UNITED KINGDOM –AstraZeneca’s Alexion will pay US$775 million to Roche’s subsidiary, Chugai Pharmaceutical to resolve all patent disputes related to the C5 inhibitor Ultomiris (ravulizumab), the two companies have said.

As both firms pointed out, the one-time payment will put an end to the legal squabble once and for all—no other payments or sales-based royalties are included in such patent settlements.

With this settlement, we will continue to advance our Ultomiris development programs in new indications and focus on our mission to transform the lives of people affected by rare diseases,” Alexion CEO Marc Dunoyer said in a statement.

In late 2018, Chugai filed lawsuits in the United States and Japan, accusing Alexion of infringing on its patents relating to the time an antibody drug can remain active in the body.

Alexion has also challenged several of Chugai’s patents in Japan and Europe since 2016, and has won a couple of cases where its competitors’ patents were invalidated.

Chugai was still appealing some of those rulings at the time of the settlement. The current settlement covers Chugai’s two lawsuits against Alexion.

Ultomiris, an antibody that targets complement C5, is Alexion’s follow-up medication to Soliris. While the predecessor is administered every two weeks, Ultomiris is administered every eight weeks after a loading dose.

AZ took over control of the C5 franchise through its US$39 billion acquisition of Alexion last year. Since the transaction was completed, the company’s primary focus has been on transitioning patients from Soliris to Ultomiris.

With the patent settlement, AZ can concentrate on growing Ultomiris.

Alexion has converted more than 70% of Soliris’ patients with paroxysmal nocturnal hemoglobinuria (PNH) to Ultomiris.

AZ has experienced a COVID-related slowdown in atypical hemolytic uremic syndrome, which is mostly treated in hospitals or emergency rooms, Dunoyer told investors during a call about the company’s fourth-quarter earnings in February.

AZ is now preparing for Ultomiris’ next phase of growth, which will include a couple of anticipated neurology indications.

The FDA has prioritized Ultomiris’ application in generalized myasthenia gravis (gMG), with a decision expected in the second quarter.

Ultomiris data in neuromyelitis optica spectrum disorder is also expected later this year, according to the company.

The expansion comes as new competitors vie for a piece of AZ’s blockbuster franchise. Empaveli, a C3 inhibitor from Apellis, is also active in paroxysmal nocturnal hemoglobinuria (PNH), and Vyvgart, a newly approved Neonatal Fc receptor (FcRn) inhibitor from Argenx, is active in gMG.

UCB recently reported positive phase 3 data for the C5 candidate zilucoplan and the FcRn drug rozanolixizumab in gMG.

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