By Sylvia M.Findlay, Research Analyst, Pharmaceutical & Biotechnology

Stepping into the era of systemic pulmonary delivery, the healthcare community is awaiting a revolution in drug delivery technology. The approval of Exubera – inhaled insulin by the US FDA has opened up a whole world of possibilities for deep lung delivery of drugs. An important milestone in treating a systemic disease with pulmonary delivery, it all set to revolutionise the drug delivery market.

Diagnosis, treatment and management of diabetes are still a major concern. Convenience and compliance in treatment regimen is proving a major hurdle in diabetes management. The introduction of a novel alternative in delivering insulin through systemic pulmonary delivery is likely to straighten the rough edges in diabetes management.

Fore-runners

Pfizer and Nektar Therapeutics are the first movers in the inhalation insulin segment. The FDA approval is likely to spur the interest among the pharmaceutical community to introduce inhaler drug for various therapeutic areas. A host of pharmaceutical and biotech companies have teamed up to explore the new arena. The excitement has ignited the interest among the healthcare community and has led to the development of various pulmonary delivery products that are in the pipeline.

Redefining drug delivery

Pulmonary drug delivery is likely to spread to various therapeutic areas and thereby expand the market potential. Exubera is the first product in this segment. Technological and product advancements are expected to redefine pulmonary drug delivery. Deep lung delivery, safety, flexible dosing, dose correction and easy monitoring are essential for efficient pulmonary drug delivery. These are likely to be incorporated in future inhalers. Pfizer is expected to face stiff competition from the advanced inhalers that are to be brought out in near future.

The pharmaceutical companies in pursuit of inhalation devices are

• Aradigm/Novo Nordisk - AERx
• Alkermes/Eli Lilly - AIR insulin,
• Mannkind - Technosphere
• Kos - MDI.
• BioSante- BioAir
• Epic’s PROMAXX

These pulmonary delivery devices boast of several advanced features that enable efficient and safe drug delivery. The therapeutic areas of usage of systemic pulmonary drug delivery ranges from diabetes to pain management including osteoporosis, migraine, sexual dysfunction, immunosuppression, smoking cessation, premature ejaculation , growth hormone deficiency, neurological problems and even certain cancers. As the number of therapeutic areas for application of this novel alternative for drug delivery is high, the market potential is estimated to be astounding.

Systemic pulmonary delivery – The challenges

The safety concern and premium pricing in pulmonary drug delivery are the only impeding factors that reside among the healthcare community. More studies are expected to substantiate the safety profile of the inhaled insulin. The premium pricing is expected to retard the market growth in the European diabetes markets. Though premium pricing may be a retarding factor, the first inhaled insulin-Exubera is likely to instigate excitement among the European diabetic community. This is likely to open up lucrative cash markets in Europe. The first pulmonary insulin to reach the global market is estimated to garner $750.0 million by 2009. The global diabetes market is awaiting the launch of pulmonary insulin. This novel drug delivery technology is all set to penetrate the entrenched subcutaneous insulin delivery market.

Future

According to the World Health Organization (WHO), the global prevalence of diabetes is expected to reach 336.0 million by the year 2030. Diabetes incidence and prevalence are expected to increase by 21.0 per cent in the next 20 years. It is posing a great burden on the limited government health care budgets. It is estimated that EU spends 29.00 billion Euros towards diabetes care costs. The increasing costs due to diabetes and its complications are likely to increase at a geometric progression in the coming years unless measures are taken to control it. The current treatment options available for diabetes are inadequate to meet the needs of the diabetic patient. Disease awareness, lifestyle changes and more compliant treatment methods are the pressing need of the day. The European governments are taking initiatives to increase awareness and education programs. The importance of lifestyle modifications and strict treatment regimen is emphasised.

Attempts are being made to reduce the burden of the insulin taking diabetics. Various options for insulin delivery are currently under research to replace the vintage concept of subcutaneous insulin delivery. Oral insulin, Transdermal insulin and diabetes vaccines are in various phases of research. Nanotechnology is presently being utilised to enable better insulin delivery. This technology has tremendous potential to change the face of insulin delivery. The human genome project has opened up avenues for gene therapy. Gene therapy for diabetes is being given much importance owing to the detection of the diabetes gene. But the research is still in the initial stages of development. As diabetes is a multigene disorder, the approach is likely to consume more time to succeed.

This article was originally published on www.frost.com

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