Depomed, Biovail update status of Glumetza NDA

Depomed and Biovail have responded to the FDA regarding an outstanding inquiry on the New Drug Application (NDA) for Glumetza, a once-daily, extended-release formulation of metformin hydrochloride (HCl) for the treatment of Type II diabetes.

Last month, the companies announced that the NDA for Glumetza was deemed "Approvable" by the FDA, pending the resolution of an issue related to finalising a manufacturing specification. This issue was addressed in a response that was filed at the FDA on April 8, 2005. Depomed and Biovail believe that the response will be considered as a Class I response, which carries a 60-day review period. Within 30 days of final approval, Biovail will make a $25m milestone payment to Depomed.

Biovail, which holds the commercialisation rights for Glumetza for the US and Canada, is currently in discussions with several potential partners to market the product in the US.

A New Drug Submission for Glumetza in Canada is currently under review by the Therapeutic Products Directorate (TPD). Upon final approval from the TPD, Biovail intends to commercialise Glumetza in Canada through Biovail Pharmaceuticals Canada, the Canadian sales and marketing division of Biovail Corporation.

Elsewhere, Depomed has entered into an agreement with LG Life Sciences for the commercialisation and distribution of Glumetza in Korea. Depomed is also in discussions with potential partners regarding additional territories.

About Glumetza

Glumetza is a once-daily extended-release formulation of metformin HCl and is intended to control diabetes mellitus - a condition characterised 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. The product may offer potential advantages and prescribing flexibility to physicians that may be advantageous when addressing the needs of certain patients who suffer from diabetes. The benefits of Glumetza may include less frequent dosing, excellent tolerability, and the ability 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.

About Diabetes

Diabetes affects an estimated 18m Americans and is increasing by about one million new cases each year in the US 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 US. 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 US, the public health cost of diabetes is more than $130bn per year.