The assessment was based on clinical trials involving more than 2,600 patients, which confirmed the safety and efficacy of Azzalure. This announcement is part of the partnership established in 2007 between Galderma and Ipsen.
Galderma will pay up to E20 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.
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.
Stephane Thiroloix, Ipsen’s executive vice president 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 team.
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.