New Data for Abbott’s TRILIPIX™ (fenofibric acid) in Combination With CRESTOR® (rosuvastatin calcium) Shows Improvement on Key Lipids for Cholesterol Management

TRILIPIX has now been studied in combination with the most commonly used doses of CRESTOR (5 mg, 10 mg, 20 mg) in patients with mixed dyslipidemia

Orlando — Data from a new study showed that Abbott’s (NYSE: ABT) TRILIPIX™ (fenofibric acid) delayed-release capsules in combination with CRESTOR® (rosuvastatin calcium) met all of the study’s primary endpoints. TRILIPIX 135 mg in combination with CRESTOR 5 mg significantly improved HDL cholesterol and triglycerides compared to CRESTOR 5 mg alone and significantly improved LDL cholesterol compared to TRILIPIX 135 mg alone in patients with multiple lipid problems. Results from this new Phase III study were presented [today] at the American College of Cardiology’s 2009 Scientific Sessions in Orlando.

TRILIPIX is a prescription medicine that can be used along with diet to lower triglycerides and LDL (bad) cholesterol, and increase HDL (good) cholesterol. TRILIPIX can also be used along with diet to lower triglycerides and increase HDL cholesterol in people who are at high risk of heart disease and are taking a statin medicine to control their LDL cholesterol. TRILIPIX has not been shown to prevent heart attacks or stroke more than a statin alone.

TRILIPIX is the first and only fibrate to be approved for use in combination with a statin. In certain patients, treatment guidelines recommend the combination of a fibrate with a statin to improve lipid levels.

In the clinical trial, TRILIPIX in combination with CRESTOR was generally well-tolerated with reported safety similar to CRESTOR alone and TRILIPIX alone. No unexpected liver, kidney or muscle safety issues were identified in this study. Muscle related problems can occur with TRILIPIX and CRESTOR alone. The risk of these side effects may be increased when TRILIPIX is used with a statin.

“More comprehensive treatment is often needed in certain patients with mixed dyslipidemia to help reach targets for all three key lipids,” said Eli Roth, M.D., University of Cincinnati College of Medicine, and Sterling Research Group, Cincinnati, Ohio. “The results from this study are encouraging because TRILIPIX combined with the lowest available dose of CRESTOR improved LDL cholesterol, HDL cholesterol and triglycerides.”

More than 100 million American adults have lipid problems, and 35 percent reported being treated with lipid-altering medications. Of the patients being treated, fewer than one in three (30 percent) were at recommended levels for all three key lipids. Treatment guidelines endorsed by the National Cholesterol Education Panel, the American College of Cardiology and the American Heart Association have called for more aggressive management of lipids, including a lower LDL goal for many patients, as well as more aggressive management of HDL and triglycerides.
About the Study Design

The efficacy and safety of TRILIPIX in combination with CRESTOR was evaluated in a multicenter, randomized, double-blind, parallel group, 12-week, Phase III study of 760 patients with mixed dyslipidemia. Patients included in the study had multiple lipid problems, with an LDL greater than or equal to 130 mg/dL, triglycerides greater than or equal to 150 mg/dL and HDL less than 40 mg/dL for men and less than 50 mg/dL for women.

Following a six-week period in which patients were not allowed to take cholesterol medications, patients were randomized to receive TRILIPIX 135 mg alone, CRESTOR 5 mg alone or TRILIPIX 135 mg in combination with CRESTOR 5 mg. The primary efficacy comparisons were mean percent changes in triglycerides and HDL with the combination versus CRESTOR alone and mean percent change in LDL with the combination versus TRILIPIX alone.
About the Study Results

Patients treated with the combination of TRILIPIX 135 mg and CRESTOR 5 mg had an increase in HDL of 23 percent compared to 12.4 percent increase with CRESTOR 5 mg alone (p less than 0.001), and decrease in triglycerides of 40.3 percent compared to a reduction of 17.5 percent with CRESTOR 5 mg alone (p less than 0.001). LDL was reduced by 28.7 percent with the combination compared to a 4.1 percent reduction with TRILIPIX 135 mg alone (p less than 0.001).

The results of this study were consistent with those of the previous studies of TRILIPIX in combination with the other two most commonly used doses of CRESTOR (10 mg and 20 mg). The combinations showed greater improvements in HDL and triglycerides compared to CRESTOR alone and greater improvements in LDL than TRILIPIX alone. The combination of TRILIPIX with the highest dose of CRESTOR (40 mg) has not been studied.

