Happy New Year, everyone! I’ve been mostly off-line this past week, attempting to enjoy the “break” while cleaning and sorting out our fresh-from-construction home. But even in that daze, I couldn’t help noticing all the fuss about MannKind’s Afrezza, which was supposed to be ruled upon by the FDA on Dec. 29.
The FDA has requested an additional four weeks to make a decision on this new inhalable insulin, after having postponed the decision by six months earlier on. Investors are in a frenzy now over whether or not the delay is a death knell, i.e. whether MannKind stock is a great tip or a just another flop waiting to happen.
As a patient, all this stock talk makes me kind of nauseas. For goodness’ sake, didn’t the Powers That Be learn anything from the Exubera debacle?! So little attention seems to be directed at the reaction / potential impact on us actual people living with diabetes.
A Forbes financial blogger got closest this weekend, by stating that “the market should decide” on Afrezza:
Mannkind’s inhaled insulin is not a me-too drug. It’s been developed at a price tag of close to $1 billion. It’s an example of homegrown innovation that has the potential to help a very sick group of patients. Despite concerns about its impact on the lungs, its safety record is impeccable. Its efficacy has also been overwhelmingly positive, though it’s hard to make an apples to apples comparison with other modalities of insulin. What’s left for the FDA to decide? It’s time wave the green flag and start the race to give doctors and patients the option to use it.
His point is well taken, although the drug’s safety record may not be as rock-solid as the company claims. Something you ought to know:
In October, former company executive John Arditi, once responsible for quality assurance, filed a lawsuit claiming that portions of MannKind’s clinical data were fraudulent (see details here). Although the suit was settled out of court last month, it’s still not clear whether Arditi was simply retaliating for what he believed to be wrongful termination, or whether he was pushed out for being a whistle-blower.
Seminal pharma blogger Ed Silverman of Pharmalot writes that the allegations “underscore ongoing concerns in some quarters … regarding clinical trials that are run in Russia and Eastern Europe. Arditi’s charges are likely to cement impressions that studies relying too heavily on data collected in such locations may be viewed as questionable.”
Still, somehow MannKind has come out smelling like a rose. The lawsuit seems to have been pretty much brushed under the rug. And despite the fact that long-term lung damage is a complete unknown, the stock is up and the general sentiment seems to be that Afrezza will eventually hit it big.
It’s got to be connected to the personal charisma of billionaire founder Al Mann, is all I can figure.
But in this new era of Empowered Patients, my point is this:
Photo: Betsy Martian
Just like with Exubera, what it’s going to come down to is just how hot we patients are to get our hands on inhalable insulin. How much risk in terms of lung damage or snafus with dosing are we willing to accept? My guess is not as much as investors think. Besides the fundamentals of safety and efficacy, ease of use and quality of life issues trump all, do they not? Plus most of us are not running scared from needles as much as they believe we are… agreed?
Agreed. Totally, agreed.
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As far as I understood it the inhalible insulin is only available for short acting insulin, meaning that every diabetic who uses a long acting type of insulin is not free of injections anyway. And as far as I can tell, this is the majority of insulin using diabetics.
Even if you use a pump instead of long acting, the idea of inhalable insulin is even more mute as you’re already attached to the pump anyway.
As far as I’m concerned, not requiring needles is a silly argument in favor of inhalable insulin.
I think for some people inhaled insulin would be a great option, big time if one is scared of needles and that is their big sticking point for not using insulin it would be helpful in that area. Though I am not sure how helpful it would be long term or for those who are type 1, maybe for type 2s it might be an option to a degree … guess well have to wait and see what happens.
I vote for it though, if nothing else it would give those who like me are scared of needles a fighting change at getting diabetes under control better (I do take my needles as needed, but I still a scared of the needle and I still try and put it off, which isn’t good for me at all).
Sometimes I understand why a lack of real information among bloggers causes people to make lousy decisions and lose money. People who have no understanding of how much difference this particular insulin would make in a diabetics life shouldn’t pretend to know about that difference. Beyond the drastically smaller size of inhaler and that there are no needles involved in the basal delivery, this insulin, IF indeed it is as safe as tests indicate, reacts at basically the same rate as insulin produced from a healthy pancreas. My daughter is diabetic 1 and when she gets “hi” it takes an hour and a half to feel better, let alone the damage being done to her organs and body. And somehow these self appointed geniuses make decisions with their money and wonder why they lose. Inhalation and absorption is the future, not needles and more needles. Along with a continuous glucose meter this insulin comes close to providing normality in a diabetics life. So take your money, mister smart investor and bet against something, about which you really have no insight. Dummies.
My Goodness Gary, are you behind all the other grouchy and defensive Afresa posts strewn all over the internet? It sounds interesting but if it’s that hard to talk about civilly, I have to wonder if there’s something up with it?
I guess if there turns out to be a deployment advantage in that it works quickly or something, maybe there’d be an advantage. I’m sorry to hear about your daughter’s challenges with running “HI” too.
I used to IV R which works a bit quicker than Afresa seems to promise but is, of course, highly hair-raising or even extremely dangerous. I have not figured out how to make the ‘log in my pump work that quickly yet but don’t have the same issues to deal with.
