It's no wonder that plenty of companies are developing diabetes drugs. There are more than 370 million people with diabetes worldwide. The global market for diabetes drugs and devices is expected to reach nearly $100 billion within the next five years. Every single one of the top 10 diabetes drugs in terms of 2012 sales was a blockbuster. Simply put, there's ample motivation for companies to pursue new treatments.
The bad news for those suffering from diabetes is that many of these new drugs are several years away from reaching the market -- if they do at all. A few diabetes drugs, though, could be available in the U.S. within the next year or two. Here are three that could be on their way relatively soon.
Partners AstraZeneca (NYSE:AZN) and Bristol-Myers Squibb (NYSE:BMY) hope that the second time is the charm for Forxiga. The U.S. Food and Drug Administration decided against approval for the type 2 diabetes drug in January 2012 and asked for more clinical data to assess the drug's benefit-risk profile.
The FDA wanted more data -- and that's exactly what it got. AstraZeneca and Bristol resubmitted the New Drug Application, or NDA, for Forxiga this year with data from 26 clinical studies involving more than 12,000 diabetic patients. A decision by the FDA is scheduled for Jan. 11.
Forxiga belongs to a new class of diabetes drugs known as sodium-glucose cotransporter 2, or SGLT2, inhibitors. These drugs help remove glucose from the body independent of insulin. While Forxiga became the first SGLT2 inhibitor approved in Europe, Johnson & Johnson's (NYSE:JNJ) Invokana grabbed that distinction in the U.S. in March of this year.
Even though both drugs work in similar ways, analysts think there's plenty of room in the market for both to succeed. Peak annual sales for Forxiga are expected to reach between $700 million and $1.5 billion,while estimates for Invokana range from $800 million to as high as $2.5 billion in annual sales.
Eli Lilly (NYSE:LLY) isn't too far behind in the approval process with dulaglutide. The big drugmaker reported positive results from a phase 3 study of the type 2 diabetes drug in April and plans to submit an NDA later this year. That should result in an FDA decision on dulaglutide in the latter part of 2014 with a possible commercial launch by early 2015.
Dulaglutide is a long-acting glucagon-like peptide 1, or GLP-1, receptor antagonist that helps stimulate the production of insulin. Lilly's phase 3 study showed that the drug worked more effectively than Bristol's Byetta, Merck's Januvia, and metformin.
The question for dulaglutide will be how well it performs against AstraZeneca's and Bristol's Bydureon, another GLP-1 receptor antagonist that received FDA approval in early 2012. Lilly's late-stage study didn't provide a head-to-head comparison versus Bydureon. The challenge for Lilly will be in differentiating its new drug against this established rival.
While these big companies look to bring non-insulin diabetes drugs to market in the near future, there's also a smaller company working hard to score commercially with a new insulin product. MannKind (NASDAQ:56400P706) recently completed late-stage studies for Afrezza, its inhaled insulin, in treating both type 1 and type 2 diabetes.
Results from these two studies were positive, so MannKind should submit the NDA for Afrezza in the next few months. Anything is possible with the FDA's decision-making process, but the chances seem good that Afrezza will gain approval sometime in 2014.
Assuming this approval is granted, how quickly Afrezza makes it to market depends largely on MannKind's efforts at securing a partner. The company has been in talks with multiple prospective organizations for a few months.
My view is that all three of these drugs seem likely to become available within the next year or so. I think that each drug can help diabetic patients. Each has a reasonable shot at commercial success.
Which could make the most impact? I'll go with Afrezza. Yes -- past inhaled insulin products haven't succeeded, but I think MannKind has gotten past the issues that plagued those products. An easy-to-take, quick-acting insulin should be appealing to many diabetic patients.
MannKind definitely needs a good partner to launch Afrezza in the best way possible. I think the company will find one. Piper Jaffray thinks so as well and pegs peak annual sales for the inhaled insulin at more than $2 billion. If the company is anywhere close to being on target, MannKind shares have plenty of room to run.