A: Azzalure is Botulinum toxin type A

By Anifat Balogun, MD - Seattle Facial Plastic Surgeon

Azzalure is a botulinum toxin type A that just recently received marketing approval in the UK. Azzalure is made by Ipsen, the same company that makes Dysport, which was finally approved for use in the USA by the FDA at the end of April. Dysport has been in use nearly worldwide for the past 20 years.

A: Azzalure is a type of Botulinum Toxin

By A. Peter Salas, MD - Manhattan Plastic Surgeon

Azzalure is a brand name for a formulation of Botulinum Toxin Type A . The same material that is found in Botox. In the USA the brand name for Azzalure is Dysport. In other words the active ingredient in Azzalure is exactly the same as Dysport. Dysport recently received FDA approval for use.

A: Azzalure is Dysport

Paris (France) and Lausanne (Switzerland), 2 February 2009 – Ipsen (Euronext: IPN), an international innovation-driven specialty pharmaceutical Group, and Galderma, the leading pharmaceutical company in dermatology, today announced that Azzalure®, a muscle relaxant specifically developed for aesthetic use, has received the collective green light from 15 European countries’ Health Authorities for the granting of national marketing authorizations. The assessment was based on clinical trials involving more than 2,600 patients, which confirmed the safety and efficacy of Azzalure®.

Stéphane Thiroloix, Ipsen’s Executive Vice-President in charge of Corporate Development said: “The collective green light from Health Authorities for Azzalure® confirms the quality of our botulinum toxin, backed by solid clinical data. In addition, this decision rewards the great work accomplished by the Ipsen and Galderma teams”. Stéphane Thiroloix added: “Once the local marketing authorizations are granted, we are convinced that Galderma’s expertise and sales force, combined with a product such as Azzalure® will efficiently bring a new treatment alternative and advancement for patients and the medical community”.

“This green light for Azzalure® is a great milestone for Galderma and confirms our company’s entry in the corrective and aesthetic dermatology market. With Azzalure®, we have devoted Galderma’s expertise to helping doctors better address the needs of their patients who want safe and effective results. Once the local marketing authorizations are granted, we will be able to meet these growing expectations rapidly”, said François Fournier, Galderma’s Vice-President of the EURMEAAS Area (Europe, Middle East, Africa, Australia and Asia).

This announcement is part of the partnership established in 2007 between Galderma and Ipsen. Under the terms of this agreement, Ipsen granted Galderma exclusive rights to develop, promote and distribute a specific formulation 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, Ipsen also granted Galderma first rights of negotiation for aesthetic indications in the rest of the world, excluding the United States, Canada and Japan. Besides, 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.

About the Azzalure® indication
Azzalure® is indicated for the temporary improvement in the appearance of moderate to severe glabellar lines (vertical  lines between the eyebrows) seen at the frown, in adult patients under 65 years, when the severity of these lines has an important psychological impact on the patient.

About Ipsen’s botulinum toxin
Ipsen’s botulinum toxin which acts to block acetylcholine release, hence reducing muscular spasm was initially developed for medical indications such as the treatment of motor disorders and various forms of muscular spasticity, including cervical dystonia (a chronic condition in which the neck is twisted or deviated), spasticity of the lower limbs (heal) in children with cerebral palsy, blepharospasm (involuntary eye closure) and hemifacial spasm. It was later developed for the treatment of a wide variety of neuromuscular disorders and aesthetic medicine.
Launched in 1991 in the UK, Ipsen’s botulinum toxin has marketing authorizations in 73 countries and is marketed under the brand name Dysport®.
In February 2007, Ipsen granted Galderma the rights to develop, promote and distribute its botulinum toxin type A for aesthetic use in Europe and certain other territories. Galderma will market the product notably under its own brand name, Azzalure®.
Moreover, in March 2006 Ipsen granted Medicis the rights to develop, promote and distribute its botulinum toxin for aesthetic use in the United States, Canada and Japan under a brand other than Dysport®, which could be Reloxin®.