www.forbes.com/sites/johnlamattina/2013/08/22/challenges-in-commercializing-inhaled-insulin/Nice overview article
The recently released preliminary results from Phase III studies 171 and 172 – or the subset that Mannkind chose to share – point to Afrezza being more effective than placebo, but not by much (HbA1C reduction of 0.82% vs 0.42% placebo in trial 175). In fact, Afrezza looks so mild that it may be a tough sell to get Type 2 diabetics – 90% of the diabetes drug market – to switch from current therapies which are more effective even if possibly less convenient.
An example: Novolog is ranked second in sales of all diabetes drugs world wide. Afrezza would compete directly with Novolog, a prandial insulin. A Type 2 diabetic taking oral medication and Novolog (a fast acting mealtime insulin) might consider switching for convenience and comfort.
The effect of Novolog on HbA1c when added to pre-existing oral medication is -1.9% to – 2.4% (depending on 1 or 2 oral meds). (From “Safety and Effectiveness of Bolus Insulin Aspart in People with Type 2 Diabetes: A1chieve Sub-Analysis”)
The effect of Afrezza when added to one or two pre-existing oral medications is -0.82% (Study 175) – only about 40% that of Novolog.
If you’re the patient’s doctor, what do you advise?
I’m not saying that nobody will buy Afrezza if approved. There will probably be a class of patients who only require a mild insulin, but with so many other options that give more benefit – even cinnamon capsules give a 0.83% benefit in HbA1c at a cost of $40 a year – it’s hard to make a case for 1. A big pharma partner stepping up as a source of up-front funds and sales force to take Afrezza to commercialization, and 2. Afrezza becoming, in Al Mann’s words “The biggest selling drug in history.”
When compared to injected mealtime insulin, Afrezza’s lower HbA1c benefit, lower percentage of patients achieving under 7.0% HbA1c target (37.7% vs 70% for either mealtime or basal insulins added to oral therapy), lower hypo risk and lower weight gain all point to the simple conclusion that Afrezza gives a lower exposure to the effects (benefits) and side effects of insulin. It’s the same effect that one would get by simply decreasing the dose of mealtime insulin, and would a doctor advise that?
I saw an analogy made recently; Afrezza may be like baby aspirin or light beer. It has lower potency, but still makes for a potentially profitable business.
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