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Roche, Shire court fight underscores high stakes in hemophilia

[July 10, 2017] By John Miller

ZURICH (Reuters) - Roche's bid to muscle in on Shire's share of the $11 billion hemophilia 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 Swiss company is due to release its latest data on the medicine at a conference in Berlin on Monday at around 0930 GMT.

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 $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 hemophilia A is expected to decline to 29 percent from 49 percent 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 characterization 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.

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'UNLAWFULLY DISPARAGED'

With Roche's guidance, Shire contends its rival "has unlawfully disparaged Shire’s proven bypassing agent", known as FEIBA.

"Shire's goal with this action is to ensure the hemophilia community receives sufficient, accurate information," the British company said.

A Roche spokeswoman said Monday it had not yet been served with Shire's injunction, so it could not comment on its contents.

But the Basel-based drugmaker stands by "100 percent" behind its statements about emicizumab as well as its guidance for doctors on how to respond to bleeds.

Roche will release data on emicizumab on Monday in Berlin at the International Society on Thrombosis and Haemostasis Annual Meeting.

(Reporting by John Miller; editing by Jason Neely)

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