Healthcare Industry News: Dermal Filler
News Release - January 17, 2007
Allergan, Inc. Announces Nationwide Availability of JUVEDERM(TM) ULTRA and JUVEDERM(TM) ULTRA PLUS Dermal FillersIRVINE, Calif.--(HSMN NewsFeed)--Allergan, Inc. (NYSE:AGN ), the maker of BOTOX® Cosmetic (Botulinum Toxin Type A), today announced nationwide availability of its 'next-generation' hyaluronic acid Dermal Filler family of products, JUVEDERM(TM) ULTRA and JUVEDERM(TM) ULTRA PLUS.
"We are pleased to now provide JUVEDERM(TM) Dermal Fillers to physicians and their patients across the country," said Robert Grant, President of Allergan Medical, a division of Allergan, Inc. "We believe that the unique scientific benefits and technologically advanced, smooth formulation of JUVEDERM(TM) will establish the brand as a leader alongside BOTOX® Cosmetic in Allergan's TOTAL FACIAL REJUVENATION(TM) offering."
The JUVEDERM(TM) Dermal Filler family of products provides physicians with the flexibility to tailor each treatment to a patient's particular needs. JUVEDERM(TM) ULTRA is a highly cross-linked formulation for more versatility in contouring and volumizing facial wrinkles and folds; and JUVEDERM(TM) ULTRA PLUS is a more highly cross-linked, robust formulation for volumizing and correction of deeper folds and wrinkles.
"In the clinical trials, I found JUVEDERM(TM) injectable gel to be a smooth-flowing product to inject, providing patients with a natural and smooth correction of facial wrinkles and folds," said Dr. Mark Pinsky, clinical investigator in the JUVEDERM(TM) Dermal Filler study. "I have seen similar results with the patients I have currently enrolled in the JUVEDERM(TM) Experience Trial, and I look forward to providing both JUVEDERM(TM) ULTRA and JUVEDERM(TM) ULTRA PLUS Dermal Fillers to many more of my patients now that the product is widely available. The ease of the injection and its long-lasting smooth and natural results make JUVEDERM(TM) an important facial rejuvenation tool in my practice."
JUVEDERM(TM) is the only hyaluronic acid Dermal Filler developed using the proprietary HYLACROSS(TM) technology, an advanced manufacturing process resulting in a malleable gel that flows easily into the skin and creates a smooth, natural look and feel. All other hyaluronic acid Dermal Fillers currently on the market, including Restylane® are granular consistency gels. An example of the granular consistency of Restylane® (under 2.4X magnification, 0.05 mL) can be seen in the accompanying photo and can be compared to JUVEDERM(TM) ULTRA and JUVEDERM(TM) ULTRA PLUS (under 2.4X magnification, 0.05 mL). The clinical significance of the differences has not been established.
Physicians and consumers are encouraged to visit www.Juvederm.com to receive additional information about JUVEDERM(TM) ULTRA and JUVEDERM(TM) ULTRA PLUS Dermal Fillers. The Web site also offers a physician locator to help consumers find a trained and qualified health care provider in their area.
Like BOTOX® Cosmetic treatment, JUVEDERM(TM) Dermal Fillers should only be administered by a trained and qualified health care provider. Further product and prescribing information is available by visiting www.Juvederm.com and www.BotoxCosmetic.com.
Important JUVEDERM(TM) Dermal Filler 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. For complete patient safety information, please visit www.Juvederm.com.
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 U.S. Food and Drug Administration 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 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.
About Allergan Medical
Allergan Medical, a division of Allergan, Inc., offers the most comprehensive, science-based, aesthetic product offerings under its TOTAL FACIAL REJUVENATION(TM) portfolio, including BOTOX® Cosmetic; hyaluronic acid and collagen-based Dermal Fillers; and physician-dispensed skin care products. Allergan Medical also offers the industry's widest range of silicone gel-filled and saline-filled breast implant options for reconstructive and aesthetic breast surgery, and leading minimally invasive devices for obesity intervention treatment.
About Allergan, Inc.
With more than 55 years of experience providing high-quality, science-based products, Allergan, Inc., with headquarters in Irvine, California, discovers, 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.
This press release contains "forward-looking statements", including the statements by Mr. Grant and Dr. Pinsky, statements regarding research and development outcomes, efficacy, market and product potential and other statements regarding BOTOX® Cosmetic and JUVEDERM(TM) Dermal Fillers. 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 market conditions; technological advances and patents attained by competitors; challenges inherent in the research and development and regulatory processes; challenges related to product marketing, such as the unpredictability of market acceptance for new products and/or the acceptance of new indications for such products; inconsistency of treatment results among patients and the potential for product failures; unknown risks associated with the investigational devices that are the subject of Allergan's clinical trials; potential difficulties in manufacturing new products; and governmental laws and regulations affecting domestic and foreign operations. Allergan expressly disclaims any intent or obligation to update these forward-looking statements except as required to do so by law.
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 September 29, 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.
® and (TM) marks owned by Allergan, Inc.
JUVEDERM(TM) is a mark owned by Corneal Industrie SAS
Restylane® is a mark owned by Medicis Pharmaceutical Corporation
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