Diabetes
FDA Approves Extended-release Formulations of Metformin
By Biovail Corporation
Jun 4, 2005, 11:06

Biovail Corporation (NYSE:BVF)(TSX:BVF) and Depomed, Inc. (Nasdaq:DEPO) announced today that they have received an Approval Letter from the United States Food and Drug Administration (FDA) for Glumetza(TM), a once-daily, extended-release formulation of metformin hydrochloride (HCl) for the treatment of Type II diabetes.

In early April, Biovail and Depomed submitted a Complete Response to the Approvable Letter received in February. The response addressed the finalization of one manufacturing specification.

Glumetza(TM) may offer potential advantages such as less frequent dosing and proven effectiveness in combination with other diabetes drugs. Glumetza(TM) also offers excellent tolerability that allows physicians to more quickly administer a high enough dose to provide glycemic control without significantly increasing the incidence of nausea, diarrhea and other side effects that are sometimes caused by metformin products.

The 500mg dosage strength was developed using Depomed's Gastric Retention (GR(TM)) drug-delivery technology. The 1,000mg dosage strength was developed using Biovail's Smartcoat delivery technology.

'Excellent Tolerability'

"Glumetza(TM) has excellent tolerability, which is important because side effects, such as nausea and diarrhea, are thought to be a primary reason that 60% of patients prescribed metformin are no longer taking their medication as prescribed after the first year," said Dr. Sherwyn Schwartz, endocrinologist and a principal investigator in the Phase III clinical trials of Glumetza(TM).

"Additionally, a Phase III clinical trial confirmed Glumetza(TM)'s effectiveness in combination with the sulfonylurea glyburide, another diabetes drug that is frequently prescribed with metformin. Glumetza(TM)'s effectiveness in combination with other diabetes drugs is key because the American College of Endocrinology and American Association of Clinical Endocrinologists recently recommended that physicians aggressively treat diabetes early, often with two or more drugs."

Biovail and Depomed's NDA for Glumetza(TM) was filed with the FDA in April 2004, just four years after Depomed initiated development of this novel formulation of metformin. The Approval Letter for Glumetza(TM) triggers a $25-million milestone payment by Biovail to Depomed.

"Type II diabetes currently affects more than 17.5 million Americans," said Dr. Douglas Squires, Chief Executive Officer of Biovail Corporation. "Hyperglycemia is a major cause of many of the complications that happen to people who have diabetes, so keeping your blood sugar as close to normal as possible not only helps you to feel better, but will help to reduce the risk of long-term complications."

Dr. John W. Fara, Chairman, President and Chief Executive Officer of Depomed, added, "Metformin is extremely well suited to improvement with Depomed's patented GR(TM) drug-delivery technology because it is preferentially absorbed in the upper GI tract. The approval of Glumetza(TM) illustrates the ability of our GR(TM) technology to improve existing drugs and paves the way for other GR(TM)-based products in our pipeline."

Glumetza(TM) will vie for a share of the $6-billion oral diabetes drug market in the United States, which grew 2.2% over the 12 months ended March 31, 2005. For the same time period, about 109.7 million prescriptions were written for oral diabetes products to treat Type II diabetes, and metformin products captured 35% of that market in terms of total prescriptions. Additionally, metformin products captured the highest share of the market in terms of new prescriptions for the 12 months ended March 2005.

Biovail, which holds the commercialization rights for Glumetza(TM) for both the United States and Canada, is currently in discussions with several potential partners to market Glumetza(TM) in the United States.

Earlier this week (May 31), Biovail and Depomed received a Notice of Compliance from the Therapeutic Products Directorate Canada for Biovail's New Drug Submission for 500mg and 1,000mg dosages of Glumetza(TM) (see Biovail news release - Biovail, Depomed Announce Regulatory Approval of Glumetza(TM) to Treat Type II Diabetes in Canada - June 1, 2005). Biovail will commercialize Glumetza(TM) in Canada through Biovail Pharmaceuticals Canada, the Canadian sales and marketing division of Biovail Corporation. Biovail anticipates launching Glumetza(TM) in the fourth quarter of 2005.

About Glumetza(TM)

Glumetza(TM) is a once-daily extended-release formulation of metformin HCl and is intended to control diabetes mellitus - a condition characterized by high levels of blood glucose resulting from defects in insulin secretion, insulin activity or both. Metformin is indicated for the control of hyperglycemia in metformin-responsive, stable, mild, non-ketosis prone maturity onset type of diabetes (Type II) which cannot be controlled by proper dietary management, exercise and weight reduction and when insulin therapy is not appropriate.

Safety Precautions

Do not take Glumetza(TM) if you have kidney problems, heart failure that is treated with medicine, or have a condition called metabolic acidosis, including diabetic ketoacidosis, which should be treated with insulin.

Glumetza(TM) can cause a rare, but serious condition, called lactic acidosis. Stop taking Glumetza(TM) and call your doctor right away if you feel very weak or tired, or have unusual muscle pain, trouble breathing, stomach pain with nausea and vomiting, diarrhea or feel cold, especially in your arms and legs, or if you feel dizzy or lightheaded, or have a slow or irregular heartbeat, or a medical condition suddenly changes.

The most common side effects of Glumetza(TM) include diarrhea, nausea, and upset stomach.

About Diabetes

Diabetes affects an estimated 18 million Americans and is increasing by approximately one million new cases each year in the U.S. alone. Approximately 90% of diabetics suffer from Type II diabetes, the most common metabolic disease in the world and the fifth-deadliest disease in the U.S. Diabetes is the leading cause of blindness, end-stage renal disease and non-traumatic loss of limb and 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 $130 billion per year.

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