Nov 20, 2014 - Stewart B. Harris, MD, Professor of Medicine, Schulich School of Medicine ..... Promote repair, remyelina
IR THEMATIC SEMINAR ON NEW MEDICINES November 20, 2014
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 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, 2013. Other than as required by applicable law, Sanofi does not undertake any obligation to update or revise any forward-looking information or statements.
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Agenda Introductory Comments ● Serge Weinberg, Chairman of the Board of Directors - CEO
Advancing Late Stage R&D Portfolio ● Elias Zerhouni, MD, President, Global R&D
Cerdelga™ / Lemtrada® ● David Meeker, MD, CEO, Genzyme
Praluent™ (alirocumab) ● Jay Edelberg, MD, PhD, Vice President, Head of the PCSK9 Development & Launch Unit ● Harold Bays, MD, Medical Director, President of Louisville Metabolic & Atherosclerosis Research Center ● Victoria Carey, Vice President, Head of U.S. Alirocumab Commercial
Q&A Session Break
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Agenda (cont’d) Toujeo® / Afrezza® / LixiLan ● ● ● ●
Riccardo Perfetti, MD, Senior Medical Officer, Diabetes Stewart B. Harris, MD, Professor of Medicine, Schulich School of Medicine, University of Western Ontario Andrew Purcell, Vice President, Commercial Business Unit Head U.S. Diabetes Pierre Chancel, Senior Vice President, Diabetes
Q&A Session Dengue vaccine ● Duane Gubler, ScD, MS, Professor, Emerging Infectious Diseases Program, Duke NUS, Singapore ● Nicholas Jackson, Associate Vice President R&D, Dengue Vaccine Company, Sanofi Pasteur ● Guillaume Leroy, Vice President, Dengue Vaccine Company, Sanofi Pasteur
Sarilumab / dupilumab ● Elias Zerhouni, MD, President, Global R&D
Conclusion ● Elias Zerhouni, MD, President, Global R&D
Q&A Session
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IR Thematic Seminar Focus on Selected New Medicines and Vaccines
Our main objectives for today are:
IR Thematic Seminar on New Medicines
1●
Highlight the unmet medical needs addressed by Sanofi’s key late stage assets
2●
Provide a high-level clinical profile of those products
3●
Share information on our strategy to seize their commercial potential
Help the Street to better evaluate near-term contribution from R&D
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Introductory Comments
Serge Weinberg Chairman of the Board of Directors CEO
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Agenda Introductory Comments ● Serge Weinberg, Chairman of the Board of Directors - CEO
Advancing Late Stage R&D Portfolio ● Elias Zerhouni, MD, President, Global R&D
Cerdelga™ / Lemtrada® ● David Meeker, MD, CEO, Genzyme
Praluent™ (alirocumab) ● Jay Edelberg, MD, PhD, Vice President, Head of the PCSK9 Development & Launch Unit ● Harold Bays, MD, Medical Director, President of Louisville Metabolic & Atherosclerosis Research Center ● Victoria Carey, Vice President, Head of U.S. Alirocumab Commercial
Q&A Session Break
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Sanofi – Opportunity for Sustainable Growth Driven by Platforms and Pipeline
Sanofi has transformed into a company positioned for sustainable growth through its growth platforms(1) and late-stage pipeline of new biologics Growth platforms now account for 76% of sales(1) 47% of sales derived from biologics(2) 72% of R&D projects are biologics(3)
(1) Growth Platforms include Emerging Markets, Diabetes Solutions, Vaccines, Consumer Healthcare, Animal Health, Genzyme & Other Innovative Products. In 9M 2014, sales from Growth Platforms accounted for 76.1% of Group sales or €18,801m (2) Biologic sales in 9M 2014 were €11,625m and included insulins (Lantus®, Apidra®, Insuman®), Genzyme rare disease products, Lovenox®, Sanofi Pasteur vaccines, Merial vaccines, selected oncology products (Thymoglobulin®, Mozobil®, Zaltrap®), Lemtrada® and half of SPMSD sales (non-consolidated) (3) R&D projects in clinical development: 33 NMEs and vaccines out of a total of 46 in Nov 2014
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R&D Plays a Major Role in the Successful Execution of Sanofi’s Strategy
1
Grow a global healthcare leader with synergistic platforms
2
Bring innovative products to market
3
Seize value-enhancing growth opportunities
4
Adapt structure for future challenges and opportunities
Deliver sustainable long-term growth by improving patients' lives
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R&D Is Entering a New Era by Increasing its Expected Contribution to the Sustainable Growth of Sanofi 2007 - 2009
2010 - 2013
2014+
Low R&D Productivity
R&D Transformation
Strong R&D Pipeline Emerging
• Confronted multiple R&D setbacks • Faced low returns despite growing R&D spend • Cleaned up R&D pipeline
• Advanced high-value development projects • Created efficient global R&D organization • Shifted portfolio from small molecules to biologics • Grew value of external R&D collaborations
• Launch new products • Maintain discipline in portfolio prioritization • Accelerate early-stage development • Expand open innovation model
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Over the Last 7 Years, Sanofi Launched Several New Drugs but Only One with Peak Sales Potential >$1bn
®
(ex-U.S.)
