Japanese CRO CMIC will pay Dyax $4 million up front as part of a collaboration agreement to develop and commercialize the latter’s FDA-approved subcutaneous drug DX-88 (Kalbitor®; ecallantide) for the treatment of hereditary angioedema (HAE) and other angioedema indications in Japan. Dyax could receive another $102 million in further development and sales milestones. Under terms of the deal CMIC will shoulder all costs associated with the development, regulatory submissions, and commercialization of DX-88 in Japan. The firm will also purchase the drug from Dyax and pay future royalties of 20-24% of net product sales.
“As Japan is an important market for us, it was critical to align with a company that has experience developing orphan drugs,” comments Gustav Christensen, Dyax president and CEO. “Our agreement with CMIC represents another significant advancement for our DX-88 global licensing strategy.”
Dyax’ flagship product, DX-88, is a selective plasma kallikrein inhibitor that has been approved for the HAE indication in the U.S., and is under regulatory review in the EU. Developed by Dyax using its phage-display technology, the drug became available in the U.S. during the first quarter of 2010 for treating acute attacks of hereditary angioedema in patients 16 years of age and older. Dyax reported $3.2 million in net product sales of Kalbitor for the first six months of 2010.
The candidate is separately under Phase II clinical evaluation against ACE inhibitor-induced angioedema and acquired angioedema, and is undergoing Phase I trials for retinal vein occlusion induced macular edema. Dyax has teamed up with Fovea Pharmaceuticals to develop DX-88 for retinal indications in the EU. In August Dyax and Defiante Farmaceutica, a subsidiary of Sigma-Tau, inked a strategic partnership to develop and commercialize subcutaneous DX-88 for the treatment of HAE and other therapeutic indications throughout Europe, North Africa, Middle East, and Russia.
Dyax is exploiting its phage-display platform both for the development of a pipeline of products in house, and through third-party licenses and collaborations under a licensing and funded research program (LFRP) initiative. The firm says it is currently managing over 70 licenses and collaborations ongoing through the LFRP program, and the licensee pipeline now includes 17 clinical-stage drug candidates.
CMIC is a fully fledged CRO providing support for pharmaceutical drug development, manufacturing, and marketing. The firm also in-licenses the rights to orphan drugs for development and commercialization in its home market.