Dyax, CMIC enter agreement to develop and commercialize DX-88 for HAE treatment

Dyax Corp. (NASDAQ: DYAX) and CMIC Co., Ltd, (CMIC) announced today an agreement to develop and commercialize subcutaneous DX-88 (ecallantide) for the treatment of hereditary angioedema (HAE) and other angioedema indications in Japan. DX-88 has been approved by the U.S. 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 Japan is an important market for us, it was critical to align with a company that has experience developing orphan drugs.”

Under the terms of the agreement, Dyax will receive $4 million upfront and $102 million in future development and sales milestones for DX-88 in HAE and other angioedema indications. CMIC is solely responsible for all costs associated with development, regulatory activities, and commercialization of DX-88 for all angioedema indications in Japan. CMIC will purchase drug product from Dyax on a cost-plus basis for clinical and commercial supply. Additionally, Dyax is eligible to receive royalties of 20%-24% on net product sales.

"Our agreement with CMIC represents another significant advancement for our DX-88 global partnering strategy," said Gustav Christensen, President and Chief Executive Officer of Dyax Corp. "As Japan is an important market for us, it was critical to align with a company that has experience developing orphan drugs." He adds, "We view CMIC's licensing collaborations with Ucyclyd Pharma, Inc. and Orphan Europe SARL as examples of their dedication to developing treatments for rare diseases. We look forward to working with CMIC toward the common goal of having DX-88 approved and commercialized for the benefit of Japanese HAE patients."

"Based on the clinical advantages of KALBITOR in the United States, we are excited to develop and commercialize DX-88 in Japan and believe there is an opportunity for significant adoption," states Dr. Kazuo Nakamura, Chief Executive Officer of CMIC. "Patients desire a non-plasma derived treatment for HAE which currently is not available in Japan. As such, DX-88 presents an advantageous option for patients and represents a significant market opportunity."