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FDA ISSUES APPROVABLE LETTER FOR EXPANDED USE OF VIVELLE-DOT™ AND ADDITION OF NEW LOW DOSE STRENGTH |
BackNovogyne's Dime-Sized Patch Will Be Smallest Estrogen Patch Ever Marketed
Miami, FL, December
11, 2001 -- Noven Pharmaceuticals, Inc. (NASDAQ: NOVN), a leader in the
development of transdermal and transmucosal drug delivery systems, announced
today that the U.S. Food and Drug Administration (FDA) has issued to Novartis
Pharmaceuticals Corporation an approvable letter relating to the expanded
use of Vivelle-Dot™ (estradiol transdermal system) and the addition
of a new low dose strength.
Currently, Vivelle-Dot
is approved for the treatment of menopausal symptoms. The expanded use
addressed in the approvable letter includes the prevention of postmenopausal
osteoporosis, which impacts about 40 million women in the U.S. -- one
in two women will suffer an osteoporosis-related fracture during her lifetime.
Vivelle-Dot is currently
available in four dosage strengths (0.0375, 0.05, 0.075 and 0.1 mg/day).
The approvable letter relates to the addition of a new 0.025 mg/day strength
for the prevention of postmenopausal osteoporosis. Upon approval of this
fifth strength, the Vivelle-Dot line will offer among the broadest dosing
ranges available for transdermal estrogen replacement therapy. The new
low dose strength will not be indicated for the treatment of menopausal
symptoms.
At 2.5 cm2, the thin
and flexible low dose patch has the same surface area as a dime. The small
size is made possible by Noven's patented DOT Matrix™ technology.
DOT Matrix is the technology behind a new class of diffusion-based drug-in-adhesive
patches that deliver drug therapy through less patch surface area without
using irritating enhancers and without compromising adhesion. DOT Matrix
patches use precise ratios of silicone, acrylic and drug to regulate the
rate of delivery through the skin, providing controlled, sustained release
directly into the bloodstream.
Vivelle-Dot is marketed
by Novogyne Pharmaceuticals, a women's health products company jointly
owned by Noven and Novartis Pharmaceuticals Corporation. Novogyne also
markets CombiPatch® (estradiol/norethindrone acetate transdermal
system), making it the only company in the U.S. offering transdermal therapies
for both the estrogen-only and combination hormone replacement therapy
markets.
"Vivelle-Dot
is already among the fastest growing estrogen replacement products in
the country," said Neil Jones, Noven's Vice President -- Marketing
& Sales. "The new indication and new low dose should help make Vivelle-Dot
an even more valuable and flexible therapy for physicians and patients
to consider."
An approvable letter
usually represents a final step before a product receives FDA clearance
for marketing in the U.S. In the Vivelle-Dot letter, the FDA states that
it has reviewed the application and that it is approvable, subject to
the completion of labeling matters and the submission and review of requested
information. The approvable letter was received from the FDA on November
19, 2001.
Vivelle-Dot is available
by prescription and delivers estradiol, the primary estrogen produced
by the ovaries, through a small, comfortable transdermal patch that is
applied twice weekly. Vivelle-Dot is indicated for the treatment of moderate-to-severe
vasomotor symptoms associated with menopause; vulval and vaginal atrophy;
and hypoestrogenism due to hypogonadism, castration or primary ovarian
failure.
In clinical trials,
the most commonly reported systemic adverse event with Vivelle-Dot was
mild headache. No erythema was observed at the application site after
removal of the systems for a majority of patients, and no occurrence of
erythema was greater than mild in severity. Systemic adverse events with
original Vivelle® and placebo, respectively, include headache
(36% vs. 30%), breast tenderness (4.9% vs. 1.1%), fluid retention (3.8%
vs. 2.2%) and back pain (13% vs. 4.5%). (Clinical note: the original formulation
(Vivelle®) that was tested in clinical trials has been
revised to reduce the patch sizes and the revised formulation (Vivelle-Dot)
was shown to be bioequivalent to the original formulation.)
Estrogens should
not be used in individuals with known or suspected pregnancy, undiagnosed
abnormal genital bleeding, breast cancer, estrogen-dependent neoplasia,
active thrombophlebitis or thromboembolic disorders, or a documented history
of these conditions. Estrogens have been reported to increase the risk
of endometrial carcinoma in postmenopausal women.
Noven Pharmaceuticals,
Inc., headquartered in Miami, Florida, is a leader in the development
of transdermal and transmucosal drug delivery systems and technologies.
Noven has developed and manufactures a series of leading-edge products,
including the world's smallest estrogen transdermal delivery system, the
United States' only combination estrogen/progestin transdermal delivery
system, and the first transmucosal patch approved for marketing by the
U.S. Food and Drug Administration. With a range of additional products
in development, Noven is committed to becoming the world's premier developer,
manufacturer and marketer of transdermal and transmucosal drug delivery
systems. For additional information on Noven, visit www.noven.com. Vivelle-Dot™,
Vivelle® and CombiPatch® are trademarks
of Novartis Pharmaceuticals Corporation; DOT Matrix™ is a trademark
of Noven Pharmaceuticals, Inc.
This
release contains forward-looking statements relating to the business of
Noven that can be identified by the use of forward-looking terminology
such as: "will offer", "upon approval", "approvable",
"should help" and "usually represents a final step".
Such statements are qualified by and subject to the risks and uncertainties
specified by Noven in its most recent filings with the Securities and
Exchange Commission and those specified herein, including the risk that
FDA will not issue final marketing clearance for the new Vivelle-Dot indication
and the new low dose because, among other reasons, the conditions to approval
identified by FDA may not be met and that FDA's review of requested information
may result in non-approval. In addition, even if approved, the new dosage
strength may not ultimately reach market or may not be accepted by patients
or physicians.
Investor &
Media Contact:
Joseph C. Jones
Vice President – Corporate Affairs
Noven Pharmaceuticals, Inc.
(305) 253-1916
Copyright © 2001 Noven Pharmaceuticals, Inc. All rights reserved.