- Alexion Pharmaceuticals Inc. has beefed up defenses around its most important franchise, disclosing Tuesday it secured three new patents for its rare disease drug Soliris.
- To be clear, the patents are all continuations of ones the U.S. Patent and Trademark Office previously OK'd. Respectively, they pertain to Soliris' composition of matter — including its heavy and light amino acid chains and any molecules that share the same sequences, the drug's pharmaceutical formulations and how it treats patients with paroxysmal nocturnal hemoglobinuria (PNH).
- The new patents will run into 2027. They will also " work in concert with other patents and regulatory exclusivities to protect Soliris in all indications," Alexion's CEO Ludwig Hantson said in an Aug. 15 statement.
Pharmaceutical companies searching for something to keep their aging products lucrative often try to lock down new patents or extensions as a way to stave off copies from rival drugmakers stealing market share.
Yet, patents' power has begun to wane as of late. A report from QuintilesIMS published in January, for instance, found that recently approved drugs are retaining their exclusivity about three years less than those that came to market in the late 1990s.
That trend can be particularly problematic for drugmakers that rely on a single medicine for the bulk of their revenue, such as Alexion. During the second quarter, Soliris (eculizumab) had net product sales of $814 million, accounting for nearly 90% of its parent company's total net product sales for the period.
Soliris is a monoclonal antibody that functions as an inhibitor to the end piece of the immune system's complement cascade, which research has shown plays a role in PNH development. The drug gained its first FDA approval in 2007 as a treatment for disease, and secured thumbs up from the agency in 2011 for another rare condition, atypical hemolytic uremic syndrome (aHUS).
"Alexion is the leader in complement biology and has invested decades of ground-breaking research and development in Soliris," company CEO Ludwig Hantson said in the Aug. 15 statement. "We continue to strengthen our patent portfolio around this unique complement inhibitor."
Soliris remains protected by regulatory exclusivity until 2019 and orphan drug exclusivity through aHUS until 2018, according to a regulatory filing.
Though the PNH market isn't large, Alexion isn't chancing losing it. In addition to the new patents, the company has a longer-acting anti-C5 antibody dubbed ALXN1210 in late-stage development as a PNH therapy. Alexion has indicated that ALXN1210 is one of its key growth drivers moving forward.