Ever since man started popping pills for various ailments, pharmaceutical companies’ Holy Grail has been the insulin pill – a pill which will replace the pinpricks that diabetics have begun to consider a part and parcel of their life. Sadly, the plan was abandoned around 80 years ago when pharma companies decided that it just wasn’t a viable option. However, the race is back on with two companies leading the pack – a tiny Israeli pharma company called Oramed Pharmaceuticals Inc and Danish pharma giant Novo Nordisk, incidentally the world’s largest seller of insulin – both believing that the pill is a viable option.
The pill, when it comes will surely revolutionise the pharma industry, almost as much as the oral contraceptive pill did in the 60s and Lipitor (a blood cholesterol lowering drug) and Viagra did in the 90s. Never before has the market been so fertile, considering there are 370 million diabetics in the world. And Novo Nordisk is ready to take the plunge with the company announcing that it will spend up to $3.65 billion till 2020 to develop and produce six different diabetes pills. The underdog isn’t standing still though; Oramed’s program is a little ahead of Novo’s with patients enrolling for Phase II clinical trials. The mastermind behind Oramed’s oral insulin is the CEO’s mother Miriam Kidron who’s done the groundwork with years of research on the diabetes. ‘She’s the chief scientist. I just went for the ride to do the business side,’ said Oramed CEO Nadav Kidron told Reuters.
Why has previous alternative insulin delivery systems failed?
The concept of the pill has been around since the 1930s but it fizzled out when it was discovered that insulin, being a protein made of amino acids would be destroyed by the digestive system. The focus on the oral insulin is back on because of the huge number of type 2 diabetics in the world, accounting for around 90-95% of the numbers. But the wait is going to be long, especially the regulatory approval and will need large scale trials to prove their efficacy and safety. Except injections, all other methods of insulin delivery have been rejected till now including Pfizer Inc’s inhaled insulin product.
Why is the pill so attractive?
Dr Rajiv Kovel, a diabetelogist explains, ‘Oral Insulin holds promise since if it gets absorbed from gastrointestinal tract then it would undergo first pass metabolism through the liver like natural insulin. When we inject insulin into subcutaneous tissue it is not the physiological site for injection. Oral insulin would increase the levels of insulin in portal system.’
While insulin is naturally produced in the pancreas and then goes to the liver, injected insulin circulates throughout the body before it gets there. The main attractiveness of an insulin pill, if it works, is that any absorbed insulin would go directly to the liver from the digestive tract.
To counter the digestive system’s natural ability to break down insulin, both companies are looking to use protective coating and molecular modifications to make sure that enough insulin gets absorbed to maintain blood sugar levels. Dr Kovil adds, ‘If one could have insulin as oral pills since one need not take injections thereafter, the compliance of patients to therapy would increase drastically.’ (Read: 10 celebrities living with diabetes)
A new dawn for diabetics?
Kidron believes that the pill, if it works, could revolutionise healthcare. ‘If we give insulin earlier on, we’re going to give the pancreas a rest,’ Kidron explained. ‘We could reduce the complications, such as blindness and amputations.’ Dr Kovil agrees, ‘If the bio-availability of oral insulin pills is good then there can be no downside. Preventing the degradation of insulin in gastrointestinal mucosa and thus increasing the levels in intestine is what many pharma companies are aiming at. But one needs to understand that the most important advantage of injectable insulin is small increments and decrements and flexibility it allows to patients and doctors. If oral insulin does not allow flexibility in our therapy then it has no value.’ (Read: Five herbal remedies for diabetes)