Amgen’s Drug Lowers Cholesterol Among Statin Intolerant

Amgen Inc., the world’s largest biotechnology company, said its experimental heart drug lowered cholesterol levels in patients unable to take standard medicines such as Pfizer Inc.’s Lipitor because of side effects.

The drug, AMG-145, which targets cholesterol-regulating gene PCSK9 in the liver, reduced LDL, or bad cholesterol, 51 percent in patients intolerant to medicines like Lipitor, called statins, after 12 weeks, and 63 percent among those taking it in combination with Merck & Co.’s cholesterol treatment Zetia, according to a study presented today at the American Heart Association meeting in Los Angeles.

Amgen is focusing on the drug’s potential to help offset declining sales of its anemia drugs Aranesp and Epogen, which together will generate $4 billion in estimated sales this year and face increased competition by 2015. The Thousand Oaks, California-based company is competing with some of the world’s biggest drugmakers, such as Pfizer, Roche Holding AG and Sanofi, to be first to market with the new cholesterol medicine.

“Close to a million people in the U.S. alone who are treated with statins cannot tolerate them or the doses needed for effective cholesterol control,” said Evan Stein, director of the Metabolic and Atherosclerosis Research Center in Cincinnati and one of the study’s researchers.

The market for these PCSK9 inhibitors 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. about 1 million can’t take statins because of side effects such as muscle soreness, he said.

Highest Dose

Pfizer today also released data on its PCSK9 inhibitor, 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.

In a separate clinical trial, Amgen said its drug 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 company said in a statement.

Amgen is scheduled tomorrow to release data at the heart meeting on how patients who are unable to reach appropriate levels of cholesterol on statins responded to AMG-145.

Under Skin

Shares of Amgen declined less than 1 percent to $86.35 at the close of trading in New York. The stock has increased 34 percent this year. Pfizer gained less than 1 percent to $24.58.

Pfizer has started another study involving 350 patients getting an injection under the skin rather than an infusion. The company expects results in June. Pfizer’s drug was developed by Scientists at Rinat Neuroscience, which Pfizer acquired in 2006.

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