Diabetes cases have skyrocketed across the globe, hitting an estimated 366 million people in 2011 and presenting some scary medical complications to patients, according to the International Diabetes Federation. The rising health threat has fueled action in the pharma industry, which is investigating many new compounds and combinations of older drugs to combat diabetes.
FierceBiotech has drilled into most of the largest pipelines of Type 2 diabetes drugs in the world, finding that there are more than 100 new therapies for patients with the disease in mid- to late-stage clinical trials, according to data from Relay Technology Management. And drugmakers are aggressively pursuing new treatments for what Standard & Poor's analysts reported last week is an annual market poised to jump from $35 billion now to $58 billion by 2018.
Yet pharma groups face some noteworthy challenges to advance new drugs for diabetes. Regulators demand extensive evidence of safety and efficacy of the drugs, especially after GlaxoSmithKline's ($GSK's) Avandia disaster put the FDA and other agencies on high alert for any safety risks related to diabetes therapies.
These growing demands from regulatory bodies have prompted developers to engineer massive clinical trial programs for new diabetes drugs, in some cases requiring data not only on how well therapies control blood sugar levels but also the impacts on cardiovascular risk.
"This bar is quite high when you have to do the cardiovascular assessment as well as the diabetes assessment. It's not only more tests but it's much longer clinical trials, much more complicated and much more expensive [studies]," said Dr. C. Ronald Kahn, an expert in metabolic disease and professor of medicine at Harvard Medical School, who serves as a scientific adviser to the startup Ember Therapeutics.
Working in favor of new diabetes drug development is the massive and increasing need for new therapies to rein in the disease in patients, who often grapple with complications such as heart problems, obesity, blindness and kidney disease. Kahn, who is also the chief academic officer at Joslin Diabetes Center in Boston, talked about the need for new treatment options for Type 2 diabetes, the noninsulin-dependent form of the disease that afflicts 90% or more of all diabetics.
"We still are in need of a good long-term pharmacologic approach for many people," he said. "Some people can be controlled with lifestyle changes [such as diet and exercise], some can be controlled with the oral hypoglycemic [drugs], but I would say over half of people over a period of time will not be controlled by those approaches."
Read on for quick summaries of the diabetes pipelines from individual Big Pharma outfits--including Sanofi ($SNY), Novo Nordisk ($NVO), Johnson & Johnson ($JNJ), Takeda and Merck ($MRK)--as well as two notable tandems, AstraZeneca ($AZN)/Bristol-Myers Squibb ($BMY) and Eli Lilly ($LLY)/Boehringer Ingelheim. The high cost and massive scale of diabetes drug development have helped these deep-pocketed drugmakers lead the way in advancing new treatments to the market, while smaller biotechs unfortunately avoid the field or rely on deals with larger outfits to advance their programs. -- Ryan McBride (email | Twitter)