Mannkind's Inhaled Insulin


Anonymous

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Will they be able to get this approved? Today, FDA announced that the MNKD resubmission is valid, and will be considered by the end of the year. Two immediate conclusions can be drawn this intriguing possibility:

1. MNKD may be the stock sensation of the year. Thousands of Mannkind supporters will be millionaires. Millions of diabetics will be freed from the inconvenience of needles, or the dangers of competitors' oral diabetes drug products.

2. LLY will suffer the loss of it's longest term claim to fame for most, with nearly everyone opting for a much safer and effective inhaler. This would be a true calamity for LLY, and no number of successes in the pipeline will pay the dividend for many years to come. This will be a bellweather year, pending the FDA's upcoming decision.

3. If AFREEZA is successful, anyone associated with the R&D arm at Lilly should be examined as potential serious liabilities. If LLY and PFE can't do it, how can an 84-year old inventor pull off such an incredible innovation. By the way, use of term "arm" as in "shot in the arm" was not intended as a pun, sorry!

4. Other injectables will follow in the wake of inhaled insulin. This would completely change the pharmaceutical landscape forever. Individual patient outcomes would benefit, and tailor-made remedies would be cheap and painless for thousands of injectable medications.
 
Will they be able to get this approved? Today, FDA announced that the MNKD resubmission is valid, and will be considered by the end of the year. Two immediate conclusions can be drawn this intriguing possibility:

1. MNKD may be the stock sensation of the year. Thousands of Mannkind supporters will be millionaires. Millions of diabetics will be freed from the inconvenience of needles, or the dangers of competitors' oral diabetes drug products.

2. LLY will suffer the loss of it's longest term claim to fame for most, with nearly everyone opting for a much safer and effective inhaler. This would be a true calamity for LLY, and no number of successes in the pipeline will pay the dividend for many years to come. This will be a bellweather year, pending the FDA's upcoming decision.

3. If AFREEZA is successful, anyone associated with the R&D arm at Lilly should be examined as potential serious liabilities. If LLY and PFE can't do it, how can an 84-year old inventor pull off such an incredible innovation. By the way, use of term "arm" as in "shot in the arm" was not intended as a pun, sorry!

4. Other injectables will follow in the wake of inhaled insulin. This would completely change the pharmaceutical landscape forever. Individual patient outcomes would benefit, and tailor-made remedies would be cheap and painless for thousands of injectable medications.

Hot on the presses, hopefully the link works, here it is from the NIH: http://www.ncbi.nlm.nih.gov/pubmed/20516362
 
From 1967 to and including TODAY, I have taken 3 insulin or humulin shots per day. It does not HURT a bit anymore with the smaller needles.

But I guarantee one thing to every person reading this. I would NEVER inhale a protein product 3 - 6 times a day. It is something that must travel through my lungs and I just won't trust such a product. It is a waste of R&D dollars.
 
The person who wrote the note above has injected themselves a total of 45,360 times so far in their lifetime!!! Seems as if these patients with diabetes should be asked to participate in some detailed market research regarding the "new idea" of inhaling rather than injecting.

Does anyone know whether the market research has shown the patients would PREFER inhaleable? It would not be the FIRST time that a pharmaceutical company never thought to ASK the patient BEFORE developing a new product.
 
You guys who enter into a situation about which you have no clue need to have a cold one. Mannkind's Afrezza acts in 15 minutes as opposed to an hour and a half for injectables. And anyone who thinks its really OK to be a pin cushion needs to stick a needle in themselves 4 to 5 times a day. My daughter of 14 has been diabetic for 2 and a half years and I pray for quick acting non injectable insulin. For those of you who have opinions without having to go through it, need to be diagnosed diabetic. And God forbid that ever happens.

GJ
 
I have been a person living with Type I for 29 years, from the age of 5. It was very difficult at age 5 to inject, but I needed to adjust. Humalog lowers my glucose within 15 minutes with injection into the stomach.

The idea of inhaling a protein into my lungs is not preferred at all to the 3 or 4 injections per day. Inhaling so often could have many unexpected results and I do not need yet another disease to deal with, thank you.
 
For me, the insulin pump works very well and is fine tuned up to 1/10 of 1 unit. The daily basal makes my glucose normal throughout the entire day. When I am READY to eat, or I WANT to eat, I bolus the units necessary for the amount of carbohydrates I will consume. It works within 15 minutes and I have used my insulin pump for 14 of my 32 years of Type I Diabetes.

As for injecting, the insulin pump allows me to inject 2 times per week, or 1 time every 3 days. That is only 10 "injections" per month and I don't have any worries.
 
You've all got it wrong.

Inhaled insulin a good idea but too costly.

PFTs (pulmonary function tests) are required before (ADDED COST) and during therapy (ADDED COST). Can't start therapy until PFTs are above a certain level. If diabetic smokers wish to use it, well, good luck with that segment of the population (those sad souls). If a patient becomes ill with a respiratory ailment (ie bronchitis or pneumonia), it's back to the needle/syringe (ADDED COST) until those conditions resolve themselves.

