Pharming Signs Manufacturing Deal with Sanofi-Aventis

Dutch biotech firm Pharming has signed a deal with French group Sanofi-Aventis to increase production capacity of its drug Ruconest and reduce costs ahead of an expected European launch this year.

A European Medicines Agency (EMA) committee last month recommended Ruconest for marketing approval in a crucial step forward for Pharming, which has struggled financially after delays in winning the right to launch its product. The manufacturing deal agreed with Sanofi Chimie, a unit of Sanofi-Aventis, will replace a deal with MSD, formerly Schering-Plough, but Pharming said it would launch Ruconest with material from MSD until the Sanofi Chimie process is validated.

The financial details of the deal were not disclosed, but a Pharming spokeswoman said the company would need to make a limited investment in adjusting the Sanofi Chimie facility, while also stressing the deal was a "joint agreement."

Pharming shares have fallen 26% on funding worries since the positive EMA recommendation last month.

"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," Chief Operations Officer Bruno Giannetti said in a statement.

The agreement will see the production of Ruconest transferred to one of Sanofi Chimie's existing manufacturing facilities and provide Pharming with sufficient production capacity, the company said. The spokeswoman said the company has enough Ruconest stock for the product launch, expected in the fourth quarter, and for the foreseeable future, but declined to indicate how long the validation process, to be done by EMA, will take.

She said the transfer of production will take place as soon as possible after validation.