Shire has obtained a preliminary injunction to stop Roche spreading “inaccurate and misleading” statements about clinical trial data. The legal tussle centers on Roche’s attempt to pin the blame for blood clotting in patients in its phase 3 emicizumab program on Shire’s bypassing agent Feiba.
Cases of blood clotting, thrombotic microangiopathy and one death have cast a shadow over the phase 3 data Roche has gathered to win approval for emicizumab and claim a slice of the $11-billion-a-year hemophilia market. Roche has downplayed the significance of the adverse events to the prospects of emicizumab, pointing to the use of Novo Nordisk’s NovoSeven and Shire’s Feiba to explain the cases and reassure observers about the safety of its bispecific antibody.
That hasn’t gone down well at Shire.
The Ireland-based drugmaker has fought back against Roche by obtaining a preliminary injunction from a court in Hamburg. Shire obtained the injunction the day before Roche was due to present data from its HAVEN 1 and HAVEN 2 trials in Berlin.
Shire took out the action to stop Roche spreading what it sees as an “inaccurate and misleading characterization” of the adverse events in HAVEN 1. Specifically, Shire wants Roche to stop stating that all the adverse events happened “when repeated high aPCC doses were used concurrently with emicizumab.” Shire’s Feiba is an aPCC (activated prothrombin complex concentrate).
As Shire sees it, Roche has “unlawfully disparaged” Feiba.
The injunction also attacks the way Roche has presented its efficacy data. In a statement last month, Roche said the primary endpoint was “treated bleeds” and claimed success against this yardstick. ClinicalTrials.gov lists “number of bleeds over time” as the primary endpoint. Shire wants Roche to “correct promotion of the primary data results.”
Shire said the legal action follows “multiple unheeded requests to Roche” to resolve the concerns.
A lot is resting on the data supporting emicizumab for both companies. If Roche can persuade regulators, payers, physicians and patients of the merits of emicizumab, the drug could rack up billions of dollars in sales. Some of those sales would come at the expense of Shire, which tied its future to hemophilia by acquiring Baxalta.
Shire has now given the anticipated tug of war for the market a legal dimension. Roche can appeal the preliminary injunction. The Swiss Big Pharma told Reuters it stands “100%” by its comments.
Roche in fact posted Haven 1 and 2 phase 3 data from its med today in The New England Journal of Medicine, with the primary endpoint in HAVEN 1 (for adults and adolescents) showing a “clinically meaningful and statistically significant reduction in treated bleeds” of 87% with emicizumab as a prophylaxis when compared with on-demand (no prophylaxis; episodic use only) bypassing agents.
It said that all 12 secondary endpoints were positive, including a statistically significant reduction of 79% in treated bleeds in a first-of-its-kind intrapatient analysis in a subset of patients comparing two prophylaxis regimens (emicizumab and BPAs).