Noven Pharmaceuticals's Lithium Product Fails to Meet Main Goal
MIAMI -- Noven Pharmaceuticals today announced that a Phase 3 clinical study of its developmental once-daily lithium carbonate product ("Lithium QD") did not meet its primary endpoint with statistical significance (p-value less than or equal to 0.15).
The Phase 3 trial was a multi-center, double-blind, randomized, placebo-controlled, parallel-group study of Lithium QD. Approximately 240 subjects were randomized. The primary objectives of the four-week study were to determine the efficacy and safety of Lithium QD compared to placebo in the treatment of acute symptoms of mania in subjects with Bipolar I disorder. The primary efficacy endpoint was change from baseline compared to placebo using the Young Mania Rating Scale (YMRS).
"Both the Noven and JDS teams are very surprised and disappointed that the study did not achieve its primary endpoint," said Robert C. Strauss, Noven's President, CEO & Chairman. "We are currently analyzing the data to determine why statistical efficacy was not achieved."
"Based on our understanding of the efficacy of lithium and the delivery profile of this formulation, we continue to believe that Lithium QD has the potential to be a valuable once-daily option in the lithium therapy category," said Strauss. "Accordingly, we remain committed to the continued development of this important product. We plan to complete our analysis of the data and consult with the FDA regarding appropriate next steps to advance development."
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. 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.
A conference call relating to today's news will be broadcast live via the Internet at www.noven.com beginning at 11:00 a.m. Eastern time this morning, October 8. Thereafter, a rebroadcast of the call will be accessible at the same website for at least two weeks. A replay of the conference call will be available from the afternoon of October 8 through October 10 by calling 877-660-6853 (from within the U.S.) or 201-612-7415 (from outside the U.S.) and entering the access code number 286 and ID number 258112.
Noven Pharmaceuticals, Inc., headquartered in Miami, Florida, has established itself as a leading developer of advanced transdermal drug delivery technologies and prescription transdermal products. Its commercialized transdermal products include Vivelle-DotÂ® (estradiol transdermal system), the most prescribed estrogen patch in the U.S., and Daytrana(TM) (methylphenidate transdermal system), the first and only patch approved for the treatment of ADHD.
With the acquisition of JDS Pharmaceuticals in August 2007, Noven has become a broader-based specialty pharmaceutical company with the infrastructure, products and category expertise to market and sell products itself, and with a substantially enhanced late-stage product pipeline.
Products currently marketed through the JDS psychiatry sales infrastructure include PexevaÂ® (paroxetine mesylate) and LithobidÂ® (lithium carbonate). Pipeline products in psychiatry consist of Stavzor(TM) (delayed release valproic acid softgel), Lithium QD (once-daily lithium carbonate), and Stavzor(TM) ER (extended release valproic acid softgel). Pipeline products in women's health consist of Mesafem(TM) (low-dose paroxetine mesylate), a non-hormonal product entering Phase 3 clinical trials for vasomotor symptoms (hot flashes).
See www.noven.com for additional information.
Forward Looking Information
Except for historical information contained herein, the matters discussed in this press release contain forward-looking statements within the meaning of Section 27A of the Securities Act of 1933 and Section 21E of the Securities Exchange Act of 1934 that involve substantial risks and uncertainties. Statements that are not historical facts, including statements which are preceded by, followed by, or that include, the words "believes," "anticipates," "plans," "expects" or similar expressions and statements, are forward-looking statements. Noven's estimated or anticipated future results, product performance or other non-historical facts are forward-looking and reflect Noven's current perspective on existing trends and information. Actual results, performance or achievements could differ materially from those contemplated, expressed or implied by the forward-looking statements contained herein. These forward-looking statements are based largely on the current expectations of Noven and are subject to a number of risks and uncertainties that are subject to change based on factors which are, in many instances, beyond Noven's control. These risks and uncertainties include, among others, risks associated with: initial review of unblinded clinical data, including the risk that additional analysis of the clinical data may yield new or additional conclusions related to the study results; uncertainties involved in the regulatory approval process, including the outcome of discussions with regulatory authorities regarding clinical studies and the timing of such discussions; the difficulty of predicting FDA actions and timing; delays regarding the regulatory approval process, including the timing of the submission of the NDA; the unproven safety and efficacy of products under development; unexpected adverse events or side effects or inadequate efficacy of a product that could delay or prevent regulatory filings, approval or commercialization, or that could result in recalls or product liability claims of approved products; the risk that Noven may ultimately decide not to pursue the development or commercialization of Lithium QD; and the possibility that patent applications may not result in issued patents, and that issued patents may not be enforceable or could be invalidated. For additional information regarding these and other risks associated with Noven's business, readers should refer to Noven's Annual Report on Form 10-K for the year ended December 31, 2006 as well as other reports filed from time to time with the Securities and Exchange Commission. Unless required by law, Noven undertakes no obligation to publicly update or revise any forward-looking statements, whether as a result of new information, future events, or otherwise.