in this CME activity titled, "New Frontiers in Managing Heart Failure: Are SGLT2 Inhibitors the Next Leap Forward in Optimizing Patient Care?" For the full presentation, downloadable infographics, monograph, complete CME information, and to apply for credit, please visit us at http://bit.ly/2JG2v9l. CME credit will be available until May 29, 2020.
Viagra Promotion Strategy Mod 23rd April 09Siddharth Soni
Got an opportunity some time back to present a promotion strategy for the wonder drug VIAGRA in India. So here's what I presented.
Did it get implemented? No! I heard that Pfizer works like a bureaucracy... Can't say anything about the veracity of the claim but if it's true, by any chance, then they need to pop the same drug that they prescribe :).
http://www.theheart.org/web_slides/1225165.do
A randomized study on Olmesartan and Calcium Antagonists Randomized (OSCAR) using high-dose of olmesartan or standard dose calcium-channel blocker (CCB) (amlodipine or azelnidipine) with patients with uncontrolled hypertension
Huy Tran is a lab and clinical haematologist at Peninsula Health. He has research interests in haemostasis and thrombosis and is a member of the Australasian committee for anticoagulation reversal. Here he presents on the new oral anticoagulants and what can be done when they cause critical bleeding
Dpp4i vs sglt2 inhibitors against the motionSujoy Majumdar
A debate showing why SGLT2 inhibitors have not have a major advantage over DPP4 inhibitors as the next add on drug after Metformin in the management of Type 2 Diabetes
Olmesartan medoxomil is an angiotensin II receptor antagonist which is used for the treatment of high blood pressure. An ester prodrug, it is completely and rapidly hydrolyzed to the active acid form. It is indicated for the treatment of hypertension. It may be used alone or in combination with other antihypertensive agents
Heart Failure with Preserved Ejection Fraction(HFpEF).ptxSarfraz Saleemi
Heart failure with preserved ejection fraction (HFpEF) is not one disease but a clinical syndrome presenting with symptoms of Heart Failure with a left ventricular ejection fraction (LVEF) ≥50 percent and evidence of cardiac diastolic dysfunction. (abnormal LV filling pattern and elevated filling pressures)
It is more common among older patients and women, and results from abnormalities of active ventricular relaxation and passive ventricular compliance. HFpEF should be part of differential diagnosis in patients with typical symptoms such as fatigue, weakness, dyspnea, orthopnea, paroxysmal nocturnal dyspnea, edema and clinical signs of chronic heart failure. Echocardiography features of normal ejection fraction with impaired diastolic function confirm the diagnosis.
John B. Buse, MD, PhD, discusses type 2 diabetes in this CME activity titled "Exploring the Science and Practice of GLP-1 Receptor Agonists: An Update on Current and Emerging Evidence." For the full presentation, downloadable infographics, monograph, complete CME information, and to apply for credit, please visit us at http://bit.ly/2oL19BK. CME credit will be available until October 21, 2020.
http://www.theheart.org/web_slides/1225165.do
A randomized study on Olmesartan and Calcium Antagonists Randomized (OSCAR) using high-dose of olmesartan or standard dose calcium-channel blocker (CCB) (amlodipine or azelnidipine) with patients with uncontrolled hypertension
Huy Tran is a lab and clinical haematologist at Peninsula Health. He has research interests in haemostasis and thrombosis and is a member of the Australasian committee for anticoagulation reversal. Here he presents on the new oral anticoagulants and what can be done when they cause critical bleeding
Dpp4i vs sglt2 inhibitors against the motionSujoy Majumdar
A debate showing why SGLT2 inhibitors have not have a major advantage over DPP4 inhibitors as the next add on drug after Metformin in the management of Type 2 Diabetes
Olmesartan medoxomil is an angiotensin II receptor antagonist which is used for the treatment of high blood pressure. An ester prodrug, it is completely and rapidly hydrolyzed to the active acid form. It is indicated for the treatment of hypertension. It may be used alone or in combination with other antihypertensive agents
Heart Failure with Preserved Ejection Fraction(HFpEF).ptxSarfraz Saleemi
Heart failure with preserved ejection fraction (HFpEF) is not one disease but a clinical syndrome presenting with symptoms of Heart Failure with a left ventricular ejection fraction (LVEF) ≥50 percent and evidence of cardiac diastolic dysfunction. (abnormal LV filling pattern and elevated filling pressures)
It is more common among older patients and women, and results from abnormalities of active ventricular relaxation and passive ventricular compliance. HFpEF should be part of differential diagnosis in patients with typical symptoms such as fatigue, weakness, dyspnea, orthopnea, paroxysmal nocturnal dyspnea, edema and clinical signs of chronic heart failure. Echocardiography features of normal ejection fraction with impaired diastolic function confirm the diagnosis.
