Pharming forges production deal with Sanofi Chimie
pharmafile | July 8, 2010 | News story | Manufacturing and Production, Sales and Marketing |Â Â HAE, Pharming, Ruconest, Sanofi ChimieÂ
Dutch biotechnology group Pharming has signed a toll manufacturing agreement with Sanofi Chimie in order to boost commercial-scale manufacturing of its lead product Ruconest for hereditary angioedema.
Pharming has made the deal in anticipation of being able to launch Ruconest (recombinant human C1 esterase inhibitor) in its first markets later this year, following a positive opinion from the European Medicine Agency’s Committee for Medicinal Products for Human Use last month.
If approved, Ruconest will be among the first pharmaceutical products worldwide to be licensed which are made using transgenic animals, in this case genetically-modified rabbits which make the protein in their milk.
Pharming has an existing manufacturing agreement for the product with MSD (formerly Schering-Plough/Organon) which will supply enough material for the first launches of Ruconest, starting in the UK and Germany and gradually rolling out elsewhere in Europe.
The Dutch company has its own facility housing hundreds of genetically-modified rabbits and has been building up reserves of transgenic milk.
However the deal with Sanofi Chimie, a subsidiary of Sanofi-Aventis, will not only increase Pharming’s capacity to make Ruconest but also allow it to reduce the cost of goods for the product, according to Dr Bruno Giannetti, the firm’s chief operating officer.
Pharming will have to make a “limited investment” to transfer the technology for manufacturing Ruconest to Sanofi Chimie, he added.
The CHMP gave a green light to Ruconest to treat acute attacks in patents suffering from HAE, a human genetic disorder characterised by acute painful and in some cases fatal swellings of soft tissues, including the skin, abdomen and the mouth and throat.
If the EMA grants full approval for Ruconest it will mark the end of a long journey for Pharming, which first filed for approval of the drug in 2006 but was turned down by the CHMP in 2008 when the panel asked for more safety and efficacy data, particularly on the risk of allergic reactions to repeat use of the drug.
Meanwhile, Pharming is hoping to file for approval of Ruconest in the US sometime this year, following discussions with the FDA at the end of 2009.
Phil Taylor
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