DX-88 has received approval from the US Food and Drug Administration (FDA) and is marketed as Kalbitor (ecallantide) for the treatment of acute attacks of HAE in patients 16 years of age and older.
As per the terms of the agreement, Dyax is expected to get $4m upfront and $102m in future development and sales milestones for DX-88 in HAE and other angioedema indications.
CMIC will be solely responsible for all costs associated with development, regulatory activities and commercialisation of DX-88 for all angioedema indications in Japan.
Dyax president and CEO Gustav Christensen said that their agreement with CMIC represents another significant advancement for DX-88 partnering strategy.
“We look forward to working with CMIC toward the common goal of having DX-88 approved and commercialised for the benefit of Japanese HAE patients,” Christensen said.
CMIC CEO Kazuo Nakamura said that based on the clinical advantages of Kalbitor in the US, we are excited to develop and commercialise DX-88 in Japan and believe there is an opportunity for significant adoption.