THOUSAND OAKS, Calif., Aug. 27, 2013 /PRNewswire/ -- 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:
Data presented on AMG 145 will include:
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.
Amgen is committed to unlocking the potential of biology for patients suffering from serious illnesses by discovering, developing, manufacturing and delivering innovative human therapeutics. This approach begins by using tools like advanced human genetics to unravel the complexities of disease and understand the fundamentals of human biology.
Amgen focuses on areas of high unmet medical need and leverages its biologics manufacturing expertise to strive for solutions that improve health outcomes and dramatically improve people's lives. A biotechnology pioneer since 1980, Amgen has grown to be the world's largest independent biotechnology company, has reached millions of patients around the world and is developing a pipeline of medicines with breakaway potential.
This news release contains forward-looking statements that are based on management's current expectations and beliefs and are subject to a number of risks, uncertainties and assumptions that could cause actual results to differ materially from those described. All statements, other than statements of historical fact, are statements that could be deemed forward-looking statements, including estimates of revenues, operating margins, capital expenditures, cash, other financial metrics, expected legal, arbitration, political, regulatory or clinical results or practices, customer and prescriber patterns or practices, reimbursement activities and outcomes and other such estimates and results. Forward-looking statements involve significant risks and uncertainties, including those discussed below and more fully described in the Securities and Exchange Commission (SEC) reports filed by Amgen, including Amgen's most recent annual report on Form 10-K and any subsequent periodic reports on Form 10-Q and Form 8-K. Please refer to Amgen's most recent Forms 10-K, 10-Q and 8-K for additional information on the uncertainties and risk factors related to our business. Unless otherwise noted, Amgen is providing this information as of Aug. 27, 2013, and expressly disclaims any duty to update information contained in this news release.
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CONTACT: Amgen, Thousand Oaks
Ashleigh Koss, 805-313-6151 (media)
Arvind Sood, 805-447-1060 (investors)
1Abifadel M et al. Nat Genet. 2003;34:154-156.
2Malik, FI et al. Cardiac myosin activation: a potential therapeutic approach for systolic heart failure. Science. 2011;331:1439-331.
3Teerlink, JR. A novel approach to improve cardiac performance: cardiac myosin activators. Heart Failure Reviews. 2009;14:289-298.
4Clinicaltrials.gov website: http://clinicaltrials.gov/ct2/show/NCT01300013. Accessed August 2013.
5Clinicaltrials.gov website: http://clinicaltrials.gov/ct2/show/NCT01786512. Accessed August 2013.
6 Amgen data on file. Investigator Brochure.
7Clinicaltrials.gov website: http://clinicaltrials.gov/ct2/results?term=%22AMG+145%22+AND+%22phase+3%22&Search=Search. Accessed August 2013.
8Clinicaltrials.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.
10Clinicaltrials.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.
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