Alexion moves to bolster patent protection of Soliris

Alexion announced that it had been granted three new patents for its lead product that will run through until 2027. This decade of breathing room would be particularly welcome, as the drug is a particular target for the creation of a biosimilar.

The patents relate to the composition of matter of Soliris, pharmaceutical formulations and also methods of treating paroxysmal nocturnal haemoglobinuria (PNH). The company also announced that it plans to follow up these patents in other regions, such as in the European Union and Japan.

PNH is a rare disease of the blood that can potentially be fatal if not treated. Numbers of people affected is not known, though, in North America, it is estimated that 10,000 to 21,000 could have the condition and approximately 1,700 new diagnoses occur each year. This means it is not a particularly huge market for Alexion but with the cost of the drug so high, it is still a market worth protecting.

The huge cost of the drug, in the region of £340,200 in the UK and $409,500 in the US, means it brings in substantial profits but makes it an attractive target to rival. Amgen, for one, considers the potential profit to be worth the inevitable legal battles and costs of developing a biosimilar by beginning clinical trials on its own candidate. It has already completed a Phase 1 trial for PNH indication and in Haemolytic uraemic syndrome in Australia.

"Alexion is the leader in complement biology and has invested decades of ground-breaking research and development in Soliris. We continue to strengthen our patent portfolio around this unique complement inhibitor," said Ludwig Hantson, Chief Executive Officer of Alexion. "These new patents work in concert with other patents and regulatory exclusivities to protect Soliris in all indications."