Pharming Ruconest Gets Positive Opinion From CHMP

With this positive opinion, CHMP has recommended the European Commission to grant the European Marketing Authorisation (MA). The product will be marketed in the EU under the name Ruconest.

Pharming said that after review of the dossier, the CHMP has concluded that there is a favourable benefit to risk balance for Pharming’s product.

CHMP concluded that the name Rhucin may lead to confusion with a similarly sounding product marketed in some EU countries. Rhucin will therefore be marketed in the EU as Ruconest. The CHMP will prepare an assessment report (EPAR) including the reasons for the CHMP opinion and details of the evaluation. The report will be published on the EMA website after the granting of the MA by the European Commission, which is expected early September 2010.

Following the granting of the MA, Ruconest will be authorised for marketing in all 30 countries of the European Economic Area (the EEA includes all 27 EU countries plus Norway, Iceland and Liechtenstein).

Pharming has marketing and distribution partnerships in place covering all countries of the EEA: Laboratorios del Dr Esteve for Spain, Portugal, Greece and Andorra, and Swedish Orphan Biovitrum International (SOBI) for all other European countries.

Bruno Giannetti, chief operations officer of Pharming, said: “The CHMP’s positive opinion for Ruconest is a landmark event for our company. We have now made the final step towards validation and commercialisation of our proprietary technology. Ruconest will be the first recombinant biopharmaceutical product from this platform to be approved in Europe and I am very proud that we have achieved this major milestone.

“We are looking forward to be able to make Ruconest available to HAE patients in the EEA. Following European approval, health care professionals will have an innovative and highly effective product with a favorable safety profile to treat patients with hereditary angioedema.”