- In an unexpected move, Shire International has secured an injunction in a Hamburg, Germany court against Roche for the Swiss pharma's as yet unmarketed hemophilia drug, emicizumab.
- The injunction claims Roche is disseminating "inaccurate and misleading characterization of the serious adverse events that occurred in the HAVEN 1 Phase 3 trial of emicizumab", as well as misinformation about "the appropriate management of breakthrough bleeds uncontrolled by emicizumab."
- Shire has also claimed that Roche is unlawfully disparaging Shire's marketed anti-inhibitor coagulant complex, Feiba. Roche has refuted all claims.
Shire and Roche are involved in a spat over hemophilia drugs. Shire's Feiba is approved for the control and prevention of bleeding episodes in patients with hemophilia A and B, dosed intravenously every other day for prophylaxis. Roche's emicizumab is in Phase 3 development, with a potential filing in 2018, and could potentially only need dosing every four weeks.
Shire claims Roche has been inaccurate and misleading in discussing the serious adverse events in its HAVEN 1 Phase 3 trial, specifically where Roche has said all of the events occurred when its drug was administered in combination with high doses of aPCC (activated prothrombin complex concentrate). The injunction also suggests Roche is promoting a secondary bleeding endpoint rather than a primary bleeding endpoint.
Shire sees these as misinforming physicians, patients and caregivers about management of breakthrough bleeds, and also as disparaging its bypassing agent, Feiba.
"We have been served the injunction. We believe these claims are categorically false. We are addressing this through the appropriate legal channels. We stand behind the emicizumab data, our clinical trial protocol and investigators and the hemophilia community. Our decisions and actions are always based on doing what is right for patients," Anja von Treskow, Roche media spokesperson, said in an email to BioPharma Dive.
This injunction could be interpreted as a concern about patient safety — Shire describes itself as advocating "in the interest of patient safety and continually defend[ing] the demonstrated 40-year safety profile of Feiba" or, it may simply demonstrate the company's concern about the potential competitive threat from a new drug that requires much less frequent dosing.
Following Shire's Sunday injunction, The New England Journal of Medicine published the results from the Phase 3 HAVEN 1 study. The data showed that emicizumab reduced bleeding by 87% compared with on-demand bypassing agents. Genentech said the drug met all 12 secondary endpoints, including an intra-patient comparison that showing emicizumab reduced the bleed rate by 79% compared to prior prophylactic bypassing agents.
Further data from HAVEN 2, which measured the effectiveness of emicizumab in children with hemophilia A inhibitors, is being presented today at International Society on Thrombosis and Haemostasis Congress. Data from both studies have been submitted to the FDA and EMA for consideration of approval of emicizumab.