NOVEN
ANNOUNCES FDA TENTATIVE APPROVAL OF |
BackNoven/JDS Sales Force Expected to Launch Stavzor™ in 2008
Miami, FL, December
26, 2007 -- Noven Pharmaceuticals, Inc. (NASDAQ: NOVN) today
announced that the U.S. Food and Drug Administration (FDA) has issued
a tentative approval letter related to the New Drug Application (NDA)
for Stavzor™ (valproic acid delayed release capsules) in 125mg,
250mg and 500mg strengths. The tentative approval relates to the use
of Stavzor™ in the treatment of manic episodes associated with
bipolar disorder, monotherapy and 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 amended
Stavzor™ NDA and that it is tentatively approved. "Tentative
approval" generally means that the FDA has concluded that a drug
product has met all required quality, safety and efficacy standards,
but because of existing patents and/or exclusivity rights, it cannot
yet be marketed in the United States.
The NDA for Stavzor™, which
was submitted by Banner Pharmacaps Inc. (the NDA holder and developer
of the product) under Section 505(b)(2) of the Federal Food, Drug, and
Cosmetic Act, references Abbott Laboratories’ Depakote® product.
Based on receipt of the tentative approval letter and Noven’s
understanding of Depakote® exclusivity, Noven continues
to expect FDA final approval of Stavzor™ 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. If approved for marketing, Stavzor™ will
be a branded product; it will not 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 occur through the Noven/JDS sales force.
“We are very pleased
that Banner’s response to the FDA’s October 2007 approvable
letter for Stavzor™ was deemed a complete response by the FDA,
and that the FDA has granted tentative approval of this important new
product for the treatment of three indications,” said Robert
C. Strauss, Noven’s President, CEO & Chairman. “Stavzor™ launch
and production planning is underway in support of an expected 2008
launch through the Noven/JDS sales and marketing organization.”
FDA's
letter does not raise any specific concerns about the safety or efficacy
of Stavzor™. Noven expects that the product label will contain
similar warnings to those described in the Depakote® product
label, including those relating to life threatening adverse reactions
concerning hepatotoxicity, teratogenicity, and pancreatitis.
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 long been established 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
a substantially enhanced late-stage product pipeline and the infrastructure,
products and category expertise to market and sell its own products.
Products currently marketed through the Noven/JDS sales infrastructure
consist of Pexeva® (paroxetine mesylate) and Lithobid® (lithium
carbonate). Developmental 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). The
development pipeline in women’s health consists 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: the difficulty of predicting FDA actions,
including the timing of such actions; 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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