Merck delays construction of protein production plant

Merck KgaA, of Germany, has decided to rely on contract manufacturing to secure supply of both its biological cancer drugs Erbitux (cetuximab) and EMD 72000, at least in the mid-term.

For the time being, therefore, the company will not invest €300m in a production plant in Jena, Germany, as had been contemplated back in March.

Merck already has contracts with both Boehringer Ingelheim and ImClone Systems for the production of the monoclonal antibody Erbitux, which is expected to be approved in Switzerland by the end of the year. EMD 72000, another monoclonal antibody cancer treatment currently in Phase II clinical trials, is expected to gain market approval in 2007 at the earliest.

'Merck has determined that adequate biological production capacity will exist to meet our mid-term requirements,' said ceo Bernhard Scheuble. 'It appears that, in order to remain flexible, our best option for the time being is to use contract manufacturing rather than tying up capital in a new, expensive plant.'

According to Scheuble, current political uncertainties in Germany have also influenced the decision, especially regarding mandatory rebates for non-reference-priced medicines and the lack of free market pricing for innovative and patented new products. Both measures would affect Merck's new biologic cancer treatments.