Noven Reports Positive Phase 2 Results for Mesafem Non-Hormonal Therapy for Vasomotor Symptoms

MIAMI--(Business Wire)--
Noven Pharmaceuticals, Inc. (NASDAQ:NOVN) today announced positive top-line
results from its Phase 2 clinical study evaluating Mesafem (low-dose paroxetine
mesylate) for the treatment of vasomotor symptoms (hot flashes) associated with
menopause ("VMS").

This was a multi-center, double-blind, randomized, placebo-controlled Phase 2
efficacy and safety study of Mesafem in the treatment of VMS. The eight-week
study, sponsored by Noven, enrolled 102 patients (with 98 patients completing)
at ten clinical locations in the U.S. Patients in the active arm of the study
received a dose of Mesafem below 10mg once daily. The primary objective of the
study was to assess the safety and efficacy of Mesafem for the treatment of VMS.
The primary outcome measures were mean changes in frequency and severity of
moderate-to-severe hot flashes from baseline to the fourth and eighth weeks of
the study.

"Although designed and powered to detect an efficacy signal, we were very
pleased to achieve statistical significance in several primary outcome measures,
and to identify clear efficacy signals in the others," said Joel S. Lippman,
M.D., Noven`s Vice President - Clinical Development & Chief Medical Officer.
"Safety and tolerability of Mesafem were similar to placebo, with no
drug-related serious adverse events. In short, Mesafem appears to be efficacious
and well-tolerated at the tested dose, and information from this study should
permit us to develop and initiate a well-designed and cost-effective Phase 3
clinical program by year-end."

Peter Brandt, Noven`s President & CEO, said: "Today`s Phase 2 results exceeded
all our internal expectations from the standpoints of both efficacy and
tolerability. With the data from this study, we plan to expedite Mesafem into
Phase 3 development, and to advance our commercialization and partnering
strategies, with the goal of making this new non-hormonal treatment option
broadly available to women who suffer from VMS, but who are not candidates for,
or who have concerns about, hormone therapy."

Concurrent with this announcement, Noven issued a press release announcing that
it had entered into a definitive merger agreement with Hisamitsu Pharmaceutical
Co., Inc. That press release is available at www.noven.com.

About Noven

Noven Pharmaceuticals, Inc. is a specialty pharmaceutical company engaged in the
research, development, manufacture, marketing and sale of prescription
pharmaceutical products. Noven`s business and operations are focused in three
principal areas - transdermal drug delivery, the Novogyne Pharmaceuticals joint
venture, and Noven Therapeutics, Noven`s specialty pharmaceutical marketing and
sales unit. Noven is committed to developing and offering products and
technologies that meaningfully benefit patients, its customers and its industry
partners. For more information, visit www.noven.com.

Safe Harbor Statement under the Private Litigation Reform Act of 1995

Except for historical information contained herein, the matters discussed in
this press release contain forward-looking statements that involve substantial
risks and uncertainties.Statements that are not historical facts, including
statements that 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 that are, in many
instances, beyond Noven`s control.These factors include, but are not limited to,
risks and uncertainties related to the cost, timing and success of the Phase 3
clinical trial for Mesafem, the risk that results from the Mesafem Phase 2
clinical trial may not be indicative of results for the Phase 3 clinical trial,
the unproven safety and efficacy of Mesafem, the difficulty of predicting FDA
approval of products, including timing, the possibility that FDA product
approval may not guarantee commercialization or commercial success, the
difficulty of predicting acceptance and demand for new pharmaceutical products,
the impact of competitive products and pricing, the risk that product acceptance
may be less than anticipated as well as 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, and the risk that any potential development partner for
Mesafem may have priorities that are different from or conflict with those of
Noven.Accordingly, no assurances can be given that any of the events anticipated
by the forward-looking statements will occur or, if any of them do, what impact
they will have on Noven`s results of operations or financial condition.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, 2008 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.

Noven Pharmaceuticals, Inc., Miami
Joseph C. Jones, Vice President - Corporate Affairs, 305-253-1916

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