Lipofen® is a novel, patented formulation of the active ingredient fenofibrate, which is used in the treatment of hyperlipidemia, a cholesterol disorder.
Hyperlipidemia is a condition characterized by high levels of low-density lipoprotein ("LDL") cholesterol and/or triglycerides (a type of fat found in the blood). Fenofibrate is known to lower LDL cholesterol and triglycerides and increase high-density lipoproteins ("HDL"), known as "good cholesterol". Fibrates have proven to be superior in lowering triglycerides and raising HDL levels.
Lipofen® received final approval from the U.S. FDA in the first quarter of 2006 and the product was launched in late 2007. The product is being marketed in the United States by our partner, Kowa Pharmaceuticals America. Kowa has a strong commitment to Lipofen®, with a sales force of more than 250 reps.
Lipofen® targets a large and growing market. According to IMS, the hyperlipidemia market in the U.S. alone exceeds US$11.7 billion and is made up of three primary groups of drugs: statins, fibrates and the prescription DHA/EPA (omega 3) market. The market for existing fenofibrate formulations in the U.S. exceeded US$1.6 billion during 2013, down from US$2.0 billion the previous year. The existing Lipofen patent is listed in the FDA's Approved Drug Products List (Orange Book) and the expiry date is January 2015.