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Esperion Drug Shows Promise in Cutting Cholesterol Levels

Wednesday, March 18, 2015   (0 Comments)
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From BloombergBusiness
By Michelle Fay Cortez

Esperion Therapeutics Inc.’s lead product in development boosted the effectiveness of drugs commonly used to lower levels of bad cholesterol in a mid-stage study, helping position it as another way to fight heart disease.

Adding the lowest dose of the drug known as ETC-1002 to treatment with statin drugs like Pfizer Inc.’s Lipitor cut bad LDL cholesterol by 17 percent more than statins alone, the Plymouth, Michigan-based company said in a statement. A higher dose increased the effect, cutting cholesterol by 24 percent.

The results come from the final study in the company’s phase 2 program, the second of three steps needed to get a new medicine onto the U.S. market. Esperion plans to begin the third and final phase of development by the end of the year and expects to get the drug approved for lowering cholesterol by the second half of 2018, said Chief Executive Officer Tim Mayleben.

“Statins are the first-line therapy but we have learned over the past eight to 10 years that people are taking statins without getting enough LDL lowering,” Mayleben said in a telephone interview. “There aren’t a whole lot of other tools in the toolbox to use.”

Esperion jumped 29 percent to $99.60 at the New York close, the biggest single-day gain since its initial public offering in June 2013. The shares had risen more than fourfold in the past 12 months through yesterday.

Zetia Competition
The medicine, taken as a pill, would compete with Merck & Co.’s Zetia, which also works differently than statins to lower cholesterol levels. Zetia has been shown to reduce the risk of heart attacks and strokes in patients already getting aggressive cholesterol-lowering therapy. Another class of drugs known as PCSK9 inhibitors, in development by Amgen Inc., Sanofi and Regeneron Pharmaceuticals Inc., reduce cholesterol levels by an even greater amount, though they must be injected.

The three-month study funded by Esperion compared ETC-1002 to a placebo in 133 patients taking a low or moderate amount of a statin. Patients started the study with an LDL cholesterol level of 132 to 143 milligrams per deciliter, well beyond the 100 mg/dL most patients strive to hit. They were taken off all other cholesterol-lowering drugs before the study began.

Patients getting the drug had lower levels of C-reactive protein, a measure of inflammation, than those on a placebo, though the difference may have been the result of chance.

Stock Offering
Esperion announced it intends to raise $150 million in a common stock offering and use the money to complete the clinical development of ETC-1002. The company plans to study a fixed-dose combination of the drug with Zetia and begin a definitive trial to see if the treatment prevents heart attacks, strokes and other cardiovascular outcomes.

While numerous companies have reached out to Esperion to help develop the drug, Mayleben said it has the expertise needed to get it through the regulatory approval process.

“There is a lot of interest in the program from potential partners, but we have the experience and the ability to take the program forward ourselves,” he said. “There is a real scarcity of oral small molecules in development.”

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