Santarus Commences GLUMETZA Promotion

Business Wire, Oct 10, 2008

Marketing Campaign Focuses on Achieving Improved Glycemic Control in Type 2 Diabetes Patients

SAN DIEGO -- Santarus, Inc. (NASDAQ:SNTS), a specialty pharmaceutical company, today announced that it has commenced promotion of GLUMETZA([R]) (metformin hydrochloride extended release tablets), a once-daily, extended-release formulation of metformin that incorporates patented drug delivery technology and is indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus. Santarus signed a promotion agreement with Depomed, Inc. in July 2008 granting Santarus exclusive rights to promote GLUMETZA in the U.S.

Metformin is widely used for the treatment of type 2 diabetes, but many patients do not achieve optimal dosing levels due to gastrointestinal (GI) side effects, and therefore do not achieve adequate glycemic control. GLUMETZA's patented delivery system may allow physicians to titrate dosing for patients up to 2000 mg a day, which is recommended by the American Diabetes Association (ADA) and has been shown to result in a more optimal level of glycemic control. GLUMETZA is available in a 500 mg tablet and a new 1000 mg tablet that adds convenience to once daily dosing by minimizing pill burden.

"We have completed the training of our sales force, and we are pleased to begin promoting GLUMETZA," said Gerald T. Proehl, president and chief executive officer. "Historically, GLUMETZA has been promotion sensitive, and our new marketing campaign focuses on educating physicians about GLUMETZA's important product attributes. A key message is the favorable tolerability profile of GLUMETZA and the importance of achieving improved glycemic control in type 2 diabetes by titrating dosing to the ADA recommended 2000 mg per day dose."

In a pivotal clinical trial comparing GLUMETZA to immediate-release metformin:

* Significantly more patients treated with GLUMETZA reached the ADA recommended goal for glycemic control of HbA1c (glycosylated hemoglobin) of less than 7%. In this study, 60.4% of patients (n=172) taking a daily dose of 2000 mg of GLUMETZA reached the ADA goal compared with 47.6% of patients (n=174) taking a daily dose of 1500 mg of immediate-release metformin (p=0.02) without significantly increasing GI side effects.

* GLUMETZA was well tolerated in the study, with an overall incidence of GI adverse events for GLUMETZA dosed up to 2000 mg per day comparable to immediate-release metformin dosed at 1500 mg per day.

* Less than 1% of patients in the study discontinued GLUMETZA therapy due to GI adverse events in the first week of the trial.

* 80% of patients taking GLUMETZA 2000 mg per day in the study were able to complete the 24-week study period.

About Diabetes

Diabetes affects an estimated 24 million Americans and its incidence is increasing by approximately 1.5 million new cases each year in the U.S. alone. Approximately 90 percent to 95 percent of people with diabetes suffer from type 2 diabetes. Diabetes is the most common metabolic disease in the world and the sixth deadliest disease in the U.S. It is the leading cause of blindness, end-stage renal disease and non-traumatic loss of limb. Diabetes can also lead to heart disease, stroke, high blood pressure, kidney disease, and other serious conditions. In the U.S., the public health cost of diabetes is more than $170 billion per year. In August 2006, the ADA and the European Association for the Study of Diabetes issued a consensus statement recommending that treatment with metformin be initiated at diagnosis along with diet and lifestyle changes in patients with type 2 diabetes.

Important GLUMETZA Safety Information

As with all metformin products, GLUMETZA has a black box warning for lactic acidosis.

GLUMETZA is contraindicated in patients with renal dysfunction, known hypersensitivity to metformin HCl or metabolic acidosis, including diabetic ketoacidosis. Use of concomitant medications that affect renal function or hemodynamic change may interfere with the disposition of metformin and should be used with caution.

Hypoglycemia does not occur in patients receiving GLUMETZA alone but could occur in deficient caloric intake or during concomitant use with other glucose-lowering agents or ethanol. Loss of glycemic control may occur when a stabilized patient is exposed to stress.

In clinical trials, the most common side effects with GLUMETZA monotherapy were diarrhea, nausea, dyspepsia, and upper abdominal pain. In a clinical trial of GLUMETZA combined with a sulfonylurea, the most common side effects included hypoglycemia, diarrhea, and nausea.

Please see full prescribing information available at www.glumetzaxr.com.

About Santarus

Santarus, Inc. is a specialty pharmaceutical company focused on acquiring, developing and commercializing proprietary products that address the needs of patients treated by gastroenterologists or primary care physicians. The company's current marketing efforts are primarily focused on ZEGERID([R]) (omeprazole/sodium bicarbonate) Capsules and Powder for Oral Suspension, which are indicated for the treatment of certain upper GI diseases and disorders, and on GLUMETZA([R]) (metformin hydrochloride extended release tablets), which is indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes. More information about Santarus is available on the company's Web site at www.santarus.com.