NOVEN
ANNOUNCES RESULTS OF PHASE 3 CLINICAL STUDY |
BackMiami, FL, October
8, 2007 -- Noven Pharmaceuticals, Inc. (NASDAQ: NOVN) ) 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 ≤ 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.
Conference Call
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.
About Noven
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-Dot® (estradiol
transdermal system), the most prescribed estrogen patch in the U.S.,
and Daytrana™ (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 Pexeva® (paroxetine
mesylate) and Lithobid® (lithium carbonate). Pipeline products
in psychiatry consist of Stavzor™ (delayed release valproic acid
softgel), Lithium QD (once-daily lithium carbonate), and Stavzor™ ER
(extended release valproic acid softgel). Pipeline products in women’s
health consist of Mesafem™ (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.
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Copyright © 2007 Noven Pharmaceuticals, Inc. All rights reserved.