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Roche, Shire court fight underscores high stakes in haemophilia
[ZURICH] Roche's bid to muscle in on Shire's share of the US$11 billion haemophilia drug market took a new, contentious turn this weekend when the British drugmaker won a court injunction against how the Swiss drugmaker talks about its new medicine.
Shire's injunction on Sunday in a Hamburg, Germany, court alleges incomplete and misleading statements by Roche about its investigational emicizumab.
The court case underscores just how much is at stake with emicizumab's impending arrival on the market, with Roche due to file for approval with regulators later this year.
Some analysts estimate US$5 billion in peak annual sales from emicizumab, a development that would likely poach sales from older drugs made by companies such as Shire.
Analysts at Bernstein say Shire's share in haemophilia A is expected to decline to 29 per cent from 49 per cent by 2021 on the combined effect of Roche's drug as well as new long-acting products from Novo Nordisk and Bayer.
Shire, which could not be reached for immediate comment, said in a statement the injunction "seeks to prevent further dissemination of the inaccurate and misleading characterisation of the serious adverse events" that occurred in a Roche trial of emicizumab, also known as ACE910.
In Roche's trial, patients who experienced bleeding despite getting emicizumab were treated with so-called bypassing agents.
Roche has blamed several instances of thromboembolic events - including damage to blood vessels in vital organs - on the bypassing agents, and recommended that doctors avoid using one specific bypassing agent as they treat the bleeds.
If that is not possible, Roche said, doctors should use the lowest dose possible.