LAPLACE-TIMI 57 Study DesignLAPLACE-TIMI 57 ( LDL-C Assessment with P CSK9 monoclona L Antibody inhibition Combined with statin th Erapy – Thrombolysis In Myocardial Infarction-57) is a Phase 2 randomized, double-blind, dose-ranging, placebo-controlled study that included eight treatment arms to evaluate the efficacy, safety and tolerability of AMG 145, administered subcutaneously, in 629 patients at risk for cardiovascular disease with LDL-C > 85 mg/dL when added to a stable dose of statin with or without ezetimibe. Treatment arms included AMG 145 (70 mg, 105 mg and 140 mg) versus placebo Q2W and AMG 145 (280 mg, 350 mg and 420 mg) versus placebo Q4W. The primary endpoint of the study was the percent change from baseline in LDL-C, measured by preparative ultracentrifugation, at week 12. Secondary efficacy endpoints included the absolute change from baseline in LDL-C at week 12 and the percentage changes from baseline to week 12 in non-high-density lipoprotein (non-HDL-C), apolipoprotein B (ApoB), total cholesterol (TC)/HDL-C ratio and ApoB/ApoA1 ratio.
MENDEL Study DesignMENDEL ( Monoclonal Antibody Against PCSK9 to Reduce Elevated LDL-C in Patients Currently Not Receiving Drug Therapy For Easing Lipid Levels) is a Phase 2 randomized, multi-center, double-blind, controlled trial designed to evaluate the efficacy, safety and tolerability of AMG 145 in 406 patients with low cardiovascular risk (LDL-C > 100 mg/dL and < 190 mg/dL) who were not receiving statin therapy. AMG 145 was evaluated across nine treatment groups, including AMG 145 at 70 mg, 105 mg and 140 mg dosed Q2W compared to placebo Q2W; and AMG 145 at 280 mg, 350 mg and 420 mg dosed Q4W compared to placebo Q4W; or daily ezetimibe 10 mg. The primary endpoint was percentage change from baseline in LDL-C, measured by preparative ultracentrifugation, at week 12. Secondary efficacy endpoints included the absolute change from baseline in LDL-C at week 12 and the percentage changes from baseline at week 12 in non-high-density lipoprotein (non-HDL-C), apolipoprotein B (ApoB), total cholesterol (TC)/HDL-C ratio and ApoB/ApoA1 ratio.
Webcast InformationAmgen will hold an analyst/investor event on Tuesday, Nov. 6, at 7:00 p.m. Pacific Standard Time to discuss data presented at AHA. A webcast of the event can be found on Amgen's website at www.amgen.com, under Investors. The audio webcast will be archived and available for replay for at least 72 hours.
About AMG 145AMG 145 is a fully human monoclonal antibody directed against proprotein convertase subtilisin/kexin type 9 (PCSK9). PCSK9 is a protein that reduces the liver's ability to remove LDL-C from the blood and thereby causes bad cholesterol to increase. AMG 145, developed by Amgen scientists, binds to PCSK9 circulating in the blood and prevents PCSK9 from binding to LDL receptors in the liver. Without PCSK9 bound to them, the LDL receptors can take up and remove LDL-C from the blood, recycle and remain available for binding additional LDL-C. The Amgen Phase 2 program for AMG 145 enrolled more than 2,000 patients across seven studies to evaluate the effects of AMG 145 across multiple patient populations who may benefit from additional cholesterol lowering treatment options. The Phase 2 program is evaluating the treatment of hyperlipidemia with AMG 145 in combination with statins, in patients with hyperlipidemia who cannot tolerate statins, as a stand-alone treatment in patients with hyperlipidemia, and in patients whose elevated cholesterol is caused by genetic disorders called heterozygous and homozygous familial hypercholesterolemia.About AmgenAmgen discovers, develops, manufactures and delivers innovative human therapeutics. A biotechnology pioneer since 1980, Amgen was one of the first companies to realize the new science's promise by bringing safe, effective medicines from lab to manufacturing plant to patient. Amgen therapeutics have changed the practice of medicine, helping millions of people around the world in the fight against cancer, kidney disease, rheumatoid arthritis, bone disease and other serious illnesses. With a deep and broad pipeline of potential new medicines, Amgen remains committed to advancing science to dramatically improve people's lives. For more information, visit www.amgen.com and follow us on www.twitter.com/amgen. Forward-Looking Statements 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 most recent 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 Nov. 6, 2012, and expressly disclaims any duty to update information contained in this news release. No forward-looking statement can be guaranteed and actual 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.