(ex-U.S.) ®
10 Launches 2007-2013
(U.S.)
(U.S.)
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Sanofi Expects to Launch High Potential New Medicines and Vaccines at an Accelerated Pace Beginning in 2014 ILLUSTRATIVE
Up to 18 Launches 2014 - 2020
Praluent™ Shan5 alirocumab
Dengue PR5i Vaccine Vaccine
(U.S.)
sarilumab (U.S.)
insulin patisiran Anti-CD38 Rotavirus Vaccine mAb lispro
Praluent™ is the intended trade name for alirocumab. The trade name is currently pre-approved in the EU but not in other regions.
Vaccine
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Significantly Improving Returns from R&D
2007 - 2013
10 launches achieved
2014 - 2020
Up to 18 launches expected
(1) At CER, 5 years for each product from and including the first full year of launch (2) Non-risk adjusted sales projections
Potential cumulative first 5 years sales
~€7.5bn(1,2)
Potential cumulative first 5 years sales
>€30bn(1,2)
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Sanofi Has Additional Potentially Transformative Drugs at Earlier Stages of Development 10 Early Assets to Watch 1
Vatelizumab(1)
6
Multiple Sclerosis 2
IL4/IL13 bi-specific mAb
Niemann-Pick type B 7
Idiopathic Pulmonary Fibrosis 3
Anti-CD38 mAb Anti-GDF8 mAb
8
Revusiran (TTRsc) Familial Amyloid Cardiomyopathy
(1) Anti-VLA2 mAb
C-MET kinase inhibitor Solid Tumors
9
Sarcopenia 5
Neo GAA Pompe Disease
Multiple Myeloma 4
rhASM
Anti-CXCR5 mAb Systemic Lupus Erythematosus
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GLP-1/GIP co-agonist Diabetes
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Sanofi Has Established a Model of Productive R&D Collaborations
Example 1
Example 2
● Global strategic collaboration
● World-class RNAi technology
● Secured access to highly productive therapeutic human antibody platform
● Focus on genetically defined diseases with a clear translational model for RNA interference
● A platform to regularly bring new mAbs into clinical development
● A platform for sustained drug development for rare diseases for Genzyme
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Strengthening the R&D Leadership Team with New Talent Jorge Insuasty
Gary Nabel SVP, CSO
SVP, Development
Maya Said
Andrew Plump SVP, Research and Translational Medicine
VP, Strategy External Innovation & Science Policy
Dominique Carouge VP, Administration & Management
Hilary Malone VP, Global Regulatory Affairs
John Shiver SVP, R&D, Sanofi Pasteur
Jay Edelberg VP, Head of Alirocumab Unit
Fabian Kausche Head of Merial R&D
Christian Antoni VP, Head Development Immunology & Inflammation
Eckhard Leifke Diabetes - Head of Development
Anthony Muslin VP, Cardiovascular & Fibrosis Unit
Mike Panzara VP, Multiple Sclerosis and Neurology, Genzyme
Philip Just Larsen Diabetes - Head of Research & Early Development
Victoria Richon Oncology - Head of Research & Early Development 16
Agenda
Genzyme
● David Meeker, MD, CEO, Genzyme
Cerdelga™ (eliglustat) Lemtrada® (alemtuzumab)
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Genzyme Understands Unmet Needs of Gaucher Patients
61% of Gaucher patients would like their treatment to be an oral formulation(1) (1) PeopleMetrics survey in Gaucher patients (n= 238) What improvements would you like to see in treatments for Gaucher Disease?
