Under the terms of the agreement, Shield will receive an immediate £11 million upfront payment, is eligible to receive up to €4.5m in short-term development milestones and up to €50m in sales milestones upon the achievement of specified targets. Shield will also receive tiered royalties ranging from 25% to 40% of net sales of Feraccru.
This long-term exclusive licence grants Norgine the right to commercialise Feraccru® in the UK, France, Germany, Italy, Spain and all other European countries which are not already covered by Shield’s previously announced licence agreements with AOP Orphan Pharmaceuticals AG and Ewopharma AG, as well as in Australia and New Zealand (the “Licensed Territories”).
Shield retains full ownership of the global intellectual property rights to Feraccru® including responsibility for the completion of the ongoing AEGIS-H2H study, a planned phase 3 paediatric study and any further significant development of the product.
Shield also retains full commercial rights to Feraccru® in all countries not covered by the licence agreements with Norgine, AOP Orphan Pharmaceuticals AG and Ewopharma AG.
Within the Licensed Territories, Norgine will be responsible for obtaining and maintaining regulatory and pricing approvals as well as all commercial activities, including post-marketing studies; while Shield will be responsible for, and bear the costs of, manufacturing and supply.
The financial terms of the agreement significantly extend Shield’s cash runway, enabling the Group to continue the development of Feraccru®, including the US NDA application, as well as pursue further opportunities to out-licence Feraccru® and exploit the Group’s other assets.
Shield Therapeutics CEO Carl Sterritt said: “I am delighted to announce this agreement with Norgine, which will significantly accelerate the commercialisation of Feraccru® in Europe. They have an excellent track record of commercial success with specialty pharmaceutical products and we have been impressed with their determination to succeed in this competitive licensing process.
“With their established infrastructure and commercial expertise, they will be a valuable partner for Shield and Feraccru® and this agreement should quickly see many more patients in Europe benefiting from Feraccru’s unique and outstanding characteristics, which differentiate it from existing oral and intravenous therapies for the treatment of iron deficiency.
Furthermore, the transaction significantly extends Shield’s previously reported cash runway, allowing us to continue the development of Feraccru in the USA and elsewhere and, with patent protection through 2035, it will allow our shareholders to have a significant share in the long-term success of Feraccru.
Norgine chairman and CEO Peter Stein said: “This agreement is an affirmation of our commitment to build a strong late-stage portfolio of transformative products for patients in Europe, Australia and New Zealand. We believe that Feraccru® is an important advance in the treatment of iron deficiency and we look forward to making Feraccru® a success for patients in need.”
Source: Company Press Release