As per the above reference to inhaling a protein - very valid point. The PFT scores/levels do show a slow, steady decline in FEV1 over time. Granted, not everyone's lungs will react this way but who is willing to take a chance?

Then there's the issue of the apparatus itself. Unless they've changed it, it is horrible - first do this, then insert this the right way, then do this, then do that.

Hopefully, by now at least, they've done further FEV studies to determine an range of decline in breathing capacity. Until then, it's a hard sell. You'll have some that jump on it initially but it won't be many.

Novel idea, this inhaled insulin, but still a bit before its time.

Just my thoughts.
 
Sure,

Thanks for your input on this matter.

Supposedly, the new device is very simple and even patients with COPD have no bioavailability issues. As far as inhaling proteins go, well, each and every one of us that is not on some kind of artificial respirator inhale all kinds of biomolecules every day, sometimes with efficacy that results in outbreaks of airborne flu or worse.

It's time to learn from nature, and nurture these new paths. It's easy to improve upon nature, and that's why the nanosphere technology is soooo hot. If not in this application, some other application will surely follow. Hopefully the drug addict crowd will not beat MNKD to the market! Can you imagine oxytocin inhalers... OMG that would result in millions of incidences of "love at first sight" in the workplace, or worse!

Take care and thanks for your feedback.

--Jan

You've all got it wrong.

Inhaled insulin a good idea but too costly.

PFTs (pulmonary function tests) are required before (ADDED COST) and during therapy (ADDED COST). Can't start therapy until PFTs are above a certain level. If diabetic smokers wish to use it, well, good luck with that segment of the population (those sad souls). If a patient becomes ill with a respiratory ailment (ie bronchitis or pneumonia), it's back to the needle/syringe (ADDED COST) until those conditions resolve themselves.

As per the above reference to inhaling a protein - very valid point. The PFT scores/levels do show a slow, steady decline in FEV1 over time. Granted, not everyone's lungs will react this way but who is willing to take a chance?

Then there's the issue of the apparatus itself. Unless they've changed it, it is horrible - first do this, then insert this the right way, then do this, then do that.

Hopefully, by now at least, they've done further FEV studies to determine an range of decline in breathing capacity. Until then, it's a hard sell. You'll have some that jump on it initially but it won't be many.

Novel idea, this inhaled insulin, but still a bit before its time.

Just my thoughts.
 
My question to Mannkind Company is this:

How many persons with Type I Diabetes, currently taking more than 2 injections per day, were in the trial? What was their personal opinion?
How many Type II people with Diabetes used it during the clinical trials?
How many times per day did they inhale the product, and what was their opinion of it?
How many persons with Diabetes currently using an insulin pump tried it? What was their personal opinion?
 
My question to Mannkind Company is this:

How many persons with Type I Diabetes, currently taking more than 2 injections per day, were in the trial? What was their personal opinion?
How many Type II people with Diabetes used it during the clinical trials?
How many times per day did they inhale the product, and what was their opinion of it?
How many persons with Diabetes currently using an insulin pump tried it? What was their personal opinion?

We may have to wait until the year's ending for such information. Great questions, keep this thread going. If I hear anything (after all I am personally involved with this topic as well) - will let you know immediately.
 
People are writing like they never heard of inhaled insulin before. Pfizer launched an inhaled insulin less than five years ago and it died on the vine. Why?

1. Insulin is a growth hormone and in trials, participants noses grew. Not an attractive side effect. Who knows what kind of side effects to the lungs, which were built for oxygen and carbon dioxide.

2. COPD and other respiratory diseases are issues, Mannkind won't see it until the product is approved and goes to the public because they won't be able to cherry pick the patients.

3. Lilly had an inhaled insulin and whacked it in phase 2 or phase 3 based on the failure of Pfizer. If Pfizer can't sell shit, nobody can, and I was w/Lilly for twelve years.
 
People are writing like they never heard of inhaled insulin before. Pfizer launched an inhaled insulin less than five years ago and it died on the vine. Why?

1. Insulin is a growth hormone and in trials, participants noses grew. Not an attractive side effect. Who knows what kind of side effects to the lungs, which were built for oxygen and carbon dioxide.

2. COPD and other respiratory diseases are issues, Mannkind won't see it until the product is approved and goes to the public because they won't be able to cherry pick the patients.

3. Lilly had an inhaled insulin and whacked it in phase 2 or phase 3 based on the failure of Pfizer. If Pfizer can't sell shit, nobody can, and I was w/Lilly for twelve years.

How fascinating. Insulin a growth hormone... so does it make the lungs grow up into the nose to make bigger noses? I don't mean to be nosy, or noisy, just curious.
 
People are writing like they never heard of inhaled insulin before. Pfizer launched an inhaled insulin less than five years ago and it died on the vine. Why?

1. Insulin is a growth hormone and in trials, participants noses grew. Not an attractive side effect. Who knows what kind of side effects to the lungs, which were built for oxygen and carbon dioxide.

2. COPD and other respiratory diseases are issues, Mannkind won't see it until the product is approved and goes to the public because they won't be able to cherry pick the patients.

