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Kalbitor

Shire Pharmaceuticals Group PLC

Drug Names(s): DX-88 (Subcutaneous), ecallantide

Description: DX-88 is also being developed as an IV formulation for coronary artery bypass graft (CABG) and as an intravitreal formulation for retinal vein occlusion (RVO).

DX-88 inhibits the protein kallikrein, a molecule involved in blood vessel responses to various stimuli. It plays a role in initiating a cascade of molecular events leading to increased vascular permeability, smooth muscle contraction, vasodilation, and pain. A deficiency of C1 esterase inhibitor (C1-INH), a naturally occurring kallikrein inhibitor, is responsible for hereditary angioedmea (HAE). When HAE involves airway passages, it can be life threatening. Plasma derived C1-INH products are marketed in certain European countries, but are unavailable in the United States. DX-88 has orphan drug status in Europe for the management of HAE.

Deal Structure: Dyax and Genzyme
In June 2003, Dyax and Genzyme entered into a collaboration for the development of DX-88. Dyax and Genzyme are developing DX-88 for HAE in a 50/50 collaboration -- the two companies are each responsible for 50% of ongoing costs incurred in connection with the development and commercialization of DX-88 for HAE and each will be entitled to receive approximately 50% of any profits realized as a result. Dyax receives potential milestone payments from Genzyme in connection with the development of DX-88. Milestone payments are due upon dosing the first patient in a pivotal clinical trial of DX-88 for HAE, for the first FDA-approved product derived from DX-88, and for additional therapeutic indications developed under the collaboration.

In February 2007, Dyax reached a mutual agreement with Genzyme to terminate their joint venture for the development and commercialization of DX-88 for HAE. The termination agreement stipulates that Dyax will receive all the...See full deal structure in Biomedtracker

Partners: taiba-ME Novellus Biopharma AG Lee's Pharmaceutical Holdings Limited


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