Sciele Pharma, Inc. and Novo Nordisk Inc. announced that the US Food and Drug Administration (FDA) approved PrandiMet (repaglinide and metformin HCl) tablets, the first and only fixed-dose combination of the fast-acting secretagogue replaglinide (also known as Prandin) and insulin sensitizer, metformin, for the treatment of type 2 diabetes.

Under a previously announced agreement, Sciele Pharma will exclusively market PrandiMet to physicians in the US. Sciele Pharma anticipates that PrandiMet will be available to physicians and patients in the US in the second half of 2008.

PrandiMet has been approved to lower the blood glucose in adult patients with type 2 diabetes whose hyperglycemia cannot be controlled satisfactorily by meglitinide and/or metformin.

The FDA approved PrandiMet based upon data demonstrating that PrandiMet 1 mg./500 mg. and 2 mg./500 mg. resulted in similar bioequivalence to co-administration of corresponding doses of repaglinide and metformin HCl as individual tablets.

As the world's leading diabetes care company, Novo Nordisk is dedicated to providing a broad portfolio of treatments that respond to each stage of diabetes. With PrandiMet, physicians will have a simplified option for Prandin and metformin combination therapy, said Jerzy Gruhn, president, Novo Nordisk Inc.

PrandiMet is the first and only fixed-dose combination of a fast-acting secretagogue and metformin. The combination of metformin and repaglinide has been shown to safely and effectively reduce hemoglobin A1c levels. PrandiMet offers the convenience of two medications in one pill. PrandiMet is comprised of two well-established anti-diabetic medications: Prandin, a fast-acting insulin secretagogue and metformin, an insulin sensitizer. Prandin stimulates the release of insulin from the pancreas after a meal, thereby reducing PPG. Metformin decreases the amount sugar produced by the liver, reducing FPG, and helps the body respond better to the insulin it makes naturally.

We are very pleased with approval of PrandiMet, an important new treatment option for people struggling to keep their blood glucose in control, said Patrick Fourteau, chief executive officer of Sciele Pharma, Inc. We've seen that many patients need more than one therapy to control their type 2 diabetes and the combination of Prandin and metformin in one pill will give patients convenient access to two medications trusted for their efficacy and safety.

PrandiMet is indicated for the treatment of type 2 diabetes and includes two products with well-established data for safety and efficacy: repaglinide (Prandin) and metformin. It is the first fixed-dose combination of a fast acting insulin secretagogue and metformin, combining two antihyperglycemic agents with different mechanisms of action in one tablet to improve glycemic control.

PrandiMet is indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus who are already treated with a meglitinide and metformin HCl or who have inadequate glycemic control on a meglitinide alone or metformin HCl alone. Do not use to treat type 1 diabetes or diabetic ketoacidosis.

Lactic acidosis can occur due to metformin accumulation. The risk increases with conditions such as sepsis, dehydration, excess alcohol intake, hepatic impairment, renal impairment, and acute congestive heart failure. Symptoms include malaise, myalgias, respiratory distress, increasing somnolence and nonspecific abdominal distress. Laboratory abnormalities include low pH, increased anion gap and elevated blood lactate. If acidosis is suspected, discontinue PrandiMet and hospitalize the patient immediately.

PrandiMet is contraindicated in patients with renal impairment, metabolic acidosis, including diabetic ketoacidosis, or patients receiving both gemfibrozil and itraconazole. Before initiation of therapy with PrandiMet and at least annually thereafter, renal function should be assessed and verified as normal. In patients in whom development of renal impairment is anticipated, renal function should be assessed more frequently and PrandiMet discontinued if evidence of renal impairment is present. PrandiMet should generally be avoided in patients with hepatic impairment.

PrandiMet is available in two dosage strengths - 1mg. (repaglinide)/500mg. (metformin) and 2 mg. (repaglinide)/500mg. (metformin), recommended to be dosed at two-three times a day with meals.