Date: 2016-01-06
Type of information: Development agreement
Compound: Dysport®/Azzalure® (botulinum toxin type A)
Company: Ipsen (France) Galderma (Switzerland)
Therapeutic area: Aesthetic medicine
Type agreement: R&D development promotion distribution
Action mechanism:
Disease: aesthetic indications
Details: * On December 3, 2012, Ipsen and Galderma have announced that their collaboration for the promotion and distribution of Dysport®, Ipsen’s botulinum toxin type A in aesthetic indications, has been extended. Both companies renewed their collaboration in Brazil and Argentina and extended their partnership to Australia where Galderma has the exclusive promotion and distribution rights for Ipsen’s Dysport® in glabellar lines indication. In Brazil (where Ipsen will continue to promote Dysport® within the neuromuscular disorder indications) and Argentina, the renewed agreements, which will come into force in January 2013, are for an additional five-year period. In Australia, the 5-year exclusive distribution agreement came into force on May 1st, 2012 and the co-promotion agreement came into force on November 23, 2012 in South Korea.Both companies also entered into a co-promotion agreement in South Korea where Galderma and Ipsen will co-promote Dysport® and Restylane®. Under the terms of the agreement signed with Ipsen in 2009, Ipsen granted Galderma exclusive rights to develop, promote and distribute its botulinum toxin type A product in the European Union and certain territories of the Middle-East and Eastern Europe. In Europe, the botulinum toxin type A product, specifically formulated for aesthetic use, is branded under the trademark Azzalure® and is approved for use in aesthetic indications (glabellar lines). Galderma is currently marketing Azzalure® in 16 countries in Europe.
Financial terms: As part of this renegotiated agreement, Galderma will pay €25 million to Ipsen and benefit from improved margins in those territories. Ipsen will manufacture and supply the finished product to Galderma and receive royalties from Galderma.
Latest news: * On January 6, 2016, Ipsen and Galderma announced that they have expanded the geographical scope of their neurotoxin partnership, whereby Galderma acquires the exclusive rights to develop, promote and distribute Dysport® in the aesthetic indications in the APAC Territory (China, India, South Korea and Indonesia under certain conditions).
Ipsen and Galderma initiated their partnership in 2007 for the commercialization of Azzalure® in the aesthetic and dermatology indications in Europe, further extended for Dysport® to Mexico, Brazil, Argentina and Australia. In 2014, the companies significantly strengthened their collaboration by prolonging their partnership until 2036, by expanding the geographical coverage to the US and Canada, and by increasing the scope of their R&D collaboration.
Further to the distribution agreement, Ipsen and Galderma extend their R&D collaboration. Ipsen is running a phase 3 study for Dysport® in Glabellar Lines in China, for which a launch is expected beyond 2020. The clinical study will be funded by Galderma in exchange for the right to use the results of such study to support regulatory filing and commercialize the product in China. In addition, Ipsen acquires the intellectual property for Galderma’s liquid toxin in the APAC territory.
* On July 11, 2014, Ipsen and Galderma announced that they have significantly expanded the scope of their neurotoxin partnership. The partnership on Dysport®/Azzalure® now covers most key territories, representing three quarters of the world market for neurotoxins in aesthetic and dermatology indications. Under the terms of the agreement, the Dysport®distribution rights in the US and Canada, held originally by Valeant, have been included in the partnership between Ipsen and Galderma for the distribution of Dysport®/Azzalure® in aesthetic and dermatology indications.This partnership now covers the US, Canada, Brazil and Europe for a period extending to 2036. As part of this renegotiated agreement, Galderma will pay €25 million to Ipsen and benefit from improved margins in those territories. Ipsen will manufacture and supply the finished product to Galderma and receive royalties from Galderma.
In addition, the companies will increase the scope of their R&D collaboration through which each company will benefit from the other party’s research compounds within its respective and exclusive areas of focus. In this regard, Ipsen will gain control of the intellectual property for Galderma’s liquid toxin in the US, Canada, Brazil and Europe in exchange for a €10 million payment, while Galderma retains commercialization rights.
