AMGEN FINISHES TRIALS FOR ARTHRITIS TREATMENT.

Byline: Jason Z. Cohen Staff Writer

Amgen researchers have completed their final round of clinical trials of a new drug they say relieves much of the pain and swelling that afflicts millions of Americans with rheumatoid arthritis.

Scientists with the Thousand Oaks-based company today will present the results of phase 3 clinical trials of the drug, called Kineret, at the annual conference of the American College of Rheumatology in Boston.

Their research shows Kineret relieved rheumatoid arthritis conditions in 42 percent of those who used it. Before it can be sold, however, the drug must be approved by the federal Food and Drug Administration. The company said it hopes to be able to market Kineret by the second quarter of 2001.

The drug is seen by the financial and medical communities as an important development in the treatment of rheumatoid arthritis, although far short of a cure for the disease - and short of a financial breakthrough as well.

Dr. Ernest Brahn, professor of medicine in the division of rheumatology at the UCLA School of Medicine, said Kineret is an important new medicine, giving Amgen a foothold in a course of treatment that other drug makers are pursuing.

``This is one more tool for us to use in the battle against rheumatoid arthritis,'' Brahn said. ``It's one of the newer biologics that's being worked on and shows promise as an effective treatment for rheumatoid arthritis.''

Added Dennis Harp, biotechnology analyst for Deutsche Banc Alex. Brown: ``This could be an important addition to new classes of drug for the treatment of rheumatoid arthritis.''

Harp speculated that Kineret could generate $300 million annually by its third year on the market. By contrast, a similar product by Immunex recently approved for rheumatoid arthritis will exceed $350 million in its first year, Harp said.

``It will be an important contributor to the bottom line, but not nearly as important as NESP,'' Harp said, referring to Amgen's longer-dose follow-up to its current flagship drug, the anemia treatment Epogen.

Amgen spokesman David Kaye said Kineret targets one of two proteins that cause the symptoms of rheumatoid arthritis - a substance known as interleukin-1, which causes joint swelling and breakdown.

All of the other drugs on the market or nearing approval target the other cause of inflammation, tumor necrosis factor, or TNF, Kaye said. Other pharmaceutical and biotechnology firms are working on drugs similar to Kineret, he added, but Kineret is further along in the approval process.

Both proteins cause the destruction of bone and cartilage, and it is believed that effective treatment can stop that damage and the pain associated with the deterioration, Kaye said.

``To do a good job slowing the disease, treating the disease, one needs to block both of those harmful substances,'' Kaye said.

Amgen also is working on a product to block TNF, and the company's goal is eventually to combine the two into one therapy. Currently, there are 2.1 million Americans with rheumatoid arthritis, a common form of arthritis which causes inflammation in the lining of the joints and ligaments.

Harp said early studies into the effectiveness of combination therapy are promising.

Brahn will chair a panel discussion at the conference on a study that demonstrated a combination therapy using drugs similar to Amgen's Kineret and Immunex's Enbril together that produced effects better than both drugs separately.

But Brahn said the preclinical study was conducted on animals and is not ready for human trials yet.

``The question of combining the two remains to be studied in (human) patients, but the animal models are very encouraging,'' Harp said.

Amgen acquired the drug in mid-development in 1994 when it purchased Synergen, a Boulder, Colo.-based drug maker. Amgen is the world's largest biotech company, with revenues last year of more than $2 billion.

Curtis Hogue, biotech analyst for Volpe Brown Whelan & Co., said the announcement of the study results is unlikely to generate much movement in Amgen's stock.

``The product may be effective,'' Hogue said. ``The problem is that it's a daily dosing regimen'' that must be injected.

Other drugs, such as Immunex's Enbril, require once-a-week dosing instead, he said. Amgen is ``going to have a hard time competing as a single agent against Enbril.''

The success of the drug will boil down to whether physicians and their patients view the drug's effectiveness as more important than the discomfort of its method of administration, Hogue said.