Shire Gains Preliminary Injunction Against Roche for Hemophilia DrugBy
Shire has obtained a preliminary injunction in a court in Hamburg, Germany against Roche to address what it says are “incomplete and misleading statements” regarding the investigational treatment, emicizumab, a drug to treat hemophilia.
Under the injunction, Shire seeks to prevent further dissemination of the characterization of the serious adverse events that occurred in a Phase III trial of emicizumab, specifically the assertion that “all events occurred when repeated high aPCC (activated prothrombin complex concentrate) doses were used concurrently with emicizumab.”
The injunction also seeks to correct promotion of the primary data results relative to “treated bleeds” (a secondary endpoint) as compared to the primary endpoint of “number of bleeds over time” established at the outset of the trial.
Shire said that based on Roche’s publicly available information to date as of July 7 2017, 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 said it 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.
The preliminary injunction is an interim measure which can be appealed by Roche.