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Therapy area focus: Diabetes

Looking at the challenges, goals and developments for the pharma industry within specific therapy areas
Therapy area focus

Diabetes is a complex condition. Controlling raised blood glucose (hyperglycaemia) is the key challenge, but the concerns of public health systems go far beyond this. Poorly managed diabetes leading to uncontrolled hyperglycaemia, over time, results in macrovascular complications (heart attack, stroke and peripheral vascular disease) and microvascular complications (nephropathy, neuropathy and retinopathy – the main cause of blindness in adults in industrialised Northern hemisphere countries). Diabetic complications come with enormous financial, psychological and social costs.

Type 1 diabetes (formerly insulin-dependent, juvenile or childhood-onset) is characterised by deficient insulin production. People with type 1 diabetes need daily insulin administration to survive. Type 2 diabetes (formerly non-insulin-dependent or adult-onset) results from deficient insulin production and/or ineffective use of insulin; 90 per cent of people with diabetes have type 2.

In 2010 there were estimated to be 285 million people with diabetes worldwide (6.6 per cent of the population); by 2030, the World Health Organization estimates that 438 million people will have diabetes (nearly 8 per cent of the population). Many people are familiar with the exponential increase in the number of people with type 2 diabetes, which is linked to obesity and a sedentary lifestyle, but it is less well known that type 1 diabetes is also increasing worldwide; the reasons for this are unclear.

The quality of diabetes management has improved significantly in the past two or three decades, but the number of people with diabetes is increasing faster than the ability to bring them to target blood glucose concentrations. Therefore an acceleration in innovation is needed.

The major challenge is to develop therapeutic solutions that go beyond the task of simply lowering blood glucose (HbA1c). The insulin products and formulations available today have significantly improved ability to control HbA1c, offering longer duration of action and more convenient dosing regimens. Such developments have made the lives of people with diabetes much easier.

Historic developments
Since the life-saving discovery by Frederick Banting and Charles Best that insulin could be extracted from the pancreas and used to treat children with type 1 diabetes in 1921, the first key milestone in the development of treatments for diabetes was the commercial production of insulin by Hoescht in 1923.

Metformin, an oral medication first developed for its blood glucose-lowering properties in the 1920s, was eventually launched in the late 1950s; along with lifestyle measures, it is now usually first-line treatment for type 2 diabetes. The 1950s also heralded the development of the other mainstay of oral treatment for type 2 diabetes, sulphonylureas (insulin secretagogues). The 1990s brought new oral agents for the treatment of type 1 and type 2 diabetes, including the meglitinides (insulin secretagogues) and thiazolidinediones (insulin sensitisers, also known as glitazones).

The age of genetic engineering led to the first synthetic 'human' insulin gaining US Food and Drug Administration approval in 1982, followed by the first insulin pump allowing continuous subcutaneous insulin infusion therapy, which came on the market in 1983. Then in 2002 came the first long-acting once-daily basal human insulin analogue with a 24-hour profile, insulin glargine. Mimicking the physiological basal-like profile of endogenous insulin, glargine provided an effective glucose control while minimising the risk of hypoglycaemia during the dose titration phase of treatment.

The incretin mimetics arrived in the mid-2000s, with dipeptidyl peptidase-4 (DPP-4) inhibitors vildagliptin, sitagliptin and saxagliptin launched in recent years. Exenatide, the first glucagon-like peptide (GLP-1) receptor agonist marketed for the treatment of type 2 diabetes, was followed by liraglutide, the first once-daily formulation. New GLP-1 analogues in development include lixisenatide, currently being assessed as a once-daily treatment in a phase III clinical trial programme involving 4,500 patients. Long-acting GLP-1 receptor agonists are also being developed, including long-acting-exenatide, albioglutide and tapsoglutide.

Future challenges
Over the next 10 years, the challenge will be to develop medicines that go beyond lowering blood glucose, to produce meaningful and beneficial effects reliably in terms of reducing morbidity, and possibly also mortality, from diabetes. Innovative answers are needed to slow, or even prevent, the onset and progression of complications like retinopathy, nephropathy, neuropathy and cardiovascular disease.

