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New drugs offer help, but won't halt huge rise in diabetes (Datamonitor Report, December 2004)

LONDON, UK, December 7, 2004 -- Even with the advent of health awareness campaigns to draw attention to the health problems associated with diabetes, the global* prevalence of diabetes is expected to climb to over 50 million by 2012.

However a new report by independent market analyst Datamonitor expects significant developments in the field of diabetes therapy. According to the report, by 2012, at least three new key classes of drugs to treat diabetes will have entered the market, with the most promising being Novartis's LAF-237 and Eli Lilly's exenatide LAR. According to Datamonitor forecasts, both drugs will acquire blockbuster status by 2012, amassing total sales in excess of $3 billion, says Datamonitor Endocrinology analyst Nick Karachalias.

Huge societal cost

Datamonitor estimates that there are 38 million diabetic people in the US, Japan, France, Germany, Italy, Spain and the UK, with almost half residing in the U.S. Despite increasing health awareness campaigns and attempts to slow down the startling increase in diabetes rates, Datamonitor predicts that the prevalence of diabetes will increase to over 50 million by 2012, Karachalias says. "Health complications and comorbidities associated with diabetes are a huge drain on national health services around the world. Based on statistics from an ADA (American Diabetes Association) report, in 2002, the direct medical and indirect expenditures in the US attributable to diabetes were estimated at $132 billion."

Despite the presence of well tried and liked compounds for the treatment of diabetes (insulin, metformin and sulfonylureas) and the recent introduction of new classes such as thiazolidinediones (TZDs), alpha glucosidase inhibitors (AGIs) and prandial glucose regulators (PGRs), there are still important unmet needs in the treatment of diabetes. Due to the high unmet need, diabetes represents a lucrative market for R&D investment, Karachalias says. "Datamonitor has identified seven new classes of compounds currently under development. Of these classes, three present the most interest, Glucagon-Like Peptide -1 (GLP-1) agonists, Dipeptidyl Peptidase IV (DPPIV) inhibitors and dual Peroxisome Proliferator Activator Receptor (PPAR) agonists."

New drugs promising

Two of the most promising drugs in the pharmaceutical pipeline are Eli Lilly's exenatide and exenatide LAR, which are expected to be launched in 2005 and 2007, respectively. The drugs belong to the class of GLP-1 agonists, have been successful in clinical trials for diabetes and appear to have a good safety profile. The main issue with these agents is their mode of administration, namely they will have to be injected, Karachalias says. "This fact may pose a problem with the uptake of exenatide and the subsequent patient compliance to therapy. However, exenatide LAR promises to solve this problem with its long acting release formulation, which means that the patients will only have to inject themselves with the agent once per week or once per month."

Another very promising drug in the pipeline is LAF-237, which is being developed by Novartis and is currently undergoing Phase III trials. LAF-237 belongs to the class of DPPIV inhibitors and is exploiting the same basic biochemical pathway as GLP-1 agonists. However, its main difference and main advantage is the fact that unlike GLP-1, it can be orally administered, Karachalias says. "This fact is expected to boost its uptake and benefit patient compliance. It is predicted that LAF-237 will be launched by 2007..."

Lifestyle changes needed

"Although the influx of new drug classes is definitely good news for both pharmaceutical companies and diabetics, none of the new drugs will be the answer to the growing diabetes problem. Lifestyle changes are still needed in order to prevent the development of the disease and slow its progression. The development of even more potent agents, with the ability to maintain their efficacy over prolonged periods of time, with excellent safety and side-effects profiles will remain crucial to combating diabetes," he says.

Dual PPAR agonists were once hailed as the next big development in the treatment of diabetes. However the recent withdrawal of many leading agents following safety concerns has prompted the FDA to request additional safety data before considering the approval of any such compounds, Karachalias says. "This development will severely delay the progress of dual PPAR analogs. As a result even the leading compound in this class, BMS and Merck and Co's muraglitazar is not expected to exceed $500m of peak sales."

*Global in this case refers to the seven major pharmaceutical markets: UK, U.S., Japan, Italy, Germany, France and Spain.

Source: Datamonitor

Posted: December 2004