MannKind Corp., the most aggressive company pushing ahead on bringing inhalable insulin to market post the Exubera debacle, took a hit last week when it was forced to announce that a critical marketing partnership didn't pan out. Investors are now fighting over the company's future.
As a PWD who watched the whole sordid Exubera story play out with a sad smirk on my face (we all knew the product was too clunky and hard to use - but darn, did they waste some money finding out!), I'm not sure whether I should be rooting for MannKind or not. I have mixed feelings on the whole notion of inhalable insulin, mainly because I worry about safety: we still have no clue what the long-term effects of insulin in the lungs will be. Who wants to be a guinea pig to find out? There's also the problem of setting doses of the inhalable stuff, which per definition cannot be nearly as precise that with injections.
On the safety issue, BioWorld Today reports that MannKind does not expect Afresa to have to be reviewed by the FDA's Endocrine and Metabolic Advisory Committee before it gains approval, hopefully early next year. The FDA is already "comfortable with insulin," a company spokesperson says.
But a few paragraphs later, the story notes that "while Exubera was simply an inhaled version of injectable insulin, Afresa has very different pharmacokinetics and pharmacodynamics." So why no scrutiny by the FDA endocrine experts?
According to MannKind: "The drug acts quickly, allowing better glucose control, yet it allows insulin levels to return to normal after digestion, preventing hypoglycemia and the need for diabetic patients to eat just to manage their insulin... (the company) has observed 'absolutely clean histology' with no indications of cancer risk in preclinical or clinical studies." I hope they have loads of data on that last bit.
It also bothers me how central money is to the whole conversation around Afresa. Let's be clear: Afresa is targeted at Type 2 patients who need basal (background) insulin only. "As happens so often in the diabetes space, investors look at the epidemic growth rate of (Type 2) diabetes and begin to see dollar signs," writes David Kliff of Diabetic Investor. "In the real world injection fears are vastly over-rated and the reason more physicians do not prescribe insulin therapy has more to do with fears of hypoglycemia and need for greater patient education. But ... it is much easier to buy into the needle fear story than to actually research the insulin market and understand its complex dynamics."
As usual, a bold statement from Mr. Kliff. He also has this to say: "The fact remains that the time for inhaled insulin has come and gone.Even if Afresa is approved by the FDA, it will never amount to anything more than a niche product with sales in the millions not billions." And that, he implies, makes inhalable insulin something of a "dead-end therapy" with no great potential to either help the masses or lead us closer to a cure.
All of this leaves me wondering whether I'd recommend Afresa to a diabetic friend or loved one — assuming it's approved and comes to market any time soon. My 74-year-old mother is on metformin. If she needed a step up in her therapy, she most certainly would not want to "go on the needle."
But would she really do well with loading plastic cartridges into a small yet complex inhaler device? Should I worry about her lungs? Or the fact that she might be facing lows, living alone? Or the premiums she'll likely have to pony up (out of her fixed income) to get this "fancier" treatment? I just don't know... I have mixed feelings. What would you do?