Biovail Corporation and Depomed, Inc. have received an approvable letter from the United States Food and Drug Administration (FDA) regarding a New Drug Application (NDA) for Glumetza, a once-daily, extended-release formulation of metformin hydrochloride (HCl) for the treatment of Type II diabetes.
The letter indicated that Glumetza is approvable pending the completion of discussions with regard to an issue related to finalizing one manufacturing specification. Biovail anticipates submitting a response to the FDA in the coming weeks. No clinical or labelling issues were identified in the letter, the release stated.
Biovail's NDA for Glumetza- in 500mg and 1,000mg dosage forms - was filed with the FDA for review in April 2004. 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, diarrhoea and other side effects that are sometimes caused by metformin products, the companies claim.
The 500mg dosage strength was developed using Depomed's Gastric Retention (GR) drug- delivery technology. The 1,000mg dosage strength was developed using Biovail's Smartcoat delivery technology.
Dr. Douglas Squires, CEO of Biovail Corporation says, "The large majority of patients who currently take metformin use the 500mg dosage. Our once-daily 1,000mg dosage will especially benefit the roughly 35 per cent of diabetes patients who require additional glycemic control."
Glumetza will vie for a share of the $6-billion oral diabetes drug market in the United States, which was characterized by year-over-year growth of 4.5 per cent in 2004.
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 US. Biovail anticipates having an agreement in place with a marketing partner during the first half of 2005.
A New Drug Submission for Glumetza in Canada is currently under review by the Therapeutic Products Directorate. Upon final approval from the TPD, Biovail fully 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. The Company is also in negotiations with potential partners regarding additional territories.