GlumetzaTreatment for Diabetes Type 2
Depomed, Biovail Update Status of Glumetza NDA
MENLO PARK, Calif., April 13, 2005 - Depomed, Inc. (NASDAQ:DEPO) and Biovail Corporation (NYSE:BVF)(TSX:BVF) today announced that a response has been submitted to the United States Food and Drug Administration (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 finalizing a manufacturing specification. This issue was addressed in a response which 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 $25 million milestone payment to Depomed.
Biovail, which holds the commercialization rights for Glumetza for the United States and Canada, is currently in discussions with several potential partners to market Glumetza in the U.S.
A New Drug Submission for Glumetza in Canada is currently under review by the Therapeutic Products Directorate. Upon final approval from the TPD, Biovail intends to commercialize 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 commercialization and distribution of Glumetza in Korea. Depomed is also in discussions with potential partners regarding additional territories.
Glumetza 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.
Glumetza 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.
Diabetes affects an estimated 18 million Americans and is increasing by about 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.
About Biovail Corporation
Biovail Corporation is an international full-service pharmaceutical company, engaged in the formulation, clinical testing, registration, manufacture, sale and promotion of pharmaceutical products utilizing advanced drug-delivery technologies.
About Depomed, Inc.
Depomed, Inc. is a specialty pharmaceutical company utilizing its innovative Gastric Retention (GR(TM)) system to develop novel oral products and improved, extended release formulations of existing oral drugs. GR-based products are designed to provide once daily administration and reduced gastrointestinal side effects, improving patient convenience, compliance and pharmacokinetic profiles. Regulatory applications for once daily Glumetza (Metformin GR) for the treatment of Type II diabetes have been submitted to agencies in the U.S. and Canada. Depomed has been notified that the NDA for Glumetza is approvable. In addition, an NDA has been submitted to the FDA for once daily Proquin (ciprofloxacin HCl extended-release tablets) for the treatment of urinary tract infections. The company is also conducting a Phase II trial with the diuretic Furosemide GR and a Phase II trial with the pain drug Gabapentin GR.
Posted: April 2005
- Depomed Receives FDA Approval for 1000 mg Strength Tablets of Glumetza - January 2, 2008
- FDA Approves Glumetza for Type 2 Diabetes - June 3, 2005
- Biovail, Depomed Receive Approvable Letter from FDA for Extended-Release Glumetza for Type II Diabetes - March 1, 2005
- Biovail, Depomed Announce Glumetza NDA Accepted by FDA - June 24, 2004
- Biovail and Depomed Submit NDA for Glumetza; Submission Includes 500mg and 1000mg dosages; Biovail/Depomed Expand Royalty Agreement to Include 1000mg dose - April 28, 2004