Leiden, The Netherlands, August 31, 2011. Biotech company Pharming Group NV (“Pharming”) (NYSE Euronext: PHARM) and Swedish Orphan Biovirum (STO: SOBI) today announce that Ruconest® is now being launched in Pharming’s home market the Netherlands. The launch follows immediately after final approval to make Ruconest available was received from the Dutch regulatory authority (College ter Beoordeling van Geneesmiddelen).
Sijmen de Vries, CEO of Pharming, said: “We are very proud that we are the first of the Dutch biotech companies that have succeeded in bringing an ’in- house’ developed biological medicine to our home market. Our partner SOBI can therefore now also provide Dutch doctors and HAE patients with Ruconest (recombinant human C1- inhibitor) as the novel biotech alternative to blood derived C1INH products. This achievement, as part of the European roll-out, is moreover important, as Ruconest represents the first product derived from Pharming’s proprietary transgenic technology platform that, as result of its EU approval, was added to the very short list of validated and independently owned “biologicals” development and production platforms. With this proprietary technology, Pharming is able to develop and produce (complex) biological medicines that are both technically and economically competitive”.
To date Ruconest is available in Sweden, Norway, Denmark, UK, Germany, France, Latvia and the Netherlands. Reimbursement applications are under review in most of the other countries; the European roll-out by SOBI continues.
About Ruconest (Rhucin) and Hereditary Angioedema
Rhucin® (INN conestat alfa) is a recombinant version of the human protein C1 inhibitor (C1INH). Rhucin is produced through Pharming’s proprietary technology in milk of transgenic rabbits and in Europe is approved under the name Ruconest® for treatment of acute angioedema attacks in patients with HAE. Rhucin has been granted orphan drug designation in the U.S. for the treatment of acute attacks of HAE, a genetic disorder in which the patient is deficient in or lacks a functional plasma protein C1 inhibitor, resulting in unpredictable and debilitating episodes of intense swelling of the extremities, face, trunk, genitals, abdomen and upper airway. The frequency and severity of HAE attacks vary and are most serious when they involve laryngeal edema, which can close the upper airway and cause death by asphyxiation. According to the U.S. Hereditary Angioedema Association, epidemiological estimates for HAE range from one in 10,000 to one in 50,000 individuals.
About Pharming Group NV
Pharming Group NV is developing innovative products for the treatment of unmet medical needs. Ruconest® (Rhucin® in non-European territories) is a recombinant human C1 inhibitor approved for the treatment of angioedema attacks in patients with HAE in all 27 EU countries plus Norway, Iceland and Liechtenstein, and is distributed in the EU by Swedish Orphan Biovitrum (STO: SOBI). The product is also under development for follow-on indications, i.e. antibody-mediated rejection (AMR) and delayed graft function (DGF) following kidney transplantation. The advanced technologies of the Company include innovative platforms for the production of protein therapeutics, technology and processes for the purification and formulation of these products. Additional information is available on the Pharming website, www.pharming.com.
This press release contains forward looking statements that involve known and unknown risks, uncertainties and other factors, which may cause the actual results, performance or achievements of the Company to be materially different from the results, performance or achievements expressed or implied by these forward looking statements.
Sijmen de Vries, CEO, T: +31 (0)71 5247400
Julia Phillips/ John Dineen, T: +44 (0)207 269 7187