LifeCycle Pharma and Sciele Pharma announce FDA approval of new formulation of Fenofibrate

Aug 13 2007

LifeCycle Pharma A/S and Sciele Pharma, Inc. have announced that LifeCycle Pharma has received U.S. Food and Drug Administration (FDA) approval for LifeCycle Pharma's novel formulation of fenofibrate in 120-milligram and 40-milligram dosage strengths for the treatment of hyperlipidemia and hypertriglyceridemia.

This fenofibrate utilizes LifeCycle Pharma's Meltdose(R) technology which is designed to provide enhanced absorption and greater bioavailability.

Under the terms of the agreement with Sciele, LifeCycle Pharma has already received an up-front payment of US$5 million, and will receive a further US$4 million milestone payment now that this fenofibrate product has received FDA approval. LifeCycle Pharma will also receive milestone payments of up to US$8 million when certain sales targets are met, and tiered royalty payments on product sales. The receipt of US$4 million in approval milestone does not change LifeCycle's financial expectations for 2007.

This fenofibrate product will have the lowest dosage strengths of fenofibrate available for patients and will be marketed in the United States by Sciele Pharma's Primary Care sales force by the end of 2007. Sciele Pharma currently has approximately 450 Primary Care sales representatives.

"We are pleased to receive FDA approval for our first product in the United States," said Dr. Flemming Ornskov, Chief Executive Officer of LifeCycle Pharma. "The near-term launch of this product marks a significant step forward for our business model. Sciele has a proven track record in the cardiovascular market with its Primary Care sales force, and we are excited about our collaboration with them."

Patrick Fourteau, Chief Executive Officer of Sciele, said, "We are enthusiastic about introducing LifeCycle Pharma's fenofibrate in 120-milligram and 40-milligram dosage strengths. This fenofibrate, along with our current Triglide product line, will enable us to increase our share of the fenofibrate market by broadening our offerings in this fast-growing area of the cardiovascular market."

According to the American Heart Association (AHA), over 140 million American adults have excessive total blood cholesterol values. Fenofibrate has proven to be very effective at lowering triglyceride concentrations and increasing High Density Lipoprotein HDL (good cholesterol). In addition, it has a superior side effect profile compared with alternative drugs. Sales of fenofibrate have increased significantly in the last few years, and in 2006, fenofibrate sales totaled US$1.7 billion worldwide, an increase of 16% over 2005. In the US alone, fenofibrate sales totaled US$1.3 billion in 2006 (source: IMS).