Biotecnol and Digna Biotech co-develop hepato-protective drug
Oeiras/Navarra – Portuguese antibody and genomics specialist Biotecnol SA and the Spanish university spin-off Digna Biotech will develop a process for manufacturing cardiotrophin-1 (CT-1) for the treatment of ischemic-reperfusion injury after liver transplantation.
Under the terms of the cross licence agreement, announced at the beginning of June, Biotecnol will set up a production process for CT-1, the member of the interleukin-6 cytokine family, with an option to progress to GMP manufacture, and onto control and release of the finished product. Digna Biotech obtained EU Orphan Drug Status (EU/3/06/396) for the use of CT1 in organ transplantation, including liver transplants and will apply to the FDA for Orphan Drug Status in the USA, initially for use of CT-1 in hepatic transplantation.
Digna Biotech will provide financial support and will gain access to Biotecnol’s proprietary production platforms and process development know-how, by paying agreed milestones. Digna Biotech has further options to subcontract future work to Biotecnol, which includes the manufacture of the finished product for a renewable five-year period, beginning with the release of the first successful finished product batch for clinical trials, for which Biotecnol will receive agreed milestone payments.
“This is probably the first sizeable deal in the biopharmaceutical sector between a Portuguese and a Spanish company”, said José Honorato Ferreira, Board Member of Biotecnol and member of Fundação Luso-Espanhola, an organisation dedicated to promote the networking and cooperation between the two countries.
“Digna Biotech has impressive expertise and in-depth knowledge in the field of liver diseases”, said Pedro de Noronha Pissarra, Chief Executive Officer of Biotecnol.
Sp1 has demonstrated hepato-protective effects in lab mice (Hepatology. 2007 Mar;45(3):639-48).