John B. Buse, MD, PhD, discusses type 2 diabetes in this CME activity titled "Exploring the Science and Practice of GLP-1 Receptor Agonists: An Update on Current and Emerging Evidence." For the full presentation, downloadable infographics, monograph, complete CME information, and to apply for credit, please visit us at http://bit.ly/2oL19BK. CME credit will be available until October 21, 2020.
Ponencia sobre 'Diabetes, lípidos y cardiopatía isquémica crónica’, presentada por la Dra. Almudena Castro en el directo online 'Lo mejor del ACC 2014', celebrado en la Casa del Corazón.
The first book to deal with the problems of communicating to a skeptical, media-blitzed public, Positioning describes a revolutionary approach to creating a "position" in a prospective customer's mind-one that reflects a company's own strengths and weaknesses as well as those of its competitors.
IFPMA-TFDA Workshop on Couterfeit Medicines
‘Integrated Approach Against Fake Medicines’
On 6th February 2015
At Taipei International Convention Center
Taipei, Taiwan
22 immutable laws of marketing by Suhag MistrySuhag Mistry
100% working Marketing techniques for businesses. Use mentioned rules and develop great marketing plan. And YES it still works. I use it for developing Marketing plan for my consultant as a Business consultant.
Details on Exact Sciences' Lung Cancer Partnership With MD AndersonExact Sciences
Exact Sciences will partner with MD Anderson to jointly develop and commercialize blood-based screening and diagnostics tests for the early detection of lung cancer. More details herein.
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.
American Noble Gas is an oil and gas exploration, development, and production company with a history of operations in Texas, Kansas, Oklahoma, and the Rocky Mountain region of the US. The Company is currently exploring and developing natural gas, helium, and other noble gases and brine minerals contained in the Hugoton Gas Field, a prolific natural gas and helium gas field spanning the states of Kansas, Oklahoma, and Texas, through a 40% participation in a farmout agreement that covers drilling and completion of up to 50 wells. American Noble Gas also owns 60.7143% of GMDOC, LLC, LLC which acquired certain oil and gas leases covering approximately 10,000 acres located in Southern Kansas near the Oklahoma border. The GMDOC leases currently produce approximately 100 barrels of oil and 1.2 million cubic feet of natural gas per day on a gross basis. The Company also owns mineral rights to approximately 11,000 acres in the Otis/Albert Field located on the Kansas Central Uplift.
Unicycive Therapeutics (UNCY) is a developer of residential communities in Northern Baja California with projects are targeted at buyers and investors of primary, vacation, and/or retirement homes. The Company’s projects in Northern Baja – a popular tourism and retirement destination – are strategically located within driving distance of Southern California and are supported by the region’s attractive demographics, large pent-up demand, and persistent housing shortages. With a goal of delivering sustainable and socially responsible solutions, the Company leverages advanced property and construction technologies to provide a seamless and efficient platform that enhances the customer sales experience. A newly added mortgage division, providing previously unattainable financing options to US buyers, is expected to drive accelerate sales growth across UNCY’s projects.
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.
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.
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.
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 “flair-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.
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 “flair-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.
micro teaching on communication m.sc nursing.pdfAnurag Sharma
Microteaching is a unique model of practice teaching. It is a viable instrument for the. desired change in the teaching behavior or the behavior potential which, in specified types of real. classroom situations, tends to facilitate the achievement of specified types of objectives.
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
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.
MANAGEMENT OF ATRIOVENTRICULAR CONDUCTION BLOCK.pdfJim Jacob Roy
Cardiac conduction defects can occur due to various causes.
Atrioventricular conduction blocks ( AV blocks ) are classified into 3 types.
This document describes the acute management of AV block.
Title: Sense of Smell
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 primary categories of smells and the concept of odor blindness.
