Pharming and Sanofi Chimie sign manufacturing agreement for the drug substance of Ruconest

08-Jul-2010 - Netherlands

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Pharming Group NV and Sanofi Chimie, wholly owned subsidiary of sanofi-aventis announced the signing of a toll manufacturing agreement to increase the production capacity of the drug substance of Ruconest(TM), which will improve RuconestTM cost of goods and competitiveness and will put Pharming in the position to satisfy future global demand.

Since 2005, Pharming has an ongoing manufacturing agreement with MSD (formerly Schering-Plough/Organon) for the production of RuconestTM. Pharming will launch and supply the markets with material from MSD until the process, up-scaled by Sanofi Chimie, has been validated. In addition, the agreement will enable Pharming to lower cost of goods and will provide Pharming with sufficient production capacity, at one of Sanofi Chimie's existing manufacturing facilities, to meet future global demands. The financial details of the agreement have not been disclosed.

"For the anticipated market launch of RuconestTM 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 RuconestTM," said Dr. Bruno Giannetti, Chief Operations Officer of Pharming. "Meanwhile, we need to take the next step towards becoming a profitable pharmaceutical company. With a limited investment for technology transfer, we will effectuate the up-scaling of the production process, which will significantly lower cost of goods of RuconestTM."

"Last month's positive opinion from the Committee for Medicinal Products for Human Use (CHMP) for RuconestTM for the treatment of angioedema attacks was a major step towards validation and commercialization of Pharming's proprietary technology. We are very pleased to be involved in this exciting project," said Francis Carré, Chief Executive Officer of Sanofi Chimie. "Pharming is the first European company with a recombinant biopharmaceutical product from this platform to be approved in Europe and we are proud to be able to support the commercialization of this innovative and highly effective product on a world-wide basis."

https://www.bionity.com/en/news/119788/pharming-and-sanofi-chimie-sign-manufacturing-agreement-for-the-drug-substance-of-ruconest.html