To: keokalani'nui who wrote (339 ) 3/21/2003 11:04:31 AM From: keokalani'nui Read Replies (1) | Respond to of 625 At the SGC conf, ABT said it's estimate of $1b peak Humira sales is for RA only.Amgen's Enbrel Shown to Improve Psoriasis Friday March 21, 8:13 am ET By Deena Beasley SAN FRANCISCO (Reuters) - Amgen Inc. (NasdaqNM:AMGN - News) on Friday said pivotal-stage trial results show that its arthritis therapy Enbrel is effective against moderate-to-severe psoriasis, a market that would greatly expand the drug's sales potential. ADVERTISEMENT The study, presented at a meeting here of the American Academy of Dermatology, found that three months of high-dose Enbrel injections improved psoriasis symptoms by at least 75 percent in 49 percent of patients, while a lower dose of the drug had the same effect in 34 percent of patients. The response rates rose to nearly 60 percent and 44 percent, respectively, after six months of treatment. Until recently, the only systemic treatments for the skin disorder were immunosuppressant drugs like methotrexate, but they can eventually damage organs like the heart or liver. In January, the U.S. Food and Drug Administration (News - Websites) approved Biogen Inc.'s (NasdaqNM:BGEN - News) Amevive as the first biologic drug for treatment of psoriasis after it was shown to reduce symptoms by at least 75 percent in 21 percent of patients after three months. Amevive is designed to work by suppressing an immunity-boosting cell that plays a central role in psoriasis, while Enbrel works by blocking a protein that causes inflammation. Amgen, the world's largest biotechnology company, had unveiled preliminary results of the Enbrel study in January. At that time, analysts said it was unlikely that the higher dose, 50 milligrams of Enbrel twice weekly, would be commercialized due to toxicity and cost concerns. Enbrel is approved for rheumatoid arthritis at the lower dose used in the psoriasis trial -- 25 mg twice a week. Amgen said Enbrel was generally well tolerated in the psoriasis studies, citing injection site reactions as the most frequent adverse side effect. Psoriasis is a disorder characterized by red, scaly patches on the skin that affects more than 4.5 million Americans, including some 1.5 million with moderate-to-severe forms of the disease. By some estimates, the market for an effective psoriasis drug could reach $5 billion. A third potential competitor in the lucrative market is Genentech Inc. (NYSE:DNA - News) and Xoma Ltd.'s (NasdaqNM:XOMA - News) experimental drug Raptiva, which was submitted to the FDA in December. In previously-released Phase III trial results, Raptiva was shown to reduce psoriasis symptoms by at least 75 percent in 29 percent of patients after three months of treatment. Raptiva is an antibody engineered to inhibit the binding of immune system cells to other cells. Genentech said it will present results from another privotal-stage trial of Raptiva at the dermatology conference later on Friday. Dr. Alice Gottlieb, professor of medicine at the Robert Wood Johnson Medical School in New Brunswick, New Jersey and author of the Enbrel study noted that the drug has a proven safety record in the treatment of more than 150,000 patients with joint disorders rheumatoid arthritis and psoriatic arthritis. "The study demonstrated that patients treated with Enbrel experienced rapid, significant, and sustained improvement in their symptoms," she said.