Galderma, the leading pharmaceutical company in dermatology, and Ipsen, an international innovation driven specialty pharmaceutical group, announced that Azzalure (botulinum toxin Type A manufactured by Ipsen), a muscle relaxant specifically developed for aesthetic use, has received a marketing authorization 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 seen at the frown (vertical lines between the eyebrows), in adult men and women aged 65 years and under, when the severity of these lines has an important psychological impact on the patient.
The approval was based on several clinical trials involving more than 2,600 patients, which confirmed the safety and efficacy of Azzalure. This new treatment is adapted from Dysport (botulinum toxin type-A), which is already marketed by Ipsen for therapeutic indications and has a 20-year long history of product consistency and safety. Azzalure will come in a very easy to use formulation with a customized dosage that is specifically designed to better meet the aesthetic needs of the patient.
This market authorisation for Azzalure follows the collective green light from 15 European countries' Health Authorities and is one of the several licenses Galderma and Ipsen anticipate in Europe this year. The treatment will be commercially available in the UK by the end of the second quarter 2009.
"Azzalure's Marketing Authorisation is an important event for corrective and aesthetic patients as Galderma develops its distribution in the UK. Patients can look forward to benefiting from Galderma's years of experience in dermatology, and our commitment to providing the highest standards of medical education and training to healthcare professionals. Azzalure is the latest product in our expanding range of dermatology treatments and emphasises our commitment to the future of dermatology" said Larry Potgieter, Galderma's regional director for UK & Northern Europe. The UK Corrective and aesthetic marketplace has been one of the fastest growing in the World. Fuelling much of this growth has been the dramatic rise in the popularity of botulinum toxin procedures with annual growth rates exceeding 25 per cent per annum. The annual value of this market, in purely drug terms, is now estimated to exceed £20million.
Galderma, created in 1981 as a joint venture between Nestlé and L'Oréal, is a global leading pharmaceutical company dedicated to the research, development and marketing of innovative therapeutic, corrective and aesthetic solutions for dermatology patients.