Ipsen's Azzalure muscle relaxant receives Spanish AEMPS marketing approval

Sep 21 2009

Regulatory News:

Ipsen (Paris:IPN):

• This market authorisation is part of a process including 15 countries in Europe
• Azzalure^® will be commercialised in Spain by Galderma

Galderma, the leading pharmaceutical company in dermatology, and Ipsen (Euronext: IPN), an international innovation-driven specialty pharmaceutical group, today announced that Azzalure^® (botulinum toxin type A manufactured by Ipsen), a local muscle relaxant specifically developed for aesthetic use, has received a marketing authorization in Spain from the Spanish Medicines and Healthcare products Agency (AEMPS) 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 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 Spain by the 4^th quarter 2009. Azzalure^® is commercially available in the UK, France, Germany and the Nordic countries.

“The marketing authorisation of Azzalure^® is a great milestone for corrective and aesthetic patients as Galderma develops its distribution in Spain. 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 Francisco Javier González, Galderma’s General Manager for Spain and Portugal.

www.ipsen.com