Unusual Public Spat Between Amgen, J&J;
The long-simmering feud between Amgen Inc. and Johnson & Johnson over the world’s bestselling biotechnology drug spilled into an annual meeting of kidney specialists here over the weekend.
Amgen, based in Thousand Oaks, said the American Society of Nephrologists allowed J&J; to stack a scientific panel discussion on a mysterious illness linked to Eprex, the anti-anemia drug taken by dialysis patients that J&J; sells in Europe under a license from Amgen. Amgen complained that the panel gave J&J; a platform to spread doubt about anemia treatments Amgen sells.
It was the first session for kidney specialists on pure red cell aplasia since May, when the Food and Drug Administration tied 78 cases of the serious immune disorder to Eprex. The number of cases has risen to 160 through July.
The unusual public spat over the panel highlights the role of medical meetings in marketing drugs. Amgen and Johnson & Johnson have long bickered over the $7-billion annual anti-anemia business they share under a 17-year-old contract. The drug brings in billions of dollars in sales for each company.
Amgen has been a ubiquitous presence at the yearly meeting of kidney specialists, and company logos adorned the weekend’s meeting programs, hotel shuttle buses and room key cards at two dozen hotels near the Philadelphia Convention Center.
But Amgen did not get a seat on the Saturday panel. Three of the five panelists were J&J; specialists. Amgen was given two minutes to make a statement at the end of the 90-minute discussion, which was attended by a standing-room-only crowd of 1,500 kidney specialists.
J&J; proposed and sponsored the session, which shed little new light on a vexing health problem that is threatening Eprex. The pace of Eprex sales slipped in the third quarter, as European physicians switched dialysis patients to alternative treatments.
Robert Narins of the American Society of Nephrology said he accepted J&J;’s offer to underwrite the panel because pure red cell aplasia was a “hot topic that had slipped through the cracks” in meeting planning.
J&J; scientists sat on the panel out “of necessity,” he said, because the company had patient data. Rounding out the panel were two European experts invited by the nephrologists.
Narins said he did not allow Amgen to sit on the panel because he did not want the session to become a commercial for any product. Amgen sells a second-generation anemia treatment not covered by the 1985 licensing pact with J&J.; Narins said Roche Group of Switzerland makes a competing anti-anemia drug and was not permitted to sit on the panel either.
“We put this on because it is a medical issue,” Narins said. “But we are not so naive to not understand that there is a cat fight going on.”
The two companies’ tussle for dominance in the anti-anemia marketplace has taken legal turns as well. Two weeks ago, a federal arbitrator ordered J&J; to pay $150 million for poaching in Amgen’s market but refused to dissolve the agreement, as Amgen requested.
Eprex is J&J;’s brand of EPO, a genetically engineered copy of the protein that spurs red blood cell production.
Amgen, the inventor of EPO, sells the drug in the United States to kidney dialysis patients. J&J; sells EPO in other U.S. markets and in Europe under a license from Amgen. Amgen developed its second-generation product, Aranesp, to reclaim sales from J&J.;
The economic stakes are huge. Together, Amgen and J&J; will take in nearly $7 billion this year from EPO sales. But Amgen estimates that business will grow to $10 billion by 2005 as more kidney disease and cancer patients take the medications.
Before the panel discussion got underway Saturday, moderator Eberhard Ritz, an academic from Germany, said he would not permit an “ugly Salem witch trial atmosphere.” His warning didn’t prevent participants from landing a few punches during the discussion.
In a pointed exchange that drew a loud murmur from the audience, a kidney specialist asked J&J; drug safety director John Knight which drug he personally would use of the three main anti-anemia drugs. Knight hedged, saying he would find a good physician and leave the decision to him.
Pure red cell aplasia is a potentially life-threatening disorder in which patients develop antibodies that attack a protein needed for red blood cell production. Severe anemia results.
The disorder began surfacing in Eprex patients in 1998, around the time J&J; changed the formulation of the drug. J&J; substituted a chemical stabilizer for albumin, a serum derived from human blood. European authorities told J&J; to replace the albumin to remove any risk of the human form of “mad-cow” disease.
EPO sold in the United States is manufactured by Amgen and contains albumin.
J&J;’s Knight told kidney specialists Saturday that a change in how patients use the drug may also have played a role in the spate of illnesses. Beginning in 1997, he said, patients increasingly began self-injecting Eprex. Before that, more patients received the drug intravenously from a doctor.
Patients might not have been refrigerating the drug, as directed, said J&J; Vice President Basant Sharma. The drug degrades at room temperature, he said. European authorities now recommend intravenous use of Eprex, he added.
J&J;’s scientists said a series of product tests and an investigation of its Eprex factory in Puerto Rico uncovered no product defects.
J&J; did not focus entirely on Eprex. During her presentation, J&J; scientist Linda Joliffe took a shot at Amgen with data showing that mice developed antibodies when given an Aranesp-like drug. No cases of pure red cell aplasia have been linked to Amgen’s second-generation medicine.
After the session, Tony Gringeri, Amgen product development vice president, called the experiment “bad science” and questioned why J&J; didn’t test Aranesp, which is readily available from drug wholesalers.
“I am going to call that what it probably was -- a commercial,” Gringeri said.
Panelist Huub Schellekens, an immunologist from the Netherlands, said in an interview that the mouse experiment left him unconvinced.
“It makes no sense,” he said.
Retired UCLA medical professor Richard Glassock said there was no reason to believe other products had the problems of Eprex. Glassock served as moderator with Ritz.
Though frozen out of Saturday’s symposium, Amgen has played a crucial behind-the-scenes role in bringing pure red cell aplasia cases to light. When French scientist Nicole Casadevall reported three cases of the illness in 1999, Amgen contacted her to learn more. The firm provided her with grant money for a lab technician and developed three tests to detect the illness in Casadevall’s patients.
Gringeri said Amgen shared results of Casadevall’s work with the FDA and J&J.; Her study appeared in the Feb. 14 issue of the New England Journal of Medicine and cast a harsh light on Eprex. The FDA released its tally of cases in response to her report.
Gringeri said that Amgen’s efforts were not directed at J&J.; Amgen offered at least twice to collaborate with its estranged business partner, to no avail, he said. Scientists from the companies met in Thousand Oaks last year but could not agree on how to share the data.
J&J; insisted on complete control and Amgen refused, said Amgen spokesman Jeff Richardson.
Discussions “got bogged down with the lawyers a little bit,” said J&J; spokesman Doug Abersfeld.
On Saturday, Harlan Weisman, president of research and development for J&J;, called on his competitors to collaborate. He wants the companies to develop worldwide registries for pure red cell aplasia and establish a standard test for the condition, among other things.
“We’re not comfortable enough is being done by us or any of the manufacturers,” he said.
