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01-11-2010: Pharming Group NV and Swedish Orphan Biovitrum announced that the European Commission has granted Pharming Marketing Authorization for its lead product Ruconest(TM) for the treatment of acute attacks of Hereditary Angioedema (HAE). Pharming will now receive a €5 million milestone payment from marketing and distribution partner Sobi.
Following the unanimous positive opinion adopted by the Committee for Medicinal Products for Human Use (CHMP), Ruconest's Marketing Authorization has now been ratified by the European Committee.
Patients suffering from HAE experience unpredictable, painful and debilitating attacks, due to reduced levels of C1 inhibitor, resulting in intense swelling of parts of the body (for example, face, throat, abdomen) which can last up to five days if left untreated. Ruconest is a recombinant version of the human C1 inhibitor protein, produced by Pharming's proprietary transgenic technology. As published in the Journal of Allergy and Clinical Immunology, Ruconest has been shown to have excellent efficacy and safety. Pharming has withdrawn the orphan status application in order to avoid delays in commercializing the product.
Dr Marco Cicardi, MD, Professor of Internal Medicine at the University of Milan, Italy, said: "Patients with HAE experience an average of eight attacks a year. This distressing and potentially life-threatening condition requires new approaches for acute treatment and Ruconest offers this. This recombinant product is the only HAE treatment achieving circa 90% of success in treating attacks."
Ruconest is now approved for use in the 27 EU countries plus Norway, Iceland and Liechtenstein. Sobi will launch Ruconest initially in Germany, the UK, Sweden, Finland and Denmark, followed by a rolling launch in each of the other European Area countries.
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