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."