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Biotech / Medical : Regeneron Pharmaceuticals -- Ignore unavailable to you. Want to Upgrade?

To: Miljenko Zuanic who wrote (559)	8/16/2001 4:49:27 PM
From: Miljenko Zuanic	Read Replies (1) \| Respond to of 3557

So, why is IMNX in opposition (in EU) in regards REGN trap patents???? Thursday August 16, 4:33 pm Eastern Time US FDA panel backs Amgen arthritis drug Kineret (UPDATE: updates throughout with panel member, analyst comments, background, closing stock price) By Lisa Richwine GAITHERSBURG, Md., Aug. 16 (Reuters) - Biotechnology giant Amgen Inc. (NasdaqNM:AMGN - news) won an important endorsement on Thursday for its drug Kineret as a U.S. panel recommended the product's approval for easing symptoms of rheumatoid arthritis. -------------------------------------------------------------------------------- A panel that advises the Food and Drug Administration voted 6 to 2 with one abstention in favor of Kineret, the first in a new family of drugs to calm the chronic disease that afflicts about 2.1 million Americans. The FDA usually follows its panels' advice, and a final decision is expected in the coming months. The hallmark of rheumatoid arthritis is painful, swollen joints that can be disabling. Many panel members called Kineret's benefits ``modest'' but a majority decided it helped enough to outweigh risks of serious infections, a worry with the newest rheumatoid arthritis drugs. ``This is not a magic bullet. It is a very modest effect,'' panel member Leigh Callahan of the University of North Carolina said of Kineret. Dr. David Felson, who voted against Kineret, said the drug's safety risks were too high, particularly since it seemed less beneficial than two other drugs, Immunex Corp.'s (NasdaqNM:IMNX - news) Enbrel and Remicade, made by Johnson & Johnson's (NYSE:JNJ - news) Centocor unit. Kineret ``is not a very strong therapy. It's also a fairly dangerous therapy,'' said Felson, a panel member from Boston University. Enbrel and Remicade come with warnings that some patients treated with the drugs have died from serious infections. A U.S. advisory panel will hear details on the safety of those products on Friday. Experts believe the therapies can make patients vulnerable to infections because they inhibit parts of the immune system in order to quell inflammation. GENETICALLY ENGINEERED Kineret, known generically as anakinra, is a genetically engineered version of a natural protein that keeps a substance called interleukin-1 from attaching to cells and causing inflammation. It is given by self-injection under the skin. Studies by Amgen, the world's largest biotechnology company, showed daily Kineret injections did better than a placebo at producing 20 percent or greater improvements. In one study, 43 percent of Kineret patients hit the level, compared with 27 percent of placebo patients. Serious infections such as pneumonia occurred in 2.1 percent of patients undergoing Kineret therapy compared with 0.4 percent of placebo patients in one study. Most patients also experienced injection-site reactions. Physicians likely would turn to Kineret after trying other drugs such as Enbrel or Remicade, some panel members said. Industry analyst Fariba Ghodsian of Roth Capital Partners projected Kineret sales of about $100 million next year. She said Amgen is likely to benefit by the continued constraints on Immmunex's ability to manufacture enough Enbrel to meet demand. Immunex has cautioned that production will fall short of demand until mid-2002, when it expects to have a new facility running. ``It looks like Amgen will probably get FDA approval for Kineret by year-end. That gives them a six- to eight-month time period to get patients who can't get Enbrel,'' Ghodian said. Early studies showed higher rates of serious infections when Kineret was use with Enbrel, the FDA said. Panel members were split on whether to warn against combining the two. Amgen still is studying whether Kineret therapy slows joint damage from rheumatoid arthritis. Remicade is approved for preventing progression of joint damage. Competitor Enbrel is approved for delaying the progression of joint damage. Amgen shares closed 91 cents higher at $61. (with additional reporting by Deena Beasley in Los Angeles)