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