Jerusalem, Israel-based drugmaker Oramed Pharmaceuticals has been granted patent approval for its oral insulin technology by the Japanese Patent office.
Entitled ‘Methods and Compositions for Oral Administrations of Proteins,’ the patent covers technology being used on Oramed’s pipeline products, an orally ingestible insulin capsule and a GLP-1 analog currently approaching Phase 2 and Phase 2a trials respectively.
The news comes after in-Pharmatechnologist.com reported last month that Novo Nordisk was one step closer to an oral solution following successful completion of an early stage trial of its own therapy.
Dr. Miriam Kidron, Director of Oramed told us that belief in oral delivery of insulin in the near future has been boosted “if a big company like Novo Nordisk” is investing time and money in developing a therapy.
She continued, adding: “We are very happy [Novo Nordisk] are going ahead as people are very skeptical [of oral insulin] following a lot of failure in the past.” There is always need for more research and development in the field, Kidron explained, and it could only be a good thing to have numerous companies investigating different types of oral insulin.
In the mid-2000s there was a lot of interest in alternative insulin delivery methods, including much investment in oral-sprays and inhalers. However, the failure of Pfizer’s inhalable insulin in 2007 did much to fizzle out speculations of hope for diabetics looking for an easier, less painful way of administering therapies, and led to pull-outs on projects by Novo Nordisk , Eli-Lilly and Alkermes .
However, there has been some progress in the task of converting injectable insulin into tablet form with Oramed and Novo Nordisk following the leads of Apollo Life Sciences (who patented its own insulin tablet technology in 2007) and Biocon , who recently teamed up with Bristol-Myers Squibb to further develop and commercialize its offering, IN-105, also currently in phase 2 trials.
When asked if a partnership with a big pharma company would be on the cards, Kidron, who is also Chief Scientific Officer at Oramed, told us it was “one of the directions” the company was looking at, if “a good proposal came along.”
Oramed’s candidate has been designed to conquer the issues in delivering proteins, like insulin, into the body by pill rather than injection. At present, proteins can’t be taken orally due to degradation in the stomach (enzymes digest the API protein) and the fact that the protein molecule is too big to be enter the bloodstream via the intestinal membrane.
Aviva Sherman, an Oramed spokeswoman, said Oramed’s technology comprises of protease inhibitors and absorption enhancers. The former “act like bodyguards blocking proteases, which degrade proteins,” whilst the latter “help protein cross the digestive membrane and reach the bloodstream.”
The tablet is also enclosed with enteric coating which is pH sensitive and thus doesn’t open until the pill is past the stomach. “When it arrives at the intestines, the increased pH signals it to open and Oramed’s technology comes into play.”