Forbes: A Big Win For Esperion
Matthew Herper, 06.26.03, 1:10 PM ET
NEW YORK - Esperion Therapeutics, a small biotech based in Ann Arbor, Mich., today announced results of a mid-stage trial of an injection to treat patients with very serious heart disease. The drug actually seems to reduce the amount of plaque building up on arteries. Analysts rushed to raise their price targets, and investors bid shares up 20% to $17.80. Five million shares--20 times average daily volume--traded before noon.
"They were able to show regression in coronary atherosclerosis, the scourge of the Western world," says Mark Monane, an analyst at Needham & Co. Needham expects or intends to receive banking business with Esperion (nasdaq: ESPR - news - people ) in the next three months.
In a study of 47 patients comparing the drug, ETC-216, to a placebo, the injection significantly reduced the volume of plaque in coronary arteries in patients receiving the drug, as measured with an ultrasound probe. (Full data will not be available until the results are published by a medical journal.) If the drug continues to prove safe and effective, it could be used in patients with severe coronary artery disease to help prevent heart attacks.
"This is the first time in this period of treatment and follow-up that there has been any change in plaque volume," says Roger Newton, Esperion's president and chief executive.
Needham's Monane notes that Merck's (nyse: MRK - news - people ) cholesterol-blockbuster drug Zocor takes at least a year to show a statistically significant reduction in the volume of artery plaque. Newton cautions that this is an apples to oranges comparison, because the Zocor studies were done with arteries in the neck, not the heart, and more tests are being done to see if ETC-216 reduces plaque in the neck. Still, the comparison shows how impressive ETC-216's performance is.
ETC-216 is a slightly different version of a protein in high-density lipoprotein, the so-called good cholesterol. In the body, HDL appears to play a role in removing cholesterol plaque from the arteries and ferrying it out of the body. The particular version of the protein was found in a population of Italians who had a remarkably low risk of heart attacks, even though they had high triglycerides and other danger signs for heart disease. Two researchers, Cesare Sirtori and Guido Franceschini, found the protein and licensed it to Pharmacia.
Pharmacia, in turn, licensed the drug to Esperion, where Newton already had experience in cardiovascular disease. He had done much of the heavy lifting in inventing and developing Pfizer's (nyse: PFE - news - people ) cholesterol medicine Lipitor, the world's best-selling drug. Newton saw that ETC-216 had potential in very sick patients. If the protein could tear off cholesterol plaque in patients who were already sick, it might cut down on heart attacks. It worked in animals; the results announced today are the first sign it may work in people.
Esperion's licensing agreement with Pharmacia, now part of Pfizer, will require it to go back to the company to negotiate a potential deal. "We committed to the fact that they would have an option," says Newton. "We're talking to a whole different cast of characters now."
ETC-216 will not be a drug for all the millions of people who suffer from severe coronary artery disease, even if it does eventually get a green light from the U.S. Food and Drug Administration. In the current trials, it was injected once a week for five weeks--a much more difficult prospect than taking a pill. However, it's very existence shows how heart drugs, once the province of Pfizer, Merck and Bristol-Myers Squibb (nyse: BMY - news - people ), are increasingly being developed at small biotechs like Esperion or Alpharetta, Ga.-based Atherogenics (nasdaq: AGIX - news - people ), which is testing a pill to reduce cardiac inflammation.
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