ProEthic Pharmaceuticals, Inc. today announced that Lipofen™ (fenofibrate capsules), a new prescription treatment for cholesterol disorders, is now available in U.S. pharmacies. Lipofen is indicated as adjunctive therapy to diet to reduce elevated LDL-C, total-C, triglycerides (TG), and Apo B, and to increase HDL-C in adult patients with primary hypercholesterolemia or mixed dyslipidemia (Fredrickson Types IIa and IIb). Lipofen is also indicated as adjunctive therapy to diet for treatment of adult patients with hypertriglyceridemia (Fredrickson Types IV and V hyperlipidemia).
Lipofen is a new formulation containing the active ingredient fenofibrate, which utilizes patented Lidose® Technology to enhance the absorption of fenofibrate. Lipofen can help patients manage elevated triglycerides and their entire cholesterol profile when diet alone is not sufficient. Lipofen is available in 150 mg and 50 mg capsules.
Carl Whatley, Chairman and CEO of ProEthic Pharmaceuticals, stated, “We are pleased to offer a new and efficacious treatment option to patients seeking to reach their lipid goals. Lipofen has been clinically proven to provide significant triglyceride reductions and may also reduce “bad” cholesterol by up to 31% while increasing “good” cholesterol by up to 15%.”
Mr. Whatley continued, “The use of fenofibrates has escalated rapidly in recent years, with increased patient demand expected to continue. Lipofen will provide ProEthic with an important commercial opportunity in this market, while at the same time, strengthening our presence in the primary care space as we continue to advance our valuable clinical treatment programs in migraine and acute pain. We believe that the establishment of Lipofen as the lead product in our company’s portfolio will enable us to continue our strong record of growth as well as help to build significant shareholder value.”
In July 2007, ProEthic announced that it had acquired the exclusive ten year marketing, sales and distribution rights to Lipofen in the U.S., its territories and possessions from Cipher Pharmaceuticals, Inc. (TSX:DND).
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 triglycerides and LDL cholesterol and increase high-density lipoproteins (HDL), known as “good cholesterol.”
Lipofen received FDA approval for three unique fenofibrate dosages: 50, 100 and 150 mg, with the 150 mg strength equivalent to Tricor® 160 mg under fed conditions. With Lipofen, the extent of absorption is increased under high-fat conditions relative to low-fat conditions. To learn more about Lipofen, visit www.lipofenrx.com.
Important Information About Lipofen
The initial treatment for dyslipidemia is dietary therapy specific for the type of lipoprotein abnormality. Excess body weight and excess alcoholic intake may be important factors in hypertriglyceridemia and should be addressed prior to any drug therapy. The use of drugs should be considered only when reasonable attempts have been made to obtain satisfactory results with non-drug methods. If the decision is made to use drugs, the patient should be instructed that this does not reduce the importance of adhering to diet.
Side effects that may occur with use of Lipofen include elevated liver function tests, abdominal pain, and back pain. In rare cases, use of fenofibrate has been associated with rhabdomyolosis, a rapid breakdown of muscle tissue. Patients should be advised to report promptly unexplained muscle pain, tenderness or weakness, particularly if accompanied by malaise or fever.
About ProEthic Pharmaceuticals, Inc.
ProEthic is an emerging specialty pharmaceutical company enhancing treatment strategies initially in the areas of pain and migraine. Founded in 2001, the privately held company focuses its efforts on the acquisition, development, licensing, and marketing of pharmaceutical products. ProEthic also markets niche generic prescription pharmaceutical products through Midlothian Laboratories LLC, a wholly owned subsidiary. For more information, please visit the ProEthic website at: www.proethic.com.