HORSHOLM, Denmark and ATLANTA, Aug. 13 -- LifeCycle Pharma A/SÂ and Sciele Pharma, Inc. today 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 $5 million, and will receive a further $4 million milestone payment now that this fenofibrate product has received FDA approval. LifeCycle Pharma will also receive milestone payments of up to $8 million when certain sales targets are met, and tiered royalty payments on product sales. The receipt of $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 $1.7 billion worldwide, an increase of 16% over 2005. In the US alone, fenofibrate sales totaled $1.3 billion in 2006 (source: IMS).
For further information please contact: LifeCycle Pharma A/S Flemming Ornskov President and CEO DK Tel. +45 24 20 03 68 US Tel. +1 917 288 6446 Michael Wolff Jensen Executive Vice President and CFO Tel. +45 40 74 62 44
About LifeCycle Pharma A/S:
LifeCycle Pharma, headquartered in Horsholm, Denmark, is an emerging pharmaceutical company with a broad and late stage product pipeline in therapeutic areas of cholesterol management, hypertension, organ transplant and autoimmune diseases. LifeCycle Pharma's proprietary technology platform, MeltDose(R) technology, offers lower dosing, reduced side effects and improved safety and patient compliance, as well as reduced product development time and development costs. LifeCycle Pharma is listed on the OMX Nordic Exchange under the trading symbol (LCP). Please visit www.lcpharma.com for further information about LifeCycle Pharma A/S.
About Sciele Pharma, Inc.:
Sciele Pharma, Inc., headquartered in Atlanta Georgia is a pharmaceutical company specializing in sales, marketing and development of branded prescription products focused on Cardiovascular/Diabetes, Women's Health and Pediatrics. The Company's Cardiovascular/Diabetes products treat patients with high cholesterol, hypertension, high triglycerides, unstable angina and Type 2 diabetes; its Women's Health products are designed to improve the health and well-being of women and mothers and their babies; and its Pediatrics products treat allergies, asthma, coughs and colds, and Attention Deficit/Hyperactivity Disorder (ADHD). Founded in 1992 and headquartered in Atlanta, Georgia, Sciele Pharma employs more than 900 people. The Company's success is based on placing the needs of patients first, improving health and quality of life, and implementing its business platform - an Entrepreneurial Spirit, Innovation, Speed of Execution, Simplicity, and Teamwork. For more information, visit: www.sciele.com.