Therapeutic area: Cardiovascular and Metabolic Disorders

Novo Nordisk recently announced the first positive Phase 2 results for an oral GLP-1 analogue. Oral therapies are typically utilized in the early lines of therapy for type 2 diabetes, but as the disease progresses more aggressive treatment is required so patients can end up on multiple oral medications.Finally, more efficacious injectable agents such as the GLP-1 analogues and insulins are employed.  AS patient generally prefer tablets over needles, there is significant sales potential for oral versions of these efficacious injectable therapies.

In the dyslipidemia market the situation appears to be fairly similar. The PCSK9s inhibitors are generating huge excitement among physicians as their efficacy, combined with the dearth of effective add-on therapies for patients unable to achieve adequate LDL-C control, has highlighted this class as the most promising treatment for dyslipidemia since the statins. However, experts state that one of the main downsides is that they are injectables. Like diabetes, an oral version would be a game changer.

Novo Nordisk's oral GLP-1 analogue OG217SC was just as clinically efficacious and safe as its injectable counterpart semaglutide in the aforementioned Phase 2 trial, and the company plans to proceed to Phase 3 clinical trials. Additionally, Novo Nordisk has the oral insulin OI-338GT in development, expecting it to enter Phase 2a trials in 2015. OI-338GT has demonstrated efficacy and safety in type 2 diabetes patients similar to therapeutically relevant subcutaneous doses of the market leader: Sanofi's Lantus (insulin glargine). The market potential of oral versions of injectable therapies has attracted the attention of other major players. Sanofi have an early stage experimental oral GLP-1 product in their pipeline, but also plan to look at external candidates, and Pfizer is developing a small molecule pill to inhibit PCSK9, which is expected to begin trials in humans this year.

The fact is the potential for oral analogues of injectable therapies is huge in the diabetes and dyslipidemia markets. For patients with these and other chronic diseases, more effective oral therapies are likely to reduce pill burdens, could improve compliance, and lead to better treatment outcomes; a win for patients and physicians. Moreover, prices for tablets are likely to be lower, subsequently forcing down prices of injectable analogues, resulting in a win for payers and national healthcare budgets. Also, oral versions of current injectables could lead to higher uptake right from launch owing to established physician familiarity, resulting in a win for company revenue. For me this looks like a clear win-win-win situation!

Stefanie Hoffart, M.Sc., is an Associate Analyst in the Cardiovascular, Metabolic, and Renal Disorders team at Decision Resources Group.

In-depth analysis of various therapeutic indications, with accompanying epidemiology driven sales forecast models, are presented in Decision Resources Group's Pharmacor reports, available here.

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