Dyax and Defiante decide to withdraw KALBITOR MAA filed with EMA

Dyax Corp. (NASDAQ: DYAX) announced today an update on KALBITOR's international regulatory status.

“We look forward to working with our partner to deliver this important treatment option to patients throughout the world.”

Dyax and Defiante Farmaceutica S.A. (Defiante), an affiliate of the pharmaceutical group Sigma-Tau, have reached a joint decision to withdraw the Marketing Authorization Application (MAA) filed with the European Medicines Agency (EMA) for KALBITOR (ecallantide) in the treatment of hereditary angioedema (HAE). This decision was made following discussions with the EMA's Committee for Medicinal Products for Human Use (CHMP) and the Rapporteurs' Day 181 Joint Assessment Report indicating the information provided was not deemed sufficient to demonstrate a positive benefit-risk balance. Based on the availability of supportive data, in particular from an ongoing bioequivalence study using a 1mL, high-strength formulation of KALBITOR, the Companies will consider a resubmission to the EMA.

The withdrawal does not impact the marketing status of KALBITOR in the United States nor any efforts to seek regulatory approvals in other important markets around the world. To that end, Dyax and Defiante continue to proceed toward marketing applications and regulatory approvals in other international territories, including Australia, the Middle East and Latin America.

"Dyax and Defiante continue to believe that the robust data package supporting FDA approval demonstrate a favorable benefit-risk profile for KALBITOR in HAE," stated Gustav Christensen, President and Chief Executive Officer of Dyax Corp. "We look forward to working with our partner to deliver this important treatment option to patients throughout the world."