Shire Reports on Four Decades of Real-World Safety Experience With FEIBA® [Anti-Inhibitor Coagulant Complex]

LEXINGTON, Massachusetts, December 2, 2016 /PRNewswire/ --

Shire plc (LSE: SHP; NASDAQ: SHPG), the leading biotechnology company focused on serving individuals with rare diseases, is presenting an update on its safety database describing 40 years of real-world experience with the bypassing agent FEIBA [Anti-Inhibitor Coagulant Complex]. Shire also revealed new in vitro data showing the potential for excessive thrombin generation when combining an investigational procoagulant bispecific antibody and bypass therapy for breakthrough bleeds. These data are now available online as part of the Proceedings of the 58th American Society of Hematology (ASH) Annual Meeting, to be held December 3-6 in San Diego, California.

Inhibitors are a rare but serious complication impacting about 5-7 percent of patients with hemophilia A. They form when the body's immune system attacks the molecules in factor therapy, causing it to be ineffective.^[1],[2] Bypassing agents help bypass the inhibitor to help the body form a clot and stop bleeding.^[3]

Recently, concerns have emerged related to the use of an investigational non-factor product when combined with marketed bypassing agents for hemophilia patients with inhibitors. Shire conducted an analysis of a sequence analogue biosimilar of one investigational agent, emicizumab, in combination with bypassing agents. Researchers characterized in vitro the rate and level of thrombin generation resulting from combining the bypassing agent and investigational non-factor product. The data found a multi-fold increase in thrombin generation, indicating a potential thrombotic risk for patients who receive the investigational agent combined with an approved bypass agent for breakthrough bleeds. (Synergistic Effects of a Procoagulant Bispecific Antibody and Rescue Therapies on Thrombin Generation- a Potential Safety Risk, http://www.bloodjournal.org/content/128/22/4952.)^[4]

"FEIBA is a widely approved treatment option for people with hemophilia A and B with inhibitors, and has a well-established safety and efficacy profile^[5]," said Leonard Valentino, M.D., Global Head of Hematology Medical Affairs, Shire. "Shire embraces new products with the potential to build on current standards of hemophilia care. As with any new product, rigorous clinical studies and careful review of safety and efficacy data are crucial to inform healthcare providers and patients on the best way to safely and effectively incorporate potential new therapeutic agents into existing management strategies."