BioCryst Pharmaceuticals Inc’s oral drug found effective in preventing from hereditary angioedema (HAE). HAE is a disease in which patient suffers from sudden attacks of swelling of the skin or mucous membranes, which can be disfiguring, painful and even fatal.
If it approves, it would be the first oral medicine of its kind. While other medicine like Shire Plc’s Firazyr, Dyax Corp’s Kalbitor and CSL Behring’s Berinert are injected to manage attacks after they occur, BioCryst’s oral preventive would directly compete with Shire’s injectable Cinryze.
BioCryst said in a statement on Tuesday that, “Patients given the drug, BCX4161, in a mid-stage trial had an average rate of 0.82 attacks per week, compared with 1.27 for those given a placebo.”
BioCryst’s CMO William Sheridan said that, “We don’t intend to study the drug head to head against Cinryze. We’d like to make Cinryze obsolete because it’s an IV therapy”.
According to analysts because of the strong patient preference for an oral therapy, it would be hard to see how there wouldn’t be significant competitive advantage for BioCryst’s drug.
HAE
BioCryst’s study verified the safety and effectiveness of a 400 mg dose of the drug managed three times a day for 28 days in patients with high HAE. Patients given the drug have experienced attack-less 22days, compared with 19 days for those given the placebo.
BioCryst plans to conduct a 12-week trial for the drug in the second half of this year on more population of HAE.
H.C. Wainwright & Co analyst Andrew Fein expected the drug to be launched in the United States in 2017 and estimated peak U.S. sales of $1.2 billion by 2031.
