Sub-analyses Investigate the Effects of alogliptin on Cardiovascular Mortality Rates and Hospitalization for Heart Failure in Type 2 Diabetes Patients with Recent Acute Coronary Syndrome
MORRISVILLE, N.C. (March 27, 2014) - Furiex Pharmaceuticals, Inc. (NASDAQ: FURX) today confirmed that its partner Takeda Pharmaceuticals Company Limited (Takeda) will present sub-analyses from the global EXAMINE (EXamination of CArdiovascular OutcoMes: AlogliptIN vs. Standard of CarE in Patients with Type 2 Diabetes Mellitus and Acute Coronary Syndrome) cardiovascular (CV) safety outcomes trial in a poster session at the American College of Cardiology's (ACC) 63rd Annual Scientific Session in Washington, DC. These sub-analyses specifically relate to the effects of alogliptin on rates of CV mortality and hospitalization for heart failure (HF).
The poster will be presented during the "Acute Coronary Syndromes: Comorbid Considerations" session on Saturday, March 29, 2014 from 2:45 to 3:30 p.m. CT.
Alogliptin is the first and to date the only dipeptidyl peptidase-4 inhibitor (DPP-4i) to demonstrate CV safety outcomes in Type 2 diabetes patients with recent acute coronary syndrome (ACS). Heart disease, or cardiovascular disease (CVD), is the leading cause of morbidity and mortality in patients with Type 2 diabetes, and is responsible for between 50 and 80 percent of deaths in people with diabetes.
Findings from the sub-analysis, "Cardiovascular mortality in patients with type 2 diabetes and recent acute coronary syndrome from the EXAMINE Trial," demonstrated no effect on rates of CV mortality [hazard ratio (HR)= 0.85, 95% confidence interval (CI): 0.66, 1.10] in patients with Type 2 diabetes and recent ACS with alogliptin, compared to placebo (n=112, 4.1% and n=130, 4.9%, respectively). There was also no increase in sudden cardiac death with alogliptin (n=59, 2.2%) versus placebo (n=73, 2.7%) [HR=0.80, 95% CI: 0.57, 1.12].
The other sub-analysis, "Alogliptin in patients with type 2 diabetes after acute coronary syndromes: Heart failure outcomes and cardiovascular safety in heart failure patients," demonstrated that in patients with Type 2 diabetes and recent ACS, the pre-specified composite CV outcome of first occurrence of all-cause mortality, nonfatal myocardial infarction and stroke, urgent revascularization due to unstable angina, and hospitalization for heart failure was similar for alogliptin compared with placebo [HR=0.98, 95% CI, 0.86-1.12]. Within this composite endpoint, hospitalized heart failure occurred in 3.1 percent of patients on alogliptin versus 2.9 percent on placebo [HR=1.07, 95% CI, 0.79-1.46]. Additionally, alogliptin neither induced new onset heart failure nor worsened heart failure outcomes in patients with a history of heart failure and / or with markers for it (elevated NT-pro-BNP levels).
"Takeda's findings demonstrate that alogliptin showed no difference from placebo on rates of cardiovascular mortality and hospitalizations for heart failure in Type 2 diabetes patients with recent acute coronary syndrome," said June Almenoff, M.D., Ph.D., president and chief medical officer of Furiex. "These findings and others from the EXAMINE trial provide assurance that alogliptin does not adversely affect cardiovascular health outcomes, which is important given that cardiovascular events are quite common among patients with Type 2 diabetes."
Fred Eshelman, Pharm.D., founding chairman of Furiex, added, "We are pleased that these sub-analyses of the EXAMINE trial are being shared at the ACC Scientific Session. The findings provide important insights about alogliptin for clinicians treating patients with Type 2 diabetes and underscore Takeda's commitment to the diabetes community."
Results from EXAMINE, a global, large, randomized, double-blind, placebo-controlled clinical trial, were published in the New England Journal of Medicine in September 2013. The trial was designed to evaluate CV safety following treatment with alogliptin in addition to standard of care, versus placebo in addition to standard of care, in patients with Type 2 diabetes and a recent ACS. The EXAMINE trial's primary composite endpoint of non-inferiority compared to placebo in addition to standard of care was met, showing no increase in CV risk in a Type 2 diabetes patient population at high risk for CV events, including CV death, nonfatal myocardial infarction and nonfatal stroke.
