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.
A specialty drug is a class of prescription medications used to treat complex, chronic or rare medical conditions. Although this classification was originally intended to define the treatment of rare, also termed “orphan” diseases, affecting fewer than 200,000 people in the US, more recently, specialty drugs have emerged as the cornerstone of treatment for chronic and complex diseases such as cancer, autoimmune conditions, diabetes, hepatitis C, and HIV/AIDS.
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.