PCSK9 Inhibitors Current Status

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1 PCSK9 Inhibitors Current Status Ryan T. Whitney, MD FACC Bryan Heart Spring Conference 2016 Disclosures, Conflicts, and Nefarious Connections I own no stock in the companies mentioned in this talk. I am not a speaker, consultant or hired gun for any device or pharmaceutical company. I am the co-founder of Together+Clinic, a local healthcare IT company. We can help you better optimize patient management and capture CCM revenue. Stop by our booth to learn more.(yes, that was a shameless plug) Proprotein convertase subtilisin/kexin type 9 (PCSK9) Plays a pivotal role in LDL metabolism Promotes the degradation of the LDL receptor and prevents it from recycling to the membrane 1

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4 Current PCSK9 Inhibitors Alirocumab(Praluent) Sanofi, Regeneron Evolocumab(Repatha) Amgen Bococizumab Pfizer 4

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8 Alirocumab Reduces HFH-Related Apheresis Therapy Phase 3 ODESSEY ESCAPE trial results March 23, 2016 press release Alirocumab(Praluent) vs placebo in HFH patients undergoing LDL apheresis Significantly reduced the frequency of apheresis therapy by 75% (p <0.0001) 63% of patients treated with Alirocumabno longer required apheresis, compared to zero percent of placebo patients 8

9 Alirocumab (Praluent) Indications 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-C. Evolocumab (Repatha) Indications Indicated as an adjunct to diet and maximally tolerated statin therapyfor the treatment of adults with heterozygous familial hypercholesterolemia (HeFH) or clinical atherosclerotic CVD, who require additional lowering of LDL-C. Indicated as an adjunct to diet and other LDL-lowering therapies (eg, statins, ezetimibe, LDL apheresis) for the treatment of patients with homozygous familial hypercholesterolemia (HoFH) who require additional lowering of LDL-C Dosing Alirocumab(Praluent) 75 mg SC q2weeks 150 mg SC q2weeks Evolocumab(Repatha) Primary hyperlipidemia: 140 mg SC q2weeks 420 mg SC once monthly HoFH 420 mg SC once monthly 9

10 Serum PCSK9 Levels The next lipid measurement? Sweden: 4,232 men and women aged 60 at the time of recruitment 52% women Baseline serum PCSK9 concentration predicted incident CVD 1.69 (95% CI ) after adjustment for sex 1.48 (95% CI ) Further adjustment for LDL, HDL, Lp(a), triglycerides, HTN, DM, smoking, overweight, obesity, physical inactivity and statin use Treatment target? Not yet, but maybe someday. Published online before print February 19, 2016, doi: /CIRCULATIONAHA Yearly Cost Alirocumab(Praluent) $14,600 Evolocumab(Repatha) $14,100 CVS: Costs Could Potentially Reach $150 Billion Annually Approximately 25 million statin users Indication creep 10 million users Most initial estimates closer to $20 billion 10

11 Amgen Sanofi Regeneron Research at Bryan Heart FOURIER SPIRE-1 SPIRE-2 Further Cardiovascular Outcomes Research with PCSK9 Inhibition in Subjects With Elevated Risk (FOURIER) A Double-blind, Randomized, Placebo-controlled, Multicenter Study Assessing the Impact of Additional LDL- Cholesterol Reduction on Major Cardiovascular Events When AMG 145 is Used in Combination With Statin Therapy In Patients with Clinically Evident Cardiovascular Disease 11

12 FOURIER Criteria Inclusion Criteria: Male or female 40 to 80 years of age History of clinically evident cardiovascular disease at high risk for a recurrent event Fasting LDL-C 70 mg/dlor non-hdl-c 100 mg/dl Fasting triglycerides 400 mg/dl Exclusion Criteria: NYHA class III or IV, or last known EF < 30% Uncontrolled HTN, VT, hyper/hypothyroidism HoFH LDL or plasma apheresis FOURIER Arms Evolocumab q2wk or qmonth with atorvastatin 20 80mg Vs Placebo q2wk or qmonthwith atorvastatin 20 80mg Outcomes Top line results are anticipated in the second half of Amgen About 27,500 patients with clinical CVD randomized Primary Outcome Measures: Time to cardiovascular death, myocardial infarction, hospitalization for unstable angina, stroke, or coronary revascularization Secondary Outcome Measures: Time to cardiovascular death, myocardial infarction, or stroke Time to death by any cause Time to cardiovascular death or hospitalization for worsening heart failure Time to ischemic fatal or non-fatal stroke or TIA 12

