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GEN News Highlights : Apr 15, 2010

Swedish Orphan Nabs 10-Year Distribution Rights to Pharming’s HAE Therapy in Europe

Firm will be able to participate in development of Rhucin for other indications.

Swedish Orphan Biovitrum negotiated rights to distribute Pharming’s hereditary angioedema (HAE) therapy, Rhucin® (recombinant human C1 inhibitor; rhC1INH) in 24 EU countries, Norway, Iceland, and Sweden. Rhucin is currently under regulatory review by the EMEA.

Under the terms of the 10-year deal Pharming will receive an undisclosed up-front payment, a regulatory approval milestone, and supply costs including tiered performance-based royalties. Biovitrum will have the right to participate in the future development and distribution of Rhucin for additional indications in the same countries.

“This orphan drug fits in perfectly with our business goals and in our product portfolio,” comments Martin Nicklasson, CEO of Biovitrum. “We are very much looking forward to a long-standing partnership with Pharming and the respective growth of both companies.”

On April 1, Pharming published studies demonstrating the ability of rhC1INH to prevent antibody-mediated rejection (AMR) following kidney transplantation in a primate model. Earlier this year the  firm published other preclinical studies indicating rhC1INH could also be effective in preventing delayed graft function following kidney transplantation. At the time Pharming said that it intended to initiate clinical studies in patients for both these indications during 2010.