Shire claims Swiss pharma group Roche is making misleading statements about its new haemophilia drug emicizumab – and has won a preliminary injunction blocking its rival from making them.
The Dublin-headquartered company claims Roche is not providing accurate information about its drug – which is still not on the market yet but has been predicted to become a blockbuster by some analysts – and could put patient safety at risk.
Shire says it has obtained the injunction in a court in Hamburg, Germany to challenge “incomplete and misleading statements” about clotting-related adverse events – including one patient death – that were seen with Roche’s drug in the HAVEN-1 trial. It also says Roche’s comments are “disparaging” to one of its own products.
HAVEN 1 trial tested emicizumab in people 12 years of age or older with haemophilia A and factor VIII inhibitors – an immune reaction that can limit the effectiveness of conventional drugs for the disease.
With emicizumab (ACE910) Roche is trying to break into a market for haemophilia drugs worth around $7bn in the world’s top seven markets (US, France, Germany, Italy, Spain, the UK and Japan) last year. The market for haemophilia A with inhibitors is currently dominated by Shire and Novo Nordisk with their Feiba and NovoSeven bypassing agents (PBAs).
Market research firm GlobalData recently predicted that emicizumab will capture a sizeable chunk of the market in both the inhibitor and non-inhibitor haemophilia A market segments, thanks to greater dosing convenience, bringing in $2.6bn by 2026. It expects the drug to make big inroads at the expense of long-acting recombinant Factor VIII products – a group that includes Shire’s own Adynovate product.
Roche has said it plans to file for approval of the new drug in the US later this year and in other market – including Europe – in 2018. In June, the company reported phase III data showing that the drug cut the bleed rate by 87% in adults and adolescents with haemophilia A with inhibitors compared to those who used PBAs.
Shire has taken issue with Roche’s assertion that “all events occurred when repeated high aPCC (activated Prothrombin Complex Concentrate) doses were used concurrently with emicizumab.”
The injunction also seeks to correct promotion of the primary data results relative to “treated bleeds” – a secondary endpoint in HAVEN-1 – rather than the primary endpoint of “number of bleeds over time” which was established at the start of the trial.
“Shire believes Roche has unlawfully disparaged Shire’s proven bypassing agent Feiba,” said the company in a statement. Shire’s inhibitor therapies collectively made sales of $452m last year.
Roche can appeal the preliminary injunction. The Swiss company has not commented on the action, but insisted its decisions and actions are “always based on doing what is right for patients”.