Silicon Investor (SI) -- The First Internet Community

STOCKTALK

We've detected that you're using an ad content blocking browser plug-in or feature. Ads provide a critical source of revenue to the continued operation of Silicon Investor. We ask that you disable ad blocking while on Silicon Investor in the best interests of our community. If you are not using an ad blocker but are still receiving this message, make sure your browser's tracking protection is set to the 'standard' level.

Biotech / Medical : Pharma News Only (pfe,mrk,wla, sgp, ahp, bmy, lly) -- Ignore unavailable to you. Want to Upgrade?

To: Anthony Wong who wrote (1000)	11/9/1998 12:14:00 PM
From: Anthony Wong	Read Replies (1) \| Respond to of 1722

Centocor's Remicade Seen Effective in Rheumatoid Arthritis Bloomberg News November 9, 1998, 11:29 a.m. ET Centocor's Remicade Seen Effective in Rheumatoid Arthritis San Diego, Nov. 9 (Bloomberg) -- Centocor Inc.'s Remicade can reduce swelling and tenderness in the joints of people with rheumatoid arthritis when combined with one of the leading approved medicines for the disease, new research shows. In a study of 428 patients, 52 percent of those given Remicade and methotrexate, a generic drug long used in hard-to- treat cases of rheumatoid arthritis, had significant reduction in their symptoms. Only 20 percent of patients given methotrexate and a placebo had the same results, Centocor said. Centocor is looking for clearance to market Remicade, approved in August as a treatment for the severe bowel disorder Crohn's disease, for expanded use as a treatments for rheumatoid arthritis. Competing drugs from Hoechst AG and Immunex Corp. won U.S. approval in the last three months, becoming the first new treatments approved for the disease in more than a decade. ''It appears as though Remicade will be a safe, effective and convenient therapy for rheumatoid arthritis patients'' with symptoms that aren't being adequately treated by current therapies, said Peter Lipsky, one of the principal investigators in the trial. Lipsky, who is director of the Harold C. Simmons Arthritis Research Center at the University of Texas Southwestern Medical Center at Dallas, discussed the study with journalists covering the American College of Rheumatology meeting in San Diego, the largest annual U.S. gathering of arthritis specialists. He will make a detailed presentation to physicians on Thursday. Centocor intends to file with the U.S. Food and Drug Administration for approval of this additional use of Remicade by early January. The results of the study presented today, known as the ATTRACT trial, were anticipated. Centocor Shares Up Centocor shares rose as much as 8 percent in early trading, boosted by separate research that shows its ReoPro heart drug can reduce the risk of death in patients who have the artery-opening procedure known as angioplasty. Centocor shares rose 3 1/8 in late morning trading to 50 3/8, after earlier trading as high as 51 1/4. There was no increase in side effects observed among those treated with Remicade and methotrexate compared to the placebo group, Lipsky said. The side effects observed in both groups included upper respiratory tract infections, headache, nausea, sinusitis, rash and cough. In previous studies of Remicade for Crohn's and rheumatoid arthritis patients, there were several cases of malignancies, including lymphomas, among patients in the Remicade groups. Lipsky said the data released today showed no sign of increased incidence of tumors or lymphomas in patients receiving Remicade, which neutralizes a factor that plays a role in the immune system. ''I don't think at this stage there is anything more to be worried about with this drug than any other drug,'' Lipsky said in an interview. ''For any new drug there are lingering concerns (about safety) until it gets into a very large patient population.'' Reduction in Symptoms The study met its main goal of showing that patients saw a signification reduction in signs and symptoms of the disease as measured by a standard known as ACR20. To meet that standard, patients had to satisfy several criteria, including a 20 percent reduction in the number of tender and swollen joints. The study also found that 28 percent of patients reported a 50 percent reduction in tender and swollen joints at the end of 30 weeks, compared to 5 percent on placebo. And 12 percent of patients achieved a 70 percent reduction, compared to none in the placebo group. In addition to reviewing trials of Remicade, specialists attending the arthritis meeting will hear data on trials of Enbrel and Arava. Remicade and Enbrel are part of a new class of drugs that neutralizes a naturally occurring compound called tumor necrosis factor, which can trigger a cascade of destructive activity in the body. Malvern, Pennsylvania-based Centocor is one of the few profitable U.S. biotechnology companies. Its leading product is the heart drug ReoPro. ReoPro and Remicade are new kinds of drugs, so-called monoclonal antibodies, that mimic in some degree the body's own defenses. --Jim Finkle in San Diego and Kerry Dooley in Washington through