ZymoGenetics Inc has signed a license agreement granting Novo Nordisk A/S exclusive worldwide rights to its recombinant Factor XIII portfolio, including all related intellectual property.

Under the agreement, Novo Nordisk will gain the right to develop and commercialize rFactor XIII on a worldwide basis. Novo Nordisk will pay ZymoGenetics $15 million upon signing, and up to $62 million in additional milestone payments. Novo Nordisk will also pay a royalty to ZymoGenetics on any products containing recombinant Factor XIII, including combinations with Factor VIIa, marketed by Novo Nordisk as NovoSeven.

This transaction transfers recombinant Factor XIII (rFactor XIII) to a company with the infrastructure and expertise needed to capture and maximize the market value of this product candidate. In turn, ZymoGenetics gains the opportunity to better focus resources on developing its genomics-derived candidates TACI-Ig and IL-21, which are in early clinical trials, and recombinant human Thrombin (rhThrombin), which is already in phase 2 trials.

This agreement also releases resources that will enable ZymoGenetics to pursue potential line extensions for rhThrombin, additional indications for its genomic product candidates, and to bring other novel drug candidates to the clinic, a release from ZymoGenetics said.

Bruce L.A. Carter, president and CEO of ZymoGenetics said, "This license enables ZymoGenetics to retain a significant share of the recombinant Factor XIII programme's future economic rewards, while freeing up resources to build even greater value elsewhere. Novo Nordisk's expertise in the field of bleeding should lead to even greater potential for the product. Within ZymoGenetics, we will invest more resources in the development of rhThrombin and TACI-Ig. We believe TACI-Ig has potential in many serious autoimmune diseases, as well as several B-cell cancers. In addition, our demonstration of synergy between IL-21 and Rituximab in the treatment of tumours in animals greatly expands the clinical potential of this candidate. We will also explore the potential of future genomics-derived protein development candidates such as IL-29 and IL-31."

Factor XIII is a protein that stabilizes and strengthens blood clots. ZymoGenetics has been developing recombinant Factor XIII for the treatment of bleeding complications associated with congenital and acquired Factor XIII deficiencies. The FDA recently informed ZymoGenetics that the company could proceed with rFactor XIII clinical trials. From its work with Factor VIIa, another protein involved in the blood-clotting cascade, Novo Nordisk has built significant expertise in the field of bleeding and coagulation that can be applied to the development of rFactor XIII. Scientific evidence suggests there may be expanded potential for Factor XIII and Factor VIIa to work synergistically in certain bleeding conditions, the release added.

ZymoGenetics is a biopharmaceutical company focused on the discovery, development and commercialization of therapeutic proteins for the prevention or treatment of human diseases.