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The Only First-Line Oral Therapy for Adults with Gaucher Disease Type 1
● Novel substrate inhibitor(1) ● Largest ever development program in Gaucher ● Almost 400 adults in 29 countries ● Efficacy demonstrated in untreated patients (ENGAGE) and in patients switching from ERT (ENCORE) ● Majority of adverse reactions are mild and transient(2) ● Genotyping required before starting therapy to determine CYP2D6 phenotype
● U.S. FDA approval granted in Aug 2014 ● EU CHMP opinion expected in Q4 2014
GD-1: Gaucher Disease type 1 ERT: Enzyme Replacement Therapy (1) Cerdelga™ is a highly specific ceramide analogue inhibitor of GL-1 synthesis with broad tissue distribution (2) AEs generally mild to moderate, most common related to treatment being diarrhea (6%), headache (4%), arthralgia (3%), flatulence (3%), abdominal pain (3%), fatigue (3%), nausea (3%). Less than 2% of people treated with Cerdelga™ discontinued treatment because of a side effect.
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Efficacy Demonstrated in Untreated Patients (ENGAGE)
ENGAGE - Change in Primary and Secondary Endpoints at 9 Months(1) Parameter
Eliglustat
Placebo
Difference
P Value
-28%
+2%
30%
€1bn(2) Existing patients
Newly diagnosed patients
(1) 2013 Gaucher Treatment Tracker Survey, n = 241 physicians from15 countries - Q4 2013 / Q1 2014 (2) Genzyme Gaucher franchise includes Cerezyme® (imiglucerase) and Cerdelga™ (eliglustat)
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Agenda
Genzyme
● David Meeker, MD, CEO, Genzyme
Cerdelga™ (eliglustat) Lemtrada® (alemtuzumab)
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New MS Treatment Goals - Focus on Patient Outcomes
Unmet Needs in MS
New Goals
Symptom Alleviation
Decrease MS activity and improve quality of life
Halt or reverse damage and disability
Promote repair, remyelination, durable disability improvement
Improve disease control
Freedom from disease activity
Convenient treatment regimens to improve compliance
Dosing options, new routes of administration, less frequent dosing
Maximize patient outcomes
Superior effectiveness and favorable benefit/risk vs. existing treatment
MS: Multiple Sclerosis
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A Large and Growing Global MS Market
Multiple Sclerosis Market Global Sales(3)
Multiple Sclerosis ● Serious disease with significant unmet medical needs
~€17bn
● Symptoms include fatigue, weakness, walking and balance difficulties, vision problems ● A major impact on family, social and professional life
● ~2.1m patients worldwide(1)
~€12bn
~57%
~€5bn 2020e ~50% ~50%
● ~410,000 patients in the U.S.(1) ● ~630,000 patients in EU(2)
~43%
2013 2007
U.S. ROW
2013-20 growth driven by new therapies, satisfying the unmet needs of convenient administration and more efficacious therapy (1) National Multiple Sclerosis Society (2) http://msj.sagepub.com/content/18/5/628.full.pdf (3) Adapted from Evaluate Pharma July 2014; Reported sales of Copaxone®, Avonex®, Rebif®, Betaseron/Betaferon®, Extavia®, Tysabri® and Gilenya® for 2013; 2007 sales converted using €/$ of 1.37, 2013 sales and 2020e sales converted using €/$ of 1.33
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Sustained Reduction in Disability Through Year 4
Disease-Free Outcomes: 3-Year Follow-up of the CARE-MS Studies(1) Parameter
CARE-MS I
CARE-MS II
% of Lemtrada® patients relapse-free
87%
82%
% of Lemtrada® patients 6-month SAD-free(2)
99%
96%
% of patients who did not receive alternative DMTs
99%
97%
% of Lemtrada® patients who did not receive retreatment in Year 3
82%
80%
DMT: Disease Modifying Treatment SAD: sustained accumulation of disability (1) Eva Havrdova, ACTRIMS-ECTRIMS 2014 (2) ln CARE-MS l, Lemtrada® was significantly more effective than interferon beta-1a at reducing annualized relapse rates; the difference observed in slowing disability progression did not reach statistical significance. ln CARE-MS ll, Lemtrada® was significantly more effective than interferon beta-1a at reducing annualized relapse rates, and accumulation of disability was significantly slowed in patients given Lemtrada® vs. interferon beta-1a.
