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FDA Approves PrandiMet

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

ATLANTA & PRINCETON, N.J.--(BUSINESS WIRE)--Jun 24, 2008 - Sciele Pharma, Inc. 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 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."

About PrandiMet

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 should be temporarily discontinued in patients undergoing radiologic studies involving intravascular administration of iodinated contrast materials and may be resumed 48 hours after the procedure only after renal function has been re-evaluated and found to be normal. Repaglinide is not indicated for use in combination with NPH insulin.

Hypoglycemia and headache were the most common adverse reactions (Greater Than or Equal to10%) reported among patients treated with repaglinide in combination with metformin HCl. Gastrointestinal reactions (e.g. diarrhea, nausea, and vomiting) are the most common adverse reactions with metformin HCl treatment and are more frequent at higher metformin HCl doses.

PrandiMet works to control three abnormalities of type 2 diabetes: impaired insulin secretion; insulin resistance and excessive hepatic glucose production.

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.

Full prescribing information for PrandiMet is available by contacting Novo Nordisk Inc. or visiting www.prandimet.com.

About Type 2 Diabetes

Type 2 Diabetes (diabetes mellitus) is a serious chronic disease in which the body does not produce or properly use insulin. Insulin is a hormone needed to convert sugar, starches and other food into energy needed for daily life.

In the United States, an estimated 20.8 million people have diabetes (7% of the population). Of the total, 6.2 million remain undiagnosed and about 1.5 million new cases of diabetes are diagnosed each year.(2) Only 57% of those with diabetes are meeting the recommended glucose levels (hemoglobin A1c goal of 7.0% or less)(3) and those who are undiagnosed or not controlled are putting themselves at risk for serious complications.

About Novo Nordisk

Novo Nordisk is a healthcare company with an 85-year history of innovation and achievement in diabetes care. The company has the broadest diabetes product portfolio in the industry, including the most advanced products within the area of insulin delivery systems. In addition to diabetes care, Novo Nordisk has a leading position within areas such as hemostasis management, growth hormone therapy, and hormone therapy for women. Novo Nordisk's business is driven by the Triple Bottom Line: a commitment to social responsibility to employees and customers, environmental soundness and economic success. With headquarters in Denmark, Novo Nordisk employs more than 26,000 employees in 80 countries, and markets its products in 179 countries. Novo Nordisk's B shares are listed on the stock exchanges in Copenhagen and London. Its ADRs are listed on the New York Stock Exchange under the symbol 'NVO.' For global information, visit novonordisk.com; for United States information, visit novonordisk-us.com.

About Sciele Pharma, Inc.

Sciele Pharma, Inc. is a pharmaceutical company specializing in sales, marketing and development of branded prescription products focused on Cardiovascular, Diabetes, Women's Health and Pediatrics. The Company's Cardiovascular and Diabetes products treat patients with high cholesterol, hypertension, high triglycerides, unstable angina and Type 2 diabetes; its Women's Health products are designed to improve the health and well-being of women and mothers and their babies; and its Pediatrics products treat allergies, asthma, coughs and colds, and attention deficit and hyperactivity disorder (ADHD). Founded in 1992 and headquartered in Atlanta, Georgia, Sciele Pharma employs more than 900 people. The Company's success is based on placing the needs of patients first, improving health and quality of life, and implementing its business platform - an Entrepreneurial Spirit, Innovation, Execution Excellence, Simplicity, and Teamwork.

Safe Harbor Statement

This press release contains forward-looking statements that are subject to risks and uncertainties that could cause actual results to materially differ from those described. Although we believe that the expectations expressed in these statements are reasonable, we cannot promise that our expectations will turn out to be correct. Our actual results could be materially different from and worse than our expectations. With respect to such forward-looking statements, we seek the protections afforded by the Private Securities Litigation Reform Act of 1995. These risks include, without limitation:

We may not attain expected revenues and earnings. If we are unsuccessful in obtaining or renewing third party payor contracts for our products, we may experience reductions in sales levels and may fail to reach anticipated sales levels. If demand for our products exceeds our initial expectations or the ability of our suppliers to provide demand-meeting quantities of product and samples, our future ability to sell these products could be adversely impacted. The potential growth rate for our promoted products may be limited by slower growth for the class of drugs to which our promoted products belong and unfavorable clinical studies about such class of drugs. We will not realize anticipated sales if our products and our licensors' products do not receive regulatory approval.

