Allergan Announces FDA Approval of Juvederm(R) Gel Family of Products for the Treatment of Facial Wrinkles and Folds
05 Junho 2006 - 11:00AM
PR Newswire (US)
- 'Next Generation' Smooth Gel, Non-Animal Dermal Fillers Offer
Natural, Long-Lasting Results - IRVINE, Calif., June 5
/PRNewswire-FirstCall/ -- Allergan, Inc. (NYSE: AGN), the makers of
BOTOX(R) Cosmetic (Botulinum Toxin Type A), today announced the
U.S. Food and Drug Administration (FDA)'s approval of the
Juvederm(R) gel family of products, a 'next generation' of
hyaluronic acid dermal fillers that provide a smooth, long-lasting
correction of facial wrinkles and folds. Juvederm(R)'s proprietary,
technologically advanced formulations result in a smooth, natural
look and contain the highest concentration of non-animal and
cross-linked hyaluronic acid of any dermal filler currently
available. These unique attributes provide optimal results with a
single treatment in the majority of patients and deliver sustained
results for up to six months or longer. "We are excited to offer
physicians and patients Juvederm(R), the next generation smooth gel
hyaluronic acid formulations approved by the FDA as an important
new option for the correction of facial wrinkles and folds," said
Scott M. Whitcup, M.D., Allergan's Executive Vice President,
Research and Development. "Juvederm(R)'s unique gel formulation is
easy to inject and provides a long-lasting clinical result." With
the FDA approval, Juvederm(R) joins BOTOX(R) Cosmetic and an array
of other dermal filler and skin care treatments in Allergan's
facial aesthetics portfolio, which provides patients and physicians
with the most comprehensive total facial rejuvenation product
offering available. Juvederm(R) is natural, biodegradable and
currently the only approved hyaluronic acid dermal filler that has
demonstrated its safety and effectiveness in patients of all skin
types and colors. It also is the only hyaluronic acid dermal filler
developed using a proprietary, technologically advanced
manufacturing process that results in a malleable smooth gel that
flows easily into the skin, creating a smooth, natural look and
feel. All other currently approved hyaluronic acid dermal fillers
utilize a gel particle suspension formulation. These gel particles
can be visibly seen as opposed to the smoother formulation used in
Juvederm(R) in the linked demonstration video: (Please copy and
paste the following link into your browser)
mms://a1111.v167318.c16731.g.vm.akamaistream.net/7/1111/16731/1149239/stream-
1.onstreammedia.com/cdn_stream/multivu/2136/24556c_p_300k.wmv "It
is very exciting to have a new facial rejuvenation tool with the
unique qualities of Juvederm(R) that we can now offer to our
patients. Our clinical investigation found Juvederm(R) to be a
smooth-flowing injection that provides our patients with a natural
appearing result. The new formulation of hyaluronic acid offers
physicians a high level of control for facial contouring," said
Gary Monheit, M.D., Total Skin & Beauty Dermatology Center,
P.C.; Associate Clinical Professor, Department of Dermatology and
Ophthalmology, University of Alabama at Birmingham; and Juvederm(R)
Clinical Investigator. The Juvederm(R) family of products offers
the highest concentration of cross-linked hyaluronic acid available
in a dermal filler, which results in a long duration of effect and
may be attributed to the majority of patients not requiring
touch-ups following their initial treatment. The smooth consistency
of the Juvederm(R) formula also may help to minimize the discomfort
that can sometimes occur during the injection procedure. The FDA
approved three different formulations for Juvederm(R) providing
physicians with the flexibility to tailor each treatment to the
particular needs of the patient. The three product formulations
include: Juvederm(R) 24HV, a highly cross-linked formulation for
more versatility in contouring and volumizing of facial wrinkles
and folds; Juvederm(R) 30HV, a more highly cross-linked robust
formulation for volumizing and correction of deeper folds and
wrinkles; and Juvederm(R) 30, a highly cross-linked formulation for
subtle correction of facial wrinkles and folds. Our presentation of
the products, including the package and accessories, is currently
being finalized and availability dates are expected to be announced
later in 2006. Physicians and consumers are encouraged to visit
http://www.juvedermcomingsoon.com/ to receive updates on product
availability. Hyaluronic acid dermal fillers represent the fastest
growing non-invasive aesthetic procedure in the United States and
BOTOX(R) Cosmetic has been the number one physician-administered,
non-surgical cosmetic procedure in the United States since 2002,
according to the American Society of Aesthetic Plastic Surgeons.
Occurring naturally in the body, hyaluronic acid is a natural
complex sugar found in all living organisms and creates volume and
elasticity in the skin. Juvederm(R) adds volume to facial wrinkles,
such as nasolabial folds (the folds running from the sides of the
bottom of the nose to the outer corners of the mouth). BOTOX(R)
Cosmetic works differently -- by relaxing the dominant frown
muscles between the eyebrows (the glabellar area). This allows the
two vertical lines between the brows, often referred to as the
"11," to temporarily diminish in appearance. Like BOTOX(R), which
has been available for more than 16 years and is currently approved
to treat 20 different medical conditions in more than 75 countries
around the world, hyaluronic acid treats multiple medical
conditions, including those associated with the eye and the knee,
and has been used for more than 20 years. The same formulation of
BOTOX(R) was approved by the FDA in 2002 as BOTOX(R) Cosmetic for
the temporary improvement in the appearance of moderate to severe
frown lines between the brows in people 18 to 65 years of age.
