Genzyme, one of the world’s leading biotechnology companies, 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, which was launched in major European markets this week, 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,” said Genzyme Senior Vice President, James A Geraghty, who oversees the company’s cardiovascular activities. “Most of these high-risk 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 cholesterol-lowering medications, such as statins, or alone. When combined with various statins, fibrates or ezetimibe (current standard treatments for cholesterol control) Cholestagel has been 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 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.
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.