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FDA Approval Is a Major Step Forward for People with Relapsing Forms of MS ● Regulatory approvals granted in >40 countries(1) ● FDA approval received on Nov 14, 2014 ●
Because of its safety profile, the use of Lemtrada® should generally be reserved for patients who have had an inadequate response to two or more drugs indicated for the treatment of MS(2,3)
●
Only available in the U.S. through a restricted distribution program: the Lemtrada® Risk Evaluation and Mitigation Strategy (REMS)
● New dedicated salesforce recruited for the U.S.(4) ●
Targeted U.S. launch approach for the first 3 months
●
Ensuring appropriate education and confidence to prescribe
●
Full launch expected throughout 2015
With Aubagio® and Lemtrada®, Genzyme is well positioned to grow its MS franchise (1) EU, Canada, Australia and other countries (2) The most common side effects of Lemtrada® are rash, headache, thyroid disorder, pyrexia, nasopharyngitis, nausea, urinary tract infection, fatigue, insomnia, upper respiratory tract infection, herpes viral infection, urticaria, pruritus, fungal infection, arthralgia, pain in extremity, back pain, diarrhea, sinusitis, oropharyngeal pain, paresthesia, dizziness, abdominal pain, flushing, and vomiting. Other serious side effects associated with Lemtrada® include autoimmune thyroid disease, autoimmune cytopenias, infections and pneumonitis. (3) Label includes a boxed warning noting a risk of serious, sometimes fatal autoimmune conditions, serious and lifethreatening infusion reactions and noting Lemtrada® may cause an increased risk of malignancies including thyroid cancer, melanoma and lymphoproliferative disorders. Lemtrada® is contraindicated in patients with HlV infection. (4) Genzyme holds the worldwide rights to alemtuzumab and has responsibility for its development and commercialízation in MS. Bayer Healthcare receives contingent payments based on global sales revenue.
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Agenda
Praluent™ (alirocumab) CV Disease Burden & ODYSSEY Program
● Jay Edelberg, MD, PhD Vice President, Head of the PCSK9 Development & Launch Unit
Clinical Perspective
● Harold Bays, MD, Medical Director and President of Louisville Metabolic and Atherosclerosis Research Center(1)
Evaluating the PCSK9 Opportunity
● Victoria Carey Vice President, Head of U.S. Alirocumab Commercial
Q&A Session
Praluent™ is the intended trade name for alirocumab. The trade name is currently pre-approved in the EU but not in other regions. (1) Harold Bays is an investigator of the ODYSSEY OPTIONS I and II clinical study
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CV Disease Remains an Area of High Unmet Need
Cardiovascular disease causes 17.3m deaths per year(1)
The estimated economic cost of CVD is huge in the U.S.(2) ● $193bn in direct health expenditures
17.3m $315bn
● $122bn in indirect cost of mortality
LDL-C contributes to 60% of coronary heart disease and 40% of all ischemic stroke(3)
60%
Despite available treatment options, including statins, 24m high-risk patients fail to reach LDL-C goals(4)
24m
(1) (2) (3) (4)
WHO. http://who.int/mediacentre/factsheets/fs317/en/ (EU, East. Mediterranean, The Americas, SE Asia, West Pacific, Africa) NHLBI. http://www.nhlbi.nih.gov/about/documents/factbook/2012/chapter4.htm WHO. http://www.who.int/whr/2002/en/whr02_en.pdf?ua=1 U.S. NHANES, Market Scan, IMS and Sanofi estimates
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Lowering LDL-C with Statins Is Effective in Decreasing CV Risk LDL-C Prevention Trials(1) 25