Explain the structure and location of the olfactory membrane and mucosa, including the types and roles of cells involved in olfaction.
Describe the pathway and mechanisms of olfactory signal transmission from the olfactory receptors to the brain.
Illustrate the biochemical cascade triggered by odorant binding to olfactory receptors, including the role of G-proteins and second messengers in generating an action potential.
Identify different types of olfactory disorders such as anosmia, hyposmia, hyperosmia, and dysosmia, including their potential causes.
Key Topics:
Olfactory Genes:
3% of the human genome accounts for olfactory genes.
400 genes for odorant receptors.
Olfactory Membrane:
Located in the superior part of the nasal cavity.
Medially: Folds downward along the superior septum.
Laterally: Folds over the superior turbinate and upper surface of the middle turbinate.
Total surface area: 5-10 square centimeters.
Olfactory Mucosa:
Olfactory Cells: Bipolar nerve cells derived from the CNS (100 million), with 4-25 olfactory cilia per cell.
Sustentacular Cells: Produce mucus and maintain ionic and molecular environment.
Basal Cells: Replace worn-out olfactory cells with an average lifespan of 1-2 months.
Bowman’s Gland: Secretes mucus.
Stimulation of Olfactory Cells:
Odorant dissolves in mucus and attaches to receptors on olfactory cilia.
Involves a cascade effect through G-proteins and second messengers, leading to depolarization and action potential generation in the olfactory nerve.
Quality of a Good Odorant:
Small (3-20 Carbon atoms), volatile, water-soluble, and lipid-soluble.
Facilitated by odorant-binding proteins in mucus.
Membrane Potential and Action Potential:
Resting membrane potential: -55mV.
Action potential frequency in the olfactory nerve increases with odorant strength.
Adaptation Towards the Sense of Smell:
Rapid adaptation within the first second, with further slow adaptation.
Psychological adaptation greater than receptor adaptation, involving feedback inhibition from the central nervous system.
Primary Sensations of Smell:
Camphoraceous, Musky, Floral, Pepperminty, Ethereal, Pungent, Putrid.
Odor Detection Threshold:
Examples: Hydrogen sulfide (0.0005 ppm), Methyl-mercaptan (0.002 ppm).
Some toxic substances are odorless at lethal concentrations.
Characteristics of Smell:
Odor blindness for single substances due to lack of appropriate receptor protein.
Behavioral and emotional influences of smell.
Transmission of Olfactory Signals:
From olfactory cells to glomeruli in the olfactory bulb, involving lateral inhibition.
Primitive, less old, and new olfactory systems with different path
Lung Cancer: Artificial Intelligence, Synergetics, Complex System Analysis, S...Oleg Kshivets
RESULTS: Overall life span (LS) was 2252.1±1742.5 days and cumulative 5-year survival (5YS) reached 73.2%, 10 years – 64.8%, 20 years – 42.5%. 513 LCP lived more than 5 years (LS=3124.6±1525.6 days), 148 LCP – more than 10 years (LS=5054.4±1504.1 days).199 LCP died because of LC (LS=562.7±374.5 days). 5YS of LCP after bi/lobectomies was significantly superior in comparison with LCP after pneumonectomies (78.1% vs.63.7%, P=0.00001 by log-rank test). AT significantly improved 5YS (66.3% vs. 34.8%) (P=0.00000 by log-rank test) only for LCP with N1-2. Cox modeling displayed that 5YS of LCP significantly depended on: phase transition (PT) early-invasive LC in terms of synergetics, PT N0—N12, cell ratio factors (ratio between cancer cells- CC and blood cells subpopulations), G1-3, histology, glucose, AT, blood cell circuit, prothrombin index, heparin tolerance, recalcification time (P=0.000-0.038). Neural networks, genetic algorithm selection and bootstrap simulation revealed relationships between 5YS and PT early-invasive LC (rank=1), PT N0—N12 (rank=2), thrombocytes/CC (3), erythrocytes/CC (4), eosinophils/CC (5), healthy cells/CC (6), lymphocytes/CC (7), segmented neutrophils/CC (8), stick neutrophils/CC (9), monocytes/CC (10); leucocytes/CC (11). Correct prediction of 5YS was 100% by neural networks computing (area under ROC curve=1.0; error=0.0).
