Cholesterol-lowering drug gains FDA approval under new name

The US Food and Drug Administration (FDA) has approved a drug formerly known as LCP-FenoChol for use in treating hyperlipidemia and hypertriglyceridemia.

The newly named Fenoglide drug, developed by Danish business LifeCycle Pharma, will contain the lowest dose of fenofibrate available for patients.

Fenoglide will be offered in 40mg and 120mg strength tablets and uses clinically validated reformulation technology - MeltDose -designed to enhance absorption and greater drug bioavailability.

"Fenoglide is our first marketed product and we are extremely pleased to launch it in the United States - and proud to be one of the very few Danish specialty pharmaceuticals companies to take a product to the US primary care market," said of LCP president and ceo Dr Flemming Ørnskov. "It is a significant step forward in our strategy of becoming a fully integrated specialty pharmaceuticals company. Sciele Pharma has a proven track record in the cardiovascular market and we are excited about our collaboration with them."

According to the American Heart Association (AHA), over 140 million American adults have excessive total blood cholesterol values. Sales of fenofibrate have increased significantly in the last few years, and in 2006, fenofibrate sales totalled $1.7bn worldwide, an increase of 16% over 2005. In the US alone, fenofibrate sales totalled $1.3bn in 2006. In 2007, the fibrate segment is estimated to increase around 14% over 2006 with estimated gross sales of $1.6bn.

The drug will be marketed across Sciele Pharma's diabetes and cardiovascular sales force teams.

"We are enthusiastic about introducing LCP's Fenoglide in 40mg and 120mg dosage strengths," said Sciele Pharma ceo Patrick Fourteau. "We expect the launch of Fenoglide, the lowest dose fenofibrate available to patients, will enable us to increase our share of the fenofibrate market, which is one of the fastest growing areas of the cardiovascular market."

LCP will receive tiered royalty payments on product sales and may also receive milestone payments of up to $8m when certain sales targets are met.

FenoGlide was developed from pre-clinical trials to FDA approval for sale in the US within five years as compared with a traditional drug development time of around eight to 11 years.