Primary prevention trials
4S CHD Events (%)
Active treatment Placebo
20
4S
15
2.8
WOSCOPS
TNT-10A
5 ASCOT
WOSCOPS AFCAPS
ASCOT
0
Placebo
110
CARE TNT-80A
Active treatment
CARE
LIPID
10
Secondary prevention trials
LIPID
AFCAPS
50
70
90
130
150
170
190
1.3
1.8
2.3
3.4
3.9
4.4
4.9
210 (mg/dL) 5.4
(mmol/L)
LDL-C
Despite high efficacy of statin therapy, unmet needs persist in familial hypercholesterolemia, high CV risk and statin intolerance (1) Adapted from O’Keefe et al. J Am Coll Cardiol 2004;43:2142-6; LaRosa JC et al. N Engl J Med 2005;352:1425-35
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Despite Current Therapy, a Significant Proportion of Hypercholesterolemic Patients Are at High CV Risk 2016 Estimates for U.S., EU Top 5 and Japan (in million patients)(1) Heterozygous Familial Hypercholesterolemia
1.2m
Statin Intolerant
2.9m
Primary Prevention 4.8m
24m Patients With High CV Risk
Diabetes(2)
10.1m Secondary Prevention 5.3m
Secondary Prevention without Diabetes
10.3m
(1) U.S. NHANES, Market Scan, IMS and Sanofi estimates (2) Diabetes with 2 Risk Factors with or w/o CV Event
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Sense of Urgency to Lower LDL-C to Reduce CV Risk Varies According to Patient Types
HeFH
Statin Intolerant
High CV Risk
● Well defined but underdiagnosed population
● High LDL-C levels comparable to HeFH
● Large and diverse population with associated CV risks
● High engagement of patients
● Pragmatic approach used by physicians but no objective definition
● Large proportion of patients with previous CV event
● Large proportion of uncontrolled patients with current therapies
● Low satisfaction level with existing treatment options
HeFH: heterozygous familial hypercholesterolemia
● Strong awareness of risk, especially for recent events ● Significant overlap with diabetes population
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The Development of Alirocumab, an Anti-PCSK9 mAb, Is a Prime Example of Modern Translational Medicine The PCSK9 Discovery Decade First Phase III study results
Loss-of-function mutations observed Proof of principle in animals(3,4)
Gain-of-function mutations observed
Phase II study results(9) Human target validation(5,6,7) First subject treated with PCSK9 mAb
PCSK9 discovery(1,2)
2003
U.S./EU regulatory submissions
PCSK9-targeted mAb preclinical(8)
2004 (1) (2) (3) (4) (5)
2005
2006
2007
2008
Seidah NG. Proc Natl Acad Sci USA 003;100:928-33 Abifadel M. Nat Genet 2003;34:154-6 Maxwell KN. Proc Natl Acad Sci USA 2004;101:7100-5 Rashid S. Proc Natl Acad Sci USA 2005;102:5374-79 Cohen JC. N Engl J Med 2006;354:1264-72
2009 (6) (7) (8) (9)
2010
2011
2012
Zhao Z. Am J Hum Genet 2006;79:514-23 Hooper AJ. Atherosclerosis 2007;193:445-8 Chan JC. Proc Natl Acad Sci USA 2009;106:9820-5 Lambert G et al. J Lipid Res 2012; 53(12): 2515-24
2013
2014
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A Differentiated Clinical Development Program
HeFH
High CV Risk
On top of max tolerated statin
On top of max tolerated statin
On top of regular statin doses
Not receiving statin
FH I (n=486)
COMBO I (n=316)
OPTIONS I (n=355)
MONO(2) (n=103)
FH II (n= 249)
COMBO II (n=720)
OPTIONS II (n=305)
CHOICE II(3) (n=200)
HIGH FH (n=107)
CHOICE I (n=700)
Statin Intolerant
LONG TERM (n=2,341) OLE(1) (n≥1,000)
ALTERNATIVE (n=314)
OUTCOMES (n=18,000)
●
Largest Phase III program
●
14 trials with >23,500 patients
●
Primary endpoint evaluated at 24 weeks
●
Double-blind design (6, 12, 18 and 24 months)
●
Evaluation of q2w and q4w dosing regimens and 75mg and 150mg doses
●
