Businessweek

Santarus, Inc., a specialty biopharmaceutical company, focuses on acquiring, developing, and commercializing proprietary products that address the needs of patients treated by physician specialists. The company owns or has rights to various trademarks, copyrights, and tradenames used in its business, including Santarus, Zegerid, Glumetza, Cycloset, Fenoglide, MMX, and MMX Multi-Matrix System and Rhucin. It has applied for trademark registration for various other names and logos, such as Uceris. Marketed and Approved Products Glumetza (metformin hydrochloride extended release tablets) The company promotes Glumetza (metformin hydrochloride extended release tablets), which is available in 500 mg and 1000 mg tablets and is a once-daily, extended-release formulation of metformin that incorporates patented drug delivery technology. Glumetza is indicated as an adjunct to diet and exercise to improve glycemic control in adult patients with type 2 diabetes. There are 4 issued U.S. patents that provide coverage for one or both of the Glumetza 500 mg dose products, with expiration dates in 2016, 2020, and 2021. There are 2 issued U.S. patents that provide coverage for the Glumetza 1000 mg dose products, with expiration dates in 2020 and 2025. Cycloset (bromocriptine mesylate) Tablets The company also promotes Cycloset (bromocriptine mesylate), which is available in 0.8 mg tablets and is a novel formulation of bromocriptine, a dopamine receptor agonist that acts on the central nervous system. Cycloset is indicated as an adjunct to diet and exercise to improve glycemic control in adult patients with type 2 diabetes. The company has a distribution and license agreement with S2 Therapeutics, Inc. and VeroScience, LLC to manufacture and commercialize the Cycloset prescription product in the U.S. There are six issued U.S. patents that provide coverage for the Cycloset, with expiration dates in 2012, 2014, 2015, and 2023. Fenoglide (fenofibrate) Tablets The company promotes Fenoglide (fenofibrate), which is available in 40 mg and 120 mg tablets and is a proprietary formulation of fenofibrate that incorporates patented drug delivery technology and provides the lowest prescription fenofibrate dose available. Fenoglide is indicated as an adjunct to diet to reduce elevated low-density lipoprotein-cholesterol total cholesterol, triglycerides, and apolipoprotein B and to increase high-density lipoprotein-cholesterol in adult patients with primary hyperlipidemia or mixed dyslipidemia. Fenoglide also is indicated as an adjunct to diet for treatment of adult patients with hypertriglyceridemia. In 2011, the company entered into a license agreement with Cowen Healthcare Royalty Partners, L.P. and Shore Therapeutics, Inc. to commercialize Fenoglide prescription products in the U.S. There is one issued U.S. patent that provides coverage for the Fenoglide products, with an expiration date in 2024. Zegerid Capsules and Zegerid Powder for Oral Suspension The company also sells and do not promote Zegerid (omeprazole/sodium bicarbonate) 20 mg and 40 mg capsules and powder for oral suspension, which are immediate-release formulations of the proton pump inhibitor (PPI) omeprazole. In addition, it receives a percentage of the gross margin on sales of an authorized generic version of its Zegerid capsules product. The company owns rights to its immediate-release PPI technology under a license agreement with the University of Missouri. Development-Stage Products In addition to the company’s commercial products, it is focused on advancing the following development-stage products to commercialization: Uceris (budesonide) Tablets Uceris (budesonide), also referred to as budesonide MMX, is a locally acting, non-systemic corticosteroid in a novel, patented, oral tablet formulation that utilizes proprietary MMX multi-matrix system technology, which is designed to result in the controlled release and distribution of budesonide throughout the length of the colon. In February 2012, the company’s new drug application was seeking approval to market Uceris 9 mg tablets for the induction of remission of mild to moderate active u