FDA
ISSUES APPROVABLE LETTER FOR STAVZOR™ |
BackNoven/JDS Sales Force Expected to Launch Stavzor™ in 2008
Miami, FL, October
23, 2007 -- Noven Pharmaceuticals, Inc. (NASDAQ: NOVN) today announced
that the U.S. Food and Drug Administration (FDA) has issued an approvable
letter related to the New Drug Application (NDA) for Stavzor™ (delayed
release valproic acid capsules) in 125mg, 250mg and 500mg strengths.
The approvable letter relates to the use of Stavzor™ in the treatment
of manic episodes associated with bipolar disorder, adjunctive therapy
in multiple seizure types (including epilepsy), and prophylaxis of
migraine headaches.
The FDA states in the letter that it has completed
its review of the Stavzor™ NDA and that it is approvable. The
FDA has requested certain non-clinical information, including additional in
vitro dissolution data, as a condition to final approval. The
FDA has not requested additional human studies or clinical data.
Because
the NDA for Stavzor™, submitted under Section 505(b)(2) of the
Federal Food, Drug, and Cosmetic Act, references Abbott Laboratories’ Depakote® product,
final approval is also subject to the expiration of any applicable
exclusivity periods benefiting Depakote®. Based on receipt of the
approvable letter, interaction with Banner Pharmacaps Inc. (the NDA
holder and developer of the product), and its understanding of Depakote® exclusivity,
Noven continues to expect Stavzor™ final approval, at the latest,
by the end of July 2008.
Stavzor™ was developed using Banner’s
patent-pending EnteriCare™ enteric soft gelatin capsule delivery
system. Noven acquired a license to market and sell Stavzor™ in
the U.S. as part of Noven’s acquisition of JDS Pharmaceuticals
in August 2007. Stavzor™ will be a branded product; it is not
expected to be AB-rated to or generically substitutable for Depakote®,
nor will Depakote® or any Depakote® generics be substitutable
for Stavzor™. Promotion of the Stavzor™ brand will target
primarily high-prescribing physicians through the Noven/JDS sales force.
“We
are very pleased to announce that the FDA has issued an approvable
letter for Stavzor™, and we offer our congratulations to the
Banner and JDS teams for this successful result,” said Robert
C. Strauss, Noven’s President, CEO & Chairman. “We
are now working with Banner to satisfy the conditions to final approval
as expeditiously as possible. Banner has advised that it expects to
respond to the FDA’s requests in the coming weeks. Concurrently,
the Noven/JDS team has begun launch and production planning in anticipation
of a 2008 launch of Stavzor™.”
Banner Pharmacaps Inc.,
headquartered in High Point, North Carolina, is a global drug delivery
and specialty pharmaceutical company developing a proprietary portfolio
of unique products and oral dosage forms, including soft gelatin capsules.
EnteriCare™ is
a trademark of Banner; Depakote® is a registered
trademark of Abbott Laboratories or its affiliates.
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 capsule), Lithium QD (once-daily lithium carbonate),
and Stavzor™ ER (extended release valproic acid capsule). 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.
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: the difficulty of predicting FDA actions,
including the timing of such actions; the risk that the FDA’s request
for additional information will not be fulfilled in a timely fashion
or in a manner satisfactory to the FDA, which could delay or prevent
final approval of the product; uncertainties in the process of obtaining
regulatory approval for new products; risks related to actions that may
be taken by competitors; the possibility that any product launch may
be delayed; and, if Stavzor™ is approved, the many risks that face
new products, including the impact of competitive products and pricing,
the risk that product acceptance may be less than anticipated, the risk
of unexpected adverse side effects or inadequate therapeutic efficacy
of a product, risks related to compliance with extensive, costly, complex
and evolving governmental regulations and restrictions, and reimbursement
policies of government and private health insurers and others. 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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