Pharmaprojects highlights a rise in R&D and an emerging drug delivery strategy which may help to combat the diabetes epidemic

PR Newswire, London, 13/06/03. This press release is distributed on behalf of Pharmaprojects.

Richmond, UK, - According to the World Health Organization, a diabetes epidemic is underway, with the latest figures showing that the number of people affected by the disease worldwide is currently at 177 million and is projected to reach 300 million by the year 2025. Diabetes is set to rapidly become a major worldwide killer and disabler. Pharmaprojects, the leading database tracking pharmaceutical R&D worldwide, today highlights a corresponding increase in research activity and novel therapies on the horizon in this disease area, on the occasion of the 63rd American Diabetes Association Scientific Sessions, being held in New Orleans, LA. 

A copy of the graph entitled 'Drugs in development for diabetes 1995-2003' is available from www.prnewswire.co.uk. Copyright (c) 2003 PJB Publications Ltd 

Between 1995-2003, there has been a steady increase in the number of diabetes R&D projects, with the total number of antidiabetics in active development increasing almost 3-fold from 93 in 1995 to 272 in 2003. Further analysis of Pharmaprojects data reveals that the number of projects in Phase II development for this area has rocketed from 13 in 1997 to over 50 in 2003. How this will translate over the coming years into new diabetes therapies reaching the market remains to be seen, but it demonstrates that the industry is responding to the disease's increasing prevalence. 

One area of particular interest in diabetes research is that of the pulmonary delivery of insulin. Projects under development for this include Exubera by Nektar Therapeutics/Pfizer/ Aventis, using the former's Inhance delivery technology; NN-1998 by Aradigm/Novo Nordisk using Aradigm's AERx delivery technology (both in Phase III); and an Alkermes/Lilly project using Alkermes' AIR technology (in Phase II). A US filing for Exubera which was originally planned for 2002 was put back pending collection of further safety data. These products, if approved, could expand the market for insulin to several times its current value as a result of patients being more willing to take the therapy if it is offered via inhalation rather than by injection. 

The two major diabetes disorders are known as Type I and Type II diabetes. Type I diabetes is a T-cell mediated autoimmune disease caused by selective destruction of the pancreatic ß cells, resulting in total absence of insulin secretion, whereas Type II diabetes (thought to affect 85-95% of diabetics) is caused by a combination of defects in insulin secretion and insulin action. The alarming increase of diabetes prevalence is projected to occur because of population ageing, unhealthy diet, obesity and a sedentary lifestyle. 

The 63rd American Diabetes Association Scientific Sessions takes place this year in New Orleans, Louisiana, the US, from June 13th - 17th and will be attended by over 8,000 healthcare professionals, including doctors and research scientists. Pharmaprojects will be attending the conference to report on the latest findings in diabetic R&D. 

About Pharmaprojects

Pharmaprojects, the leading database tracking pharmaceutical development from early preclinical study through to launch or discontinuation, has 23 years' experience as an information provider to the industry. Pharmaprojects uses a fully-searchable application that allows you to pinpoint the specific information you are looking for, whether it be comprehensive drug profiles, a competitor's pipeline or licensing opportunities. Pharmaprojects is available monthly on the Web and via CD-ROM format; the data is also accessible weekly via online hosts PJB Publications, Dialog and Datastar, Ovid Technologies and STN International. The Pharmaprojects team is available for comment or to provide presentations on trends in pharmaceutical R&D; for details, please contact Ian Lloyd, Managing Editor.

TWO

Study shows insulin detemir results in less variability in blood glucose compared to NPH insulin and insulin glargine

PR Newswire, London, 16/06/03. This press release is distributed on behalf of Novo Nordisk.

- Poster no. 518: "Lower within-subject variability of insulin detemir in comparison to NPH insulin and insulin glargine in subjects with type 1 diabetes"

New Orleans, Louisiana - Insulin detemir, a basal insulin analogue currently under development, was found to vary less in absorption and effect on blood glucose compared to NPH (neutral protamine Hagedorn) insulin or insulin glargine in 54 people with type 1 diabetes (clamp study), according to findings(1) presented today at the 63rd annual meeting of the American Diabetes Association. In this first study to systematically compare these three basal insulins, the results showed insulin detemir is less variable than both NPH insulin and insulin glargine (intrapatient variability).

"In this study, we found insulin detemir was more consistent in its absorption and effect on blood glucose, suggesting it might provide a more predictable therapeutic effect than either NPH insulin or insulin glargine," said Dr. Tim Heise, Profil Institute for Metabolic Research, Germany. He commented that many people with diabetes worry about variability in glucose levels, which may increase the risk of hypoglycemic episodes (low blood glucose), as well as hyperglycemia (high blood glucose). "The more consistent effect provided by insulin detemir is an encouraging indication that insulin detemir may be able to help alleviate these concerns," he added. 

Currently available basal insulins may produce variable blood glucose responses to the same dose given on different days. Insulin detemir has a unique mode of prolonging insulin action (protraction), due to its distinct chemical structure, which is associated with slow and stable absorption from the injection site. As shown in the present study, this results in blood glucose levels that are consistent from day to day.

THREE

UK Lipitor trial in patients with Type 2 diabetes stopped two years early 

PR Newswire, London, June 17. This press release is distributed on behalf of Pfizer Ltd.

Pfizer Ltd today welcomes the announcement from the CARDS Steering Committee, that a major UK trial, studying the reduction of cardiovascular disease (CVD) risk in type 2 diabetes patients using the cholesterol-lowering medicine Lipitor (atorvastatin), has been stopped early. The decision to stop the trial early was made because results collected already showed a significant benefit to patients receiving atorvastatin in reducing primary endpoints of major coronary events, stroke or coronary revascularisation procedures. The interim results are significant and beyond the early termination threshold agreed for the interim analyses (1 sided p-value < 0.0005 Cox Regression)

The study, known as CARDS (Collaborative AtoRvastatin Diabetes Study), was carried out in the UK and Ireland and involved 2,838 patients. CARDS was designed to compare the effectiveness of the lipid-lowering drug, for the primary prevention of cardiovascular disease (CVD) in diabetic patients with some additional risk factors for CVD. Those given atorvastatin 10mg, were found to have significant reductions in primary endpoints compared to those receiving placebo.

The trial, a collaboration between Diabetes UK, the Department of Health and Pfizer UK, has been terminated early by the CARDS Steering Committee because interim analyses confirmed the benefit of treatment. All patients are being notified and will have appropriate study follow-up arranged. 

"Stopping this study early is an exciting development" said Dr Moira Murphy, Director of Research at Diabetes UK. "Diabetes UK co-sponsored this work in recognition of its potentially critical importance for people with diabetes. We look forward to seeing the analysed data later this year and hope that it will add to the existing evidence of the benefit statins can have for people with diabetes. People with the condition are up to 5 times more likely to develop cardiovascular disease and we should look at the best ways to prevent this".

"This is the second major atorvastatin trial in the last 12 months which has stopped earlier than anticipated due to benefits over placebo" said Dr Michael Zaiac, Deputy Medical Director at Pfizer UK.

In the UK it is estimated that 1.4 million people have been diagnosed with diabetes, and this is set to double by 2010. Type 2 diabetes is the most common form, affecting about three-quarters of those with the disease. Cardiovascular complications (especially coronary artery disease and stroke) are the principle cause of death in up to 75% of patients with type 2 diabetes.

Atorvastatin is currently not licensed for the prevention of coronary or cardiovascular events and is a prescription only medicine.