The last two years have been transformational for the Leiden-based specialty company Pharming Group NV. In 2016, it had effectively lost control of the commercialization of its intravenous hereditary angioedema (HAE) product, Ruconest, a recombinant human C1 esterase inhibitor (rhC1INH), produced in rabbits, through a series of licensing deals on both sides of the Atlantic, but now its fortunes have turned.
The drug was approved by the US FDA and in Europe in 2014, but Pharming did not market the drug in either territory, as Valeant Pharmaceuticals International Inc and Swedish Orphan Biovitrum AB (SOBI) held the respective rights. (Pharming had originally partnered Ruconest in North America with Santarus Inc.