Abbott says its cholesterol combo drug proves safe

CHICAGO (Reuters) - Abbott Laboratories Inc. (ABT.N) said its new treatment aimed at cutting triglycerides and raising "good" HDL cholesterol proved safe and effective when taken alone or in combination with other cholesterol-lowering drugs in two studies.

Abbott's experimental drug, dubbed ABT-335, is the successor to the company's blockbuster TriCor medicine to control triglycerides, a type of blood fat which contributes to clogging of the arteries.

Abbott tested ABT-335 in combination with individual members of the popular statin family of cholesterol drugs, including Merck's (MRK.N) Zocor, generically known as simvastatin, Pfizer's (PFE.N) Lipitor, or atorvastatin, and Astrazeneca's (AZN.L) Crestor, or rosuvastatin.

Abbott presented data at the American College of Cardiology meeting in Chicago from one study testing its drug with Zocor and the other with Lipitor.

"All of our studies met their endpoints (goals)," Dr. Jim Stolzenbach, a senior Abbott research executive, said in a telephone interview.

Patients who took Zocor with ABT-335 saw their triglycerides fall 37.4 percent, versus a 14.2 percent decline when Zocor was taken alone. HDL levels rose 17.8 percent when both drugs were used, compared with 7.2 percent taking the statin alone.

Among patients taking Lipitor with ABT-335, triglycerides dropped 45.6 percent, versus 16.5 percent when Lipitor was taken alone. There was a 14 percent increase in HDL when both drugs were taken, compared with a 6.3 percent increase when Lipitor was taken alone.

Results from a similar study combining Crestor with ABT-335 will be presented later this year.

Stolzenbach said the Crestor study produced results that were consistent with the Lipitor and Zocor studies.

"Things doctors will ask about are whether there are any new side effects with the liver, kidneys or muscles, or whether side effects multiply. They didn't....there was nothing unexpected. There were no signals of any side effects for any of the statins we used."

Statins help reduce LDL, but often do not address high triglycerides or low HDL, he said, noting that about a quarter of patients who take statins still don't achieve optimal lipid levels.

Of the estimated 110 million Americans who have unhealthy levels of cholesterol, about 42 million have problems in two or more categories, he added.

The Lake Forest, Illinois-based company said it expects to have the drug on the U.S. market by the fourth quarter.

The market for cholesterol drugs is about $20 billion in the United States and combination therapy makes up about 15 percent of that total, according to Abbott.

Solvay has rights to ABT-335 outside the United States.

In a recent research note, Morgan Stanley analyst Glenn Reicin said, "The positive outcomes for these studies should take Abbott's Cardiovascular franchise to another level by having the first fenofibrate that can support labeling and efficacy claims for combination therapy with all statins."