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| + | == Does Esperion Therapeutics Have A Blockbuster With ETC == | ||
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| + | Does Esperion Therapeutics Have A Blockbuster With ETC<br><br>Esperion Therapeutics (ESPR) is a $230.36M market cap biopharmaceutical company focused on the research, development and commercialization of therapies for the treatment of patients with elevated levels of lowdensity lipoprotein cholesterol (LDLC),12-1-1129867, also known as "bad cholesterol," and other cardiometabolic risk factors.<br><br>The company was founded in April 2008 by former executives of, and investors in,nike tn 2014, the original Esperion Therapeutics, Inc. The original Esperion was focused on the research and development of therapies to regulate highdensity lipoprotein cholesterol, or HDLC. After successfully completing a Phase 2a clinical trial with its synthetic HDL therapy, the original Esperion was acquired by Pfizer Inc. (PFE) in 2004 for approximately $1.3 billion.<br><br>Statinbased drugs dominate the cholesterol control drug market. Over the past five years, statin prescriptions have increased by 17% to 214 million a year, while other cholesterol remedies lost 28% of their scripts. Nonstatin drugs now account for only 50 million prescriptions a year.<br><br>The company's founder, executive chairman and chief scientific officer, Roger Newton, codiscovered the statin drug, Lipitor (atorvastatin calcium),nike tn requin site officiel, the most prescribed LDLC lowering therapy in the world and one of the bestselling drugs ever developed. Before losing its patent protection on November 30, 2011,nike tn trainers, Lipitor was generating about $7.9 billion in annual sales in the United States, and nearly $11 billion worldwide,boutique nike tn, representing about 16% of Pfizer's annual revenue.<br><br>Some analysts contend that the popularity of statins has peaked. In "Statins Market to 2018," GBI Research forecasted that the valuation of the worldwide market for statins will tumble from $19.7 billion in 2012 to $12.2 billion in 2018 while generics' market share will increase from 11% in 2011 to 34% in 2018.<br><br>GBI predicts that the statin market will decrease significantly due to the increasing availability and use of generic drugs,05 PM PDT By Amanda Kooser, the implementation of costcontainment policies, weak product pipelines and a shift of focus towards the use of combination therapies and nonstatins.<br><br>Despite the proven effectiveness of statins,nike free run pas cher, many individuals with elevated risk of heart disease are unable to benefit from these drugs due to the side effects such as muscle pain or weakness, memory loss, and increased glucose levels. In rare and extreme cases,nike requin pas cher, muscle breakdown, kidney failure and death have occurred. The FDA now recommends that liver enzyme tests should be performed before starting statin therapy, and as clinically indicated. The FDA concluded that serious liver injury with statins was rare and unpredictable in individual patients, and that routine periodic monitoring of liver enzymes does not appear to be effective in detecting or preventing this rare side effect. The agency advised that patients should notify their healthcare professional immediately if they experience unusual fatigue or weakness, loss of appetite, upper belly pain,nike free run pas cher, darkcolored urine, yellowing of the skin or the whites of the eyes. Statin labels now include information about some patients experiencing memory loss and confusion. These reports generally have not been serious and the patients' symptoms were reversed by stopping the statin.<br><br>The new labels now disclose that increases in blood sugar levels (hyperglycemia) have been reported with statin use. The FDA announced that it was also aware of studies showing that patients being treated with statins may have a small increased risk of increased blood sugar levels and of being diagnosed with type 2 diabetes mellitus. The labels now warn healthcare professionals and patients of this potential risk.<br><br>Esperion's lead product candidate, ,nike air max, is a firstinclass therapy designed to significantly lower levels of LDLC and improve other cardiometabolic risk factors without the side effects associated with statin use. is a novel, firstinclass, orally available, oncedaily LDLlowering small molecule therapy designed to lower levels of LDLC and to avoid many of the side effects associated with existing LDLC lowering therapies.<br><br> has a unique dual mechanism of action with the potential to regulate both lipid and carbohydrate metabolism. The investigational drug works by inhibiting ATP citrate lyase a key enzyme in the cholesterol biosynthetic pathway, and activating a complementary enzyme, 5 monophosphateactivated protein kinase (AMPK). Both enzymes are known to play significant roles in the synthesis of cholesterol and glucose in the liver. By inhibiting cholesterol synthesis in the liver, causes the liver to take up LDL particles from the blood,nike free run, which reduces LDLC levels.<br><br>Esperion has studied in 388 patients in three Phase 1 as well as three Phase 2 clinical trials. In these studies, Esperion researchers found that reduced LDLC as much as 43%, and has also decreased levels of high sensitivity Creactive protein, (hsCRP), a key marker of inflammation associated with cardiovascular disease,nike tn magasin, at levels similar to statin drugs.