Organizations have highlighted this week the ugly extent of the diabetes epidemic, the disastrous consequences for patients and the huge tolls on economies. The scary numbers, which come on World Diabetes Day, show why America's pharma outfits are advancing hundreds of new drugs to treat diabetes, which isn't adequately controlled with current therapies on the market.
More than 371 million people worldwide have diabetes, up from 366 million estimated last year, according to the latest numbers from the International Diabetes Federation. The U.S. accounts for about 26 million of those patients, and spending on care for patients with the disease totaled a whopping $218 billion in 2007, according to figures cited by the Pharmaceutical Research and Manufacturers of America (PhRMA). The industry group says that drug companies in the country are developing 221 new medicines against diabetes.
Last month, FierceBiotech featured a special report on the global industry's top 10 diabetes drug pipelines, featuring efforts at AstraZeneca ($AZN), Eli Lilly ($LLY) and 8 other companies or partners.
Diabetes rates, in Type 2 diabetes specifically, have skyrocketed in the U.S. and around the world in large part due to the calorie-rich diets of patients and low levels of physical activity. As the Financial Times reports, physicians initially try to get diabetics to become more active and eat less sugary foods. Beyond lifestyle changes, there are a variety of existing medicines to treat the disease, but recommendations of lifestyle changes and existing meds fail to help some patients control their blood-sugar levels.
The hundreds of new drugs in development promise to provide better outcomes for patients. Take Novo Nordisk's ($NVO) degludec--or Tresiba--an ultra-long-lasting insulin that is effective for 24 hours with a single injection, an advantage over the current best selling insulin, Sanofi's ($SNY) Lantus, which lasts for 12 hours or more. If Novo gets hoped-for approvals in the U.S. and Europe, Tresiba will gain the inside track to becoming a blockbuster seller.
Yet developing diabetes drugs isn't simple and is often extremely expensive. Novo's experience with Tresiba is an excellent example of the challenges of diabetes drug development. The company has faced multiple delays in the U.S. review of the product, and an analysis of data from clinical trials raised the question of potential heart risks associated with the drug.
Novo now expects to shell out about $256 million for a long-term cardiovascular outcomes study to satisfy U.S. regulators, which still haven't decided on the approval of the drug more than a year after Novo's request to begin selling the product. The expense for the CV outcomes study would easily bankrupt many drug developers, but such a monster outlay is a cost of doing business in diabetes drug development.
Regulators have good reason to be careful in their reviews of diabetes drugs, which have to be safe for patients to take them for a long time to treat their chronic disease. Yet nothing seems easy in combating diabetes, which is expected to keep occurring at higher rates unless some dramatic measures are taken among patients and other stakeholders.
- here's PhRMA's release
- see the FT's coverage
Special Report: Top diabetes drug pipelines of 2012