Alexion beefs up Soliris IP to help keep biosimilars at bay

By Dan Stanton

- Last updated on GMT

Image: iStock/adrian825
Image: iStock/adrian825
Alexion has strengthened its Soliris (eculizumab) manufacturing IP and is developing a longer-acting C5 antibody ahead of potential biosimilar competition.

Alexion’s lead product Soliris, approved for the treatment of paroxysmal nocturnal hemoglobinuria (PNH) and atypical hemolytic uremic syndrome (aHUS), is one of the most expensive medicines in the world, costing patients as much as £340,200 ($448,000) per year, according to the UK’s National Institute for Health and Care Excellence (NICE).

With its European and US exclusivity set to expire in 2020 and 2021 respectively, several drugmakers, including Amgen, are developing biosimilar versions of the monoclonal antibody.

But with a number of new Soliris patents filed, CEO David Hallal said Alexion is in a “very strong position”​ to protect the bestseller from competition.

“We continue to strengthen our position with additional patents that we have filed for around new indications, method of use, methods of manufacturing, as well as our proprietary business methods for commercializing eculizumab,”​ Hallal said on a conference call discussing Q2 results yesterday.

Last month, the firm was awarded US patent 9,371,377​, a patent based on anti-C5 antibodies having a number of improved properties relative to eculizumab, including for example, increased serum half-life in a human.

“We believe that Soliris is well positioned through the end of this decade and we expect well into the next.”

AbbVie and Humira

Alexion follows the lead of other reference drugmakers in beefing up IP in light of potential biosimilar competition.

AbbVie, for example​, has an extensive estate of over 70 formulation, manufacturing and method of treatment patents for its bestseller biologic Humira (adalimumab). However, the firm is embroiled in several legal challenges from biosimilar makers including Coherus​ and Amgen​, the latter having its candidate up for US FDA review in September​.

Alexion is also developing a longer-acting C5 antibody, ALXN1210, to treat the same indications as Soliris, and while management said it was too early to comment on a go-to-market strategy, it too could help protect from biosimilar erosion.

The candidate is in Phase I/II clinical studies and Alexion is targeting an approval date in 2018 for the PNH indication.

For the three months ending June 30, Alexion reported total Soliris sales of $701m, up 10% on the same period last year.

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