“The recent approval of TRILIPIX and the results of this combination study with CRESTOR further support Abbott’s clinical program and our commitment to patient health,” said Eugene Sun, M.D., vice president, Global Pharmaceutical Clinical Development, Abbott.
TRILIPIX Clinical Development Program

The TRILIPIX clinical program studied 3,458 patients with mixed dyslipidemia in four controlled studies where patients received TRILIPIX alone, TRILIPIX in combination with one of the three most commonly prescribed statins (atorvastatin, simvastatin or rosuvastatin) or statin alone. The clinical program also included a 52-week, long-term, open-label extension study.

Abbott and AstraZeneca are working together to develop a fixed-dose combination of TRILIPIX and CRESTOR with plans to submit a new drug application to the FDA in the second half of 2009. The companies also have an agreement to co-promote CRESTOR in the United States.
TRILIPIX Indication

TRILIPIX is a prescription medicine that can be used along with diet to lower triglycerides and LDL (bad) cholesterol, and increase HDL (good) cholesterol. TRILIPIX can also be used along with diet to lower triglycerides and increase HDL cholesterol in people who are at high risk of heart disease and are taking a statin medicine to control their LDL cholesterol. TRILIPIX has not been shown to prevent heart attacks or stroke more than a statin alone.
Important Safety Information About TRILIPIX

TRILIPIX should not be taken by people with liver, gallbladder, or severe kidney disease, nursing mothers, or those allergic to any product ingredient. Unexplained muscle pain, tenderness, or weakness, particularly when occurring with tiredness and fever, may be a sign of a serious side effect and should be reported to a healthcare provider right away. Rarely, muscle-related problems can cause kidney damage and can be fatal. The risk of these side effects may be increased when TRILIPIX is used with a statin. Patients should tell their healthcare provider about all the medicines they take to help avoid serious side effects. Blood tests may be performed before and during treatment with TRILIPIX to check for liver or kidney problems. Patients should contact their healthcare provider if they experience abdominal pain, nausea, or vomiting while taking TRILIPIX. These may be signs of inflammation of the gallbladder or pancreas. Women who are pregnant should not take statins and should talk with their healthcare provider about TRILIPIX if they are pregnant or may become pregnant. The most common side effects with TRILIPIX include headache, heartburn, nausea, muscle aches, and increases in muscle or liver enzymes that are measured by blood tests. Full Prescribing Information is available at www.rxabbott.com/pdf/trilipix_pi.pdf. Visit www.trilipix.com or call Abbott Medical Information at 1-800-633-9110 for more information about TRILIPIX.
Important Safety Information About CRESTOR

CRESTOR is indicated as an adjunct to diet to reduce elevated Total-C, LDL-C, ApoB, non-HDL-C, and TG levels and to increase HDL-C in patients with primary hyperlipidemia and mixed dyslipidemia. CRESTOR is also indicated as an adjunct to diet to slow the progression of atherosclerosis in adult patients as part of a treatment strategy to lower Total-C and LDL-C to target levels. CRESTOR is not approved to reduce cardiovascular morbidity and mortality.

CRESTOR is contraindicated in patients with a known hypersensitivity to any component of this product, in patients with active liver disease, which may include unexplained persistent elevations of hepatic transaminase levels, in women who are pregnant or may become pregnant, and in nursing mothers.

Cases of myopathy and rhabdomyolysis with acute renal failure secondary to myoglobinuria have been reported with HMG-CoA reductase inhibitors, including CRESTOR. These risks can occur at any dose level, but are increased at the highest dose (40 mg).

CRESTOR should be prescribed with caution in patients with predisposing factors for myopathy (eg, age 65 years, inadequately treated hypothyroidism, renal impairment). The risk of myopathy during treatment with CRESTOR may be increased with concurrent administration of some other lipid-lowering therapies (fibrates or niacin), gemfibrozil, cyclosporine, or lopinavir/ritonavir.

Therapy with CRESTOR should be discontinued if markedly elevated CK levels occur or myopathy is diagnosed or suspected. All patients should be advised to promptly report unexplained muscle pain, tenderness, or weakness, particularly if accompanied by malaise or fever. It is recommended that liver enzyme tests be performed before and at 12 weeks following both the initiation of therapy and any elevation of dose, and periodically (eg, semiannually) thereafter. Should an increase in ALT or AST of greater than 3 times ULN persist, reduction of dose or withdrawal of CRESTOR is recommended. CRESTOR should be used with caution in patients who consume substantial quantities of alcohol.

CRESTOR 40 mg should be used only for those patients not achieving their LDL-C goal with 20 mg. Patients initiating CRESTOR therapy or switching from another statin should begin treatment with CRESTOR at the appropriate starting dose.

In the controlled clinical trials database, the most common adverse reactions were headache (3.7 percent), myalgia (3.1 percent), abdominal pain (2.6 percent), asthenia (2.5 percent), and nausea (2.2 percent).