Genzyme Corp. announced the launch of Cholestagel (colesevelam hydrochloride), Genzyme's first commercially available cardiovascular product, in Europe. Cholestagel is a new, non-absorbed, cholesterol-lowering agent aimed at treating patients with primary hypercholesterolemia who cannot meet their targeted cholesterol levels with standard therapies alone.
"Cholestagel offers patients at high risk of life-threatening cardiovascular disease a new way to manage their cholesterol. Most of these high-risk patients are seen at specialized treatment centres, and the launch of Cholestagel in Europe is consistent with our efforts to provide treatments for patients with serious unmet medical needs. We intend to do so with a small and highly-focused field organization that leverages Genzyme's existing country organizations," said James A. Geraghty, senior vice president, Genzyme, who oversees the company's cardiovascular activities.
Developed by Genzyme, Cholestagel is a polymer in tablet form that lowers LDL (or "bad") cholesterol. It can be taken in combination with other cholesterol-lowering medications, such as statins, or alone. When combined with various statins, fibrates or ezetimibe, current standard treatments for cholesterol control, Cholestagel was shown to have an additive LDL-cholesterol lowering effect in the range of 10 to 16 per cent. A post-approval study launched in August 2007 by Genzyme aims to specifically demonstrate the efficacy of Cholestagel as an add-on therapy in patients with familial hypercholesterolemia (FH) - an inherited disorder that causes exceptionally high levels of LDL-cholesterol - who cannot reach their target LDL-cholesterol levels with a maximum regimen of statins and ezetimibe alone.
This double-blind, randomized "Triple" study will involve 80 patients with FH enrolled in six European centres (including in the UK, Netherlands, Sweden and France) and preliminary results are expected in Q3 2008, the company said.
"Patients with genetic conditions like familial hypercholesterolemia are at particularly high risk of early coronary heart disease," said Dr. Anthony Wierzbicki, St. Thomas' Hospital, London and a board member and chairman of the Medical Scientific and Research Committee of FH patient association 'Heart UK'. "Patients have to take multiple cholesterol-lowering therapies and yet still often require further cholesterol reduction to reach target lipid levels recommended for patients at risk of cardiovascular events. New non-systemic agents are a welcome addition for these patients to help them achieve these targets."
Unlike most other cholesterol-lowering treatments, Cholestagel is non-systemic, and therefore is not absorbed into the bloodstream. Cholestagel binds bile acids in the intestine, impeding their reabsorption. This process - called bile acid sequestration -results in an increased clearance of LDL cholesterol from the blood. Cholestagel is also well tolerated, with minimal gastrointestinal side effects similar to those seen in placebo, and has limited drug-interaction.
Colesevelam has been approved for use in the United States since 2000, where it is marketed by Daiichi Sankyo Inc. under the trade name WelChol. Genzyme plans to launch Cholestagel in the United Kingdom, the Netherlands and the Scandinavian region this quarter, and in additional European countries next year. Genzyme also intends to pursue regulatory approvals for Cholestagel in Latin America, Canada, and the Asia Pacific region.
Genzyme has been conducting innovative research in the field of cardiovascular disease for several years. The company is currently running a phase II gene therapy trial with the intention of forming new blood vessels to improve the flow of oxygen in the legs of patients with peripheral arterial disease.
Primary hypercholesterolemia comprises a range of disorders in which LDL cholesterol blood levels are above normal (usually above 200mg/dl or 5mmol/l) due to a number of possible genetic mutations such as familial hypercholesterolemia, where patients inherit a gene that prevents them from metabolizing LDL cholesterol properly. These patients face a markedly increased risk of premature cardiovascular disease and CVD-related death.
One of the world's leading biotechnology companies, Genzyme is dedicated to making a major positive impact on the lives of people with serious diseases. Since 1981, the company has grown from a small start-up to a diversified enterprise with more than 9,500 employees in locations spanning the globe and 2006 revenues of $3.2 billion.