DSM revises biologics license with Valentis

DSM Biologics has dissolved its relationship with fellow Dutch company Qiagen and Valentis of the USA regarding the pAlliance, a consortium for manufacturing and supplying customers in the gene therapy and genetic vaccination sectors with ultra-pure, stable DNA plasmids and formulated DNA.

Under a revised agreement, a license granted by Valentis to DSM Biologics for the US firm's plasmid DNA manufacturing technology is affirmed, but on revised financial terms, and outstanding disputes regarding prior plasmid DNA manufacturing services performed by DSM Biologics for Valentis have been resolved. Qiagen can continues to use the pAlliance trademark in its business.

The new agreement reinstates DSM's 1998 license to Valentis' technology, but has been modified to add a royalty to the US firm in addition to the previously-agreed profit-sharing arrangement. The deal also wipes out $1.1 million (€925,000) in liabilities accrued by Valentis, and it will also receive a net payment of $600,000 from DSM.

Meantime, Valentis has been granted a new plasmid DNA purification patent in Europe. The invention relates to the use of a gel layer for nucleic acid purification or filtration during ultrafiltration. The claims of the patent (EP 923592) broadly cover a particularly useful method of ultrafiltration and diafiltration in plasmid DNA purification, without other process limitations. Similar patents have been issued in the USA and Australia.

In addition, Valentis has been granted a US Patent (No 6,534,483) claiming a method of formulating nucleic acids with transfection facilitating agents by in-line mixing as well as co-lyophilised complexes of nucleic acids with formulating agents such as poloxamers and polyvinyl pyrrolidone. This patent expands Valentis' patent position relating to its co-lyophilised, poloxamer formulated Del-1 gene product, which is in Phase I trials.