AstraZeneca’s Alexion agrees on $775m settlement with Chugai for Ultomiris

AstraZeneca’s (AZ) rare disease group subsiduary Alexion has reached a settlement agreement with Chugai Pharmaceutical Co (Chugai). The agreement resolves all patent disputes between the two companies regarding Ultomiris (ravulizumab) – Alexion’s long-acting complement C5 inhibitor for haemolytic uraemic syndrome (HUS) and paroxysmal nocturnal haemoglobinuria.

According to the settlement agreement, the two companies have agreed to withdraw patent infringement proceedings filed with the US District Court for the District of Delaware and Tokyo District Court.

Under the agreed terms of the settlement, Alexion will make a single payment of $775m in the second quarter of 2022, which includes no additional payments, aside from a single lump sum payment which is scheduled to be made in the second quarter.

Marc Dunoyer, chief executive officer, Alexion, said: “With this settlement, we will continue to advance our Ultomiris development programmes in new indications and focus on our mission to transform the lives of people affected by rare diseases.”

Commenting on the agreed settlement, AstraZeneca said the agreement would be recorded as a non-core charge in its second-quarter results. For Chugai, the company said the affect on its financial results for the financial year ending December 2022 ‘is currently under review’.

Ultomiris is a follow-up to Alexion’s best selling treatment Soliris (eculizumab), which is approaching the end of its patent life, while other drug manufacturers produce biosimilar competitors.

Compared to Soliris, with a dosing regimen of every two weeks, Ultomiris requires dosing every eight weeks. The company hopes that sales of the newer treatment will be driven by a reduced frequency, while also maintaining the ability to defend the future of the C5 inhibitor franchise.

AstraZeneca and Alexion are in the process of developing Ultomiris for generalised myasthaenia gravis and neuromyelitis optica spectrum disorder, while also working to produce a new subcutaneous formulation of the medicine which would give patients the ability to administer it themselves, rather than having to have an intravenous treatment at a clinic or hospital.