Swedish Orphan Biovitrum (STO:SOBI) has posted data to support the long-term use of its Biogen ($BIIB)-partnered hemophilia B drug, Alprolix. And with Sobi now set to commercialize the drug in its home territory if the European Medicines Agency (EMA) looks favourably on its submission, shares in the company were buoyed by the news.
Stockholm, Sweden-based Sobi exercised its right to handle commercialization of Alprolix in Europe and a few other territories last month, ratcheting up the importance of the upcoming EMA decision and subsequent talks with national payers for the company. The release of data from the long-term, open-label Phase III trial gives Sobi another piece of evidence on which to base arguments that the drug offers good value to healthcare systems. Patients who took weekly prophylactic doses had median annualized bleeding rates of 2.28, compared to 11.27 who received on-demand treatment.
"Study participants receiving prophylactic treatment continue to experience low bleeding rates during this long-term study. The B-YOND study plays an important role in helping us understand this therapy`s long-term clinical profile and therapeutic value," Barts and the London School of Medicine and Dentistry's Professor John Pasi said in a statement. London is one of 46 locations to host a site involved with the ongoing trial, which is also taking place in Belgium, France, Germany, Italy, Poland and Sweden.
Shares in Sobi ticked upward almost 6% on the day the data were presented. The next big event on the horizon for Alprolix is a decision by EMA. The regulator validated the marketing authorization application for the treatment in June, moving Alprolix a step closer to adding a the European Union to the list of territories in which it is available. Biogen has already picked up regulatory nods for the drug in the United States, Canada, Australia and Japan.
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