Ipsen: AZZALURE(R) Approved In Spain For Aesthetic Use In The Treatment Of Glabellar Lines

Main Category: Cosmetic Medicine / Plastic Surgery
Also Included In: Regulatory Affairs / Drug Approvals
Article Date: 21 Sep 2009 - 5:00 PDT

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Galderma, the leading pharmaceutical company in dermatology, and Ipsen (Euronext: IPN), an international innovation-driven specialty pharmaceutical group, 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 4th 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.

About the agreement

This announcement represents the latest developments in a partnership established in 2007 between Galderma and Ipsen. Under the terms of this agreement, Galderma has been granted by Ipsen exclusive rights to develop, promote and distribute Azzalure®, a customized dosage of its botulinum toxin type A product Dysport®, for aesthetic indications. This agreement includes the European Union and certain territories of the Middle East and Eastern Europe. In addition, Galderma has also been granted first rights of negotiation for aesthetic indications in the rest of the world, excluding the United States, Canada and Japan. Last December 2007 Ipsen and Galderma entered into another partnership for the exclusive promotion and distribution of Ipsen's botulinum toxin type A product, for use in aesthetic medicine and dermatological indications in Brazil, Argentina and Paraguay.

Galderma will pay up to €20 million to Ipsen upon the achievement of certain milestones, including local market approvals and product launches in certain territories. Ipsen will manufacture and supply Galderma's finished product at a fixed supply price. In addition, Galderma will pay royalties on net sales to Ipsen.

Source
Galderma