Amgen to highlight new data at upcoming ESC Congress 2013

Amgen (NASDAQ:AMGN) today announced that it will present new data on omecamtiv mecarbil, a small molecule cardiac myosin activator that is being studied for the treatment of heart failure in collaboration with Cytokinetics. Amgen will also present data on AMG 145, an investigational 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 Amgen will present the data at the upcoming ESC Congress 2013, organized by the European Society of Cardiology, in Amsterdam.

Data from the Phase 2b ATOMIC-AHF study (Acute Treatment with Omecamtiv Mecarbil to Increase Contractility in Acute Heart Failure), which evaluates the safety, tolerability and efficacy of an intravenous formulation of omecamtiv mecarbil in patients with acute heart failure, will be featured during a Hot Line Late Breaking Trials Session on Sept. 3 at 11:00 a.m. CEST.

Additionally, Amgen will highlight findings from the AMG 145 clinical program, including efficacy and safety data from a pooled analysis of four Phase 2 studies, which include MENDEL, LAPLACE-TIMI 57, GAUSS and RUTHERFORD.

“The data presented at this year’s ESC Congress 2013 will highlight what we are doing through our R&D efforts to develop novel treatments that we hope will meet today’s urgent cardiovascular needs,” said Sean E. Harper, M.D., executive vice president of Research and Development at Amgen. “Amgen is establishing its presence in cardiovascular medicine and is committed to addressing difficult scientific questions, with the goal of advancing cardiac care and improving the lives of patients worldwide.”

Data presented on omecamtiv mecarbil will include:

• ATOMIC-AHF: Acute Treatment with Omecamtiv Mecarbil to Increase Contractility in Acute Heart Failure: Results from ATOMIC-AHF
  Abstract 4503, Hot Line Late Breaking Oral Presentation, Tuesday, Sept. 3, 11:18 – 11:30 a.m. CEST (Amsterdam – Central Village)

Data presented on AMG 145 will include:

• Efficacy of AMG 145, a Fully Human Monoclonal Antibody to PCSK9: Data from 1252 Patients in Four Phase 2 Studies
  Abstract 831, Oral Presentation, Sunday, Sept. 1, 8:30 – 8:45 a.m. CEST (Algiers – Village 4)
• Safety of AMG 145, a Fully Human Monoclonal Antibody to PCSK9: Data from Four Phase 2 Studies in 1314 Patients
  Abstract 683, Poster Presentation, Saturday, Aug. 31, 2:00 – 6:00 p.m. CEST (Posters – Village 9)
• Statin Therapy is a Major Determinant of PCSK9 Plasma Concentration: Data from Four Clinical Trials with AMG 145
  Abstract P681, Poster Presentation, Saturday, Aug. 31, 2:00 – 6:00 p.m. CEST (Posters – Village 9)
• Intolerance to Statins and Response to PCSK9 Inhibition with AMG 145
  Abstract P682, Poster Presentation, Saturday, Aug. 31, 2:00 – 6:00 p.m. CEST (Posters – Village 9)
• Safety, Tolerability, and Efficacy of Long-Term Administration of AMG 145: Preliminary Results from the OSLER Study
  Abstract P4182, Poster Presentation, Monday, Sept. 2, 2:00 – 6:00 p.m. CEST (Posters – Village 9)

About Omecamtiv Mecarbil

Omecamtiv mecarbil is a small molecule activator of cardiac myosin, the motor protein that causes cardiac contraction.2,3 The compound is being evaluated in both intravenous and oral formulations as a potential treatment for heart failure. Omecamtiv mecarbil is being developed by Amgen in collaboration with Cytokinetics.

About the Omecamtiv Mecarbil Clinical Trial Program

The Phase 2b clinical trial known as ATOMIC-AHF (Acute Treatment of Omecamtiv Mecarbil to Increase Contractility in Acute Heart Failure) is an international, multicenter, randomized, double-blind, placebo-controlled study designed to evaluate the safety, tolerability and efficacy of an intravenous formulation of omecamtiv mecarbil in approximately 600 patients with left ventricular systolic dysfunction who were hospitalized with acute heart failure.4

Oral formulations of omecamtiv mecarbil are currently being evaluated in a Phase 2 trial known as COSMIC-HF (Chronic Oral Study of Myosin Activation to Increase Contractility in Heart Failure). COSMIC-HF is a multicenter, randomized, double-blind, placebo-controlled, dose escalation study designed to evaluate the safety and efficacy of oral omecamtiv mecarbil in approximately 420 patients with chronic heart failure and left ventricular systolic dysfunction.5

Additional information about clinical trials of omecamtiv mecarbil can be found at www.clinicaltrials.gov.

