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Diabetes Rivals Climate Change, War, Economy in Global Relevance

BioWorld Today Staff Writers

Editor's note: The following article is compiled from BioWorld's Diabetes Report 2008: Developments and Opportunities in Drugs and Devices. For more information or to order a copy of the report, please click here.

Diabetes: One of the World's Top Dynamics
Society tends to make critical economic, health and safety decisions that have a defining-to-cataclysmic range-of-effect, based on its consideration of important current events or factors, be it global warming, war, recession, natural disasters, bioterrorism or disease.

Such barometric dynamics are important, compelling and powerful enough to establish definition and primacy in major markets, write or change the course of history, make or break fortunes or economies, and even determine life and death.

Diabetes is such an element. It is a factor that cannot be disregarded or go untreated in society without incurring a catastrophic global consequence. (Click here for a chart of the Number of People with Diabetes Worldwide, 1985-2030.)

Diabetes takes a $378 billion bite out of the global economy, including $175 billion from the U.S. The U.S. total alone is almost equal to the nation's combined annual price tag for the conflicts in Iraq, Afghanistan and the global war on terrorism. Its maintenance cost is more than double the $150 billion in damage caused by Hurricane Katrina. (Click here for a chart of the Worldwide Diabetes Market, 2000-2012.)

Given its ongoing global impact and dire bearing on the future of the economy and health of society, it observably ranks as one of the world's most influential and critical dynamics. When its financial impact spills over into secondary indications such as diabetes-related heart disease, hypertension, anemia, respiratory disease, amputation surgery, blindness, prosthetics, assisted-living care and more, diabetes may be a trillion-dollar epidemic.

Diabetes is poised on a track that "will ruin a generation of Americans," said Helen Darling, president of the National Business Group on Health, a non-profit organization that represents large employer companies, in a recent interview with USA Today newspaper. She said that within the coming decades, diabetes will encumber both state and local economies, as communities will be forced to redirect funds from assigned budget areas to other critical diabetes-related areas to attend to patients.

Diabetes Overview
Diabetes is a disease characterized by excessive levels of sugar in the blood.

There are three major types of diabetes:

  • Type I diabetes is usually diagnosed in childhood. The body makes little or no insulin, and daily injections of insulin are needed to sustain life.
  • Type II diabetes is far more common than Type I and makes up most of all cases of diabetes. It usually occurs in adulthood. The pancreas does not make enough insulin to keep blood glucose levels normal, often because the body does not respond well to the insulin. Many people with Type II diabetes do not know they have it, although it is a serious condition. Type II diabetes is becoming more common due to the growing number of older Americans, increasing obesity, and failure to exercise.
  • Gestational diabetes is high blood glucose that develops at any time during pregnancy in a woman who does not have diabetes.

Additionally, prediabetes exists in a latent state until symptoms are manifest.

Diabetes Factors and Treatment
Diabetes can be caused by too little insulin, resistance to insulin, or both. The American Diabetes Association recommends that all adults over age 45 be screened for diabetes at least every 3 years. A person at high risk should be screened more often.

There are many risk factors for diabetes, including:

  • A parent, brother or sister with diabetes
  • Obesity
  • Age greater than 45 years
  • Gestational diabetes or delivering a baby weighing more than 9 pounds
  • High blood pressure
  • High blood levels of triglycerides (a type of fat molecule)
  • High blood cholesterol level
  • Not getting enough exercise
  • Some ethnic groups (particularly African-Americans, Native Americans, Asians, Pacific Islanders and Hispanic-Americans)

There is no cure for diabetes. Current treatment methods involve medicines, diet and exercise to control blood sugar and prevent symptoms and complications.

A Life(-Long) or Death Matter
Diabetes is not always a death sentence; however, when it's not, it is a literal life sentence.

There is no cure impending, or projected for any point in the future, for the disease that afflicts millions and affects billions, but without the ongoing therapeutic, medical device and research progress in the diabetes market, the disease would be a full-scale, unconstrained global scourge, rather than the burgeoning epidemic society currently faces.

