The collaboration combines the proprietary peptide oral-delivery and process technology of Nobex with the proven peptide production capabilities of Biocon. The firms will focus on the development of an oral insulin product that can be used to treat a diabetic population that will increase to more than 200 million worldwide by the year 2030, said the Indian company
Earlier this year, Nobex reported promising Phase I/II data for its hexyl-insulin monoconjugate 2, its lead orally active insulin candidate. The results, published in the journal Metabolism, showed that oral HIM2, when added to a basal insulin regimen, was safe and may have utility in controlling post-prandial hyperglycaemia in diabetic patients.
HIM2 is designed primarily as a therapy for type 2 diabetes patients to supplement the insulin that is decreased in secretion but still produced by the pancreas, noted the company. The product is currently undergoing Phase II evaluation. The product had been partnered by GlaxoSmithKline, but the drug major handed back rights to Nobex at the end of last year.
The two companies indicated that the collaborative effort in developing the oral insulin product would require several years to reach the market. In the meantime, it looks possible that inhaled products could emerge as the first non-injectable versions of insulin in diabetes therapy.
Chairman and managing director of Biocon, Kiran Mazumdar-Shaw, and Nobex CEO Christopher Price said they expect to have significant clinical data and make firm progress towards the manufacturing within two years.
Mazumdar-Shaw also said the agreement provided for Biocon to invest in the equity of Nobex. Other financial terms of the deal were not disclosed.
This is the second manufacturing agreement signed by Nobex in a matter of months. Earlier this year, the company started a collaboration with Dow Chemical on the plant-based production of the latter's NLC-001, a proprietary peptide currently undergoing preclinical evaluation as a potential appetite suppressant to treat obesity. In that deal, Nobex will provide a proprietary gene sequence that will be used in conjunction with Dow's expression technology.