Abbott Laboratories is looking to strengthen its position in the cholesterol medicine market and has filed its new combination drug Simcor with US regulators.
The firm has submitted a New Drug Application to the US Food and Drug Administration for Simcor, a fixed-dose combination of the firm’s Niaspan (extended-release niacin) and simvastatin, the active ingredient in Merck & Co’s Zocor which came off-patent last year. Abbott said that the product “seeks to target multiple lipid parameters in a single pill,” noting that Niaspan is used to raise high-density lipoprotein or ‘good’ cholesterol levels, while simvastatin is effective in reducing low-density lipoprotein ‘bad’ cholesterol.
The combination is being submitted for FDA approval to address LDL, HDL and triglycerides, “which may lead to improved patient convenience and outcomes,” said the company, and the Simcor application includes data from two large clinical studies, composed of more than 1,150 randomised patients, which evaluated safety and efficacy of the combination of Niaspan and simvastatin in patients with mixed dyslipidemia.
Eugene Sun, vice president of global clinical development at Abbott, said Simcor is “a promising next step in our efforts to develop therapies that support more comprehensive cholesterol management with one pill,” adding that “combination lipid therapies are an increasing trend to help physicians reach their patients’ treatment goals.” According to the American Heart Association, more than 38 million Americans have complex lipid disease and combination therapy makes up around 15% of the more-than-$17 billion US cholesterol management market and represents the fastest-growing segment.
Simvastatin, in combination with Zetia (ezetimibe), is already sold by Merck and partner Schering-Plough as the blockbuster Vytorin, though the former firm announced at the end of 2006 that it was delaying the forecast filing date for MK-524B, which combines simvastatin with MK-524A, a novel compound that is currently in Phase III testing. This delay can only help the prospects of Simcor, which was developed by Kos Pharmaceuticals, the firm Abbott recently acquired for $3.7 billion, and Niaspan contributed $142 million to first-quarter sales.
