SemBioSys prepares to file novel insulin product with FDA
its novel plant-produced insulin product in preparation for its
submission to US regulatory authorities.
The work, which will assess the toxicology of repeated doses of the drug in rodent and simian models, is designed to further examine its safety and comparability to pharmaceutical grade human insulin and is a requirement of the FDA's abbreviated review process. By 2012, independent observers estimate that the combined effect of earlier diagnosis and the increasing incidence of diabetes in the developing world will cause the global insulin market to grow to around $15bm, even despite a slight reduction in demand projections following Pfizer's high profile withdrawal of Exubera. At present, recombinant insulins produced by genetically modified bacteria, using a technique first developed by Eli Lilly and latterly Genentech and Novo Nordisk, dominate the global diabetes market, which is estimated to be worth around $7bm a year. While such products are functionally indistinguishable from native forms of the hormone, the expense of maintaining the modified bacterial lines coupled with the relatively low yields that they produce mean that there is significant room for improvement in the insulin production process in economic terms. In contrast with current pharmaceutical insulins, SemBioSys' product is manufactured using a genetically modified strain of the herbaceous plant safflower (Carthamus tinctorius), an acre of which, according to previous reports by the company, is capable of producing enough insulin to meet the needs of 2,500 diabetes patients. The Calgary-headquartered firm said that previously conducted studies have established that its product is structurally and physiologically indistinguishable from pharmaceutical-grade human recombinant insulin. Additionally, quantitative blood sugar assays performed in rabbits (insulin tolerance test) demonstrate its pharmacodynamic equivalence to currently marketed forms of the drug. SemBioSys believes that its product, if successful in trials, will offer dramatic capital and operating cost reductions and provide potential licensees with the opportunity to enter the market in a cost effective manner. As CEO Andrew Baum commented: "insulin is currently one of the largest volume recombinant biopharmaceutical products on the market and demand is projected to increase dramatically in the coming year," adding that "the scalability of our safflower-produced insulin has the potential to provide a cost-effective source of insulin to meet this growing demand." Mr Baum concluded that, assuming the toxicology assessments are completed successfully, the firm is on track to begin phase I/II clinical trials later in the year.