CONCLUSIONS: 5YS of LCP after radical procedures significantly depended on: 1) PT early-invasive cancer; 2) PT N0--N12; 3) cell ratio factors; 4) blood cell circuit; 5) biochemical factors; 6) hemostasis system; 7) AT; 8) LC characteristics; 9) LC cell dynamics; 10) surgery type: lobectomy/pneumonectomy; 11) anthropometric data. Optimal diagnosis and treatment strategies for LC are: 1) screening and early detection of LC; 2) availability of experienced thoracic surgeons because of complexity of radical procedures; 3) aggressive en block surgery and adequate lymph node dissection for completeness; 4) precise prediction; 5) adjuvant chemoimmunoradiotherapy for LCP with unfavorable prognosis.
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
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.
2. 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 labeling 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.
2
Sanofi Forward Looking Statements
3. This presentation includes forward-looking statements that involve risks and uncertainties relating to future events and the future performance of Regeneron
Pharmaceuticals, Inc. ("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 Praluent® (alirocumab) Injection; unforeseen safety issues and possible liability resulting from the administration
of products (including without limitation Praluent) and product candidates in patients; serious complications or side effects in connection with the use of
Regeneron's products and product candidates in clinical trials, such as the ODYSSEY OUTCOMES trial evaluating Praluent; ongoing regulatory obligations and
oversight impacting Regeneron's marketed products (such as Praluent), research and clinical programs, and business, including those relating to the enrollment,
completion, and meeting of the relevant endpoints of post-approval studies such as the ODYSSEY OUTCOMES trial evaluating Praluent; 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; 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, including without limitation Praluent; the impact of the opinion adopted by the European Medicine Agency’s
Committee for Medicinal Products for Human Use discussed in this presentation on the European Commission’s decision regarding the Marketing Authorization
Application for Praluent in the European Union; 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; 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,
2014 and its Form 10-Q for the quarterly period ended March 31, 2015. 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.
Regeneron Forward Looking Statements
3
5. SECTION 1
Jay Edelberg, MD, PhD
Vice President, Head of the PCSK9 Development & Launch Unit, Sanofi
6. CV Disease Is a Major Health and Economic Burden
#1
$315Bn
Cause of death U.S. and worldwide(1)
Estimated U.S. cost of CV disease management(2)
Reducing LDL-C has been a major focus of therapy for patients with
cardiovascular disease, yet many patients are not at their LDL-C goal
(1) Centers for Disease Control and Prevention. Heart Disease Facts. Available from http://www.cdc.gov/heartdisease/facts.htm. Last accessed 29 April 2015
(2) Go AS, Mozaffarian D, Roger VL, et al. Heart disease and stroke statistics--2014 update: a report from the American Heart Association. Circulation. 2014;129(3):
e28-e292
(3) Zhao Z, Winget M. Economic burden of illness of acute coronary syndromes: medical and productivity costs. BMC Health Serv Res. 2011;11:35
$50,000 –
$119,000
The estimated one-year cost of an ACS among working-age
Americans (direct and indirect)(3)
6
7. Praluent® (alirocumab) - First PCSK9 Inhibitor Therapy Approved
in the U.S.
Praluent® is indicated as adjunct to diet and maximally tolerated statin therapy for the
treatment of adults with heterozygous familial hypercholesterolemia or clinical
atherosclerotic cardiovascular disease, who require additional lowering of LDL
cholesterol (LDL-C)