3. Lilly had an inhaled insulin and whacked it in phase 2 or phase 3 based on the failure of Pfizer. If Pfizer can't sell shit, nobody can, and I was w/Lilly for twelve years.

WHY??? Because no one would pay for the "convenience" of inhaled insulin. The cost of the inhaler devices is much more than pens or vials. Health plans/insurers (and gov'ts outside the US) couldn't justify the additional expense for most patients. When you couple that with the safety concerns mentoipned by the earlier post above, there was a general lack of demand. Lilly bailed because the costs kept rising and the forecast kept shrinking.

There is enough humulin in freezers in Indy to supply the market for a long time since they had stockpiled large quantities for the inhaled insulin (due to poor absorption you need bigger amounts delivered). I wouldn't be surprised if that wasn't that trigger for the deal with Walmart branded Humulin R. It was better to give it away cheap than let it expire or take up costly space in cold storage.
 
WHY??? Because no one would pay for the "convenience" of inhaled insulin. The cost of the inhaler devices is much more than pens or vials. Health plans/insurers (and gov'ts outside the US) couldn't justify the additional expense for most patients. When you couple that with the safety concerns mentoipned by the earlier post above, there was a general lack of demand. Lilly bailed because the costs kept rising and the forecast kept shrinking.

There is enough humulin in freezers in Indy to supply the market for a long time since they had stockpiled large quantities for the inhaled insulin (due to poor absorption you need bigger amounts delivered). I wouldn't be surprised if that wasn't that trigger for the deal with Walmart branded Humulin R. It was better to give it away cheap than let it expire or take up costly space in cold storage.

W.O.W. - thank you so much, you answered so many of my lingering questions. Okay, so this explains the give-away of insulin to African nations last year. And, as you said, the Wal-mart deal. You are correct that in many cases, it's best to just give it away than to put it into incinerators. Lilly has put plenty of material into incinerators over the past decade or so, and knows, that has to stop completely. I suppose that this is also a way to go head-to-head with "ruthless" competitors outside the company (as if Lilly employees don't feel competition from within the company - figure that out!) .... sure, just give it away, and it's bye bye Novartis.

THAT BEING SAID ... Mannkind is working on much more than just insulin. Go visit their website http://www.mannkindcorp.com/Technology.aspx and see how tiny the device is, much smaller than those syringes. Hey, the old Mann is one stubborn and clever inventor and obviously in this for more than just the money! Now THAT is COMPETITION. He is not the type to go hype "innovation" in all the media for $12 million/year - he would rather die. No, he will live until he sees this technology come to fruition, and it won't be simple insulin.

Viruses have learned how to permeate our lungs a million years ago, even interchange genes (those would be the retroviruses) - use our own bodies as a cloning device. Just think about it... this is just the tip of an iceberg, but it's a friendly iceberg.
 
Hey great thread... just saw this in an email... http://seekingalpha.com/article/216330-mannkind-tries-again-with-inhaled-insulin the consensus seems to be that the resubmission will not require years and years (like Prasugel did) - but only a few months - which means, if you own some Lilly stock, you might want to cash in on that and by some MNKD.... use your severance pay if necessary but by all means do your due diligence. Please don't use Lilly mgmt as a model for decisions - they dropped a billion bucks on this and just followed in Pfizered footsteps ... maybe this will be good for LLY on the other hand. If, as has been posted elsewhere in the cafe - IF LLY really has millions of doses of insulin analogs in the deep freeze, hey, sell it to MNKD, everybody gets rich and some of us get huge bonuses ... --JL
 
I have taken insulin for 48 years, beginning with PZI, Protamine Zinc Iletin and now I use Humalog in my insulin pump. I would never consider inhaling a protein. Even 30 years after the first inhaled insulin because the long term danger will still not be known for a hundred years. Read on:

My question to Mannkind Company is this:

How many persons with Type I Diabetes, currently taking more than 2 injections per day, were in the trial? What was their personal opinion?
How many Type II people with Diabetes used it during the clinical trials?
How many times per day did they inhale the product, and what was their opinion of it?
How many persons with Diabetes currently using an insulin pump tried it? What was their personal opinion?
 
all of your answers may be found here. Basically, this nanomaterial using insulin is just one application of thousands of possible applications. It's based on the very simple fact that particles, once formulated to a very small size, behave as gases. Gases directly interact with pulmonary blood. http://seekingalpha.com/article/216316-is-mannkind-the-next-takeover-target?source=yahoo Okay that's the idea, and it's brilliant. Sorry, Lilly and Pfizered were not able to pull this off. Maybe they spent too much time on the PM plans, ROTGLMAO !!!!!!

This is not about just insulin.... it's about a new platform for direct contact of peptides, large or small, with pulmonary blood. What is so difficult here? Maybe you like being a pin cushion?
 
No, I do not "like being a pin cushion" but the latest insulin syringes are so small, I do not feel the prick. Well, not that prick. Since I have taken insulin shots for 42 years, I am much more well qualified than YOU are, sir. No protein will be inhaled into these lungs. It is an ignorant idea and the problems will not be seen for 30 years. Wait and see. Just wait and see. Ignorant pri*k!
 


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