Noven Pharmaceuticals, Inc. (NASDAQ:NOVN) today announced that a Phase 3 clinical study of its developmental once-daily lithium carbonate product did not meet its primary endpoint with statistical significance (p-value ≤ 0.15) in the treatment of acute symptoms of mania in subjects with Bipolar I disorder.
Approximately 240 subjects were randomized and the primary objectives of the four-week study were to determine the efficacy and safety of Lithium QD compared to placebo.
The company is analyzing the data to determine why statistical efficacy was not achieved and it says it continues to believe that Lithium QD has the potential to be a valuable once-daily option in the lithium therapy category. Noven also said it remains committed to the continued development of this important product and it plans to complete analysis of the data and consult with the FDA regarding appropriate next steps to advance development.
Noven said that Lithium QD is subject to U.S. patents that extend to 2022 and may also benefit from three years of exclusivity under the Hatch-Waxman Act as there are currently there are no FDA-approved once-daily lithium products on the market. The current U.S. market for lithium products, calculated at branded prices, is estimated to exceed $400 million annually.
Shares of Noven are halted in early pre-market activity and currently set to re-open at 8:35 AM EST. Shares closed relatively flat on Friday at $16.69 and the 52-week trading range is $14.99 to $27.80. Its market cap was $414 million, it has generated over $15 million per quarter in revenues, is expected to now post over $20 million in quarterly revenues, and is currently profitable.
Jon C. Ogg
October 8, 2007