Dyax and Sigma Tau unit pull EU filing on Kalbitor
USA-based Dyax Corp (Nasdaq: DYAX) says it reached agreement with Defiante Farmaceutica, a unit of privately-held Italian drugmaker Sigma Tau, to withdraw the Marketing Authorization Application (MAA) filed with the European Medicines Agency for Kalbitor (ecallantide) in the treatment of hereditary angioedema (HAE).
Last year, Dyax entered a strategic partnership with Defiante develop and commercialize subcutaneous DX-88 (ecallantide) for the treatment of HAE and other therapeutic indications throughout Europe, North Africa, Middle East and Russia worth a potential $105 million to the US firm (The Pharma Letter June 22, 2010). The HAE drug candidate has been licensed to CMIC for the Japanese market under a $106 million deal (TPL October 1, 2010).
Data did not demonstrate positive benefit-risk balance
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