Limitations of Use
The effect of Praluent® on cardiovascular morbidity and mortality has not been
determined
INDICATION STATEMENT
7
8. Who are ASCVD and HeFH Patients?
ASCVD = Clinical Atherosclerotic Cardiovascular Disease, RCT= Randomized Clinical Trial, MI= Myocardial Infarction, TIA= Transient Ischemic Stroke,
HeFH= Heterozygous Familial Hypercholesterolemia
(1) AHA/ACC Guidelines, Stone et al
(2) Based on five double-blind, placebo-controlled studies that are included in the label
Diagnosed using Simon Broome criteria or Dutch Lipid
Networking criteria that are based on a combination of
cholesterol levels, physical manifestations, family history
and genetic testing, if available
Diagnostic Criteria for HeFH
Defined as acute coronary syndromes,
or a history of MI, stable or unstable angina, coronary
or other arterial revascularization, stroke, TIA,
or peripheral arterial disease presumed to be
of atherosclerotic origin(1)
Definition According to
AHA/ACC Guidelines for ASCVD
90% of the ODYSSEY population met this criteria(2)
• 54% were Non-heterozygous FH with clinical ASCVD
• 36% had Heterozygous FH
Heterozygous Familial
Hypercholesterolemia
Clinical Atherosclerotic Cardiovascular Disease
8
9. Two Approved Doses Provide Flexibility: 75 mg and 150 mg Q2W
75 mg
dose
150 mg
dose
The recommended
starting dose of
Praluent® is 75 mg,
administered
subcutaneously once
every 2 weeks,
since the majority of
patients (57%-83%)
achieve sufficient
LDL-C reduction
with this dosage
If the LDL-C
response is
inadequate, the
dosage may be
increased to the
maximum dosage of
150 mg administered
every 2 weeks
9
Both doses available as pen and pre-filled syringe
10. Robust and Durable LDL-C Reduction Maintained
over 52 Weeks in ODYSSEY FH I and FH II PooledFH I and FH II
Mean % Change from Baseline in LDL-C over 52 Weeks in Patients with HeFH on Maximally
Tolerated Statin Treated with Praluent® 75/150 mg Q2W and Placebo Q2W(1)
p<0.0001 at Week 24
Praluent®
Placebo
(1) The means were estimated based on all randomized patients, with multiple imputation of missing data taking into account treatment adherence
(2) Number of patients with observed data
Placebo (N)(2)
Praluent® (N)(2)
10
11. Robust and Durable LDL-C Reduction Maintained over
52 Weeks in ODYSSEY LONG TERMLONG TERM
Mean % Change from Baseline in LDL-C over 52 Weeks in Patients on Maximally
Tolerated Statin Treated with Praluent® 150 mg Q2W and Placebo Q2W(1)
Praluent®
Placebo
p<0.0001 at Week 24
(1) The means were estimated based on all randomized patients, with multiple imputation of missing data taking into account treatment adherence
(2) Number of patients with observed data
Placebo (N)(2)
Praluent® (N)(2)
11
12. Important Safety Information
12
● Praluent® is contraindicated in patients with a history of a serious
hypersensitivity reaction to Praluent®
● Hypersensitivity reactions (e.g., pruritus, rash, urticaria), including some serious
events (e.g., hypersensitivity vasculitis and hypersensitivity reactions requiring
hospitalization), have been reported with Praluent® treatment. If signs or
symptoms of serious allergic reactions occur, discontinue treatment with
Praluent®, treat according to the standard of care, and monitor until signs and
symptoms resolve
● The most commonly occurring adverse reactions (≥5% of patients treated with
Praluent® and occurring more frequently than with placebo) are
nasopharyngitis, injection site reactions, and influenza
13. Clinical Experience With Low LDL in Patients Who Received
Praluent® 75 mg or 150 mg Q2W
• In a pool of both placebo- and active-controlled clinical trials, 3,340 patients were treated with Praluent®:
• 796 patients (24%) had 2 or more calculated LDL-C values <25 mg/dL
• 288 patients (9%) had 2 or more consecutive LDL-C values <15 mg/dL
• Changes to background lipid-altering therapy (e.g., maximally tolerated statins) were not made in response to low
LDL-C values, and Praluent® dosing was not modified or interrupted on this basis
• Although adverse consequences of very low LDL-C were not identified in these trials, the long-term effects of very
low levels of LDL-C induced by Praluent® are unknown
Low LDL-C
13
14. CHMP Adopts Positive Opinion For Praluent® in Europe
CHMP recommended granting Praluent® marketing authorization for adults with primary
hypercholesterolaemia (heterozygous familial and non-familial) or mixed dyslipidaemia, as an adjunct to
diet:
• in combination with a statin or statin with other lipid lowering therapies in patients unable to reach
LDL-C goals with the maximum tolerated dose of a statin or,
• alone or in combination with other lipid-lowering therapies in patients who are statin-intolerant, or for
whom a statin is contraindicated
The effect of Praluent® on cardiovascular morbidity and mortality has not yet been determined
