* Shire wins preliminary injunction against Roche
* Roche stands “100 percent” behind statements
* Share of big $11 bln haemophilia market at stake (Adds details from preliminary injunction in paragraphs 8, 9)
By John Miller
ZURICH, July 10 (Reuters) - Swiss drugmaker Roche’s bid to take a chunk of the $11 billion haemophilia drug market dominated by Shire took another blow with the Irish company winning a preliminary injunction over its Swiss rival’s medication.
Shire said its injunction in a court in Germany, where Roche presented data on its drug emicizumab on Monday, sought to remedy Roche’s “incomplete and misleading” statements about the role of Shire’s drug FEIBA in adverse events in Roche trials.
The fight underscores the high stakes of emicizumab’s approaching arrival on the haemophilia A market, with some analysts estimating $5 billion in annual sales. That would poach business from Shire’s older drugs for the condition in which sufferers’ blood does not clot properly.
Roche blamed several instances of thromboembolic events, including damage to blood vessels in vital organs, in haemophilia A patients on Shire’s bypassing agent. It recommended doctors avoid using FEIBA, if possible, to treat bleeds that developed in patients, despite getting emicizumab.
Shire, which says Roche “unlawfully disparaged” FEIBA, said it aimed “to prevent further dissemination of the inaccurate and misleading characterisation of the serious adverse events” in the Roche trial.
While Shire’s drug carries warnings for thromboembolic events, Juliana Dierks, its global haematology franchise head, said Roche has failed to provide adequate data to back up its claim.
“To imply a cause-and-effect of FEIBA having caused the severe adverse events is misleading,” Dierks told Reuters. “We are looking forward to transparency. Give us the data, give us the facts.”
In the Hamburg court’s order, among other things, Roche was forbidden for now from making promotional statements describing emicizumab it as “well tolerated” or saying that adverse events occurred in four people when they received high doses of Shire’s drug concurrently with Roche’s medication.
The court said it had jurisdiction because Roche was preparing to present information about emicizumab at the International Society on Thrombosis and Haemostasis congress this week in Berlin.
The injunction is an interim measure and Roche can appeal it. Roche said it was reviewing it after being served on Monday.
A spokeswoman said on Monday the Basel-based drugmaker stood “100 percent” behind its statements about emicizumab and guidance for doctors treating bleeds.
Roche shares were up 0.5 percent at 1300 GMT, while Shire’s were down 1.6 percent.
This is the latest legal battle involving Shire against Roche over emicizumab. Baxalta, which Shire bought in 2016, is suing the Swiss company over patent infringement.
Bernstein has said Shire’s share in haemophilia A is expected to fall to 29 percent from 49 percent by 2021 on the combined effect of Roche’s drug and other new medicines.
Roche, which has filed emicizumab for European and U.S. approval, said the drug cut the treated bleed rate by 79 percent compared with bypassing agents, according to its latest data. (Reporting by John Miller; editing by Jason Neely and Susan Thomas)