There has been significant progress in the past five years in identification of a molecular target for the treatment of retinopathy, which may herald a breakthrough in the next decade. However, any therapy that significantly modifies the course of disease has to be compatible with people's lifestyles. Future therapies must follow this imperative, because daily management of diabetes must be driven primarily by patients themselves.

Work in progress
The area of incretin mimetics continues to develop further with promising once-weekly and oral human GLP-1 agents for the treatment of type 2 diabetes. Combination products of basal insulin and GLP-1 compounds are also in development, with oral insulin on the horizon along with next-generation rapid-acting and ultra long-acting insulin analogues.

Blood glucose monitoring devices have evolved significantly in recent years to reflect the needs and desires of people with diabetes, further empowering and enabling their self-management of blood glucose variation.

Innovation in this area is generating not only better insulin pumps and blood glucose meters, but the monitoring technologies are starting to offer i-connectivity to personalise and integrate convenient, accurate blood glucose management with decision-making support into people's lifestyles.

Continuous blood glucose monitoring via a disposable glucose sensor placed just under the skin is a recent innovation, with long-lasting bio-implants for monitoring currently in development; there is also future potential for non-invasive detection technologies requiring no contact with blood, such as near-infrared spectroscopy, ultrasound and dielectric spectroscopy.

Value
These exciting innovations may revolutionise life with diabetes in coming years. First, however, the key priority is demonstrating the 'value' of these innovations for patients, healthcare providers and payers.

How will 'innovation' come to be defined in diabetes? In the past two or three decades, the quality of diabetes treatment has improved, but the number of people with diabetes continues to rise faster than they can be brought to target on HbA1c.

For healthcare systems paying for diabetes solutions, medicines alone may not add sufficient value to the bigger picture of comprehensive diabetes care. The solution is the integration of medicines, monitoring, delivery devices and services, each talking directly to the other and putting convenience and control into the hands of people managing diabetes.

For patients, value means achieving control of HbA1c and minimising the risk of complications simply and easily. Connectivity and easy integration into their lifestyles are vital. Physicians simply value a better outcome for people with diabetes, with reduced long-term morbidity and mortality. Value, for payers, means better cost/benefits balance in managing budgets, which comes through better outcomes and reduced morbidity.

The focus should not start with the disease, product or even the target, but with the needs of people with diabetes. The first challenge is innovation, the next demonstration of its value. The end goal is to do more together to truly match diabetes care with the diverse needs and specific lifestyles of those managing the disease. Simply put, it is about making their lives easier.

The Authors
Pierre Chancel, SVP (Diabetes Division) and Riccardo Perfetti, VP (Global Medical Affairs), sanofi-aventis

To comment on this article, email pme@pmlive.com






 

Diabetes at-a-glance



Diabetes market
Click image for larger view


Spending
Click image for larger view



Spending/Top Five 
Click image for larger view


 

 Spending by corporation

Corporations

Spending ($K)

%

% change

Merck & Co

882,417

16.8%

65.0%

Novo Nordisk

719,370

13.7%

37.0%

sanofi-aventis

627,344

11.9%

4.9%

Takeda

602,712

11.4%

0.3%

Novartis

385,916

7.3%

149.3%

Bristol-Myers Squibb

375,221

7.1%

987.8%

Lilly

358,884

6.8%

-14.4%

Ono Yakuhin Kogyo

343,902

6.5%

684.3%

GlaxoSmithKline

173,681

3.3%

-23.9%

Suzeken Group

148,426

2.8%

-3.6%

Source: Cegedim Strategic Data Promotion Database, MAT Q3 2010

Spending by product

Brands

Spending ($K)

%

% change

Januvia

749,923

14.2%

66.5%

Onglyza

375,971

7.1%

++

Lantus

370,036

7.0%

1.5%

Actos

369.870

7.0%

-23.6%

Glactiv

337,623

6.4%

++

Victoza

291,448

5.5%

++

Galvus

284,024

5.4%

304.6%

Janumet

229,669

4.4%

30.2%

Levemir

217,936

4.1%

-30.0%

Seibule

147,524

2.8%

-3.9%

Source: Cegedim Strategic Data Promotion Database, MAT Q3 2010
 

29th March 2011

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