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Shire wins court injunction against Roche over 'misleading' statements about haemophilia drug

Published: 15:41 10 Jul 2017 BST

Shire
Shire and Roche are locked in a legal dispute over emicizumab

Shire Plc (LON:SHP) has today won a court injunction in Germany to stop its Swiss rival Roche from spreading “incomplete and misleading” statements about the Irish company’s bypassing agent FEIBA.

Roche blamed FEIBA for its role in adverse events during trials of its emicizumab drug for treating haemophilia, a rare condition that affects the blood's ability to clot.

The Swiss pharmaceutical group claimed that Shire’s bypassing agent had caused several instances of thromboembolic events, including damage to blood vessels in vital organs, in haemophilia A patients.

The adverse events occurred in four people when they received high doses of Shire's drug concurrently with emicizumab, Roche had said.

Roche recommended that doctors avoid using FEIB to treat patients.  

Shire says Roche's claims are 'inaccurate'

Shire said Roche had “unlawfully disparaged” FEIBA and had provided inadequate data to back up its claim.

It added that the injunction would prevent further dissemination of the “inaccurate and misleading characterisation of the serious adverse events" in the Roche trial.

"To imply a cause-and-effect of FEIBA having caused the severe adverse events is misleading," Juliana Dierks, Shire’s global haematology franchise head, told Reuters. "We are looking forward to transparency. Give us the data, give us the facts."

The Hamburg court’s decision has dealt a blow to Roche’s bid to take a larger slice of the US$11mn haemophilia drug market, dominated by Shire.

Roche reviews court decision

Roche has been forbidden from making any promotional statements on its medication during the injunction. But the injunction is temporary and Roche will be able to appeal the decision.

Roche said it is reviewing the decision and continues to stand behind its statements about emicizumab and guidance for doctors treating bleeds.

It marks the latest legal dispute between Roche and Shire over emicizumab. Shire's owner Baxalta is suing Roche over patent infringement, claiming its share in haemophilia A is expected to fall to 29% from 49% by 2021 on the effect of the Swiss company's drug and other new medicines.

 

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