Oramed submits an IND application to FDA for their experimental oral insulin

January 9, 2013 | By Márcio Barra

The market potential for an oral insulin product is huge. With no oral insulin options available for sale, type I and type II diabetes patients must endure frequent and painful insulin shots in order to control their blood sugar levels. The simple act of switching to oral pills would change everything for the 25.8 millions who have diabetes in the USA (2010 data), and the 55.4 million people in Europe (2010 data). A pill formulation would also be less expensive, a big plus in today’s market trends.

What is the roadblock stopping oral insulin from being a reality? Getting it past digestion in the stomach. Further bioavailability issues are also  major challenges. A solution to these problems is worth up to $10 billion in sales a year, enough to dethrone Lipitor.

Novo Nordisk, a major player in diabetes healthcare, has been seeking a solution for this challenge since 2006. Their prototype drug NN1952, an oral insulin analogue, is currently in phase I. It’s one of the big focus of the company, as reaching a solution first would ensure that their existing diabetes business is not harmed by companies who also wish to develop oral insulin solutions.

But Israeli-based Oramed pharmaceuticals might be ahead of them in the race. Today they submitted an IND to the FDA to conduct a phase II study in 147 type II diabetic patients for their oral insulin prototype, ORMD-0801.The press release shows that Oramed’s compound is further along than Novo Nordisk’s, indicating that their technology may be better. If all goes well, a 2015 release is expected by analysts, which could turn Oramed in a big competitor in the diabetes field with its blockbuster drug. That is, unless Novo Nordisk buys them for a hefty amount, as pharma companies are getting ready to buy.

Sources:

http://www.news-medical.net/news/20130109/Oramed-files-IND-with-FDA-to-begin-ORMD-0801-Phase-2-trial-for-type-2-diabetes.aspx

http://seekingalpha.com/instablog/1240561-ray-dirks/687261-why-oramed-pharmaceuticals-oral-insulin-drug-could-make-it-an-acquisition-candidate

1 comment
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