Afresa seems very interesting but it seems odd that there would be flamewars breaking out about it? I think their strongest argument is that it works faster and doesn’t require measurement and carb counting. I’d be all over that but couldn’t give a hoot about needles. I am saving 6000 of them in my garage for a rainy day. Although my ‘research’ (sic, I don’t take notes…) suggests that old needles wear out even when they aren’t in use?
[...] The FDA decided last week to wait another four weeks before determining whether or not to approve Afrezza, an inhalable form of insulin that is being developed by Mannkind Corp. There’s some insightful analysis at DiabetesMine.com: [...]
This looks like a sound analysis. I’m hopeful that the FDA is able to approve – as it sounds like a great option for some – but it doesn’t seem like investors’ concerns should come into the mix as far as making the decision. More commentary here: http://blog.corengi.com/2011/01/will-the-fda-approve-afrezza/
Hello im robert and i have been a diabetic for 33 yrs.I do not know much about the inhalable insulin but i hope it works out for everyone.Taking shots every day sucks for any one having to do it,especially the kids,the pump sucks because your always hooked to tubing and you always have to pay for many other things like batteries ,inserters ,tubing,reservoirs,i.v.prep,alcolhol,etc…the makers are making a killing off of the people needing this stuff to stay alive and they dont care about it.I am waiting to see a company that truly cares and will come out with something thats not going to cost you an arm and a leg after you buy it to maintain.I would hope something like the inhaled insulin or the oralynn spray would be the holy grail for us diabetics whether you are type 1 or type 2.I will still have to sit back and wait a few years after they come out to see if they really work and to see how safe they really are ,then i will take my chance.good luck to all and good nite !
The biggest questions I have are technical; i.e. 1] are the safety claims accurate or a time-bomb waiting to happen when a larger sampling size of patients takes up the technology and 2] are the claims for freedom from hypoglycemia going to hold up over long term usage. I have never understood the claimed mechanism that allows insulin inhaled into the lungs to be matched properly to glucose levels in the blood stream thus allowing the lungs to act as a surragate pancreas. This implies some sort of controlled storage and release ability in the lungs that I am unaware of. If anyone can shed technical light on this claim, I would love to hear more about it.
As to investibility of MNKD, if you look at the 2/11 options after the next supposed decision time in late Januarty for the FDA, both sides are showing >30% premiums to purchase either puts or calls so it seems obvious that noone really knows how this decision breaks.
My little girl would rather inhale insulin than get a shot any day.
Market this to parents of children who cry, fight back, bite, scream, run and hide, bruise, bleed are too little to understand and must be held down for shots.
Adults may prefer pumps etc but KIDS HATE SHOTS. PERIOD.
I’m hopeful this is approved for children soon.
As an asthmatic, I would never put anything into my lungs that is not absolutely necessary. So Afrezza is not for me (I love my pump, anyway).
I’m not sure how the dosage of Afrezza works, but it might be a real help to Type 2′s who don’t need as precise a dosage as Type 1′s. Plus it would be a real boon to needle-phobics.
As far as children, I don’t know whether it would work or not, because you have to time your inhalation with the press of whatever button releases the medication. A small child would probably not be able to do that. For an older child, it might be useful.
Well, we’ll just have to wait and see. I think it’s a good thing to have more options, anyway.
I’ll stick with my syringes thank you. At least I know the exact dosage, no worries about tubes getting clogged, pens not dosing right, etc etc. An insulin inhaler would make me look like I just have asthma. Come on, I’m so awesome my pancreas couldn’t take it anymore!
Besides, I think everyone is missing the fun joy of using the syringes – freaking people out in restaurants when you shoot up in front of them.
Not at all interested in inhalable insulin. There is another product, Ora-lyn, which is sprayed into the buccal cavity of the mouth. Can’t imagine the taste……. but interested because Oralynn is supposed to be absorbed very quickly, unlike injected insulin. So may eliminate postprandial spikes quite nicely. And supposedly much safer than inhaled insulin.
John Arditi Dropped his lawsuit it was not “Settled out of Court” There was no payment or action by the company, the 1 and only wrongful termination suit was DROPPED!
I think in theory it’s a good idea but I don’t think the market is big enough to sustain this type of product for very long. Yes there are certain people who could greatly benefit from inhaled insulin but there are far more that are either concerned with side effects of long term use, how consistent dosing is or are just not really interested.
Ever since I heard about what MannKind was doing a while back I’ve wondered if they are barking up the wrong tree with Afrezza, I guess well find out relatively soon.
Jan ; spend some time to understand the pk profile of afrezza and orallyn; while you are at it, check the bioavailability; also find out how many trials were done for both products; it is never too late to know something
mcityrk
1) regarding safety claims, Pfizer compiled 8 year data for patients using Exubera. They didn’t find any issue
link
http://afresa.blogspot.com/2010/12/inhaled-insulin-long-term-lung-function.html
2) “are the claims for freedom from hypoglycemia going to hold up over long term usage”
it is easier to explain the lower incidence of hypos by checking the PK profile of Afrezza Vs. RAA.
Afrezza shuts off hepatic glucose secretion faster than RAA, and most of action is over in 4 hours. Humalog acts for 6 hours.
Also read feedback from Afrezza trial participants
http://afresa.blogspot.com/2010/08/afrezza-blog-sitemap.html#Physicians
great website. very informative
Great website. Lots of information
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