Santarus, Inc. and Shore Therapeutics, Inc. have entered into an exclusive license agreement to commercialize Fenoglide (fenofibrate) tablets 40 mg and 120 mg in the US.
Fenoglide is indicated as an adjunct to diet to reduce elevated low-density lipoprotein-cholesterol (LDL-C), total cholesterol, triglycerides and apolipoprotein B (Apo B), and to increase high-density lipoprotein-cholesterol (HDL-C) in adult patients with primary hyperlipidemia or mixed dyslipidemia. It is also indicated as an adjunct to diet for treatment of adult patients with hypertriglyceridemia.
“Fenoglide fits well with the prescribing habits of our called-on physicians as high cholesterol is one of the co-morbid conditions frequently associated with type 2 diabetes,” said Gerald T Proehl, president and chief executive officer of Santarus. “We have assumed distribution for Fenoglide and we expect to commence active promotion of the product in the first quarter of 2012. We are pleased to add a third prescription product to complement our commercial efforts and believe that Fenoglide will respond well to increased promotional activity.”
According to IMS Health, sales of Fenoglide in the US were $8.7 million for the 12 months ended October 31, 2011. Fenoglide was previously promoted by Shionogi Pharma, Inc. (formerly Sciele Pharma, Inc.) from February 2008 to August 2010 and according to IMS Health achieved peak US sales of approximately $23 million for the 12 months ended August 31, 2010. Shore Therapeutics subsequently promoted Fenoglide through a small part-time contract sales force.
Under the terms of the license agreement, Santarus will pay Shore an $11 million upfront fee and tiered royalties on net sales of Fenoglide. The royalties are 5% on net sales up to $10 million commencing in 2013, a 20% royalty on net sales between $10 million and $20 million, and a 25% royalty on net sales above $20 million, subject to certain potential offsets. Santarus also will be obligated to pay one-time, success-based milestones of $2 million if calendar year net sales equal or exceed $20 million and $3 million if calendar year net sales equal or exceed $30 million. Santarus is responsible for commercial, manufacturing and regulatory activities for Fenoglide.
Fenoglide is a prescription medicine for the treatment of high cholesterol. Along with a healthy diet, Fenoglide lowers “bad” cholesterol (LDL-C) and triglycerides and increases “good” cholesterol (HDL-C).
Fenofibrate was not shown to lower the risk of illness and death related to heart disease in patients with diabetes.
Fenoglide is contraindicated in patients with severe renal dysfunction, including those receiving dialysis, active liver disease, including those with primary biliary cirrhosis and unexplained persistent liver function abnormalities, gallbladder disease, nursing mothers, and in patients with known hypersensitivity to fenofibrate, such as severe skin rashes, Stevens-Johnson syndrome and toxic epidermal necrolysis. Fenoglide may increase the effects of coumarin-type anticoagulants. Anticoagulant dosage adjustment based on frequent prothrombin time/International Normalized Ratio determinations is advisable.