In 2016, the Shire plc pipeline will include more than 10 programs in Phase 3 trials and compounds already under regulatory review. Shire’s planned Phase 3 programs for 2016 include SHP-616 (Cinryze) for subcutaneous delivery for HAE prophylaxis, SHP-616 (Cinryze) for HAE prophylaxis in Japan, and Firazyr for HAE in Japan.
Pending the approval by Dyax shareholders and the close of the proposed acquisition by Shire of Dyax Corp., Shire’s Phase 3 pipeline would also include DX-2930. A long-acting injectable monoclonal antibody for HAE prophylaxis, DX-2930 has the potential to lower rates of HAE attacks and significantly improve patient convenience based on clinical trial data reported to date. DX-2930 received Fast Track, Breakthrough Therapy and Orphan Drug designations by the FDA and Orphan Drug status in the EU.