Healthcare Industry News: PRO-513
News Release - July 11, 2007
ProEthic Pharmaceuticals Enters Into U.S. Licensing and Distribution Agreement for LipofenMONTGOMERY, Ala.--(HSMN NewsFeed)--ProEthic Pharmaceuticals, Inc., today announced that it has entered into a definitive licensing and distribution agreement with Cipher Pharmaceuticals, Inc. (TSX: DND ), under which Cipher has granted ProEthic the exclusive right to market, sell and distribute Lipofen(TM) in the United States, its territories and possessions. Lipofen is a novel, patented formulation of the active ingredient fenofibrate, which is used in the treatment of hyperlipidemia, a cholesterol disorder.
Carl Whatley, Chairman and Chief Executive Officer of ProEthic, stated, "Lipofen will be the lead product for the company as we seek to build our presence in the important primary care space. Total fenofibrate prescriptions have increased strongly over the past several years, with U.S. prescriptions rising 18% in 2006. Demand for the molecule is expected to rise in the coming years based on demographic trends and the increasing awareness of the need to manage a patient's total cholesterol profile."
"Completing this agreement was a top priority and represents an important milestone for our organization," said Larry Andrews, President and Chief Executive Officer of Cipher Pharmaceuticals. "ProEthic is a young, rapidly growing company with a particular focus on primary care physicians, which is a key target audience for Lipofen. We look forward to working with ProEthic's sales and marketing team to commercialize this product in the fast-growing, $1.1 billion U.S. fenofibrate market."
Under the terms of the agreement, Cipher will receive an up-front licensing fee of $2 million. Cipher could receive additional milestone payments of up to $20 million based on the achievement of certain net sales targets. Cipher will also receive a royalty on a percentage of net sales, which escalates from the mid-teens to mid-twenties based on annual sales targets and the level of promotional support provided by ProEthic. The agreement is for a period of ten years, and ProEthic has the right to extend the term for additional two-year periods. ProEthic expects to launch the product in the early part of the fourth quarter of 2007.
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.
About ProEthic Pharmaceuticals
ProEthic is an emerging specialty pharmaceutical company enhancing treatment strategies through innovative technologies. Founded in 2001, the privately held company focuses its efforts on the acquisition, development, licensing, and marketing of pharmaceutical products directed at the primary care physician. ProEthic's growing primary care sales force currently operates in approximately 22 states with plans to attain national sales coverage by year end 2008. ProEthic has experienced annual revenue growth of over 50% in each year since 2002. Other products in the ProEthic pipeline include PRO-513 for acute migraine and PRO-571 for acute pain. Both utilize ProEthic's DBT (dynamic buffering technology). For more information, please visit the ProEthic website at: www.proethic.com.
About Cipher Pharmaceuticals Inc.
Cipher Pharmaceuticals is a drug development company focused on commercializing novel formulations of successful, currently marketed molecules using advanced drug delivery technologies. Cipher's strategy is to in-license products that incorporate proven drug delivery technologies and advance them through the clinical development and regulatory approval stages, after which the products are out-licensed to international partners. Because Cipher's products are based on proven technology platforms applied to currently marketed drugs, they are expected to have lower approval risk, shorter development timelines and significantly lower development costs. Cipher currently has three late-stage drugs in its pipeline. The Company's lead compound, CIP-FENOFIBRATE, received final approval from the U.S. Food and Drug Administration and Health Canada in the first quarter of 2006. In addition, Cipher is developing formulations of the pain reliever tramadol (currently under regulatory review by the FDA) and the acne treatment isotretinoin (currently under regulatory review by the FDA).
Cipher is listed on the Toronto Stock Exchange under the symbol 'DND' and has approximately 24 million shares outstanding. For more information, please visit www.cipherpharma.com.
Source: ProEthic Pharmaceuticals
Issuer of this News Release is solely responsible for its
Please address inquiries directly to the issuing company.