Otsuka Pharmaceutical has expanded its licensing agreement with US-based Ionis Pharmaceuticals for the latter’s hereditary angioedema (HAE) drug candidate donidalorsen.
The expanded agreement gives the Japan-based Otsuka Pharmaceutical exclusive rights across the Asia-Pacific region for the investigational drug.
Donidalorsen is a Ligand-Conjugated Antisense (LICA), RNA-targeted prophylactic candidate designed to target prekallikrein (PKK), associated with HAE.
As per the agreement, the Nasdaq-listed Ionis Pharmaceuticals will retain primary responsibility for the development of the drug candidate.
On the other hand, Otsuka Pharmaceutical will oversee territory-specific development, regulatory filings, and commercialisation in the Asia-Pacific region and Europe.
Ionis Pharmaceuticals intends to submit a new drug application to the US Food and Drug Administration (FDA) this year and plans to independently launch donidalorsen in the US upon approval.
Both firms had previously announced a licensing agreement for the drug candidate in Europe.
Additionally, Otsuka Pharmaceutical is preparing to file a marketing authorisation application with the European Medicines Agency this year.
Under the new Asia-Pacific agreement, Ionis Pharmaceuticals will get an upfront payment of $20m.
The American biotechnology firm will also be entitled to get milestone payments which will be contingent on meeting regulatory and sales targets.
It will also be eligible for tiered royalties, structured similarly to the terms of the European agreement signed in December last year.
Ionis Pharmaceuticals CEO Brett Monia said: “Ionis and Otsuka share a steadfast commitment to bring donidalorsen to as many people living with HAE as possible.
“We look forward to working alongside Otsuka to advance regulatory discussions across Europe and the Asia-Pacific region based on our positive Phase 3 results for donidalorsen, which were presented late last month.
“In the US, we’ve built a robust commercial infrastructure in preparation for our near-term anticipated launches for olezarsen in familial chylomicronemia syndrome and donidalorsen in HAE.”
Recently, Ionis Pharmaceuticals announced positive results for the HAE candidate from the Phase 3 OASIS-HAE and OASISplus trials.
