Amgen’s Heart Drug Lowers Patient Cholesterol in Study

Amgen Inc., the world’s largest biotechnology company, said its experimental heart drug lowered cholesterol levels in patients taking statins such as Pfizer Inc.’s Lipitor, keeping pace with rivals racing to be first on the market with the new class of medicines.

The drug, AMG-145, which targets cholesterol-regulating gene PCSK9 in the liver, reduced LDL, or bad cholesterol, as much as 66 percent in patients taking statins, according to a study presented today at the American Heart Association meeting in Los Angeles. Some of the patients were also taking Merck & Co.’s cholesterol treatment Zetia.

Amgen’s drug is one of several that companies are developing to target the cholesterol-regulating gene PCSK9 in the liver, a new approach to current therapies that generate $39 billion in annual sales. Some of the world’s biggest drugmakers, Pfizer, Roche Holding AG and Sanofi are testing versions.

The therapy from Sanofi and its partner, Regeneron Pharmaceuticals Inc.,’s therapy reduced LDL levels 73 percent in a study, the companies said Oct. 31 in a statement. Pfizer’s drug lowered bad cholesterol in patients on statins by 56 percent, the New York-based company said yesterday at the meeting.

“The bottom line is, the early-stage data look similar,” Michael Yee, an analyst with RBC Capital Markets in San Francisco, said in an e-mail. “Amgen appears to be looking toward monthly injections versus others who are bi-weekly.”

The market for drugs targeting the liver cholesterol gene may be at least $10 billion, Adnan Butt, an analyst with RBC Capital Markets in San Francisco, said in an e-mail last week. In the U.S. alone, about 11 million patients aren’t keeping their cholesterol low enough with statins and another 1 million people are intolerant.

Blockbuster Potential

These patients represent “a multi-blockbuster potential opportunity with room for multiple players,” Butt wrote in a note to clients on Nov. 1. He said Sanofi and Regeneron are the furthest along in developing this class of therapy.

In a separate study released yesterday, Amgen reported AMG-145 reduced LDL by 51 percent in patients intolerant to statins, after 12 weeks, and 63 percent among those taking it in combination with Merck’s Zetia.

It also reduced LDL as much as 56 percent in patients with a genetic disorder called heterozygous familial hypercholesterolemia, some of whom were also taking statins and Zetia. HeFH, which affects at least 1 in 500 people worldwide, elevates LDL as well as total cholesterol and leads to early cardiovascular disease and death, the Thousand Oaks, California-based company said in a statement.

Further Testing

Amgen plans to begin testing the drug in a larger, Phase 3 trial early next year, said Sean Harper, the company’s executive vice president of research and development.

“This mechanism appears to be very effective, and safe,” Harper said in a phone interview. “Our enthusiasm level has only gone up.”

Three phases of testing usually are required for new drugs to gain U.S. regulatory approval.

Pfizer also released data on its PCSK9 inhibitor yesterday, RN 316, showing the drug at its highest dose lowered bad cholesterol in patients on statins by 80 percent after their first treatment. Cholesterol fell so low for some in the 135-person study, they weren’t eligible to get a second dose, said Barry Gumbiner, lead researcher on the medicine for New York-based Pfizer, the world’s largest drugmaker.

At the end of the 12-week study, those getting the highest dose had a decline in LDL of 56 percent. Pfizer didn’t see any unusual safety signals, Gumbiner said.

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