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Pharming receives European Commission approval for treatment of acute hereditary angioedema attacks in children with RUCONEST®

Operational updates

Pharming Group N.V. announces that it has received formal European Commission approval to treat acute hereditary angioedema (HAE) attacks in children with RUCONEST®. Following the positive opinion and recommendation from the European Medicine Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP) on the extension of the indication for RUCONEST® received on 26 March 2020.

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Pharming reacquires RUCONEST®-licensed territories from Sobi

Operational updates

Pharming Group N.V. today announced it has entered into a definitive agreement with Swedish Orphan Biovitrum AB (publ) (“Sobi”) to reacquire the commercial rights to Pharming’s product, RUCONEST®, in all remaining territories, which includes all remaining EU markets. Under the agreement, the license is being terminated with effect from 1 January 2020 in all 36 countries with a smooth handover planned in the countries where Sobi has sales activities. Pharming will pay Sobi €7.5 million in two tranches.

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Pharming announces FDA Acceptance for Review of Supplemental Biologics License Application for RUCONEST® for Prophylaxis of Hereditary Angioedema Attacks

Operational updates

Pharming Group N.V. today announced that the U.S. Food and Drug Administration (FDA) has accepted for review Pharming’s supplemental Biologics License Application (sBLA) for RUCONEST® [Recombinant Human C1 Esterase Inhibitor/ conestat alfa] for routine prophylaxis to prevent attacks in adult and adolescent patients with hereditary angioedema (HAE).

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