Pharming extends Ruconest distribution agreement with Cytobioteck

Pharming has extended the exclusive distribution agreement with Cytobioteck for the distribution of Ruconest (recombinant, non-blood derived human C1 inhibitor) for the treatment of acute attacks of Hereditary Angioedema (HAE) by adding countries in Central and South America.

Pharming entered into the original exclusive distribution agreement with Cytobioteck last year for the distribution of Ruconest in Colombia and Venezuela. Under the extended agreement, Cytobioteck will also exclusively distribute Ruconest in Argentina, Costa Rica, the Dominican Republic and Panama. Cytobioteck will continue to drive all regulatory processes and purchase its commercial supplies of Ruconest from Pharming at a fixed transfer price.

Commenting on the agreement extension, Sijmen de Vries, Pharming’s CEO, said: “We are very pleased that we have been able to extend the agreement with Cytobioteck for the distribution of Ruconest in Central and South America.  Over the past year Cytobioteck have made good progress with the regulatory processes in Colombia and Venezuela and several emergency treatments have already been provided to HAE patients in these countries in accordance with local regulations.”

Cytobioteck’s CEO, Dr. Osvaldo Piñeros, added: “We look forward to being able to provide HAE patients with Ruconest in Argentina, Costa Rica, the Dominican Republic and Panama, in addition to Colombia and Venezuela. Our role is to deliver the best therapies available for our patients and we believe Ruconest provides a significant treatment option for HAE patients as the one and only recombinant, non-blood derived C1-esterase inhibitor replacement therapy with a proven and consistent efficacy and safety profile.”  

Ruconest returns C1-INH levels to normal range

HAE is caused by a deficiency of the C1 esterase inhibitor protein, which is present in blood and helps control inflammation (swelling) and parts of the immune system. A shortage of C1 esterase inhibitor can lead to repeated attacks of swelling, pain in the abdomen, difficulty breathing and other symptoms. Ruconest contains C1 esterase inhibitor at 50 IU/kg.

When administered at the onset of HAE attack symptoms at the recommended dose, Ruconest works to return a patient’s C1-INH levels to normal range and quickly begins to relieve the symptoms of an HAE attack with a low recurrence of symptoms. The therapy is the first and only plasma-free, recombinant C1-INH approval from the US Food and Drug Administration (FDA) and was approved in July 2014 and by the European Medicines Agency (EMA) in October 2010.