Diabetes patients could soon bid goodbye to syringes. Researchers at pharma as well as biotech majors seem to be in a race to develop a blockbuster needle-free insulin delivery mechanism. Syringes continue to be mainstream but the medical world seems to be betting on patches, inhalers and most recently pens and also recombinant insulins.
Undeterred by some early failures like Exubera, an insulin inhaler recently scrapped by Pfizer, global drug firms like Novo Nordisk and Eli Lilly seem to be working hard on developing an alternative insulin delivery system. Indian companies like Biocon are not far behind. While Biocon is learnt to have developed an insulin pill for which it is conducting trials and also exploring options of selling marketing rights to international companies, Shreyas Life Sciences is getting into a distribution agreement for an oral insulin product.
Reasons are obvious. Majority of the world?s 246 million diabetics today find it hard to inject themselves. With sufferers forecasted to be 380 million by 2025, business imperatives for the pharma bigwigs in the $22 billion diabetes market are obvious. It?s not easy to miss the focus on countries like India, where diabetes has affected over 41 million people, compared to 19 million in the US. A huge segment of these 41 million diabetics today need to take injectable insulin.
?The delivery mechanisms have come a long way. Traditional insulin delivery with a vial and syringe makes it difficult to administer small doses of insulin and does not allow for discrete injections. This has prompted the development of alternative routes of insulin delivery that are more simplified and acceptable to patients, such as insulin injection pen devices,? confirms Novo Nordisk (India) managing director Melvin D?Souza. And he is not alone. Biocon, for one, is gung-ho on the oral options. Dr Reddy?s Laboratories is also conducting phase III clinical trials and is hoping its Balaglitazone, slated to be launched in 2011, to be a blockbuster. We are bullish on the demand for insulin and if we are successful with our clinical trials, we may be the first Indian company to launch a blockbuster drug for diabetes,? says Anji Reddy, chairman, Dr Reddy?s Laboratories.
Medical therapy for diabetes mellitus has changed dramatically since Banting and Best discovered insulin in 1921 but insiders feel that we could be on the verge of seeing a completely transformed insulin treatment. These advancements in technology have provided various sizes of syringes and needle systems. The traditional insulin injection process, however, remains time-consuming, cumbersome, inconvenient, and apparently somewhat painful.
According to experts, there are dosage errors while administering via syringe or the conventional system. New devices like insulin pens could go a long way in breaking barriers to early initiation of insulin by improving compliance among diabetic patients. ?These devices provide improvements in flexibility, convenience, and freedom for insulin-requiring patients. Insulin delivery devices also help promote dosing accuracy and improve compliance with insulin therapy,? says D?Souza.
Biocon and Novo Nordisk are betting big on insulin pens. The latest insulin pen devices such as the FlexPens by Novo Nordisk, combine the insulin container and the syringe in a single unit. Their compact size allows discreet insulin administration and the technology also provides for extremely accurate insulin delivery. Advances in the technology of needle manufacturing continue to make needles more comfortable to use. With all these refinements combined, insulin pens have demonstrated that patients will adhere more closely to recommended insulin dosage schedules.
Inhalers are being seen as another ray of hope by many, despite the recent backlash of insulin inhalers by the Exubera story. After selling only $12 million worth of inhaled insulin in the first nine months of the year, Pfizer last month said it would take a $2.8 billion charge and abandon the product. Critics say the Exubera inhaler was cumbersome and was seen as causing a slight decline in lung function. Nevertheless, several companies promise to soon bring out better devices that are currently in clinical trials. In short, inhalers continue to hold a promise.
Biocon has clear plans to enter the domestic oral insulin market by 2010, with the drug now in second of the three stages of clinical trials. Its other product, Nasulin, an intra-nasal insulin spray, is being co-developed with Bentley Pharmaceuticals Inc. Both the products are expected to enter the market by 2010. It has filed three PCT applications for patent on the process for the manufacture of r-human insulin. The company was also the first to launch Insugen, claimed to the world?s first recombinant human (r-DNA) insulin using a unique Pichia expression system in 2004. It is now developing IN-105?a conjugated insulin molecule that is orally delivered and targeted towards the treatment of diabetes. In the clinic, this molecule has completed phase I trials and is expected to enter phase II in India later this year to illustrate proof of concept.
Another promise comes from Generex Oral-lyn?proprietary oral insulin spray product recently approved for sale in India. With this, Generex Biotechnology Corporation is claiming to be the first non-injectable buccalinsulin approved in India. Unlike inhaled insulin products, buccally absorbed Generex Oral-lyn does not reach the lungs. For this, the company has entered into product licensing with Shreya Life Sciences, which is claimed be the fourth largest distributor of insulin.
Interestingly, the search for better patient care doesn?t end at inhalers, patches and pens. Globally, medical device companies are waking up to the need to introduce better designs and more intuitive user interfaces to the $3.5 billion market for equipment to monitor diabetes. Already, medical device companies are believed to be joining hands with design firms to attract patients.
In fact, efforts are on to look for ways to defeat diabetes at all stages of its progression including new types of insulin or insulin analogues. ?We are developing new delivery systems for insulin, including a pulmonary administration system that will allow precise dosing of insulin by inhalation and developing new compounds that can be used to reduce glucose production. We are developing an analogue of a natural stimulator of insulin secretion and inhibitor of glucagon secretion (GLP-1) that in disease models normalises blood glucose without causing a risk of hypoglycaemia,? says D?Souza.
?In addition, we are looking into compounds that can be used to reduce glucose production from the liver and thereby improve treatment. In our labs, we are studying other mechanisms that help the body handle excess glucose and excess lipids that act together to reduce the cells? ability to respond to insulin,? he adds.
Clearly, insulin delivery devices are not likely to remain the same for long, as research for developing painless and non-invasive devices gains momentum. Pen devices that are easy and efficient to operate correctly and with minimal discomfort appear to increase patient?s acceptance and compliance with treatment regimens. We could also see a plethora of oral products in the market within a couple of years. This is encouraging, as enhanced compliance may also result in improved glycemic control and thus reduce diabetic complications.
And as syringes make way for painless treatment, we could soon see a big change in the way diabetes is treated.
