Large pharmaceutical companies make an enormous amount of money from people suffering from chronic and acute diseases. For years, non-injectable insulin that could be taken orally has been something of a ‘holy grail’ in the diabetes medical market. The Canadian biotechnology company Generex were the first to reach this goal, and released oral insulin in Ecuador at the end of 2005. Whether biotech companies such as Generex are actually a threat to the big pharma industry is unknown at this stage.
Generex cleverly bypassed both European and American regulatory law and had Oral-ly, a buccal insulin spray delivered via RapidMist inhalers, approved for release in Ecuador. The oral insulin was approved following clinical trials of just 250 type 2 diabetics. Generex plans to capture more of the South American market later this year, and then take the drug into the larger international markets in North America and Europe.
In Europe and American, to get beyond Phase III clinical trials requires enormous-scale studies. The route chosen by Generex outlines one way in which biotech companies can undercut the pharmaceutical giants. Although, with the release of Exubera, it seems that large pharmaceutical companies are already moving to sew up the market, Biotech companies specialising in oral insulin may herald new treatment for the future of insulin.

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