Wednesday, June 25, 2008

FDA Approves PrandiMet™, a Replaglinide and Metformin Fixed-Dose Combination Tablet for Treatment of Type 2 Diabetes

BUSINESS WIRE--Sciele Pharma, Inc. (NASDAQ:SCRX) and Novo Nordisk Inc. today announced that the U.S. 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 U.S. Sciele Pharma anticipates that PrandiMet will be available to physicians and patients in the U.S. 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.1

As the worlds 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. Weve 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.

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