A new drug being developed by Merck & Co. could follow Lipitor as the next mega-blockbuster cholesterol drug, if it clears several important hurdles.
The new drug, anacetrapib, is aimed at a significant number of patients who are not being helped by statin medicines like Pfizer’s current best seller Lipitor, and eventually could net billions of dollars in annual sales for Merck. But analysts caution that more clinical testing awaits, regulatory approval is still several years away, and profitability depends on side effects and whether any warnings or use restrictions are attached to an approval.
Still, the drug holds promise simply because it targets a large patient population.
“This isn’t an orphan drug,” said Erik Gordon, a professor and analyst at the University of Michigan’s Ross School of Business. “This is for people’s heart conditions.”
Anacetrapib has shown in studies that it can boost good cholesterol while dropping bad cholesterol in patients. Those results caused a stir recently at the American Heart Association conference in Chicago, but the drug needs more testing to see if those effects lead to fewer heart attacks, strokes and deaths.
Doctors have focused on lowering bad cholesterol, or LDL, to cut heart risks with statin medicines like Lipitor and Zocor.
Studies have shown that these statins reduce the risk of a cardiovascular event like a heart attack for about a third of patients, said Tony Butler, an analyst with Barclays Capital, which has done investment banking work for both Merck and Pfizer. The Merck drug holds the potential to help the two-thirds of patients who are still at risk.
The drug is being studied for patients who have had a heart attack or are at high risk of one because of diabetes or other factors.
Lipitor, which brought in $2.53 billion in sales in the third quarter, is the best-selling drug in the world. But it loses U.S. patent protection next year, and its sales are expected to fall sharply to generic competition.
Butler said generics likely will be used in patients with poor cholesterol who have yet to have a heart attack. But Merck may compel doctors to switch back to branded drugs by using anacetrapib on patients who have already had a cardiovascular attack.
Pfizer walked away from an $800 million investment in torcetrapib, a similar drug it was developing four years ago, because of blood pressure problems. Butler said the safety profile of anacetrapib appears to be “substantially” different, but that still needs to be clarified with more testing.
Anacetrapib is part of a Merck cardiovascular program that dwarfs the competition, Butler said. The drugmaker has about 100,000 patients in late-stage clinical trials for cardiovascular medicines, while many other drug companies have backed away from the market.
“Nobody’s involved quite as in-depth as Merck,” he said.
Date: November 17, 2010
Source: Associated Press