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Shire and Roche haemophilia spat spills into court

Published on 10/07/17 at 10:04am

Roche released new scientific data at a conference in Berlin regarding its developmental drug in haemophilia, emicizumab, and Shire chose the day prior to announce its injunction against the company, stoking a heated battle in the haemophilia sector.

The injunction relates to ‘misleading statements’ Shire claims that Roche made against its bypassing agent, FEIBA, which it claims ‘unlawfully disparaged’ its product. The preliminary injunction that was obtained in Hamburg, Germany, will cast a shadow in light of any results that are posted today regarding Roche’s drug.

The case relates specifically to a death in Roche’s Phase 3 Haven 1 study, where a patient died of a serious rectal haemorrhage. Roche released a statement shortly afterwards that the death was not related to the use of its drug and suggested it had received clinical guidance to “avoid the use of aPCC, if possible”.

The case then hinges on where the blame lies for the death in the trial, with Roche claiming it was due to the bypassing agent and Shire defending its product.

In Shire’s statement regarding the information that was publically supplied: “Based on Roche’s publically available information to date, physicians, patients and caregivers may be misinformed about the appropriate management of breakthrough bleeds uncontrolled by emicizumab. In addition, through these actions, Shire believes Roche has unlawfully disparaged Shire’s proven bypassing agent, FEIBA (Anti-Inhibitor Coagulant Complex). Shire has issued multiple unheeded requests to Roche in an effort to resolve these concerns in an appropriate manner. As a result, Shire made the decision to seek court intervention.”

In reality, regardless of the injunction outcome, the legal battle is really a spat over the haemophilia market. Emicizumab could potentially steal away part of the marketplace that Shire holds a strong position in. Roche’s drug is slated to become a blockbuster drug and could snatch its share from traditional treatments, such as those produced by Shire and Novo Nordisk.

In this case, it is a win-win scenario for Shire – even if it does not win the case, it brings the deaths in Roche’s trials back into the limelight and will serve to stoke fears over the safety of the drug in the long-term.

Ben Hargreveaves

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