BOTOX(R) Makers Get UK Approval For VISTABEL For Cosmetic Use For The Treatment Of Glabellar Lines (Vertical 'Frown' Lines)

Main Category: Cosmetic Medicine / Plastic Surgery
Article Date: 19 Mar 2006 - 0:00 PST

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Allergan Ltd. today announced that VISTABEL(R) (botulinum toxin type A) has been granted a licence in the UK from the Medicines and Healthcare products Regulatory Agency (MHRA) for the temporary improvement in the appearance of moderate to severe glabellar lines (vertical 'frown' lines between the brows) in adult women and men aged 65 and younger, when the severity of these lines has a psychological impact for the patient. With dosing specific to treat glabellar lines, BOTOX(R) for cosmetic use will be marketed in the UK under the brand name VISTABEL(R) and is the only brand of botulinum toxin type A licensed for cosmetic use in the UK.

"VISTABEL(R) has proven to be an effective treatment option for minimising wrinkles between the brows, achieving a naturally refreshed and relaxed upper face rejuvenation that so many people are seeking today," said Dr Nick Lowe, Consultant Dermatologist, Cranley Clinic, London. "The licensing of VISTABEL(R) reinforces that this is a product with an established safety profile with demonstrated benefits that result in high levels of patient satisfaction."

VISTABEL(R) works in a targeted way to relax the specific muscles that cause frown lines to form by blocking nerve impulses that trigger wrinkle-causing muscle contractions with the temporary effect lasting for up to four months.1 VISTABEL(R) is a prescription-only product and should only be administered in a medically appropriate setting.

Data show that botulinum toxin type A is well tolerated and that it is an effective treatment for reducing the severity of glabellar lines,1,2 with treatment achieving high levels of patient satisfaction.1 A retrospective review of long-term safety data compiled during more than 15 years of botulinum toxin type A use found that the product has a good safety profile and is well-tolerated when used for multiple treatment sessions over extended periods of time and when administered by a qualified and trained healthcare professional.3 Additionally, a recent systematic review and meta-analysis of clinical trials published between 1986 and 2002 shows that botulinum toxin type A has a favourable safety and tolerability profile across a broad spectrum of cosmetic and therapeutic indications.4

Based on controlled clinical trial data, the proportion of patients that would be expected to experience an adverse reaction after treatment with VISTABEL(R) is 23.5% versus 19.2% with placebo. Most adverse events reported are of mild to moderate severity and these adverse reactions may be related to treatment, injection technique or both. In general, adverse reactions occur within the first few days following injection and are transient. With more than 1,965 publications on botulinum toxin type A in scientific and medical journals, botulinum toxin is a widely researched medicine.

"We are delighted to have received cosmetic approval for VISTABEL(R) in the UK," said Judy Williams, BOTOX(R) Business Unit Director, Allergan, UK. "VISTABEL(R) shares the heritage of BOTOX(R) as an important versatile medicine that for more than 15 years has demonstrated its established safety profile, efficacy and unique versatility in addressing patients' medical needs."

Since 1989, BOTOX(R) has been approved for 20 indications in more than 75 countries and is prescribed to patients who suffer from a range of serious or debilitating disorders, as well as to those with cosmetic needs. In the UK, BOTOX(R) is licensed for six therapeutic indications: hemifacial spasm, blepharospasm, cervical dystonia, focal spasticity in paediatric cerebral palsy, severe axillary hyperhidrosis and upper limb spasticity in adult post-stroke patients.

Both BOTOX(R) and VISTABEL(R) are Allergan's brands of botulinum toxin type A, a purified protein derived from the bacterium Clostridium botulinum. Health authorities in some countries, including the MHRA in the UK, require that BOTOX(R) for cosmetic use be renamed to clearly distinguish between therapeutic and cosmetic use of the product. With dosing specific to treat frown lines between the brows, BOTOX(R) for cosmetic use is now marketed as BOTOX(R) Cosmetic in the U.S. and Canada; as VISTABEL(R) in the UK, France, Spain, Switzerland and many other EU countries; and as VISTABEX(R) in Italy.

About Allergan

Allergan, Inc. with UK offices in High Wycombe, Bucks and worldwide headquarters in Irvine, California, US, is a technology-driven, global health care company providing specialty pharmaceutical products worldwide. Allergan develops and commercialises products in the ophthalmology, neurosciences, medical dermatology, medical aesthetics and other specialty markets that deliver value to its customers, satisfy unmet medical needs, and improve patients' lives. http://www.allergan.co.uk

The BOTOX(R) name is a trademark and a proprietary pharmaceutical product name owned by Allergan, Inc. and is registered in the US and over 90 other countries, including EU countries. The BOTOX(R) trademark identifies the botulinum toxin type A purified neurotoxin complex product manufactured and sold by Allergan. Use of the trademark "BOTOX(R)" distinguishes that product from different botulinum toxin products manufactured and sold by others. Accordingly, any use of the BOTOX(R) trademark refers only to the product that is manufactured by Allergan References:
1. Bowler PJ. A retrospective study in the use of botulinum toxin type-A in a UK multidisciplinary cosmetic practice. Journal of Cosmetic Dermatology 2005;4:89-92.
2. Carruthers JA, Lowe NJ et al. A multicentre, double-blind, randomized, placebo-controlled study of the efficacy and safety of botulinum toxin type A in the treatment of glabellar lines. J Am Acad Dermatol June 2002; 46(6):840-9.
3. Carruthers J, Carruthers A. Data presented at the American Academy of Dermatology (summer meeting), July 2004.
4. Naumann, M., Jankovic, Safety of botulinum toxin type A: a systematic review and meta-analysis. J Curr Med Res Opin. 2004;20:981-990.
5. VISTABEL(R) Summary of Product Characteristics. Available at http://www.emc.medicines.org.uk.

Allergan Ltd.
Coronation Road
High Wycombe
Bucks HP12 3SH
UK
(01494) 444722
http://www.allergan.co.uk