The US-based drug major Eli Lilly confirmed that it will go ahead with its plans for inhalable insulin, AIR Insulin, despite the recent setback faced by Pfizer's inhalable insulin Exubera. The company considers that inhalable insulin does have potential to combat deadly diabetics.

"Our enthusiasm for AIR Insulin and the inhaled insulin class has not diminished. We remain committed to developing AIR Insulin as an important and valuable potential treatment option for people with diabetes," said, Dr Vinod Mattoo, medical director, Eli Lilly and Company India Pvt. Ltd., in an e-mail reply to Chronicle Pharmabiz.

The company also affirmed that the withdrawal of Exubera has not put an end to the era of inhalable insulin. "With regard to insulin injections, we believe that there are many patients who would prefer to use inhaled insulin instead of an injectable, if the system met their needs and preferences. In fact, in a phase 2 study, we found that 80 per cent of type 1 patients preferred AIR Insulin to injectables. By continuing to understand the target patient and their healthcare professionals, we are confident that inhaled insulin has a place in the diabetes continuum of care," Dr Vinod Mattoo added.

Asked whether fears of questionable effects on lung function (that Exubera reported) and the inefficiency to replace insulin injections would work against AIR Insulin, he replied, "First of all, we are committed to the safety of our patients and providing them and their healthcare professionals with the answers they need to make good decisions related to their healthcare. Our clinical program is developed to comprehensively assess the potential impact of AIR Insulin in the lungs, even in those patients with comprised pulmonary conditions such as COPD, asthma and upper respiratory infection. When our phase 3 safety data results are available, we believe that our results, along with Exubera's eight-year safety results, will enable us to evaluate any existing safety questions and then work effectively with patients and their healthcare professionals to address these questions"

Often, patients with diabetes face a number of decisions when diagnosed, including when to move to insulin treatment, which is the proven gold standard for effective diabetes management. But many patients delay moving to insulin for a number of factors, including, but not limited to, the fear of multiple injections, concern about hypoglycemia (dangerously low blood sugar) and concern that a 'complicated' insulin regimen will interfere with their lifestyle.

"We believe we have addressed some of these barriers to insulin use with a system designed to be what we feel is a patient-friendly, easy-to-use system that is small, discreet and maintenance free. AIR Insulin has also been designed to offer simple directions for use and multiple dosing options, which are critical to ensuring the best outcome for the patient. We believe the system not only provides patients with an easy to use, small, and discreet system that can remove some of the barriers to injections, but more importantly, we believe our AIR Insulin provides a treatment option that helps patients embrace the use of insulin earlier and could delay the onset of some debilitating and potentially fatal diabetes-related complications," Dr Vinod Mattoo said.

Eli Lilly pointed out that there is a wider market for inhalable insulin as there are over 246 million diabetes patients around the world today with more than half of them not meeting their treatment goals. "With the epidemic growth rate of diabetes and the increasing usage of insulin, there continues to be a market for an inhaled form of insulin. As long as there is this large population with an unmet medical need, the market will continue to demand options to help those with diabetes manage their disease more effectively and appropriately," he noted.

Replying to a question on whether inhalable insulin has got any edge over insulin injections, Dr Vinod Mattoo said, "It's not about an edge over injectables, it's about providing another treatment option for patients with diabetes to help them embrace the insulin gold-standard earlier into their treatment regimen and with the goal of better outcomes. Two prevailing causes of poor control are the delay in starting insulin, the most reliable therapy (gold standard) for achieving blood sugar control, or the delay in advancing to a basal / bolus regimen. We believe that the Lilly AIR Insulin System will provide patients with diabetes and the physicians who treat them with an innovative treatment option that can help lead to these better outcomes."

Eli Lilly made it clear that the company is committed to the programme and pleased with its progress. The company also disclosed that it does not foresee any delays in moving forward and would make FDA filing in 2009.