AstraZeneca and Roche recently decided to end a patent infringement fight around Ultomiris. Now, we know the price of the deal.
AstraZeneca’s Alexion will pay $775 million to Roche’s Chugai Pharmaceutical to resolve all patent disputes related to the C5 inhibitor, the two companies said Thursday.
As both firms noted, the one-time payment will put an end to the legal tussle once and for all—no other payment or sales-based royalties that are typical in such patent settlements are included.
“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.
Chugai filed lawsuits in the U.S. and Japan in late 2018, accusing Alexion of infringing its patents relating to the time an antibody drug can remain active in the body. Since 2016, Alexion has also challenged several of Chugai’s patents in Japan and Europe and scored a couple of wins where its rivals patents were invalidated. At the time of the settlement, Chugai was still appealing some of those rulings.
The current settlement covers the two lawsuits Chugai has against Alexion.
Ultomiris, an antibody targeting the complement C5, is a follow-up med to Alexion’s Soliris. While the predecessor is given every two weeks, Ultomiris is dosed every eight weeks following a loading dose.
AZ took over control of the C5 franchise through its $39 billion acquisition of Alexion last year. Since closing the deal, the company's focus has consistently been on switching patients from Soliris to Ultomiris. With the patent settlement, AZ can focus on expanding Ultomiris.
Alexion has converted more than 70% of Soliris’ paroxysmal nocturnal hemoglobinuria (PNH) patients to Ultomiris. Still, AZ has hit a COVID-related slowdown in atypical hemolytic uremic syndrome, which is mostly treated in hospital or emergency settings, Dunoyer told investors during a call about AZ’s fourth-quarter earnings in February.
AZ is now gearing up for Ultomiris’ next phase of growth with a couple anticipated neurology indications. Ultomiris’ application in generalized myasthenia gravis (gMG) is under FDA priority review with a decision expected in the second quarter. The company also expects Ultomiris data in neuromyelitis optica spectrum disorder later this year.
The expansion comes as new competitors are lining up to take a shot at AZ’s blockbuster franchise. Apellis’ C3 inhibitor Empaveli is also playing in PNH, and Argenx’s newly approved FcRn inhibitor Vyvgart is targeting gMG. UCB has recently reported positive phase 3 data for C5 candidate zilucoplan and FcRn drug rozanolixizumab in gMG.