Pharming Group N.V.
amsterdam : PHARM

August 15, 2011 01:16 ET

Pharming announces extension of their license agreement for the commercialization of Ruconest®

LEIDEN, NETHERLANDS--(Marketwire - Aug 15, 2011) - Biotech company Pharming Group NV ("Pharming") (NYSE Euronext: PHARM) today announced that they have agreed an extension of their existing agreement with Swedish Orphan Biovitrum (STO: SOBI) to include new territories in the Balkans, North Africa and the Middle East for the commercialization of Ruconest® (recombinant human C1 inhibitor) for the treatment of acute angioedema attacks in patients with Hereditary Angioedema (HAE).

In addition, SOBI has placed a significant additional order for vials of Ruconest®. The shipment forms part of SOBI's preparation for the continued roll-out and intensified marketing of Ruconest® across Europe. SOBI will over a period of 1 year pay EUR1.5 million to Pharming for these additional shipments under this order. Under the terms of the distribution partnership, SOBI buys finished product from Pharming for a transfer price that includes a sales related tiered royalty component.

Sijmen de Vries, CEO of Pharming, said "We are delighted to expand our current commercialization deal with SOBI. This is another significant step towards making Ruconest more widely available. With this extension, patients in all EC territories, the Balkans, North Africa and the Middle East will soon be able to benefit from the efficacy and safety that Ruconest offers as the only recombinant enzyme replacement therapy for HAE".

About Ruconest (Rhucin) and Hereditary Angioedema

Ruconest® / 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,

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.

Press release (PDF):

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Source: Pharming Group N.V. via Thomson Reuters ONE


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