Replies to post #207232 on Biotech Values

[DewDiligence]

SHPG wins PI against Roche’s “misleading” information about Emicizumab:

https://www.shire.com/en/newsroom/2017/july/mqjg9b

Shire International GmbH [SHPG’s German subsidiary] has obtained a preliminary injunction in a court of Hamburg, Germany against F. Hoffmann-La Roche Ltd. (Roche) to address incomplete and misleading statements that may impact important issues of patient safety regarding the investigational treatment emicizumab.

Under the injunction, Shire seeks to prevent further dissemination of the inaccurate and misleading characterization of the serious adverse events that occurred in the HAVEN 1 Phase 3 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.

Based on Roche’s publically available information to date (as of 7 July 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 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.