Allergan's Botox Product Receives Approval in France for the Treatment of Glabellar Lines -Brow Furrow-.Business Editors/Health/Medical Writers IRVINE, Calif.--(BUSINESS WIRE)--Feb. 25, 2003 New Cosmetic Indication will be Marketed in France as VISTABEL(R) Allergan, Inc. (NYSE NYSE See: New York Stock Exchange :AGN AGN Again (Amateur Radio) AGN Active Galactic Nucleus AGN Acute Glomerulonephritis AGN Accountants Global Network AGN Air Gabon (ICAO code) ) today announced that its BOTOX(R) (botulinum toxin type A botulinum toxin type A Botox, Botox Cosmetic, Dysport (UK), Vistabel (UK) Pharmacologic class: Neurotoxin Therapeutic class: Neuromuscular blocker Pregnancy risk category C Action) product has received the first approval in France by the Agence Francaise de Securite Sanitaire des Produits de Sante (AFSSAPS AFSSAPS Agence Francaise de Securite Sanitaire des Produits de Sante ) for this type of product to treat glabellar lines. In conjunction with this approval, BOTOX(R) will be marketed in France for this use under the name VISTABEL(R). France will act as the Reference Member State in the mutual recognition process for this indication within the European Union European Union (EU), name given since the ratification (Nov., 1993) of the Treaty of European Union, or Maastricht Treaty, to theEuropean Community . This newly approved indication approved indication, n 1. reliable signs that a certain remedy should be used. Not synonymous with “authorized.” 2. FDA-approved condition for a drug or other treatment that allows labeling. is now licensed for use in 19 countries including the United States, Canada, Australia, New Zealand New Zealand (zē`lənd), island country (2005 est. pop. 4,035,000), 104,454 sq mi (270,534 sq km), in the S Pacific Ocean, over 1,000 mi (1,600 km) SE of Australia. The capital is Wellington; the largest city and leading port is Auckland. and Switzerland. Glabellar lines are vertical frown lines that occur between the eyebrows, which are formed by excessive contractions of two of the major muscles in the forehead, the corrugator and procerus muscles. Continued excessive contraction of these two muscles can leave one with a stressed or angry-looking appearance, even when that emotion is not felt. BOTOX(R) COSMETIC/VISTABEL(R) works to relax these muscles by blocking nerve impulses that trigger wrinkle-causing muscle contractions, smoothing and improving the appearance of the frown lines between the brow. Administered in a few tiny injections of purified protein, this minimally invasive treatment is simple and quick and delivers dramatic results with minimal discomfort. Results can be seen as early as 24-48 hours and the effect lasts up to four months. "We are extremely pleased to have received this approval in France for VISTABEL(R). This marks a significant step toward increasing the number of approvals worldwide for this use and we hope to receive additional approvals in 2003 throughout Europe," said Lester J. Kaplan, Ph.D., Allergan's President of Research and Development and Global BOTOX(R). "We believe strongly in the safety and effectiveness of the BOTOX(R) product and are excited to be able to offer this treatment to consumers in France." The safety of BOTOX(R) COSMETIC/VISTABEL(R) as a treatment for wrinkles has been proven in multiple clinical studies. In a 12-month repeated treatment study in the U.S. and Canada, the four-month double-blind, placebo-controlled period that evaluated the efficacy of BOTOX(R) COSMETIC/VISTABEL(R) showed that 80% of those patients treated with BOTOX(R) Cosmetic experienced maximum effect after 30 days. After two additional injections, maximum reduction of glabellar lines was achieved with 89% of the patients. Treatment with BOTOX(R) COSMETIC/VISTABEL(R) should be administered in a medically appropriate setting by a qualified and aesthetic-specialty physician with an in-depth knowledge of facial anatomy. BOTOX(R) COSMETIC/VISTABEL(R) is contraindicated in the presence of infection at the proposed injection site(s) and in individuals with known hypersensitivity hypersensitivity, heightened response in a body tissue to an antigen or foreign substance. The body normally responds to an antigen by producing specific antibodies against it. The antibodies impart immunity for any later exposure to that antigen. to any ingredient in the formulation. The most common side effects Side effects Effects of a proposed project on other parts of the firm. , if any occur, may include headache, respiratory infection, flu syndrome, temporary eyelid eyelid /eye·lid/ (-lid) either of two movable folds (upper and lower) protecting the anterior surface of the eyeball. eye·lid or eye-lid n. droop and nausea. Full prescribing information for BOTOX(R) Cosmetic in the United States is available at www.botoxcosmetic.com. Allergan's BOTOX(R) product carries the unique distinction of being the only product of its kind with over 20 years experience in clinical development and 14 years as a successfully marketed product that has been used in over a million people worldwide. It is currently approved in over 70 countries providing significant clinical benefits for previously untreated disorders in a broad range of neurological and aesthetic conditions including cervical dystonia cervical dystonia Spasmodic torticollis, see there , juvenile cerebral palsy cerebral palsy (sərē`brəl pôl`zē), disability caused by brain damage before or during birth or in the first years, resulting in a loss of voluntary muscular control and coordination. , strabismus strabismus (strəbĭz`məs), inability of the eyes to focus together because of an imbalance in the muscles that control eye movement; also called squint. (crossed eyes), blepharospasm bleph·a·ro·spasm n. Spasmodic winking caused by the involuntary contraction of an eyelid muscle. blepharospasm spasm of the orbicularis oculi muscle of the eyelid. (uncontrollable blinking), post-stroke spasticity spasticity /spas·tic·i·ty/ (spas-tis´i-te) the state of being spastic; see spastic (2). spas·tic·i·ty n. 1. A spastic state or condition. 2. Spastic paralysis. , hemifacial spasm, hyperhidrosis and glabellar lines. BOTOX(R) for aesthetic use is marketed as BOTOX(R)/BOTOX(R) COSMETIC/or VISTABEL(R) depending on the country of approval. Forward-Looking Statements This press release contains "forward-looking statements", such as statements of Dr. Kaplan and statements regarding the effectiveness of the BOTOX(R)product and its potential uses. 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 general industry and pharmaceutical market conditions; general domestic and international economic conditions, such as interest rate and currency exchange rate fluctuations; technological advances and patents attained by competitors; challenges inherent in 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; potential difficulties in manufacturing a new product formulation; domestic and foreign health care reforms; and trends toward managed care and health care cost containment, 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 "Certain Factors and Trends Affecting Allergan and its Businesses" in Allergan's 2001 Form 10-K and Allergan's Form 10-Q for the quarter ended September 27, 2002. Copies of Allergan press releases and additional information about Allergan is available on the World Wide Web at www.allergan.com or you may contact the Allergan Investor Relations Department by calling 714/246-4636. About Allergan, Inc. Allergan, Inc., with headquarters in Irvine, California, is a technology-driven, global health care company providing eye care and specialty pharmaceutical products worldwide. Allergan develops and commercializes products in the eye care, neuromodulator, skin care and other specialty markets that deliver value to our customers, satisfy unmet medical needs, and improve patients' lives. |
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