Based on a year-long study with its rheumatoid arthritis drug Kineret - approved just a year ago - Amgen Inc. submitted a supplemental biologics license application to the FDA for use of the drug to inhibit progression of structural damage in adults with moderate to severe RA.
"It's definitely a positive," said Rebecca Hamm, spokeswoman for Thousand Oaks, Calif.-based Amgen. "We're sort of in a unique situation because we now have Enbrel, which is becoming the gold standard of treatment."
Enbrel (etanercept), an antitumor necrosis factor treatment for RA, was gained in the merger with Immunex Corp., of Seattle. Kineret (anakinra) was approved last November for RA and was launched immediately as Amgen's first drug in an indication other than oncology or anemia.
Compared to placebo, more of the 990 patients treated in the study with the interleukin-1 inhibitor (the only drug of its kind for RA) showed no progression in bone erosions or cartilage degradation, the company said. Results from the trial are expected to be presented this weekend at the meeting of the American College of Rheumatology in New Orleans.
Hamm acknowledged that analysts, who have noted efficacy levels with Kineret that are somewhat lower than the anti-TNF treatments, were viewing the Kineret filing as a mild positive, since the Kineret label still would not specify the drug for first-line use against RA or as a therapy in combination with the anti-TNF therapies.
"The way we're approaching this now is that Enbrel would be used before an anti-IL-1 such as Kineret," she said, noting the possibility of benefit from using the two together. "We're going to have some results coming out of the ACR meeting this weekend because it's been of scientific interest," she said.
Experiments were done to learn more about apparent "synergistic activity" between the two types of drug, and "we wanted to see if that actually panned out in the clinical setting," Hamm told BioWorld Today, declining to comment on whether Kineret will be pursued as a first-line treatment.
Kineret often is prescribed for patients who have failed treatment with Enbrel or with Malvern, Pa.-based Centocor Inc.'s Remicade (infliximab, another anti-TNF drug).
At the ACR meeting, Hamm said, data from trials with Enbrel in psoriatic arthritis will be offered. "Also, in the RA arena, we now have five-year data [with Enbrel]," she said.
Amgen's stock (NASDAQ:AMGN) gained 20 cents Wednesday to close at $50.
Separately, after the market closed, Amgen released its third-quarter financial report, showing earnings per share of 34 cents vs. 30 cents for the third quarter of 2001, an increase of 13 percent. Adjusted net income was $437 million compared to $330 million in last year's third quarter, a 32 percent increase.
Overall revenue increased 49 percent, to $1.5 billion. The earnings report excluded expenses related to the acquisition of Immunex in the third quarter, during which Amgen reported a loss of $2.6 billion, or $2.10 per share, mainly due to the one-time write-off of in-process research and development of $3 billion related to the merger.