About AMG 145

AMG 145 is a human monoclonal antibody that inhibits proprotein convertase subtilisin/kexin type 9 (PCSK9). PCSK9 is a protein that targets LDL receptors for degradation and thereby reduces the liver’s ability to remove LDL-C, or “bad” cholesterol, from the blood. AMG 145, being developed by Amgen scientists, is designed to bind to PCSK9 and inhibit PCSK9 binding to LDL receptors on the liver’s surface. In the absence of PCSK9, there are more LDL receptors on the surface of the liver to remove LDL-C from the blood.6

About the AMG 145 Clinical Trial Program

PROFICIO, which stands for the Program to Reduce LDL-C and Cardiovascular Outcomes Following Inhibition of PCSK9 In Different POpulations, is a large and comprehensive clinical trial program evaluating AMG 145.7,8

The Phase 3 clinical trial program for AMG 145 builds upon the successful Phase 2 studies and includes 12 trials, with a combined planned enrollment of more than 27,000 patients.3 The Phase 3 studies will evaluate AMG 145 administered every two weeks and monthly in multiple patient populations, including in combination with statins in patients with hyperlipidemia (LAPLACE-2), in patients with hyperlipidemia who cannot tolerate statins (GAUSS-2), as a stand-alone treatment in patients with hyperlipidemia (MENDEL-2), and in patients whose elevated cholesterol is caused by genetic disorders called heterozygous (RUTHERFORD-2) and homozygous (TESLA and TAUSSIG) familial hypercholesterolemia.7

Five studies of AMG 145 will provide long-term safety and efficacy data, including the FOURIER (Further Cardiovascular OUtcomes Research with PCSK9 Inhibition in Subjects with Elevated Risk) study, which will assess whether treatment with AMG 145 compared to placebo reduces recurrent cardiovascular events in approximately 22,500 patients with cardiovascular disease.9-13

Additional information about clinical trials of AMG 145 can be found at www.clinicaltrials.gov.

References

1. Abifadel M et al. Nat Genet. 2003;34:154-156.
2. Malik, FI et al. Cardiac myosin activation: a potential therapeutic approach for systolic heart failure. Science. 2011;331:1439-331.
3. Teerlink, JR. A novel approach to improve cardiac performance: cardiac myosin activators. Heart Failure Reviews. 2009;14:289-298.
4. Clinicaltrials.gov website: http://clinicaltrials.gov/ct2/show/NCT01300013. Accessed August 2013.
5. Clinicaltrials.gov website: http://clinicaltrials.gov/ct2/show/NCT01786512. Accessed August 2013.
6. Amgen data on file. Investigator Brochure.
7. Clinicaltrials.gov website: http://clinicaltrials.gov/ct2/results?term=%22AMG+145%22+AND+%22phase+3%22&Search=Search. Accessed August 2013.
8. Clinicaltrials.gov website: http://clinicaltrials.gov/ct2/results?term=REGN727+AND+%22phase+3%22&Search=Search. Accessed August 2013.
9. Clinicaltrials.gov website: http://clinicaltrials.gov/ct2/show/NCT01764633?term=%22AMG+145%22+AND+%22phase+3%22&rank=11. Assessed August 2013.
10. Clinicaltrials.gov website: http://clinicaltrials.gov/ct2/show/NCT01624142?term=%22AMG+145%22+AND+%22phase+3%22&rank=4. Accessed August 2013.
11. Clinicaltrials.gov website: http://clinicaltrials.gov/ct2/show/NCT01516879?term=%22AMG+145%22+AND+%22phase+3%22&rank=5. Accessed August 2013.
12. Clinicaltrials.gov website: http://clinicaltrials.gov/ct2/show/NCT01813422?term=%22AMG+145%22+AND+%22phase+3%22&rank=6. Accessed August 2013.
13. Clinicaltrials.gov website: http://clinicaltrials.gov/ct2/show/NCT01854918?term=%22AMG+145%22+AND+%22phase+3%22&rank=12. Accessed August 2013.