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news.Shares in both Biovail Corporation and Depomed have risen after the companies received an approvable letter from the FDA for their once-daily diabetes treatment, Glumetza.
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The letter indicated that Glumetza is approvable pending the completion of discussions about finalizing a manufacturing specification. Biovail anticipates submitting a response to the FDA in the coming weeks.
Biovail’s new drug application (NDA) for Glumetza – in 500mg and 1,000mg dosage forms – was filed with the FDA for review in April 2004. Glumetza is a once-daily, extended-release formulation of metformin hydrochloride (HCl) for the treatment of type 2 diabetes.
According to Biovail and Depomed, 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.
Glumetza will vie for a share of the $6 billion oral diabetes drug market in the US, which was characterized by year-over-year growth of 4.5% in 2004.
Biovail, which holds the commercialization rights for Glumetza for the US and Canada, is currently in discussions with several potential partners to market Glumetza in the US and anticipates having an agreement in place with a marketing partner during the first half of 2005.
Depomed’s shares rose over 11% on the news, while Biovail stock saw an increase of almost 5%.