The company claims it could become a cheaper alternative to meet the demand for insulin as the incidence of diabetes increases worldwide. The worldwide insulin market is immense, with sales of over $5bn (€3.9bn) in 2004 and yearly growth of almost 10 per cent. Furthermore, the market is highly concentrated, with three companies monopolising available market share – Eli Lilly, Novo Nordisk and Sanofi-Aventis booked record sales of more than $7.2bn in 2005. Pharmaceutical companies have thus been encouraged to become more innovative in order to better respond to the needs of diabetics. In particular, there have been calls for companies to develop insulin with different durations of action (prolonged, intermediate, short, mixed) and alternatives to subcutaneous injection delivery, thereby allowing treatments to be customised to suit the individual patient's needs. The recent approval of inhaled insulin Exubera from Pfizer marks the beginning of the new era of needle-free insulin administration and the entry of a fourth Big Pharma player into the lucrative insulin market. However, inhalation of insulin needs five times more insulin than injection due to the poor bioabsorption, therefore, availability of high volume supply of insulin at a lower price will be key to meet this expansion in demand – production of insulin in transgenic plants may be an alternative. SemBioSys claims its insulin, produced from transgenic safflower, can reduce capital costs by 70 per cent and product costs by 40 per cent compared to existing insulin manufacturing methods. "In addition, because of the ease in scaling-up crop acreage, plant-produced insulin offers significant improvements in the flexibility and speed of scale-up," the company said. With this new deal, SemBioSys will starts working with Cangene to implement technology transfer of the manufacturing process, which will allow Cangene to manufacture safflower-produced insulin for preclinical and early stage development trials. "We continue to advance our insulin development plan," said Andrew Baum, president and CEO of SemBioSys Genetics. "In the near term, we expect to announce the regulatory strategy we will pursue in the US for our insulin product and to receive in vivo and in vitro bioequivalence results comparing insulin produced from safflower to commercially available insulin products." The company also said that the execution of this contract is the second significant development objective for its insulin programme – last July, SemBioSys announced it achieved commercially viable levels of insulin accumulation in safflower. With manufacturing capacity in place, SemBioSys is hoping to complete its preclinical work and file an investigational new drug application in the fourth quarter of 2007.