Interim data on lower rate of adjudicated major CV events in LONG TERM trial
●
≥4,500 patient years exposure(4)
All studies: every two weeks (q2w) regimens (75/150mg with potential dose ↑ from 75 to 150 mg) except CHOICE I (300mg q4w) and II (150mg q4w) (1) Open-Label Extension open to HeFH patients included in other studies (2) ODYSSEY MONO included patients at moderate CV risk (3) ODYSSEY CHOICE II includes some patients on additional non-statin lipid-lowering therapy (4) ≥4,500 double-blind patient years at completion of pivotal studies in initial submission
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Next Regulatory Milestones and Development Steps
1
Regulatory submissions in the U.S. and EU on track ● U.S. submission expected before year end 2014 6-month FDA priority review from filing date expected ● EU submission also targeted before year end 2014
2 ODYSSEY CHOICE I & II and Open Label Extension (OLE) ongoing ● CHOICE I & II explore monthly dosing of alirocumab ● Expect to report primary endpoints in 2015 and beyond 3
ODYSSEY OUTCOMES ongoing (n=18,000)(1) ● Assess the potential of alirocumab to demonstrate CV benefit
(1) Rationale and design in Schwartz GG et al. Am Heart J 2014;0:1-8.e1. 35
Agenda
Praluent™ (alirocumab) CV Disease Burden & ODYSSEY Program
● Jay Edelberg, MD, PhD Vice President, Head of the PCSK9 Development & Launch Unit
Clinical Perspective
● Harold Bays, MD, Medical Director and President of Louisville Metabolic and Atherosclerosis Research Center(1)
Evaluating the PCSK9 Opportunity
● Victoria Carey Vice President, Head of U.S. Alirocumab Commercial
Q&A Session
(1) Harold Bays is an investigator of the ODYSSEY OPTIONS I and II clinical study
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Significant and Consistent LDL-C Reduction across All 10 Reported Trials LDL-C Change from Baseline at 24 Weeks
Study
Dosing q2w
Baseline LDL-C (mg/dL)
HIGH FH
150 mg
198
↓ 46%
↓ 7%
placebo
FH I
75/150 mg(1)
145
↓ 49%
↑ 9%
placebo
FH II
75/150 mg(1)
134
↓ 49%
↑ 3%
placebo
LONG TERM
150 mg
122
↓ 61%
↑ 1%
placebo
COMBO I
75/150 mg(1)
102
↓ 48%
↓ 2%
placebo
COMBO II
75/150 mg(1)
108
↓ 51%
↓ 21%
ezetimibe
OPTION I
75/150 mg(1)
105
↓ 44-54%
↓ 21-23% ↓ 5% ↓ 21%
ezetimibe statin x2 statin switch
OPTION II
75/150 mg(1)
111
↓ 36-51%
↓ 11-14% ↓ 16%
ezetimibe statin switch
Statin Intolerant
ALTERNATIVE
75/150 mg(1)
191
↓ 45%
↓ 15%
ezetimibe
Moderate CV Risk
MONO
75/150 mg(1)
140
↓ 48%
↓ 16%
ezetimibe
HeFH
High CV Risk
Alirocumab
Comparator
On top of max statin doses
On top of regular statin doses
Not receiving statins
Primary efficacy endpoint met in all 10 reported trials (1) Per protocol dose increase to 150 mg possible based on pre-specified LDL-C levels
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Robust and Durable LDL-C Reduction Maintained over 52 Weeks
LONG TERM
Achieved LDL-C Over Time(1) All Patients on Background of Maximally Tolerated Statin ± other LLT Mean (SE) LDL-C in mg/dL 140
123.0 mg/dL (+4.4%)
118.9 mg/dL (+0.8%)
120
Placebo Alirocumab 150 mg q2w
100
Difference −61.9%
80
Difference −61.3%
60 40
53.1 mg/dL (−56.8%)
48.3 mg/dL (−61.0%)
20 0
Week 0
4
8
12
16
24
LLT: Lipid lowering therapy Intent-to-treat analysis (1) LDL-C: Calculated LDL-C, least-squares (LS) means (SE standard error)
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52
38
Consistent LDL-C Reduction across a Range of Baseline LDL-C Values
LONG TERM
LDL-C Change from Baseline(1) All Patients on Background of Maximally Tolerated Statin ± Other LLT Mean % Change in LDL-C from Baseline to Week 24 Placebo Alirocumab Interaction p-value