We may encounter problems in the manufacture or supply of our products, for which we depend entirely on third parties. Strong competition exists in the sale of our promoted products, which could adversely affect expected growth of our promoted products' sales or increase our costs to sell our promoted products. We may not be able to protect our competitive position for our promoted products from patent infringers. If generic competitors that compete with any of our products are introduced, our revenues may be adversely affected.

Certain of our products have experienced manufacturing issues. If the issues recur and cannot be resolved, our ability to acquire product for sale and sampling will be adversely affected. We may incur unexpected costs in integrating new products into our operations.

We may be unable to develop or market line extensions for our products or, even if developed, obtain patent protection for our line extensions; further, introductions by us of line extensions of our existing products may require that we make unexpected changes in our estimates for future product returns and reserves for obsolete inventory. If these risks occur, our financial results could be adversely affected.

If we have difficulties acquiring new products or rights to market new products from third parties, our financial results could be adversely impacted. Our licensor/supplier can terminate our rights to commercialize Nitrolingual and the 60mg dose size of this product has not yet met our expectation.

We may not experience the beneficial results of our acquisitions that we expect to receive, and the acquired products may not meet our sales expectations.

We depend on a small senior management group, the departure of any member of which would likely adversely affect our business if a suitable replacement member could not be retained.

An adverse interpretation or ruling by one of the taxing jurisdictions in which we operate could adversely impact our operating results. An adverse judgment in the pending patent litigation involving Prandin or in the securities class action litigation in which we and certain current and former directors and executive officers are defendants could have a material adverse effect on our financial results and liquidity.

Our business is subject to increasing government price controls and other healthcare cost containment measures. Side effects or marketing or manufacturing problems with our products could result in product liability claims which could be costly to defend and could result in the withdrawal or recall of products from the market which would adversely affect our business. We may be found noncompliant with applicable federal, state or international laws, rules or regulations which could result in fines and/or product recalls or otherwise cause us to expend significant resources to correct such non-compliance.

A small number of customers account for a large portion of our sales and the loss of one of them, or changes in their purchasing patterns, could result in substantially reduced sales, substantially and adversely impacting our financial results. If third-party payors do not adequately reimburse patients for our products, doctors may not prescribe them.

We rely on operational data obtained from IMS, an industry accepted data source. IMS data may not accurately reflect actual prescriptions (for instance, we believe IMS data does not capture all product prescriptions from some non-retail channels).

Our business and products are highly regulated; the regulatory status of some of our products makes these products subject to increased competition and other risks; and we run the risk that we, or third parties on whom we rely, could violate the governing regulations.

Some unforeseen difficulties may occur.

The above are some of the principal factors that could cause actual results to differ materially from those described in the forward-looking statements included above. These factors are not intended to represent a complete list of all risks and uncertainties inherent in our business, and should be read in conjunction with the more detailed cautionary statements and risk factors included in our other filings with the Securities and Exchange Commission.

(1) Moses, et al. "Effect of replaglinide addition to metformin monotherapy on glycemic control in patients with type 2 diabetes." Diabetes Care, 22 (1999): 119 - 122

(2) Centers for Disease Control. "CDC's Diabetes Program: National Diabetes Fact Sheet." http://www.cdc.gov/diabetes/pubs/estimates05.htm#prev. Also, American Diabetes Association. "All About Diabetes: Overview," http://www.diabetes.org/about-diabetes.jsp.

(3) Hoerger, et al. "Is glycemic control improving in US adults?" Diabetes Care 13 (2008):81-86.

Contact

Sciele Pharma, Inc.
Joseph T. Schepers
Director of Investor Relations
678-341-1401
ir@sciele.com
or
Novo Nordisk
Media Inquiries:
Sean Clements, 609-902-9164
or
Investor Inquiries:
Christian Qvist Frandsen, 609-919-7937

Posted: June 2008

PrandiMet (repaglinide and metformin) FDA Approval History

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