Physicians often will use a combination of products to obtain a
desired facial rejuvenation look that is natural, expressive and
fresh. With more than 55 years of experience providing
high-quality, science- based products, Allergan, together with its
INAMED division, is the only company with a global facial
aesthetics franchise offering the most comprehensive array of
innovative products, including: BOTOX(R) Cosmetic; Juvederm(R) and
other hyaluronic acid dermal fillers; the only collagen-based
dermal fillers (non- animal based CosmoDerm(R) and CosmoPlast(R))
that require no prior allergy testing; and physician-dispensed
products such as PREVAGE(R) MD, which contains the most powerful
antioxidant available in a skin care product today. Like BOTOX(R)
Cosmetic, Juvederm(R) should only be administered by a trained and
qualified health care provider. Further product and prescribing
information is available by visiting
http://www.juvedermcomingsoon.com/ and
http://www.botoxcosmetic.com/. INAMED, a division of Allergan, has
an exclusive licensing agreement with the Corneal Group for the
Juvederm(R) family of products and future product line extensions
in the United States, Canada and Australia and a non-exclusive
agreement in certain strategically important European markets under
the name HydraFill(TM). Juvederm(R) is a registered mark of
Laboratoires D'esthetique Appliquee Corporation, a member of the
Corneal Group. Juvederm(R) Clinical Studies The FDA's approval of
Juvederm(R) was based on data from a double-blind, randomized and
controlled clinical trial. A total of 439 subjects were followed
for six months after injection with one of three Juvederm(R)
formulations (Juvederm(R) 24HV, Juvederm(R) 30HV, Juvederm(R) 30)
in one nasolabial fold, and Zyplast(R) (bovine-based collagen) in
the other. Juvederm(R) was found to provide a more persistent
wrinkle correction than Zyplast(R) over the 6-month course of the
study, with up to 90% of subjects maintaining at least a 1-grade
improvement in nasolabial fold correction with Juvederm(R) compared
to 36-45% with Zyplast(R). At the conclusion of the study, up to
88% of subjects expressed a preference for Juvederm(R) while only
5-12% expressed a preference for Zyplast(R). In addition, among
non-Caucasian patients (all Fitzpatrick Skin Types), Juvederm(R)
was found safe and effective and demonstrated no increased risk of
hyperpigmentation or hypertrophic scarring. Important Juvederm(R)
Safety Information In clinical studies, adverse events were usually
mild to moderate in nature, did not require intervention and lasted
seven days or less. The most common side effects included temporary
injection site reactions including redness, pain/tenderness,
firmness, swelling, lumps and bumps and bruising. Important
BOTOX(R) Cosmetic Safety Information BOTOX(R) Cosmetic is indicated
for the temporary improvement in the appearance of moderate to
severe frown lines between the brows in people 18 to 65 years of
age. BOTOX(R) Cosmetic is the only product of its type approved by
the FDA for the treatment of moderate to severe frown lines between
the brows. BOTOX(R) Cosmetic should only be administered by a
trained and qualified health care provider. Serious heart problems
and serious allergic reactions have been reported rarely. If you
think you are having an allergic reaction or other unusual
symptoms, such as difficulty swallowing, speaking or breathing,
call your doctor immediately. The most common side effects
following injection are temporary eyelid droop and nausea.
Localized pain, infection, inflammation, tenderness, swelling,
redness and/or bleeding/bruising may be associated with the
injection. Patients with certain neuromuscular disorders such as
ALS, myasthenia gravis or Lambert-Eaton syndrome may be at
increased risk of serious side effects. Forward-Looking Statements
This press release contains "forward-looking statements", including
the statements by Dr. Scott Whitcup and Dr. Gary Monheit and other
statements regarding the effectiveness of Juvederm(R), BOTOX(R)
Cosmetic and BOTOX(R). These statements are based on current
expectations of future events. If underlying assumptions prove
inaccurate or unknown risks or uncertainties materialize, actual
results could vary materially from Allergan's expectations and
projections. Risks and uncertainties include, among other things,
general industry and pharmaceutical market conditions;
technological advances and patents attained by competitors;
challenges inherent in the research and development and regulatory
processes; challenges related to new product marketing, such as the
unpredictability of market acceptance for new pharmaceutical and
biologic products and/or the acceptance of new indications for such
products; inconsistency of treatment results among patients;
potential difficulties in manufacturing a new product formulation;
and governmental laws and regulations affecting domestic and
foreign operations. Additional information concerning these and
other risk factors can be found in press releases issued by
Allergan, as well as Allergan's public periodic filings with the
Securities and Exchange Commission, including the discussion under
the heading "Risk Factors" in Allergan's 2005 Form 10-K and
Allergan's Form 10-Q for the quarter ended March 31, 2006. Copies
of Allergan's press releases and additional information about
Allergan is available on the World Wide Web at
http://www.allergan.com/ or you can contact the Allergan Investor
Relations Department by calling 1-714-246-4636. About Allergan,
Inc. With more than 55 years of experience providing high-quality,
science- based products, Allergan, Inc., with headquarters in
Irvine, California, develops and commercializes products in the
ophthalmology, neurosciences, medical dermatology, medical
aesthetics, obesity intervention and other specialty markets that
deliver value to its customers, satisfy unmet medical needs, and
improve patients' lives. DATASOURCE: Allergan, Inc. CONTACT:
Caroline Van Hove, +1-714-246-5134 (media), or Jim Hindman,
+1-714-246-4636 (investors), or Joann Bradley, +1-714-246-4766
(investors), all for Allergan, Inc. Web site:
http://www.allergan.com/ http://www.botoxcosmetic.com/
http://www.juvedermcomingsoon.com/
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