Pharming inks supply deal with Sanofi Chemie
Ruconest is due to launch in the UK and Germany in the fourth quarter and with Pharming seeking approval in other regions it has decided to strengthen supply. The supply deal with Sanofi supplements the current agreement with MSD, the subsidiary of Merck & Co.
Marjolein van Helmond, manager corporate communication at Pharming, told Outsourcing-Pharma that the company chose to work with two contract manufacturing organisations (CMO) to gain the supply security of a back up facility.
Pharming is now working with a Sanofi site in France to achieve this security. Before production can begin the process needs to be transferred to the Sanofi site and validated. Pharming is making a “limited investment” in this process which it believes will cut costs when finished.
By scaling up the process at the Sanofi site Pharming expects to be able to lower the cost of goods. Van Helmond was unable to provide an estimate of when the process at Sanofi will be validated.
While this process is ongoing Pharming will meet demand for Ruconest through its deal with MSD. In a press statement, Pharming said MSD will supply Ruconest for the launches in the UK, Germany and other counties in the European Economic Area.
Pharming is also seeking regulatory approval in other regions and the Sanofi deal will allow it to meet global supply demands. An application through a third-party is ongoing and Pharming is also in discussions with the US Food and Drug Administration (FDA).
"Pharming is the first European company with a recombinant biopharmaceutical product from this platform to be approved in Europe”, said Francis Carré, CEO of Sanofi Chemie. Carré said Sanofi is proud to support the worldwide commercialisation of the product.
Financial details of the deal have not been disclosed.
