11.10.15
Advancing its strategy to become a leading global biotech Shire plc has acquired Dyax Corp. for approximately $5.9 billion. Dyax is a publicly traded, Massachusetts-based biotechnology company primarily focused on the development of plasma kallikrein (pKal) inhibitors for the treatment of HAE, a debilitating and sometimes life-threatening rare genetic disease. Dyax has successfully developed and commercialized Kalbitor, which is approved for HAE acute treatment in patients 12 years of age and older, and represented an early innovation in HAE treatment.
Dyax’s most advanced clinical program is DX-2930, a phase 3-ready, fully humanized monoclonal antibody targeting pKal with proof-of-concept phase 1B efficacy data. This data demonstrate a greater than 90% reduction in HAE attacks compared to placebo in the 300mg/400mg arms in patients with greater than 2 attacks in the 3 months prior to study entry.
DX-2930 has received fast track, breakthrough therapy, and orphan drug designations by the FDA and has also received orphan drug status in the EU. It is expected to enter phase 3 clinical trials by year-end 2015. If approved for the prevention of type 1 and type 2 HAE, DX-2930 could generate estimated annual global sales of up to $2 billion.
Dyax’s most advanced clinical program is DX-2930, a phase 3-ready, fully humanized monoclonal antibody targeting pKal with proof-of-concept phase 1B efficacy data. This data demonstrate a greater than 90% reduction in HAE attacks compared to placebo in the 300mg/400mg arms in patients with greater than 2 attacks in the 3 months prior to study entry.
DX-2930 has received fast track, breakthrough therapy, and orphan drug designations by the FDA and has also received orphan drug status in the EU. It is expected to enter phase 3 clinical trials by year-end 2015. If approved for the prevention of type 1 and type 2 HAE, DX-2930 could generate estimated annual global sales of up to $2 billion.