Healthcare Industry News: Dermal Filler
News Release - June 5, 2006
Allergan Announces FDA Approval of Juvederm(R) Gel Family of Products for the Treatment of Facial Wrinkles and Folds'Next Generation' Smooth Gel, Non-Animal Dermal Fillers Offer Natural, Long-Lasting Results
IRVINE, Calif.--(HSMN NewsFeed)--June 5, 2006--Allergan, Inc. (NYSE:AGN ), the makers of BOTOX® Cosmetic (Botulinum Toxin Type A), today announced the U.S. Food and Drug Administration (FDA)'s approval of the Juvederm® 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®'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®, 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®'s unique gel formulation is easy to inject and provides a long-lasting clinical result."
With the FDA approval, Juvederm® joins BOTOX® 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® 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® in the linked demonstration video.
"It is very exciting to have a new facial rejuvenation tool with the unique qualities of Juvederm® that we can now offer to our patients. Our clinical investigation found Juvederm® 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® Clinical Investigator.
The Juvederm® 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® formula also may help to minimize the discomfort that can sometimes occur during the injection procedure.
The FDA approved three different formulations for Juvederm® providing physicians with the flexibility to tailor each treatment to the particular needs of the patient. The three product formulations include: Juvederm® 24HV, a highly cross-linked formulation for more versatility in contouring and volumizing of facial wrinkles and folds; Juvederm® 30HV, a more highly cross-linked robust formulation for volumizing and correction of deeper folds and wrinkles; and Juvederm® 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 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® 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® 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® 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®, 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® was approved by the FDA in 2002 as BOTOX® 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® Cosmetic; Juvederm® and other hyaluronic acid Dermal Fillers; the only collagen-based Dermal Fillers (non-animal based CosmoDerm® and CosmoPlast®) that require no prior allergy testing; and physician-dispensed products such as PREVAGE® MD, which contains the most powerful antioxidant available in a skin care product today.
Like BOTOX® Cosmetic, Juvederm® should only be administered by a trained and qualified health care provider. Further product and prescribing information is available by visiting www.JuvedermComingSoon.com and www.BotoxCosmetic.com.
INAMED, a division of Allergan, has an exclusive licensing agreement with the Corneal Group for the Juvederm® 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® is a registered mark of Laboratoires D'esthetique Appliquee Corporation, a member of the Corneal Group.
Juvederm® Clinical Studies
The FDA's approval of Juvederm® 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® formulations (Juvederm® 24HV, Juvederm® 30HV, Juvederm® 30) in one nasolabial fold, and Zyplast® (bovine-based collagen) in the other.
Juvederm® was found to provide a more persistent wrinkle correction than Zyplast® 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® compared to 36-45% with Zyplast®. At the conclusion of the study, up to 88% of subjects expressed a preference for Juvederm® while only 5-12% expressed a preference for Zyplast®. In addition, among non-Caucasian patients (all Fitzpatrick Skin Types), Juvederm® was found safe and effective and demonstrated no increased risk of hyperpigmentation or hypertrophic scarring.
Important Juvederm® 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® Cosmetic Safety Information
BOTOX® 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® 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® 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're 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.
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®, BOTOX® Cosmetic and BOTOX®. 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 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.
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