European Regulatory Updates, In Brief
Executive Summary
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
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Business News In Brief
Shire's velaglucerase approved: FDA's clearance of Shire's VPRIV (velaglucerase) on Feb. 26 adds a second approved therapy for Gaucher disease, a rare lysosomal storage disorder, to the U.S. market. The action comes at a key time as Genzyme's Cerezyme, the first drug approved for Gaucher, has been in short supply since Genzyme's primary manufacturing facility was shut down for six weeks last summer due to viral contamination. Velaglucerase and Protalix's telaglucerase (Uplyso, now partnered with Pfizer) have been available under emergency use authorization and accepted for accelerated review. VPRIV's safety and efficacy were evaluated based on three clinical trials involving 82 Gaucher patients, including some who switched over from Cerezyme. In announcing the approval, FDA noted that patients who previously received Cerezyme could switch safely to Shire's product. Shire also is seeking approval for velaglucerase in Europe, where its marketing authorization application has been accepted under accelerated assessment (1"The Pink Sheet" DAILY, Feb. 19, 2010)