Tony Hagen is senior managing editor for The Center for Biosimilars®.
In a settlement announced via a Securities and Exchange Commission filing, Alexion said it had settled with Amgen over eculizumab patent disputes, allowing Amgen to bring a competing biosimilar to market in 2025.
A recent settlement over patent challenges will enable Amgen to bring its biosimilar for eculizumab to market March 1, 2025, giving originator company Alexion breathing space to bolster its revenue base by developing sales of a follow-on product.
Alexion announced in a May 29, 2020, Securities and Exchange Commission filing that it has settled 3 inter partes patent challenges initiated by Amgen, which seeks to gain a share of the nearly $4 billion in yearly revenue generated by Alexion’s eculizumab (Soliris) product for paroxysmal nocturnal hemoglobinuria (PNH), an ultra-rare disease.
PNH is a rare blood disease characterized by the breakup of red blood cells due to the absence of a protein that protects the cells against the immune system. Alexion’s Soliris costs about $500,000 per patient, per year, making it one of the most costly medicines.
It is also by far the highest revenue-generating agent in Alexion’s drug portfolio. In 2019 the drug generated $3.95 billion in sales, which made up the majority of Alexion’s $4.99 billion 2019 revenue haul.
A follow-on product Alexion has developed for PNH is ravulizumab (Ultomiris) has shown marginally better efficacy and is rapidly growing in sales as Alexion works to convert Soliris patients and generate loyalty to the replacement product.
Ultomiris brought in $222.8 million in revenue in the first quarter of 2020 alone, as opposed to $338.9 million in all of 2019.
A key selling point from the consumer perspective is that Ultomiris requires intravenous administration every 8 weeks as opposed to every 2 with Soliris, which reduces the number of doses needed per year to 6 from 26.
Although Alexion has sought to move its Soliris PNH patients over to Ultomiris to defend against loss of eculizumab market share to biosimilars, Soliris’ sales have continued to rise, thanks in part to the addition of new indications, for generalised myasthenia gravis and neuromyelitis optica spectrum disorder, also both rare diseases. Soliris generated $1 billion in net sales in the first quarter of 2020, up from $962 million in the comparable year-ago quarter.
The settlement reached on the patent challenges before the Patent Trial and Appeal Board of the US Patent and Trademark Office grants Amgen a nonexclusive, royalty-free license to manufacture and market biosimilar eculizumab in the United States.
Amgen’s eculizumab biosimilar candidate is ABP 959, and phase 1 trial findings supporting pharmacokinetic and pharmacodynamic equivalence were released last year.
A randomized, double-blind, controlled phase 3 study of ABP 959 is underway in patients with PNH to compare the biosimilar candidate with the reference product on basis of efficacy and safety.
Roche, Novartis, and Akari have previously initiated development of other potential competitors to eculizumab.