The first patients have been enrolled in a real-world study of Sobi’s haemophilia A therapy Elocta aimed at showing its benefits to “physicians, patients and reimbursement authorities”.
The study – called A-SURE – takes the form of a 24-month assessment of Elocta (efmoroctocog alfa) in European haemophilia patients taking the Factor VIII replacement drug to prevent bleeding episodes.
Around 350 patients from around 10 countries in Europe will be recruited, said the company. Sobi (Swedish Orphan Biovitrum) secured approval for Elocta in Europe at the end of 2015 and started rolling it out in EU markets early last year.
It took over EU commercialisation rights from partner Biogen – which sells the drug as Eloctate in the US – last March. Thanks to complicated tender processes the roll-out of a new haemophilia therapy in Europe can be slow, however, and Sobi needs all the evidence it can muster if it is to wrest market share from established haemophilia A therapies such as Shire/Baxalta’s Advate (octocog alfa).
Stefan Lethagen, vice president of medical and clinical sciences for haemophilia at Sobi, said: “Elocta is the first extended half-life Factor VIII product approved by the European Commission and, as such, represents a meaningful step in the treatment of haemophilia.”
The phase III A-LONG trial programme showed that Elocta’s longer half-life in the body afford extended protection against bleeds compared to conventional haemophilia products given at the same dose, he noted, adding “A-SURE is an important study that aims to evaluate the effectiveness of Elocta in a real world-setting.”
Sobi has secured reimbursement for Elocta in a dozen EU markets, including Germany, the UK, France, Italy and Spain, and the company reported third quarter sales of the drug were SEK 132m (around $15m) in the first nine months of 2016.
Analysts from Credit Suisse have estimated that sales of Elocta will reach around $650m by 2020, with ex-US sales – including Europe, Japan and other world markets – accounting for around $300m of that total.
Sobi is currently looking for a replacement chief executive after current CEO Geoffrey McDonough announced he will leave the company in the summer.