Rare drug Ultomiris posts KRW 40 billion in sales in 3 yrs

Soliris follow-on drug… improved convenience in intake from ‘every 2 weeks →8 weeks’

Posts sales of KRW 19.5 billion, KRW 43.1 billion, and KRW 37.8 billion by Q3 in 2021,2022,2023, respectively

Costs KRW 5,598,942 per 30ml vial…offers financial savings over existing drugs

Becoming a KRW 40 billion blockbuster in just 3 years since its launch, the growth potential of AstraZeneca’s Ultomiris Inj (ravulizumab) is gaining industry-wide attention.

 

The biological orphan drug Ultomiris Inj.

 

is considered to be the successor to Soliris Inj.

 

(eculizumab) with significant improvements in dosing convenience.

 

The drug was approved in June 2021 at a reimbursed price of KRW 5,598,942 for the 30 ml vial and is indicated for paroxysmal nocturnal hemoglobinuria (PNH) and atypical hemolytic uremic syndrome.

 

By Q3 2021, 2022, 2023, Ultomiris has generated sales of KRW 19.5 billion, KRW 43.1 billion, and KRW 37.8 billion, respectively.

 

Ultomiris is administered every 8 weeks as a maintenance dose (through intravenous infusion 2 weeks after administering a loading dose based on body weight).

 

In contrast, Soliris is dosed with weekly intravenous infusions for the first 4 weeks, followed by a 5th dose 7 days after the fourth dose, and then every 2 weeks thereafter.

 

While Ultomiris is a follow-on to Soliris, it is notable that Soliris still maintains sales as a blockbuster drug that posts sales in the KRW 10 billion range, by securing indications such as systemic myasthenia gravis and neuromyelitis optica spectrum disorder.

 

Soliris had generated KRW 43.8 billion to KRW 43.9 billion in sales in 2019-2020 before the launch of Ultomiris.

 

Since then, it has maintained sales of KRW 31 billion, KRW 10.1 billion, and KRW 6.4 billion through Q3 in 2021, 2022, and 2023, respectively.

 

In addition, Soliris has undergone two drug price cuts from KRW 6,138,844 in February 2017 and is currently priced at KRW 5,132,364 per 30ml vial.

 

PNH is a life-threatening rare blood disease characterized by the destruction of red blood cells by the complement component that is part of the immune system.

 

Without treatment, 4 out of 10 patients die within 5 years after diagnosis.

 

In Korea, around 200 patients suffer from PNH.

 

Until Ultomiris’s launch in Korea in 2012, Soliris was the only treatment for PNH and was shown to improve the 5-year survival rate by 95.5%.

 

Meanwhile, Ultomiris’s efficacy was demonstrated through 2 prospective studies (Study 301 and Study 302) that were conducted on PNH patients.

 

In both studies, Ultomiris demonstrated non-inferiority compared to Soliris in the primary efficacy endpoints of avoidance of the need for transfusions, LDH normalization, and LDH change rate, as well as in the secondary endpoints of LDH change rate, change in the quality of life (FACIT-Fatigue), breakthrough hemolysis, and proportion of patients with stabilized hemoglobin.

 

In addition, a preference assessment study that was conducted as an extension study in patients with paroxysmal nocturnal hemoglobinuria who were previously treated with both Soliris and Ultomiris showed that 93% of patients preferred Ultomiris.