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Thursday, October 25, 2007
Genzyme ship out first batches of cholesterol drug
ONE of the world’s leading biotechnology companies, Genzyme, this week shipped the first batches of Cholestagel (colesevelam hydrochloride) from their state-of-the-art facility in Waterford where over 380 people are employed.
Genzyme’s first commercially- available cardiovascular product and launched in major European markets this week, Cholestagel is a new nonabsorbed 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 lifethreatening cardiovascular disease a new way to manage their cholesterol,” said Genzyme Senior Vice President, James A Geraghty, who oversees the company’s cardiovascular activities. “Most of these highrisk patients are seen at specialised treatment centres and the launch of Cholestagel in Europe is consistent with our efforts to provide treatments for patients with serious unmet medical needs.”
Developed by Genzyme, Cholestagel is a polymer in tablet form that lowers LDL (or “bad”) cholesterol. It can be taken in combination with other cholesterollowering 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 additional 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 LDLcholesterol levels with a maximum regimen of statins and ezetimibe alone.
This double-blind, randomised “TRIPLE” study involves 80 patients with FH enrolled in six European centres and preliminary results are expected in the third quarter of 2008.
“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 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 nonsystemic 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.
Since 2000, Colesevelam has been approved for use in the United States 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. It is currently running a Phase 2 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.
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