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
"The data presented at this year's
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
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
About the AMG 145 Clinical Trial Program
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.
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
No forward-looking statement can be guaranteed and act ual results may differ materially from those we project. Discovery or identification of new product candidates or development of new indications for existing products cannot be guaranteed and movement from concept to product is uncertain; consequently, there can be no guarantee that any particular product candidate or development of a new indication for an existing product will be successful and become a commercial product. Further, preclinical results do not guarantee safe and effective performance of product candidates in humans. The complexity of the human body cannot be perfectly, or sometimes, even adequately modeled by computer or cell culture systems or animal models. The length of time that it takes for us to complete clinical trials and obtain regulatory approval for product marketing has in the past varied and we expect similar variability in the future. We develop product candidates internally and through licensing collaborations, partnerships and joint ventures. Product candidates that are derived from relationships may be subject to disputes between the parties or may prove to be not as effective or as safe as we may have believed at the time of entering into such relationship. Also, we or others could identify safety, side effects or manufacturing problems with our products after they are on the market. Our business may be impacted by government investigations, litigation and products liability claims. We depend on third parties for a significant portion of our manufacturing capacity for the supply of certain of our current and future products and limits on supply may constrain sales of certain of our current products and product candidate development.
In addition, sales of our products are affected by the reimbursement policies imposed by third-party payors, including governments, private insurance plans and managed care providers and may be affected by regulatory, clinical and guideline developments and domestic and international trends toward managed care and healthcare cost containment as well as U.S. legislation affecting pharmaceutical pricing and reimbursement. Government and others' regulations and reimbursement policies may affect the development, usage and pricing of our products. In addition, we compete with other companies with respect to some of our marketed products as well as for the discovery and development of new products. We believe that some of our newer products, product candidates or new indications for existing products, may face competition when and as they are approved and marketed. Our products may compete against products that have lower prices, established reimbursement, superior performance, are easier to administer, or that are otherwise competitive with our products. In addition, while we routinely obtain patents for our products and technology, the protection offered by our patents and patent applications may be challenged, invalidated or circumvented by our competitors and there can be no guarantee of our ability to obtain or maintain patent protection for our products or product candidates. We cannot guarantee that we will be able to produce commercially successful products or maintain the commercial success of our existing products. Our stock price may be affected by actual or perceived market opportunity, competitive position, and success or failure of our products or product candidates. Further, the discovery of significant problems with a product similar to one of our products that implicate an entire class of products could have a material adverse effect on sales of the affected products and on our business and results of operations.
The scientific information discussed in this news release related to our product candidates is preliminary and investigative. Such product candidates are not approved by the
1Abifadel M et al.
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
5Clinicaltrials.gov website: http://clinicaltrials.gov/ct2/show/NCT01786512. Accessed August 2013.
7Clinicaltrials.gov website: http://clinicaltrials.gov/ct2/results?term=%22AMG+145%22+AND+%22phase+3%22&Search=Search. Accessed
8Clinicaltrials.gov website: http://clinicaltrials.gov/ct2/results?term=REGN727+AND+%22phase+3%22&Search=Search. Accessed
9 Clinicaltrials.gov website: http://clinicaltrials.gov/ct2/show/NCT01764633?term=%22AMG+145%22+AND+%22phase+3%22&rank=11. Assessed
10Clinicaltrials.gov website: http://clinicaltrials.gov/ct2/show/NCT01624142?term=%22AMG+145%22+AND+%22phase+3%22&rank=4. Accessed
11 Clinicaltrials.gov website: http://clinicaltrials.gov/ct2/show/NCT01516879?term=%22AMG+145%22+AND+%22phase+3%22&rank=5. Accessed
12 Clinicaltrials.gov website: http://clinicaltrials.gov/ct2/show/NCT01813422?term=%22AMG+145%22+AND+%22phase+3%22&rank=6. Accessed
13 Clinicaltrials.gov website: http://clinicaltrials.gov/ct2/show/NCT01854918?term=%22AMG+145%22+AND+%22phase+3%22&rank=12. Accessed