Danish biotech company LifeCycle Pharma's novel fenofibrate formulation for the treatment of high cholesterol levels has been approved by the US Food and Drug Administration (FDA), making it the first Danish biotech product to get FDA approval. The product utilizes a technology developed by the company to provide enhanced absorption and greater bioavailability.
As recently reported on this website, LifeCycle Pharma has entered a licence agreement with USA's Sciele Pharma, which expects to launch the product on the US market by the end of this year. Sales of fenofibrate have increased significantly in the last few years, with the US market estimated by IMS to be worth USD 1.3 bn (2006 figure). According to the American Heart Association, over 140 million American adults have excessive total blood cholesterol values.
Under the terms of the deal with Sciele, LifeCycle Pharma has already received a USD 5 m up-front payment, and will now get a USD 4 m milestone payment following FDA approval. LifeCycle Pharma will also receive sales-related milestone payments of up to USD 8 m and tiered royalty payments on product sales. The news was reported by financial daily newspaper Børsen and on LifeCycle Pharma's website.
LifeCycle Pharma is based in Hørsholm north of Copenhagen and specialises in the areas of cholesterol management, hypertension, organ transplantation and autoimmune diseases. The company utilizes its proprietary Meltdose technology to improve the bioavailability of known and established compounds so that patients can absorb them more effectively. LifeCycle Pharma is listed on the OMX Nordic Exchange.
Atlanta-based Sciele Pharma, Inc. specialises in several areas including cardiovascular and diabetes, where it markets products to treat high cholesterol, hypertension, high triglycerides, unstable angina and Type 2 diabetes. The company was founded in 1992 and today employs more than 900 people.