That may be a mitigated consolation in context, but the fact is, until the most realistic chance for a cure comes along, most likely in some form of a virtually futuristic gene therapy that can genetically manipulate the predisposition for diabetes affliction in humans, the next-best option for success may be to acknowledge, pursue and rely on the aspiring and crucial research and development agendas and efforts being formulated and conducted in the administrative centers and laboratory trenches of diabetes drug and device companies and organizations. That research is the first line of defense that is keeping this disease from rivaling the historic plagues that decimated populations before the birth of the modern drug development industry.

Adding insult to injury — or additional relevance to existing prevalence — it is not merely a hereditary affliction, as it also is a disease that is exceedingly susceptible to being acquired through some of the most popular mores and habits of Western society.

Enduring Prevalence Requires Ongoing Investment
Those factors are projected to drastically drive up the global affliction rates. The number of people with diabetes, recorded at 25 million in 1985, is forecasted to increase from 241 million in 2008 to 325 million in 2020 and 388 million in 2030. Without a cure, that represents an enormous market to treat and a cry for evolving, robust and well-financed therapeutics and medical device market responses to manage the disease.

The demographic with the most new diagnosed cases of diabetes through 2005 was the 40-59 years-of-age group, with 700,000 cases, according to the National Health Interview Survey that was commissioned by the Centers for Disease Control and Prevention.

Market Approvals, Advancements and Expectations

The diabetes market is on a pattern of growth that doesn't quite parallel the market-doubling growth of cost and prevalence in the indication, but one that nevertheless indicates a very vigorous and profitable market expansion through the next decade and beyond. There is promising news and positive market developments in many areas of the diabetes treatment market. (Click here for a table of the Top Diabetes Drugs in Development to Watch and for a table of the Top Diabetes Drugs of 2007.)

The following products for diabetes were approved in 2007:

Drugs:

  • Janumet, a tablet combining a DPP-IV inhibitor, sitagliptin (also known as Januvia), and metformin for Type II diabetes. From Merck & Co. Inc. Approved April 2007.
  • Galvus, a DPP-IV inhibitor drug for Type II diabetes. From Novartis AG. Approved in February 2007 in U.S. (currently on voluntary marketing hold) and in September 2007 in EU.
  • Oral-lyn oral insulin spray, a non-injectable buccal insulin. From Generex Biotechnology Corp. Received approval in India in November 2007.

Devices:

  • SymlinPen 120 injection, pre-filled pen-injector devices. From Amylin Pharmaceuticals Inc. Approved in October 2007.
  • FreeStyle Navigator continuous glucose monitoring system. From Abbott Diabetes Care. Received CE-mark approval in June 2007.
  • Guardian Real-Time System, a doctor-prescribed, personal, continuous glucose monitoring (CGM) system. From Medtronic. Launched in March 2007.

Although approvals were few in the diabetes market in 2007, there are some prospective drug candidates in late-stage trials that could file new drug applications in the U.S. market in 2008. Takeda Pharmaceutical got an early jump on a group of companies with Phase III candidates when the company filed an NDA on January 2. Takeda is hoping for an early-third quarter 2008 approval. Some of the other late-stage drugmakers hope to file NDAs in the diabetes indication market by mid-year.

A couple of drugs made great market strides in 2007 that are continuing into 2008. Merck & Co. Inc's DPP-IV drug, Januvia, has grown at a blockbuster pace since its fourth-quarter 2006 entry into the market. It accounted for $668 million in 2007 and is improving on that pace so far in early 2008. It is capable of joining the billion-dollar drug club in 2008, indicating the value and appeal of the DPP-IV class.

Amylin Pharmaceuticals Inc. posted revenue of $636 million in 2007 for its new incretin mimetics drug, Byetta. The drug mimics the effects of naturally-occurring intestinal hormones to provoke the body to make more insulin.

According to the BioWorld Top 25 Biotechnology Drug Report, seven of the 45 top-selling biotechnology drugs were medicines for direct diabetes treatment and its complications. The report also says 11 of the 125 top-selling pharmaceutical and biotechnology drugs in 2006 were diabetes drugs. BioWorld estimates that in 2008, 18 percent of the 200 top-selling drugs will be for diabetes and its complications disease applications.

Published: August 21, 2008