To: Bradpalm1 who wrote (6386 ) 11/30/1998 8:01:00 PM From: BigKNY3 Read Replies (1) | Respond to of 9523
FDA Cmte To Review Monsanto's Celebrex On 12/1 11/30/98 Federal Filings Newswires WASHINGTON (FFBN) -- The U.S. Food and Drug Administration's Arthritis Advisory Committee will review on December 1 G.D. Searle & Co.'s Celebrex for the treatment of acute or chronic signs and symptoms of osteoarthritis and rheumatoid arthritis and the management of pain. G.D. Searle, a unit of Monsanto Co. (MTC), has joined forces with a pharmaceutical powerhouse, Pfizer Inc. (PFE), to promote the drug. Analysts estimate that Pfizer has already paid Searle $240 million for the right to market Celebrex, reported the Wall Street Journal. If ultimately approved by the FDA, market watchers anticipate sales estimates for Celebrex to be as much as $4 billion a year. Celebrex, generically known as celecoxib, belongs to a class of drugs known as COX-2 inhibitors. Celebrex is designed to block the COX- 2 enzyme activated in inflammation. Additionally, the drug does not affect the activity of the COX-1 enzyme, which protects the lining of the GI tract. Searle conducted Phase III studies to ascertain the safety and efficacy of Celebrex. Based on the results, the drug was not involved in causing gastrointestinal (GI) discomfort, specifically the formation of ulcers. This gives Celebrex an advantage over current prescription and over-the-counter nonsteroidal anti-inflammatory inhibitors (NSAIDs) that do have a high potential to cause GI discomfort. In clinical studies, Celebrex was compared to the NSAID Naproxen in patients affected by osteoarthritis and rheumatoid arthritis. The study showed that Celebrex was just as effective as Naproxen, but contained a "superior GI safety profile," according to the company. Rheumatoid arthritis is a chronic autoimmune disorder that affects approximately 2.1 million people in the U.S. This condition causes the body's immune system to identify non-foreign tissues as foreign and attempts to destroy them via white blood cells and antibodies. Approximately 21 million individuals in the U.S. suffer from osteoarthritis, mostly after age 45. Osteoarthritis is a joint disease aggravated by mechanical stress. It is characterized by degeneration of the cartilage that lines joints, leading to pain, stiffness and sometimes loss of function of the affected joint. Merck & Co. Inc. (MRK) will also be vying for a position in the arthritis market. The company is developing its own investigational new osteoarthritis drug, Vioxx (rofecoxib), and has submitted a new drug application (NDA) with the FDA for review. This puts Merck only three months behind Searle's application. Merck expects to file similar regulatory applications for Vioxx worldwide by the end of the year. As reported, Immunex Corp.'s (IMNX) Enbrel (etanercept) was granted marketing approval in early November for the treatment of moderate to severe rheumatoid arthritis. Recently, the company filed a supplemental biologics license application (SBLA) with the FDA to expand Enbrel's labeling to include the treatment of children and teenagers with moderate to severe active polyarticular course juvenile rheumatoid arthritis (JRA), a population consisting of approximately 50,000 in the U.S.