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The Possibility of an Oral Insulin Treatment for Type 1 and Type 2 Diabetes is Near

(Pub. 27th August 2012)

Keeping blood sugar under control is a lifelong commitment for patients with both type 1 and type 2 diabetes. Patients who require insulin to keep their blood sugar levels under control need to meet target HbA1c levels of less than 7%, and have to administer it by injection. This need for regular daily injections is a frustrating and overwhelming issue for diabetic patients, and causes a reduction in compliance with this medically necessary treatment. The idea of creating an oral diabetes medication, one to replace the insulin format of administration has been under examination by research scientists for years.

The oral route of drug administration is expected to be the safest and most practical, and one which shall promote the highest level of compliance among patients. The oral–portal insulin delivery has the additional benefit of replicating the physiological pathway of endogenous insulin secretion while avoiding peripheral hyperinsulinaemia and hypoglycemia.

Recently, several companies have begun to make headway in developing alternative modes of insulin delivery that are safe and effectual.

On July 11, 2012 Oramed, a developer of oral drug delivery systems, made an announcement regarding their latest development. Oramed announced that its patent, which is titled “Methods and Compositions for Oral Administrations of Proteins,” was approved by the New Zealand Patent Office. This is Oramed’s second patent to be granted in New Zealand,  making this forward thinking company’s portfolio more comprehensive than ever. Consisting of 4 issued patents, as well as 33 patents pending, Oramed is seeking to create innovative and efficacious options for diabetes treatments.  Oramed is currently applying its oral delivery technology to its two flagship products, an oral insulin capsule, known as ORMD-0801, and an oral GLP-1 analog capsule, known as ORMD-090. They are currently in Phase 2b studies.

Additional advancements in oral Insulin diabetes treatments to replace injectable drugs have been pursued by Canadian company Generex Biotechnology. Their development of Oral-Lyn, an oral spray formulation of human insulin indicated for the treatment of type 1 and 2 diabetes, is currently FDA approved as an investigational new drug program.  The Ecuadorian Ministry of Public Health has already approved the use of Oral-Lyn for type 2 diabetes, based on data from clinical trials conducted in Ecuador which involved more than 250 patients with type 2 diabetes. These studies revealed positive results, and showed that Oral-Lyn had comparable efficacy to prandial insulin injections in this patient population.

The Norwegian University of Science and Technology  have developed a new type of capsule, called TAM, or the Trondheim Alginate Microcapsule, which is designed to camouflage the insulin-producing cells to the body’s immune system. Ideally this capsule, when fully tweaked, developed and efficacious, will allow nutrients to enter the insulin cells while insulin is transported out. With international cooperation, this project, coined the Chicago Project, intends to find a permanent and functional cure for type 1 diabetes.

On May 3, 2012 Midatech and Monosol announced positive bioavailability and pharmacokinetic results from a first-in-human Phase 1 clinical study of their Midaform™ Insulin PharmFilm product in a study comprised of 27 healthy volunteers. By delivering monomeric insulin through the use of a rapidly dissolving mucoadhesive film that is placed onto the inside of the cheek, this novel treatment is both fast acting and effective. MidaSol’s product showed a faster onset of action compared to subcutaneous insulin. The apparent success of Midaform is yet another exciting treatment on the horizon.

There are several other global companies who have invested millions of dollars in order to study and develop novel mechanisms for oral Insulin delivery technology. Currently, the major players in Diabetes drugs market worldwide include (amongst others): Abbott Laboratories, Novo Nordisk, Merck and Sanofi-Aventis

 With the total number of diabetes patients in the world expected to grow from 275 Million in 2010 to 425 Million by 2030, options for patients currently reliant on injectable treatments are crucial. Just as insulin injections revolutionized the treatment of diabetes when they were first introduced into clinical practice in the 1920s, the future of non-injectable treatments is set to create a second revolution.

 

YES Pharma is proud to be a leading supply source for Insulin (Human, Recombinant) (CAS#: 11061-68-0, 11070-73-8, 9004-10-8) to several global pharmaceutical companies and academic research institutes, while recognizing that we play a significant part in promoting the struggle against Diabetes. The Insulin that YES Pharma supplies is intended for laboratory R&D use only.

References:

Diabetes Technology & Therapeutics, Comparison of Oral Insulin Spray and Subcutaneous Regular Insulin at Mealtime in Type 1 Diabetes http://www.sciencedaily.com/releases/2007/06/070624121236.htm
World Diabetes Drugs & Devices Market to Grow 13.5% to 2016, December 20, 2011, PRLO
http://www.monosolrx.com/index.htm 
 

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Dun and Bradstreet