European Regulatory Updates, In Brief

Pharming obtains positive opinion for its HAE therapy: Pharming's Ruconest (conestat alfa), a human recombinant protein extracted from the milk of transgenic rabbits, was recommended for approval by the European Medicines Agency for the acute treatment of angioedema attacks in patients with hereditary angioedema (HAE). The orphan product, a recombinant human C1 esterase inhibitor formerly known as Rhucin, will be marketed by two partners - Dr Esteve in Spain, Portugal, Greece and Andorra, and Swedish Orphan Biovitrum in all other EU countries as well as Iceland, Norway and Liechtenstein. Pharming estimates the current value of the European HAE market at €110 million ($136 million). Ruconest previously was rejected by the Committee for Medicinal Products for Human Use in December 2007, when it said there was insufficient data to support its approval (1"The Pink Sheet" DAILY, Dec. 14, 2007). The company refiled the product with additional data from a recently completed North American Phase III trial