Date: 2016-07-14
Type of information: Distribution agreement
Compound: Ruconest® (Rhucin® in non-European territories - conestat alfa)
Company: Pharming (The Netherlands) Swedish Orphan Biovitrum (Sweden)
Therapeutic area: Rare diseases
Type agreement: licensing commercialisation distribution
Action mechanism:
Disease: acute angioedema attacks in patients with Hereditary Angioedema
Details:
Financial terms: SOBI will over a period of 1 year pay €1.5 million to Pharming for these additional shipments under this order. Under the terms of the distribution partnership, SOBI buys finished product from Pharming for a transfer price that includes a sales related tiered royalty component.
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Latest news: * On July 14, 2016, Pharming and Swedish Orphan Biovitrum (SOBI) announced an amendment of the Ruconest® distribution agreement signed in 2009 with Sobi. In addition to Austria, Germany and Netherlands, Pharming will market Ruconest® directly into an additional 21 countries, effective 1 October 2016. These countries include Algeria, Andorra, Bahrain, Belgium, France, Ireland, Jordan, Kuwait, Lebanon, Luxembourg, Morocco, Oman, Portugal, Qatar, Syria, Spain, Switzerland, Tunisia, United Arab Emirates, United Kingdom and Yemen. To support the commercialization, Pharming will expand the current small European team of experienced HAE marketing and medical affairs specialists. * On October 13, 2014, Pharming and Swedish Orphan Biovitrum (SOBI) announced the amendment and extension of the Ruconest® distribution agreement. Effective immediately, Pharming will focus on direct commercialization in Austria, Germany and Netherlands, and Sobi will extend its Ruconest® sales territory with the addition of Azerbaijan, Belarus, Georgia, Kazakhstan, Russia, Serbia and Ukraine. Pharming has recently started the hiring of a small European team of experienced HAE commercialisation and medical affairs specialists to take-over the direct commercialization activities from Sobi for Ruconest® in Austria, Germany and Netherlands. To ensure a seamless hand- over, in particular to guarantee the continuous availability of Ruconest® to patients and the drug safety monitoring and reporting of Ruconest®, Sobi will continue to deliver Ruconest® as before and will continue the drug safety monitoring and reporting during the remaining months of 2014. * On August 29, 2011, Pharming Group has reached mutual agreement with Esteve to return the rights to market Ruconest® in Spain, Portugal, Andorra and Greece. SOBI will now take up the exclusive distribution rights in these countries, extending its territories for Ruconest® to all European Union countries, Iceland, Norway and Switzerland. The swedish company now has exclusive rights for the commercialization of Ruconest® for the treatment of acute angioedema attacks in patients with Hereditary Angioedema (HAE) in all European markets where the product has received market authorization through central European approval. * On August 15, 2011, Pharming has agreed an extension of its existing agreement with Swedish Orphan Biovitrum (SOBI) to include new territories in the Balkans, North Africa and the Middle East for the commercialization of Ruconest® (recombinant human C1 inhibitor) for the treatment of acute angioedema attacks in patients with Hereditary Angioedema. In addition, SOBI has placed a significant additional order for vials of Ruconest®. The shipment forms part of SOBI's preparation for the continued roll-out and intensified marketing of Ruconest® across Europe.
To ensure a seamless hand-over and guarantee the continuous availability of Ruconest® to patients, Sobi will continue to deliver RUCONEST® and continue the drug safety monitoring and reporting, until 1 October 2016.