EMA approval expected in late September 2015
CHMP: Committee for Medicinal Products for Human Use
14
15. The effect of Praluent® on morbidity and mortality has not yet been determined.
ODYSSEY OUTCOMES Expected to be Fully Enrolled by Year-End
2015
(1) High intensity statin therapy include atorvastatin 40/80mg or rosuvastatin 20/40mg
(2) Patients can also qualify with apoB>80mg/dL or non-HDL-C > 100 mg/dL
(3) Primary endpoint is a composite endpoint of coronary heart disease (CHD) death, non-fatal myocardial infarction (MI), fatal and non-fatal ischemic stroke,
and unstable angina requiring hospitalization
N=9,000
Run-in period
Randomization must be
4-52 weeks
after index event
Screening visit:
Initiate high dose
statin therapy(1)
Double-blind treatment period (minimum of 2 years)
Qualifying visit:
LDL-C must be
>70mg/dl(2)
R
Patients with
recent ACS
>40 years of age
Praluent® 75mg SC Q2W
Up-titration at Week 12 if needed
Placebo SC Q2W
N=9,000
+ Diet (NCEP ATP III TLC or
equivalent diet)
Continued
high dose statin
Primary
Endpoint(3)
A composite of
major CV
endpoints
Expect to complete study by 2017
15
17. Maximizing existing
medicines
• Increasing Adherence
• Optimizing Statin dose
Patient, physician,
access considerations
• Awareness
• Adoption
• Willingness to inject
• Access limitations
Potential PCSK9
inhibitor
treatment
population
APPROX.
8-10 MILLION
U.S
PATIENTS(1)
CLINICAL ASCVD
or HeFH
in need of further
LDL-C lowering
Many Factors Will Determine Ultimate PCSK9 Inhibitor
Treatment Population
(1) NHANES Examination Survey 2011-2012
17
18. Praluent® Potentially Offers Significant Medical Value to Patients
Who Need to Lower Their LDL-C
Important
medical value
to patients with
serious need
despite
maximally
tolerated dose
of statins
Favorably
benchmarked
estimated NNT
for ASCVD and
HeFH*
Projected to be
cost-effective
based on
standard QALY
model analyses*
Projected to be
cost-effective
based on
standard QALY
model analyses*
Access benefits
to patients
Access benefits
to patients
Patients
frustrated and
worried about
poorly controlled
LDL-C
Patients
frustrated and
worried about
poorly controlled
LDL-C
Strong,
consistent
efficacy and
safety across
ODYSSEY
program
Strong,
consistent
efficacy and
safety across
ODYSSEY
program
QALY = quality-adjusted life years
NNT = number needed to treat
*based on internal models
The effect of Praluent® on morbidity
and mortality has not been
determined.
18
19. Complex Reimbursement, Access Environment;
Actual Cost to The Healthcare System Will Be Lower Than WAC
Additional factors that impact cost:
• Rebates paid to pharmacy benefit managers to
reduce costs to their employer clients
• Mandated rebates to certain government payers,
such as Medicaid
• Co-pay assistance for non-government pay
patients
• Temporary free goods to bridge patients from when
they get a Praluent® prescription until their insurer
offers prescription coverage
• Patient assistance for the uninsured and under-
insured
Actual costs to patients, payers
and health systems are
anticipated to be lower as WAC
pricing does not reflect
discounts or rebates,
nor co-pay programs
19
WAC= Wholesale Acquisition Cost
20. Praluent® Pricing
• The average Wholesale Acquisition Cost (WAC) for Praluent® will be $40 per day
or $1,120 per 28 days
• Flat pricing — both doses are priced the same
• Marketed, patient-administered biologics range in WAC price from approximately
$25,000 to $50,000 annually
• Praluent® represents the lowest WAC, patient-administered monoclonal antibody
therapy
Wholesale Acquisition Cost is based upon significant unmet need in the
indicated patient population and the value provided by Praluent®
20
21. MyPraluent™ Provides Comprehensive Support for U.S. Prescribers
and Patients
Coverage
& Access
Cost
Adherence
& Education
Initiate Therapy and
Educate on Self-Injection
Acquisition
21
22. Programs to Support Broad Patient Access in the U.S.
Copay
Card
Bridge
Program
Patient
Assistance
For commercially insured
patients
• No income requirements
• Available through MyPraluent™
For eligible commercial and
government-insured patients
• For patients who received initial
coverage denial and appeal
submitted
For uninsured or under-insured
patients
• Free Praluent® for eligible patients
22