Shares of Alexion fell more than 11 percent Friday as the office instituted an inter partes review for the drug, Soliris, in the blood disorder paroxysmal nocturnal hemoglobinuria.
Soliris, the drugmaker's cash cow approved for the same disease, faces biosimilar competition as patent expiry looms.
Munck Wilson Mandala Partner Greg Howison shared his perspective on some of the legal ramifications around AI, IP, connected devices and the data they generate, in response to emailed questions.
After a slow start, the race is on to inhibit key proteins and pathways within the complement system -- a biological cascade that is central to the innate immune system and many different diseases. As an added incentive, the one drug approved in this space is priced at $440,000 per year.
Alexion's CEO and CFO abruptly departed in December, there's allegation of sales fraud, and its 10-Q for the third quarter remains outstanding. The company really needed some good news, but its Phase 2/3 study of Soliris in delayed graft function just didn't deliver.