Date: 2016-02-09
Type of information: Distribution agreement
Compound: Ruconest® (conestat alfa)
Company: Pharming (The Netherlands) Cytobioteck (Colombia)
Therapeutic area: Rare diseases - Genetic diseases - Hematological diseases
Type agreement: distribution
Action mechanism: enzyme inhibitor/C1-esterase inhibitor. Ruconest® (conestat alfa) is a human recombinant C1-esterase inhibitor purified from the milk of transgenic rabbits. Hereditary angioedema, which is caused by having insufficient amounts of a C1-esterase inhibitor, affects approximately 6,000 to 10,000 people in the United States. People with HAE can develop rapid swelling of the hands, feet, limbs, face, intestinal tract, or airway. These acute attacks of swelling can occur spontaneously, or can be triggered by stress, surgery or infection. Swelling of the airway is potentially fatal without immediate treatment. Ruconest® is intended to restore the level of functional C1-esterase inhibitor in a patient’s plasma, thereby treating the acute attack of swelling. Ruconest® is the first and only plasma-free, recombinant C1-INH approval from the FDA and was approved in July 2014 and by the European Medicines Agency (EMA) in October 2010.
Disease: hereditary angioedema (HAE)
Details: * On May 25, 2015, Pharming announced that it has entered into an exclusive distribution agreement with Cytobioteck, a privately owned Bogota, Colombia based specialty healthcare company, for the distribution of Ruconest® (recombinant human C1 inhibitor) for the treatment of acute attacks of Hereditary Angioedema (HAE) in Colombia and Venezuela. Under the agreement, Cytobioteck will drive all regulatory processes and will purchase its commercial supplies of RUCONEST from Pharming at a fixed transfer price.
Financial terms:
Latest news: * On February 9, 2016, Pharming announced that it 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. 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.