<br><br>On June 7, 2013, Esperion announced positive topline results from a Phase 2a clinical study of in 56 patients with hypercholesterolemia with a history of intolerance to two or more statins. The study met its primary endpoint, demonstrating that lowered LDLC by an average of 32%. Researchers found the drug candidate was well tolerated.<br><br>On May 4, 2013, Esperion reported the findings of a Phase 1 trial of comprised of 32 subjects treated with daily doses of up to 120 mg or placebo for 14 days and 21 subjects treated with 120 mg of or placebo for 28 days. Researchers found a statistically significant lowering of LDLC in mildly dyslipidemic subjects and a favorable safety profile that served as a "solid foundation for clinical evaluation in patients with other cardiometabolic abnormalities."<br><br>On May 2, 2013, the company announced the results of a Phase 2 clinical trial of in 60 patients with Type 2 diabetes and hypercholesterolemia. The trial met its primary endpoint, demonstrating that lowered LDLC by up to 43% and was associated with improvements in control of other cardiometabolic risk factors. In addition,rose donne requin tn, was well tolerated.<br><br>On March 25, 2012, Esperion revealed the results of a 12week, randomized, multicenter, doubleblind, placebo controlled study of 177 dyslipidemic subjects who were evaluated to assess the lipid regulating safety and efficacy of . The primary objective of the study was to assess the LDLC lowering using daily doses of up to 120 mg/day or placebo for the duration of the study. Secondary objectives included assessing the ability of to lower plasma triglycerides and to beneficially modulate other lipid and nonlipid biomarkers. Safety and tolerability and pharmacokinetic analyses were also performed. Results from the Phase 2 trial found that LDLC levels were maximally decreased in subjects treated with up to 27% after two weeks of treatment and was sustained over the remaining 10 weeks. Other relevant biomarkers, including Apo B, LDLP and nonHDLC, were also significantly decreased.<br><br>On September 03, 2013, Esperion announced positive topline results from a Phase 2a study of when added to statin therapy in patients with elevated levels of LDLC. The study demonstrated that oral, oncedaily achieved incremental LDLC lowering of 22% at eight weeks, compared with 0 percent in the placebo group, when added to 10 mg of atorvastatin. The researchers found that was well tolerated over eight weeks of treatment when added to a statin. No serious adverse events were reported.<br><br>"Since a 10 mg dose of atorvastatin provides 30 to 35 percent LDLC lowering, the addition of could potentially provide LDLC lowering of greater than 55 percent with an oral dosing regimen. While statin therapy remains the standard of care for high cholesterol, it is estimated that 11 million Americans are still unable to reach their LDLC treatment goals despite taking a statin," Newton stated,<br><br>"This study answered important questions about the safety, tolerability and efficacy of as an addon to statin therapy," said Tim M. Mayleben, Esperion's president and CEO. "We are now in a position to build on these positive results with a robust, paralleldose design Phase 2b study to establish further the potential of to provide incremental LDLC lowering for patients already taking a statin and not at their LDLC goal."<br><br>The 007 study was a randomized, doubleblind, placebocontrolled, multicenter, Phase 2a study to evaluate the safety and tolerability of when added to 10 mg of atorvastatin and assesses the effect of on the pharmacokinetics of atorvastatin in patients with hypercholesterolemia.<br><br>Secondary objectives were to assess the effect of on LDLC and other cardiometabolic risk factors when added to atorvastatin. In the study, 58 hypercholesterolemia patients were washed out of any lipid regulating therapies prior to a four week runin period on 10 mg atorvastatin. Researchers randomized 42 of these patients to receive plus 10 mg atorvastatin. All treated patients received escalating daily doses of 60, 120,nike tn requin, 180 and 240 mg , each over a two week period, for a total of eight weeks. Sixteen patients received placebo plus 10 mg atorvastatin also for eight weeks.<br><br>In October 2013, Esperion plans to initiate the 008 Phase 2b clinical study in approximately 322 patients with hypercholesterolemia and either a history of statin intolerance or a history of statin tolerance. The goal of this study is to demonstrate comparable tolerability and superior efficacy to Merck's Zetia (ezetimibe) for the treatment of patients with elevated LDLC levels and intolerance to two or more statins due to musclerelated adverse events.<br><br>Esperion also plans to initiate 009, a Phase 2b clinical trial in patients currently on statin therapy who are unable to achieve their LDLC goals. These residualrisk patients will receive multiple dose strengths of along with atorvastatin calcium. The trial is expected to start by the end of 2013.<br><br>Esperion initially plans to seek approval of as a therapy for patients with elevated levels of LDLC who are unable to tolerate statin therapy due to muscle pain or weakness. Subsequently,12-1-1127059, the company hopes to seek approval for in a broader population of patients who are unable to achieve their LDLC goals, and despite being on statins remain at an increased risk for cardiovascular disease. | ||
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