To print: Select File and then Print from your browser's menu --------------------------------------------------------------------------------------- Title: FDA Approves Welchol (Colesevelam) Lipid-Lowering Agent URL: http://www.pslgroup.com/dg/1D407A.htm Doctor's Guide May 31, 2000
WALTHAM, MA -- May 31, 2000 -- GelTex Pharmaceuticals, Inc. and Sankyo Parke Davis announced that the U.S. Food and Drug Administration (FDA) has granted marketing approval for Welchol™ (colesevelam hydrochloride), a novel, non-absorbed, lipid-lowering agent. The FDA approved Welchol, administered alone or in combination with an HMG-CoA reductase inhibitor ("statin"), as adjunctive therapy to diet and exercise for the reduction of elevated LDL cholesterol in patients with primary hypercholesterolemia. Welchol is a non-absorbed, lipid-lowering drug that has been specifically engineered to efficiently bind bile acids in the intestine, impeding their reabsorption. This initiates a cascade of events, the final result being increased clearance of LDL cholesterol from the blood, resulting in decreased serum LDL (or "bad") cholesterol levels. Clinical studies demonstrated that Welchol reduced total cholesterol, along with LDL cholesterol, and increased HDL (or "good") cholesterol. It is estimated that approximately 52 million people in the United States have at least mild hypercholesterolemia and would benefit from lipid-lowering therapy. Studies have shown that elevated levels of total and LDL cholesterol and decreased levels of HDL cholesterol are associated with development of atherosclerosis. The lipid-lowering market is one of the fastest growing in the nation, generating over $6 billion US (+24 percent) in sales and nearly 95 million prescriptions (+20 percent) during the last 12 months (IMS). Welchol is the second product in approximately 18 months to be approved by the FDA that is derived from GelTex's non-absorbed polymer technology. Renagel® (sevelamer hydrochloride) was approved in October 1998, and is being made available through a joint venture between GelTex and Genzyme Corporation. Welchol has been licensed to Sankyo Pharma Inc., and will be marketed by Sankyo Parke Davis in the United States. "Welchol therapy alone offers an important, non-absorbed alternative to systemic cholesterol-lowering drugs for patients with mild-to-moderate hypercholesterolemia," said Scott Grundy, M.D., Professor of Internal Medicine and Director, Center for Human Nutrition at the University of Texas Southwestern Medical Center. "In this significant part of the U.S. hypercholesterolemic population, a non-absorbed, cholesterol-lowering agent like Welchol would be useful therapy, therefore avoiding systemic side-effects that might accompany absorbed cholesterol-lowering agents." "Welchol also has the potential for significant use in combination therapy with statins," added Michael Davidson, M.D., Assistant Professor, Department of Medicine, Rush-Presbyterian-St. Luke's Medical Center, and President, Chicago Center for Clinical Research. "Despite increased awareness among the public and physicians, high blood-cholesterol levels still commonly go under-treated. Using Welchol in combination with statins will help physicians manage hypercholesterolemic patients, many of whom are at risk for or have been previously diagnosed with coronary heart disease, to their appropriate NCEP (National Cholesterol Education Program) cholesterol goals." The ability of Welchol to lower serum LDL cholesterol was demonstrated in eight clinical trials with approximately 1,400 patients and treatment durations of 4 to 50 weeks. Welchol was found to be effective as initial monotherapy for patients with mild-to-moderate hypercholesterolemia. Co-administration of Welchol and an HMG-CoA reductase inhibitor (atorvastatin (Lipitor®), lovastatin (Mevacor®), or simvastatin (Zocor®) demonstrated an additive reduction of LDL cholesterol in three clinical studies. In clinical trials, Welchol demonstrated a side-effect profile similar to placebo. The most common side-effects were flatulence (12 percent versus 14 percent for placebo) and constipation (11 percent versus 7 percent for placebo). Welchol is contraindicated in individuals with bowel obstruction and in those who have shown hypersensitivity to any of the components of Welchol. "All of us at GelTex are very excited with the approval of Welchol," stated Mark Skaletsky, President and CEO of GelTex Pharmaceuticals, Inc. "We join the few biotechnology companies that have taken two products from discovery through FDA approval. This is a wonderful statement about the quality and dedication of the people at GelTex." "The launch of Welchol is an important building block for Sankyo's commercial organization in the U.S.," said Joe Pieroni, President of Sankyo Parke Davis. "Sankyo has a long tradition of introducing unique compounds for the treatment of hypercholesterolemia, and we look forward to continuing that tradition with Welchol." GelTex develops and markets non-absorbed polymer drugs that bind and eliminate targeted substances within the gastrointestinal tract. In addition, GelTex is developing small-molecule pharmaceuticals consisting of novel polyamine analogues and metal chelators. Therapeutic areas of interest include hyperphosphatemia, hypercholesterolemia, cancer, iron overload, and infectious diseases. Sankyo is the second-largest pharmaceutical company in Japan, with worldwide sales in excess of $5 billion in 1999. A global innovator and a primary source of new, antihypertensive and cardiovascular agents, Sankyo is the originator of the statin lipid-lowering class of drugs. Pravastatin is licensed to companies throughout the world. Sankyo is also the originator of cefpodoxime proxetil, a cephalosporin antibiotic sold in 57 countries. Headquartered in Tokyo and established in 1899, Sankyo employs over 7,000 people worldwide. 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