For those who haven't read it yet, the most-emailed article on the New York Times website yesterday was titled "4 Diabetes Drugs Are Seen Raising Hope and Profit" by Alex Berenson. Written from an analyst's point of view, it talks about Byetta, Exubera, Januvia, and Galvus. Byetta is already on market and Exubera will be released next month. The other two are pending FDA approval.
Diabetes drugs are currently at ~ $15 billion in worldwide annual sales and the article notes that some analysts anticipate this will see a $10 billion increase to $25 billion by 2011 because of increasing numbers of patients being diagnosed with the disease every year (see our June 23 blog on rising type 2 incidence). With these numbers, the NYT says, there's plenty of market share for effective new therapies and Berenson reports that analysts believe all four will become blockbuster drugs with more than $1 billion in sales.
Byetta (exenatide), an incretin mimetic, is clearly the favorite of the moment because it is the first major drug that lowers both HbA1c and weight - a fact that has generated fervent support from the patients and physicians who have used it since its release in May, 2005. For us, the question isn't whether it will reach $1 billion - that's a foregone conclusion - but exactly how many billions it might generate in sales by 2011. If LAR is approved, the answer is certainly multi-billion - and if LAR for some reason is not approved - we still think the answer is multi-billion, but perhaps just not as many as fast.
Of the other three drugs, Exubera is the most commercially uncertain. Developed by Pfizer and approved by the FDA in January, it is the long-anticipated inhaled form of insulin intended for patients not at their glcyemic target who currently avoid insulin because they don't like injections. Although the safety data was deemed sufficient by an FDA panel last year, some researchers still have questions and certainly advise against its use in patients with pulmonary disorders. Any possible safety issues aside, many have focused on the size of the inhaler as a deterrent. We think that is probably overused as an excuse - if people want to take it, they'll get over the size of the inhaler, which will certainly shrink over time, anyway. Reimbursement for us is the main (maybe the only) question right now -- if it isn't paid for, most patients won't want it. Whether insurers will reimburse for a more expensive insulin that has no new physiological benefits remains an open question.
Novartis' Galvus (vildagliptin) and Merck's Januvia (sitagliptin) are DPP-4 inhibitors (now known as gliptins) that increase glucose sensitivity. Gliptins have less dramatic HbA1c lowering effects than would be ideal, but even so their tolerability and weight neutrality may result in recommendations for them as replacements for existing first- and second- and third-line therapies like sulfonylureas and TZDs - TZDs, of course, are now a $4 billion global market and SFUs commanded in the billions before going generic. There are significant side effects with both, including weight gain and other difficulties (edema, GI problems, etc) and it will be interesting to watch, in fact, whether SFUs even survive.
For more detailed information about all of these drugs, check out our latest DCU issue with our ADA download! In it we report on what we learned about these drugs at the conference, with a heavy focus on incretins in particular.