Under its agreement with Takeda, Furiex is entitled to royalties on alogliptin sales and potential sales-based milestones.
EXAMINE randomized 5,380 patients in 49 countries with Type 2 diabetes with an ACS within the previous 15-90 days. The EXAMINE primary endpoint of non-inferiority compared to placebo in addition to standard of care was met, showing no increase in CV risk in a Type 2 diabetes patient population at high risk for CV events based on the primary composite endpoint of CV death, nonfatal myocardial infarction and nonfatal stroke. The primary endpoint occurred at similar rates in the alogliptin and placebo groups (in 11.3% of patients vs. 11.8% of patients during a median follow-up period of 18 months; HR, 0.96; upper boundary of the one-sided repeated CI, 1.16).
About Type 2 Diabetes
Type 2 diabetes is the most common form of diabetes and has reached epidemic proportions globally. The global health care expenditures to treat and prevent diabetes and its complications were estimated at $471 billion in 2012. By 2030, this number is projected to exceed $595 billion. In addition to diet and exercise, patients often need to take multiple medications to help manage blood glucose. Due to the chronic nature of this disease, combination therapy is often required to maintain diabetic control over many years of therapy.
Alogliptin is a DPP-4i for the treatment of Type 2 diabetes in adults as an adjunct to diet and exercise. DPP-4is are designed to slow the inactivation of incretin hormones GLP-1 and GIP. As a result, an increased amount of active incretins enables the pancreas to secrete insulin in a glucose-dependent manner, thereby assisting in the management of blood glucose levels.
Alogliptin is approved as a monotherapy and also in fixed-dose combination (FDC) with pioglitazone and metformin HCl for the treatment of Type 2 diabetes in adults as adjuncts to diet and exercise. These therapies are not for treatment of Type 1 diabetes or diabetic ketoacidosis.
Alogliptin therapies are approved by the U.S. Food and Drug Administration under the brand names Nesina® (alogliptin), Kazano® (alogliptin and metformin) and Oseni® (alogliptin and pioglitazone). In addition to the U.S., alogliptin is available in many markets across Australia, China, Europe, Japan, Mexico and South Korea.
Furiex Pharmaceuticals is a drug development collaboration company that uses innovative clinical development design to accelerate and increase value of drug development programs by advancing them through the drug discovery and development process in a cost-efficient manner. Our drug development programs are designed and driven by a core team with extensive drug development experience. The Company collaborates with pharmaceutical and biotechnology companies and has a diversified product portfolio and pipeline with multiple therapeutic candidates, including one Phase III-ready asset, two compounds in Phase III development, one of which is with a partner, and four products on the market. The Company's mission is to develop innovative medicines faster and at a lower cost, thereby improving profitability and accelerating time to market while providing life-improving therapies for patients. For more information, visit www.furiex.com.
Except for historical information, all of the statements, expectations and assumptions contained in this news release are forward-looking statements that involve a number of risks and uncertainties. Although Furiex attempts to be accurate in making these forward-looking statements, it is possible that future circumstances might differ from the assumptions on which such statements are based. In addition, other important factors which could cause actual results to differ materially include the following: inability of collaborators to effectively market approved products for which we receive royalty and sales-based milestone payments; progress of compounds in clinical trials and regulatory approvals; potential changes to regulatory guidance by regulatory agencies such as the U.S. Food and Drug Administration and the European Medicines Agency; the risk of finding a collaborator for our late-stage compounds, or risks involved in our attempting to commercialize compounds ourselves; continuing losses and our potential need for additional financing; the risks and expense of continuing the research and development activities of our existing compounds; changes in the safety and efficacy profile of our existing compounds as they progress through research and development; new collaborative agreements that we might enter into in the future; the costs of defending any patent opposition or litigation necessary to protect our proprietary technologies; and the other risk factors set forth from time to time in the SEC filings for Furiex, copies of which can be found on our website.