Valeant Pharmaceuticals International, Inc. announced that its wholly owned subsidiary, Valeant International (Barbados) SRL, has received notice that the New Drug Submission for colesevelam hydrochloride (colesevelam), an oral bile acid sequestrant for hypercholesterolemia, has been approved by the Canadian regulatory authority Health Canada.

“Cardiovascular Disease is the cause of one in three deaths in Canada and managing Hypercholesterolemia, by lowering LDL-C (bad) cholesterol has been well-recognized as the primary goal of treatment, in managing the risk of cardiovascular disease,” said Dr Jean Davignon, director of the Hyperlipidemia and Atherosclerosis Research Group of the Institut de recherches cliniques de Montreal (IRCM). “The Canadian Cardiovascular Society has recently adopted more aggressive LDL-C targets; however, a substantial proportion of patients treated with a statin class of medications either do not attain their LDL-C targets or are unable to comply with their treatment due to adverse effects. The launch of new drugs, such as colesevelam, that can be added to statins will be an important component of the pharmacological armamentarium to get many of these more difficult to manage patients to their recommended, much more aggressive lower LDL-C targets.”

“Colesevelam is a strong addition to our Canadian franchise,” said J Michael Pearson, Valeant's chairman and chief executive officer. “Bile acid sequestration is a time-tested and well-established method that has been used literally for generations to lower both total and LDL-cholesterol. Clinical trials have shown reduced cardiovascular events with the use of bile acid sequestrants, either as monotherapy or in combination with other agents. Compared with conventional bile acid sequestrants, colesevelam has enhanced specificity, greater affinity, and higher capacity for binding bile acids, due to its polymer structure engineered for bile acid sequestration. This product will be promoted by our existing sales force in Canada and will be a complementary fit with our existing Tiazac XC promotions.”

Colesevelam is a specifically engineered, orally administered, bile-acid sequestrant with proven efficacy in reducing LDL-C lipoproteins and an enhanced drug-interaction and tolerability profile comparable to placebo. It is developed by Genzyme and marketed in the US by Daiichi Sankyo under the brand name WelChol and elsewhere by Genzyme under the tradename Cholestagel. Colesevelam is indicated as an adjunct to diet and exercise to reduce elevated low-density lipoprotein cholesterol (LDL-C) in patients with primary hyperlipidemia as monotherapy and combination therapy with a statin.

Unlike most other cholesterol-lowering agents, Colesevelam is non-systemic, and therefore is not absorbed into the bloodstream. Colesevelam binds bile acids in the intestine, impeding their reabsorption. This process - called bile acid sequestration - results in an increased clearance of LDL-C from the blood. Colesevelam is also well-tolerated, with minimal gastrointestinal side effects similar to those seen with placebo, and has limited drug interactions.

Valeant Pharmaceuticals International, Inc. is a multinational specialty pharmaceutical company that develops, manufactures and markets a broad range of pharmaceutical products primarily in the areas of neurology, dermatology and branded generics.