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November 13, 2012


New Report Shows Over 220 New Medicines in Development for Diabetes


Currently, 221 new medicines to treat diabetes, one of the fastest-growing diseases in America, are being developed by America’s pharmaceutical research and biotechnology companies, according to a national report by the Pharmaceutical Research and Manufacturers of America (PhRMA). (Click here to see the full report.)


Nationwide, diabetes affects more than 25.8 million Americans, or about 8.3 percent of the U.S. population.  New cases have risen more than 90 percent among adults over the last 10 years, and since 1987 the number of deaths from the disease has risen by 45 percent, according to the U.S. Centers for Disease Control and Prevention and the American Diabetes Association.


Diabetes is a chronic disease in which the body does not produce or properly use insulin, a hormone needed to convert sugar, starches, and other food into energy. The cause of diabetes continues to be a mystery.


Type 2 diabetes, which is closely linked to lifestyles, was once called “adult onset” diabetes because it was so rare among children. But as more and more children are increasingly overweight or obese and inactive, the disease is being seen in even very young children. If present trends continue, 1 in 3 American children born in 2000 will develop diabetes in their lifetimes.


The new medicines currently in the pipeline, some in early development stages and some awaiting FDA approval, include numerous drugs to treat eye diseases associated with diabetes. New medicines to treat foot ulcers could reduce the need for amputations. Researchers are pushing into new territories that include gene therapy and are working on such treatments as a once-weekly medication similar to a natural hormone critical to blood sugar regulation.





Lowering Blood Glucose Levels – Patients with type 2 diabetes absorb greater amounts of glucose in their kidneys than people who do not have diabetes, which can contribute to elevated glucose levels in the blood. An investigational medicine in development blocks the reabsorption of glucose by the kidneys, increasing glucose excretion and lowering blood glucose levels. In clinical trials, the medicine has shown to significantly reduce blood glucose levels when used as an add-on therapy to insulin in patients with type 2 diabetes who are at greater risk for cardiovascular disease.


Stimulating Insulin Secretion – A potential first-in-class medicine in development is a selective agonist of GPR40, a receptor expressed in the pancreatic islet cells (a cluster of cells that produce hormones). Insulin, which breaks down glucose in the body to create energy, is secreted when glucose levels rise. This potential new medicine increases insulin secretion without causing insulin to significantly lower blood sugar.


Next-Generation Oral Treatment – A next-generation medicine in development for the treatment of type 2 diabetes is part of the DPP-4 inhibitor class of medicines, but chemically different than other approved medicines in this class.  DPP-4 inhibitors work by stimulating the production of insulin and producing less glucose.  In clinical trials the medicine was able to inhibit more than 80 percent of its target enzyme for seven days, making it potentially a once-weekly treatment versus daily.


Lowering Cardiovascular Risk – A medicine in development for the treatment of type 2 diabetes is comprised of two proteins that regulate the expression of genes that are responsible for lipid homeostasis (the process of maintaining internal balance of lipids within cells) and insulin resistance (when the body produces insulin but does not use it properly).  Due to its dual action, it is expected to be effective as a single drug for addressing both high blood sugar and cholesterol problems, while also lowering the cardiovascular risk in patients with diabetes.


Once-Weekly Treatment – A medicine in development is in the same class of drugs as some other approved medicines, but with a longer therapeutic life that may make it suitable for once-weekly dosing. The medicine is a human glucagon-like peptide (GLP-1) analogue that lowers blood glucose and reduces body weight.


Facilitating Glucose Regulation – A potential medicine in development is a gut sensory modulator (GSM) delivered directly to the stomach where is intensifies the body’s natural food-driven signals that facilitate glucose regulation. The medicine, a delayed-release formulation of metformin (a medicine used to treat diabetes alone or in combination with other medicines), targets the lower gut to avoid systemic absorption in the bloodstream, making it useful to diabetes patients with renal impairment who are unable to use metformin due to the risk of building metformin up in the blood (lactic acidosis).


Painful Nerve Damage – Nerve damage is a common symptom of diabetes, about half of all people with diabetes have some form of nerve damage, or neuropathy, according to the American Diabetes Association. Over time, blood glucose can injure the walls of tiny blood vessels that nourish nerves causing pain, especially in the legs. A medicine in development is designed to improve the symptoms of diabetic neuropathy by inhibiting the activity of an enzyme that causes the accumulation of intracellular sorbitol (a sugar alcohol) that causes diabetic neuropathy.


Diabetic Kidney Disease – A potential first-in-class medicine is in development for the treatment of diabetic nephropathy – a chronic progressive kidney disease that is the leading cause of end-stage renal disease (ESRD) or kidney failure.  From 1990 to 2006, ESRD due to diabetic nephropathy increased 2.5 times. The medicine has demonstrated the potential to protect kidney function and slow disease progression when added to existing therapy.

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