Cholesterol Champions - Pharmaceutical Executive

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Cholesterol Champions
The scientists who developed Lipitor are once again making history in the war on plaque.


Pharmaceutical Executive


Roger Newton and David Scheer were the co-founders of Esperion. Newton now leads Esperion as a unit of Pfizer’s global R&D. Scheer is president of Scheer & Co., a venture capital consultancy.

Every year, 1.5 million people cross a threshold into a dangerous disease. The plaque lining the inside of their arteries becomes thick or unstable enough to put them at risk for a heart attack. Known as atherosclerosis, the condition affects 12–15 million people worldwide and has a high mortality rate. In addition, hundreds of millions of patients suffer from high cholesterol levels, which cause that plaque to form. The pharmaceutical industry has produced a group of statins—all with blockbuster sales—to lower cholesterol levels, but so far, a medicine that reverses the buildup of plaque has been elusive.

Such a product may now be in sight. Several of the scientists who developed Lipitor (atorvastatin), an anti-cholesterol drug that became the best-selling prescription product in the world at $9 billion a year—have wowed clinicians with their next breakthrough. The new therapy, which includes a recombinant form of apolipoprotein A-I, known as Apo-I Milano, has demonstrated in a small Phase II clinical trial that it can reverse plaque buildup by an average of 4 percent in five weeks.


Cholesterol Cycle. High-density lipoprotein (HDL), otherwise known as "good cholesterol," enters the arteries where it converts cholesterol to a new form, then carries it away from the arteries to the liver, where it is processed for disposal. Low-density lipoprotein (LDL) or "bad cholesterol," on the other hand, delivers cholesterol to the arteries, where it can build up in the form of plaque. Esperions pipeline candidates mimic the action of HDL, and Apo-I Milano takes it a step further by reducing the volume of plaque that has already built up.
"The results were as spectacular as any I have ever seen," says Steve Nissen, MD, of the Cleveland Clinic, who designed, conducted, and reported the trial. "They've set the research world on fire. People will be talking about this for a long time."

Before the Apo-I Milano champions could bring the protein to that point, they had to license the compound and start their own company, Esperion. But this story really begins long before that in a small town in Italy.

Protein Journey Limone sul Garda sits high in the mountains of Northern Italy on the western shore of Lake Garda. In the 1970s, two scientists from the University of Milano, Guido Franceschini and Cesare Sirtori, discovered that 44 of its inhabitants had dangerously low levels of high-density lipoprotein (HDL), also known as "good cholesterol."


The Arsenal. Esperion has a full line of cholesterol-regulating candidates in development to beat the war on plaque.
What's good about HDL is that it converts and carries cholesterol away from the arteries to the liver, where it is processed for disposal. Low-density lipoprotein (LDL) or "bad cholesterol," on the other hand, delivers cholesterol to the arteries, where it can build up in the from of plaque. (See "Cholesterol Cycle.")


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