Five Phase 3 Studies With Evolocumab (AMG 145) to be Featured in Late-Breaking and Clinical Research Presentations – Data Form the Basis of Global Filing Plan

THOUSAND OAKS, Calif.  — Amgen today announced that it will present pivotal Phase 3 data from five clinical studies evaluating evolocumab (AMG 145), an investigational fully human monoclonal antibody that inhibits PCSK9, a protein that reduces the liver’s ability to remove low-density lipoprotein cholesterol (LDL-C), or “bad” cholesterol, from the blood.1 The results from the five Phase 3 studies with evolocumab will be presented in three Featured Clinical Research and two Late-Breaking Clinical Trial sessions at the upcoming American College of Cardiology’s 63rd Annual Scientific Session (ACC.14), being held March 29 – 31 in Washington, D.C. 

“We are eager to share the detailed findings from our Phase 3 cholesterol-lowering studies of evolocumab at ACC,” said Sean E. Harper, M.D., executive vice president of Research and Development at Amgen. “The robust data from these studies in more than 4,000 patients form the basis of our global filing plan and we look forward to potentially providing a new treatment option to improve the lives of patients with high cholesterol, who have increased LDL-C levels despite existing therapies.”

Among the abstracts are five oral presentations from the large and comprehensive evolocumab clinical trial program, PROFICIO (Program to Reduce LDL-C and Cardiovascular Outcomes Following Inhibition of PCSK9 In Different POpulations). Data from three Phase 3 studies will be presented in a Featured Clinical Research session on Saturday, March 29, at 2 p.m. EDT and results from two Phase 3 studies will be featured in a Late-Breaking Clinical Trials session on Sunday, March 30, at 8 a.m. EDT.

Data presented on evolocumab will include:

Featured Clinical Research

• Efficacy and Safety of Evolocumab (AMG 145) Monotherapy Compared With Ezetimibe and Placebo in Hypercholesterolemic Subjects: A Phase 3 Randomized Clinical Trial
  Abstract 400-03, Featured Clinical Research, Oral Presentation, Saturday, March 29, 2 – 2:18 p.m. EDT (Room 147 B)
  
• Long-term Tolerability and Efficacy of Evolocumab (AMG 145) in Hyperlipidemic Subjects: A 52-week Phase 3 Double-blind, Randomized, Placebo-controlled Study
  Abstract 400-04, Featured Clinical Research, Oral Presentation, Saturday, March 29, 2:18 – 2:36 p.m. EDT (Room 147 B)
  
• The Addition of Evolocumab (AMG 145) Allows the Majority of Heterozygous Familial Hypercholesterolemic Patients to Achieve Low-density Lipoprotein Cholesterol Goals - Results from the Phase 3 Randomized, Double-blind, Placebo-controlled Study
  Abstract 400-05, Featured Clinical Research, Oral Presentation, Saturday, March 29, 2:36 – 2:54 p.m. EDT (Room 147 B)
  

Late-Breaking Clinical Trials

• The Low-density Lipoprotein Cholesterol Assessment With PCSK9 Monoclonal Antibody Inhibition Combined With Statin Therapy - 2 Trial: A Phase 3, Double-blind, Randomized, Placebo and Ezetimibe Controlled, Multicenter Study to Evaluate Safety, Tolerability and Efficacy of Evolocumab (AMG 145) in Combination With Statin Therapy in Subjects With Primary Hypercholesterolemia and Mixed Dyslipidemia
  Abstract 402-10, Late-Breaking Clinical Trials, Oral Presentation, Sunday, March 30, 8:15 – 8:25 a.m. EDT (Hall D, Main Tent)
  
• A Phase 3 Double-blind, Randomized Study to Assess the Safety and Efficacy of Evolocumab (AMG 145) in Hypercholesterolemic Subjects Unable to Tolerate an Effective Dose of Statin
  Abstract 402-16, Late-Breaking Clinical Trials, Oral Presentation, Sunday, March 30, 9 – 9:10 a.m. EDT (Hall D, Main Tent)

Additional Poster Presentation

• Effects of Evolocumab on Lipoprotein Particles and Subclasses in Hypercholesterolemic and Heterozygous Familial Hypercholesterolemia Subjects on Statin Therapy
  Abstract 1183-134, Poster Presentation, Sunday, March 30, 9:45 – 10:30 a.m. EDT (Hall C)

Amgen will also host a webcast investor meeting at ACC.14 on Sunday, March 30, at 7 p.m. EDT. Sean E. Harper, M.D., executive vice president of Research and Development at Amgen, along with members of Amgen's clinical development team and clinical investigators, will participate at the investor meeting to discuss Amgen’s cardiovascular program, including the primary analyses of five Phase 3 evolocumab studies being presented at ACC.14.

Live audio of the investor meeting will be simultaneously broadcast over the Internet and will be available to members of the news media, investors and the general public.

The webcast, as with other selected presentations regarding developments in Amgen's business given by management at certain investor and medical conferences, can be found on Amgen's website, www.amgen.com, under Investors. Information regarding presentation times, webcast availability and webcast links are noted on Amgen's Investor Relations Events Calendar. The webcast will be archived and available for replay for at least 90 days after the event.

Source: Amgen