Canadian biotech firm SemBioSys Genetics has presented an update on its project to promote plant-derived recombinant human insulin on a commercial scale, expecting to hop directly to Phase II trials early next year.
The company intends to pursue an abbreviated clinical trial, entering directly into a Phase II trial in early 2008 with commercialization of the plant-based insulin set for as early as 2010.
According to the company, this method of insulin manufacture could play a significant role in reducing the burden in the face of the growing worldwide demand for insulin. While insulin demand is currently at around 6,000kg a year, by 2012 the company puts demand at a much higher 16,000kg.
The increase will be driven not only by earlier diagnosis and increasing incidence of diabetes in the both the developed and developing world, claims the company, but also new methods of insulin delivery, which could drive significant growth in insulin demand.
Inhalable insulin, for example, requires five to twenty times more insulin per dose than standard injectable methods, to overcome lower bioavailability. However, Exubera - the so-called big name in inhalable insulin - is proving to be somewhat of a damp squib, falling short of expected sales and proving unpopular with physicians, which could perhaps act to slow the anticipated hike in insulin demand.
SemBioSys is confident that its transgenic plant option will make the difference in avoiding insulin shortages and avoiding exorbitant costs as the insulin market continues to grow.
Earlier this year the company announced that it had completed studies that showed its plant-derived insulin was indistinguishable from pharmaceutical grade human recombinant insulin, both analytically and physiologically.
In addition to this, SemBioSys exceeded its targets by achieving levels of insulin within the plant seeds even higher than were required for the process to appear commercially viable. The firm achieved 1.2 per cent accumulation of insulin within the seeds of its transgenic safflower plants, meaning that a single acre of safflower could produce enough insulin to supply 2,500 patients for an entire year.
Going by the company's projected insulin demand, it would therefore also mean that around 25,000 acres of safflower would satisfy the entire insulin demand for 2012.
"Plants are a transformative platform for the production of biopharmaceuticals," said Andrew Baum, president and CEO of SemBioSys.
"They are ideally suited to large volume products such as human insulin, where capacity is in short supply. Plants offer unprecedented capacity and flexibility for low-cost biopharmaceutical manufacturing and provide by far the most attractive economics, both in terms of capital and cost of goods."
The company has estimated the capital cost of insulin manufacture using its transgenic plant platform at 70 per cent less than traditional methods that rely on yeast or E. Coli, and a 40 per cent saving in product costs.
With the insulin market value estimated due to balloon to $10bn or even $15bn over the next few years, cost effective methods of production will be an attractive option to pharma firms and potential partners for SemBioSys.
However, despite the interest in transgenic production of biopharmaceuticals, it may take some time before companies wholeheartedly embrace the unfamiliar production process. It may well be the case that only after a few pioneering companies take the plunge to help establish the platform that we might begin to see transgenics viewed as the norm in biopharmaceutical production.