Alexion wins 3 new Soliris patents as Amgen works on biosimilar of pricey drug

With a Soliris biosimilar showing up in its rearview mirror, Alexion is piling on patents for its superexpensive drug, hoping to put some more distance between it and any sales-grabbing copies.  

The New Haven, Connecticut-based drugmaker announced today that it has won three new patents for the rare-disease drug that are valid until 2027, six and seven years beyond its current EU and U.S. patent expirations. They cover its active ingredient eculizumab, its formulations and a method of treating the ultra rare, but potentially fatal, paroxysmal nocturnal hemoglobinuria.

"We continue to strengthen our patent portfolio around this unique complement inhibitor," Ludwig Hantson, the recently appointed CEO, said in a statement. "These new patents work in concert with other patents and regulatory exclusivities to protect Soliris in all indications."

Soliris, which lists for more than $500,000 per patient year, is one of the most expensive drugs in the market and brought in more than $2.8 billion a year for the drugmaker. It is projected to hit up to $5.6 billion in sales by 2020. And U.S. biotech Amgen hopes to capture some of that cash when Soliris patents can be penetrated. Eculizumab is one of six biologics Amgen this year reported in its biosimilar pipeline.

The threat comes at a difficult time for Alexion, which turned over pretty much its entire C-suite late last year after a sales fraud investigation that ultimately showed the company’s higher-ups had inappropriately pressured staff to pad sales of lead med Soliris. On top of that, federal investigators are looking at Alexion’s support of organizations that help Medicare patients and Brazilian authorities in May raided the company’s Sao Paulo, Brazil, offices as part of a probe into whether the company had subsidized lawsuits for patients to gain Soliris access.

Also, recently launched rare-disease med Kanuma, acquired in Alexion’s $8.4 billion Synageva buyout, has also been struggling mightily, prompting some FirecePharma readers to nominate that deal as one of the biggest duds of the decade.