Approval of Rhucin/Ruconest in Europe is imminent, firm claims, with BLA filing planned by year-end.
Santarus is to pay Pharming $15 million up front as part of an agreement for development and commercialization of the latter’s hereditary angioedema (HAE) drug, Rhucin® (known Ruconest™ in Europe), in the U.S., Canada, and Mexico. In June Pharming announced that it expects to submit a BLA for Rhucin as a treatment for acute attacks of HAE to FDA by early 2011 at the latest. Meanwhile, European approval of the treatment is imminent, Pharming points out.
Under terms of the North American deal Pharming will receive additional clinical and commercial milestones including $5 million once the Rhucin BLA submission has been accepted by FDA. Pharming will shoulder the clinical development of Rhucin for HAE and all HAE-related regulatory activities in the U.S. Santarus takes on responsibility for regulatory approval of the treatment in Canada and Mexico The companies will share responsibility for and costs associated with clinical development of Rhucin as a treatment for or prevention of renal transplantation rejection. Santarus will be responsible for regulatory activities related to this indication in North America.
Rhucin is a recombinant human C1 esterase inhibitor protein expressed in the milk of transgenic rabbits. The product is in development initially for the treatment of acute attacks of HAE. In June European regulatory authorities adopted a positive opinion for Ruconest, and Pharming says final approval throughout the EU is expected very soon. The firm aims to launch the product in Europe during the fourth quarter of this year.