Epogen Drug

Amgen Inc., the world's largest biotechnology company, said Friday that it received a second subpoena from the U.S. attorney's office in Washington state in connection with the company's anemia drugs. Amgen received the "supplemental" subpoena July 18 for documents regarding "the sales and marketing of our products, and our collection and dissemination of information" on the drugs' efficacy and safety, the Thousand Oaks company said in a filing with the Securities and Exchange Commission.

DaVita Inc., a provider of dialysis services, said U.S. investigators had asked for records of drug claims made to Medicare, the government health program for the elderly and disabled. The request, from the inspector general of the Health and Human Services Department, concerns claims related to the drug Epogen, the El Segundo-based company said. The medicine is made by Amgen Inc. and given to treat anemia in dialysis patients whose kidneys have failed.

Lawmakers have asked Amgen Inc. and Johnson & Johnson to suspend all consumer advertising of their anemia medications until after U.S. regulators complete their safety review. In letters sent Tuesday to the chief executives of both companies, Rep. John D. Dingell (D-Mich.), chairman of the House Energy and Commerce Committee, also asked Amgen and Johnson & Johnson to cease financial incentives to doctors related to the anemia drugs and turn over documents related to promotion efforts.

For-profit dialysis chains treating the bulk of kidney disease patients in the U.S. are more aggressive in using lucrative anemia drugs compared with their nonprofit peers, a study released Tuesday said. The Journal of the American Medical Assn. study compared prescribing patterns at nonprofits versus big corporate chains and found that doctors at chains gave patients bigger increases and total doses of epoetin.

An updated analysis of data from studies of anemia drugs used with cancer treatments showed that they increased risk of death and blood clots, an industry newsletter reported Friday. The findings showed that use of the drugs, which include Amgen Inc.'s Aranesp and Epogen as well as Johnson & Johnson's Procrit, increased risk of death 11% and risk of blood clot 59% when compared with oncology patients who did not use the drugs, according to the Cancer Letter.

Medicare needs to change the way it pays for anemia drugs to discourage excessive use in kidney dialysis patients, a key lawmaker said Tuesday. The federal health insurance program for the elderly and disabled spends about $2 billion annually on Amgen Inc.'s Epogen, part of a class of anti-anemia drugs called erythropoiesis-stimulating agents (ESAs). Critics say current payment methods have promoted aggressive treatment.

Amgen Inc. and Johnson & Johnson may have to limit doses of anemia drugs to lower risks for patients, U.S. regulators said Friday. The change would reduce revenue from the top-selling medicines. The anemia drugs, marketed as Aranesp and Epogen by Amgen and Procrit by J&J, raised the danger of heart attacks, strokes and death at high doses, staff of the Food and Drug Administration said in an analysis posted on the agency's website.

It's been a brutal summer for Amgen Inc. -- and the heat goes on. After a series of regulatory setbacks, layoffs and financial jolts, the company faces additional hurdles over the next few weeks surrounding its top-selling anemia drugs, Epogen and Aranesp, which together accounted for nearly 50% of Amgen's sales last year. Depending on how the next month plays out, Amgen's recent blues could begin to lift.

Amgen Inc., the world's largest biotechnology company, said Wednesday that it had sued Roche Holding Ltd., accusing the drug maker of infringing six patents covering its Epogen anemia treatment. Thousand Oaks-based Amgen said the suit, filed in U.S. District Court in Boston, sought an injunction to prevent Roche from making or selling recombinant human erythropoietin, including "pegylated" versions that last longer in the body.

By any measure, Epogen is a true wonder drug. Since it went on sale 15 years ago, it has improved the lives of thousands of kidney dialysis patients and made its inventor, Amgen Inc., a biotech behemoth. The medicine has racked up more than $17 billion in sales since 1989 and reduced the need for blood transfusions in patients with anemia, a consequence of kidney failure. Now the agency that administers the federal Medicare program is asking whether Epogen's success has come at too high a price.