Pharmaceutical Business review

Pharming, Sanofi Chimie Enter Into Ruconest Manufacturing Agreement

Pharming said it was into an ongoing manufacturing agreement with MSD (formerly Schering-Plough/Organon) for the production of Ruconest, since 2005.

Pharming is expected to launch and supply the markets with material from MSD until the process, up-scaled by Sanofi Chimie, has been validated.

As per the terms of the agreement Pharming is able to lower cost of goods, while Sanofi Chimie is expected to provide Pharming with sufficient production capacity, at one of its existing manufacturing facilities, to meet future demands.

Bruno Giannetti, chief operations officer of Pharming, said: “For the anticipated market launch of Ruconest this year in Germany and the UK and the further roll-out of the product in the European economic area and beyond, we will continue the cooperation with MSD for the supply of Ruconest.

“With a limited investment for technology transfer, we will effectuate the up-scaling of the production process, which is expected to lower cost of goods of Ruconest.”

Francis Carre, CEO of Sanofi Chimie, said: “Last month’s positive opinion from the Committee for Medicinal Products for Human Use (CHMP) for Ruconest for the treatment of angioedema attacks was a major step towards validation and commercialisation of Pharming’s technology.”