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Amgen Fights Rival for Different Uses of Drugs

Posted on: Friday, 20 May 2005, 00:00 CDT

May 20--Even as Amgen Inc. and Johnson & Johnson reported positive studies this week on their competing drugs to treat anemia, Johnson & Johnson revealed it has won approval to sell its anti-inflammatory drug Remicade to treat psoriatic arthritis.

The U.S. Food and Drug Administration's approval of Remicade to treat psoriatic arthritis pits the drug, also used to treat rheumatoid arthritis, against Amgen's drug Enbrel. Enbrel received FDA approval in 2004 to treat psoriatic arthritis.

Remicade is Johnson & Johnson's third-biggest drug, representing 10 percent of the company's drug sales last year, Merrill Lynch analyst Katherine Martinelli said in a report. The drug had worldwide sales of $2.1 billion last year. Martinelli said it might become Johnson & Johnson's second-biggest drug by 2008.

Amgen's Enbrel had $1.9 billion in sales in 2004.

The two companies are fierce competitors in the anemia and anti-inflammatory markets. Citing positive study results about their drugs is key as they vie for market share.

Company-sponsored studies presented at the annual meeting of the American Society of Clinical Oncology on Sunday in Orlando, Fla., supported their respective anemia-fighting drugs to boost red blood cell counts.

Thousand Oaks-based Amgen reported that a study found its drug Aranesp, given every two weeks, was as effective as Johnson & Johnson's Procrit given once a week to boost red blood cell counts in cancer patients undergoing chemotherapy. The company also released findings from an ongoing study that showed Aranesp was effective when given every three weeks.

Aranesp is a longer-lasting version of Amgen's first drug, Epogen. Through an agreement made with Johnson & Johnson in Amgen's early years, Amgen produces Epoetin alfa for both Epogen and Johnson & Johnson's drug, Procrit. Procrit is marketed by Ortho Biotech Products L.P., a Johnson & Johnson subsidiary.

Under that agreement, Amgen sells Epogen in the United States to treat anemia in patients undergoing dialysis, but not to treat anemia in patients undergoing chemotherapy. Procrit has that market in the U.S.

But Amgen can sell Aranesp in the U.S. for chemotherapy-induced anemia. Amgen officials said at a Robert W. Baird and Co. Inc. conference that Aranesp's market share in 2004 was 50 percent for treating U.S. cancer patients. In 2002, when Aranesp received FDA approval to treat chemotherapy patients, Procrit had 100 percent of that market.

The study shows that Aranesp is equally effective with comparable rates of transfusions, quality of life and number of patients with higher hemoglobin, or red blood cell, levels to patients on Procrit, while allowing patients to receive half the number of shots, said Kristen Davis, a spokeswoman for Amgen.

Johnson & Johnson pointed to a different study that found that 47 percent of patients treated with Procrit had the recommended increase in hemoglobin within the first four weeks of the study, compared to 33 percent of patients treated with Aranesp.

That study also found that patients treated with Procrit received fewer red blood cells through transfusions at an average of 2.5 units compared with an average of 3.9 units per patient on Aranesp.

Both studies found that the difference in the percentage of patients receiving transfusions on the two drugs were not statistically significant.

"We're pleased to be able to have additional data to inform clinical decision making," said Greg Panico, an Ortho Biotech spokesman. "That's why we do these studies, to give prescribers more information." Davis said the major difference between the studies was that the Amgen study had nearly four times as many patients than the study supported by Ortho Biotech. Panico responded that Ortho Biotech's study was designed as a direct head-to-head study of the two drugs.

Amgen had worried about how Aranesp would fare this year, because the Medicaid reimbursement for the drug was reduced. But officials have said the change has not hurt sales. That caused the company to increase its predictions for this year to revenue growth in the low double-digits to mid-teens.

Sales for Aranesp were $723 million for the first quarter of this year.

At a healthcare conference, Amgen officials said Aranesp has increased opportunities for market penetration through less frequent injections. Amgen has applied to the FDA for approval of administering Aranesp every three weeks to treat chemotherapy-induced anemia in certain cancer patients, a dosing regimen that would better parallel patients' chemotherapy treatments.

The Associated Press contributed to this report.

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AMGN, JNJ,

Source: Ventura County Star

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