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 Germany from the regulatory authorities (Bundesinstitut für Arzneimittel und Medizinprodukte) 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. Azzalure is adapted from Dysport (botulinum toxin type-A), which is already marketed by Ipsen for a variety of indications and has a 20-year long history of product consistency and safety. Azzalure will come in a very easy to use customized dosage that is specifically designed to better meet the patient and physician need.
This marketing 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. Azzalure will be commercially available in Germany by the beginning of the 3rd quarter 2009. "Azzalure's marketing authorisation is an important event for patients who need corrective and aesthetic procedures. 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 emphasizes our commitment to the future of dermatology," said Marc Wannhoff, general manager of Galderma Germany.
The world Corrective and Aesthetic marketplace was estimated in 2008 to 5 billion euros by Medical Insight (report published last year). Its growth could reach up to 10% in 2009. In Europe, the average annual growth expected between 2009 and 2012 is 13.2%, driven by dramatic rise in the popularity of easy to use and non invasive treatments, such as botulinum toxin procedures, that already represent 60% of specialist procedures in Europe.
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.
Ipsen is an innovation-driven international specialty pharmaceutical group with over 20 products on the market and a total worldwide staff of nearly 4,200.