13 The Evaluation of Bococizumab in Reducing the Occurrence of Major Cardiovascular Events in High Risk Subjects SPIRE-1 and SPIRE-2 (closed to enrollment January 2016) SPIRE-1 (Bococizumab) Inclusion Criteria: Must be on background lipid lowering treatment. Must be at high risk of a CV event. Must have an LDL C >=70 mg/dland < 100 mg/dlor non-hdl-c >= 100 mg/dl and < 130 mg/dl. Exclusion Criteria: An LDL C < 70 mg/dl or >= 100 mg/dl or non HDL-C < 100 mg/dl or >=130 mg/dl. Planned coronary (PCI or CABG) or other arterial revascularization. New York Heart Association Class IV congestive heart failure or left ventricular ejection fraction < 25% by cardiac imaging. Chronic renal insufficiency with creatinine clearance of <30 or with end state renal disease on dialysis. History of hemorrhagic stroke. Prior exposure to bococizumabor other investigational PCSK9 inhibitor. SPIRE-2 (Bococizumab) Inclusion Criteria: Must be on background lipid lowering treatment. Must be at high risk of a CV event. Must have an LDL C >=100 mg/dlor non HDL C >=130. Exclusion Criteria: An LDL C <100 mg/dl or non HDL C <130 mg/dl. Planned coronary (PCI or CABG) or other arterial revascularization. New York Heart Association Class IV congestive heart failure or left ventricular ejection fraction < 25% by cardiac imaging. Chronic renal insufficiency with creatinine clearance of <30 or with end state renal disease on dialysis. History of hemorrhagic stroke. Prior exposure to bococizumabor other investigational PCSK9 inhibitor. 13

14 August 30, 2015: European Society of Cardiology (ESC A Subcutaneously Administered Investigational RNAi Therapeutic (ALN-PCSsc), Targeting PCSK9 for the Treatment of Hypercholesterolemia: Initial Phase 1 Study Results Kevin Fitzgerald, PhD Co-authors: Amy Simon 1, Suellen White 1, Anna Borodovsky 1, Nirav Patel 1, Brian Bettencourt 1, Valerie Clausen 1, Jay Horton 3, Peter Wijngaard 2, Robert Kauffman 1, David Kallend 2 1 AlnylamPharmaceuticals, 300 Third Street, Cambridge, MA USA 2 The Medicines Company, 8 Sylvan Way, Parsippany, NJ USA 3 Universityof Texas South Western, 5323 Harry Hines Blvd, Dallas, TX USA Declaration of Interest: Employees of Alnylam Pharmaceuticals 1 Employees of The Medicines Company 2 41 PCSK9 Therapeutic Hypothesis LDL LDLR Endosome Lysosomal degradation Anti-PCSK9 Mabs Transiently block PCSK9 binding To LDL receptor (LDLR) LDLR synthesis PCSK9 Synthesis Inhibitors Durably block PCSK9 synthesis and all intracellular and extracellular PCSK9 functions ALN-PCS PCSK9 synthesis PCSK9 mrna Nucleus PCSK

15 Initial ALN-PCSsc Phase 1 Study Results SAD PCSK9 Knockdown Relative to Baseline Mean (SEM) % PCSK9 Knockdown (Change from Baseline) Treatment Placebo 25 mg 100 mg 300 mg 500 mg 800 mg Months Day/Treatment combinations where N=1 not displayed 43 Data in database as of 04 August 2015 Initial ALN-PCSsc Phase 1 Study Results SAD LDL-C Lowering Relative to Baseline Mean (SEM) % LDL-C Lowering (Change from Baseline) Treatment Placebo 25 mg 100 mg 300 mg 500 mg 800 mg Months Days/Treatments where N=1 not displayed LDL-C analyzed by Beta-Quantification 44 Data in database as of 04 August 2015 Initial ALN-PCSsc Phase 1 Study Results MD PCSK9 Knockdown Relative to Baseline Mean (SEM) % PCSK9 Knockdown (Change from Baseline) Treatment Placebo 125 mg qwx4 250 mg q2wx2 300 mg qmx2 300 mg S^qMX2 500 mg qmx2 500 mg S^qMX Months qw, q2w, or qm S ^ =On stable dose of statin Two subjects excluded from all MD analyses: One placebo subject elected to discontinue; One subject in 300 mg statin group was incarcerated on Day Data in database as of 04 August

16 Initial ALN-PCSsc Phase 1 Study Results MD LDL-C Lowering Relative to Baseline 0 Mean (SEM) % LDL-C Lowering (Change from Baseline) Treatment Placebo 300 mg S ^ qmx2 125 mg qwx4 500 mg qmx2 250 mg q2wx2 500 mg S ^ qmx2 300 mg qmx Month qw, q2w, or qm 46 Data in database as of 04 August 2015 S ^ =On a stable dose of statins Two subjects excluded from all MD analyses: One placebo subject elected to discontinue; One subject in 300 mg statin group was incarcerated on Day 14 PCSK9 Inhibitors Current Status Ryan T. Whitney, MD FACC Bryan Heart Spring Conference

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