The deal, which gives Biogen a license to Forward Pharma’s intellectual property, could help the US company extend the life of Tecfidera.
Under several circumstances outlined in the deal, Biogen will pay Forward Pharma royalties on net sales of its products for the treatment of multiple sclerosis that are covered by a Forward Pharma patent and have dimethyl fumarate (DMF) as an active pharmaceutical ingredient.
Biogen stated that the agreement will not put an end to the pending issues in either of the ongoing Opposition Proceeding in the European Union or the Interference Proceeding in the US.
Biogen CEO Michel Vounatsos said: “We are very pleased to have reached this settlement with Forward Pharma. We believe this agreement will clarify and strengthen our intellectual property for TECFIDERA, the leading oral therapy for multiple sclerosis.”
The deal is subject to the approval of the shareholders of Forward Pharma besides other customary conditions.
Both the pharma companies plan to permit the Patent Trial and Appeal Board (PTAB), the US Court of Appeals for the Federal Circuit, the European Patent Office, and the Technical Board of Appeal and the Enlarged Board of Appeal, make a final determination in the proceedings before them.
Forward board of directors chairman Florian Schönharting said: “This agreement limits our downside risk should we not be successful in either the US or European proceedings and it provides clarity as to our royalty stream should we be successful in either or both of those proceedings.
“We continue to believe in the strength of Forward’s positions in the pending proceedings and this settlement allows those cases to continue to move forward to final decisions while delivering Forward an immediate cash payment of $1.25bn.”
The Danish pharma could get royalties of 10% of Tecfidera’s net sales from 2021 and 20% of the drug’s net sales from 2029 from Biogen, subject to the result of certain current litigation and the receipt of regulatory approvals.