Pharming and Sanofi Chimie Sign Manufacturing Agreement for the Drug Substance of Ruconest

LEIDEN, NETHERLANDS and ARAMON, FRANCE -- (MARKET WIRE) -- 07/06/10 -- Biotech company Pharming Group NV ("Pharming") (NYSE Euronext: PHARM) and Sanofi Chimie, wholly owned subsidiary of sanofi-aventis (NYSE Euronext: SAN, NYSE: SNY) announced today the signing of a toll manufacturing agreement to increase the production capacity of the drug substance of Ruconest™, which will improve Ruconest™ 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 Ruconest™. 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 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™," 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 Ruconest™."

"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 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."

About Pharming Group NV

Pharming Group NV is developing innovative products for the treatment of genetic disorders, ageing diseases, specialty products for surgical indications, and nutritional products. On June 24, the European Medicines Agency adopted a positive opinion for Ruconest™ (Rhucin) for the treatment of angioedema attacks. Market Authorization in the European Economic Area is therefore expected to be granted in September 2010. The product is also under development for follow-on indications, i.e. antibody-mediated rejection (AMR) and delayed graft function (DGF) following kidney transplantation. The advanced technologies of the Company include innovative platforms for the production of protein therapeutics, technology and processes for the purification and formulation of these products, as well as technology in the field of DNA repair (via DNage). Recently the partial spin off of DNage was initiated. Additional information is available on the Pharming website, http://www.pharming.com.

About sanofi-aventis

Sanofi-aventis, a leading global pharmaceutical company, discovers, develops and distributes therapeutic solutions to improve the lives of everyone. Sanofi-aventis is listed in Paris (EURONEXT: SAN) and in New York (NYSE: SNY). Sanofi Chimie is a wholly owned subsidiary of sanofi-aventis, which deals with active pharmaceutical ingredients manufacture, both for internal and external purposes.

This press release contains forward looking statements that involve known and unknown risks, uncertainties and other factors, which may cause the actual results, performance or achievements of the Company to be materially different from the results, performance or achievements expressed or implied by these forward looking statements.

 

Pharming contact:
Ms. Marjolein van Helmond
T: +31 (0)71 52 47 431
T: +31 (0)6 109 299 54
Sanofi Chimie contact:
Mr. Michel Arraou
T: +33 (0) 4 66 57 71 30

 

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Press release (PDF) : http://hugin.info/132866/R/1429831/376822.pdf


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Source: Pharming Group N.V. via Thomson Reuters ONE

 
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