Mannkind's Inhaled Insulin

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Anonymous said:
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.
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Are they hiring?
 


Anonymous said:
Are they hiring?
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ummm read between the lines (John you are still working on that, go back to your corner!)

"On June 19, 2009, MannKind Corporation (the “Company”) completed its acquisition from Pfizer Inc. (“Pfizer”) and its wholly owned subsidiary, Pfizer Manufacturing Frankfurt GmbH (the “Seller”), of a portion of the Seller’s inventory of bulk insulin and the Seller’s and Pfizer’s rights under a license to manufacture insulin for pulmonary delivery pursuant to that certain Insulin Sale and Purchase Agreement between the Company, Pfizer and the Seller dated March 6, 2009 (the “Insulin Agreement”). In accordance with the terms of the Insulin Agreement, on June 19, 2009, the Company, Pfizer and the Seller also entered into an Insulin Maintenance and Call-Option Agreement (the “Option Agreement”) pursuant to which the Company agreed to maintain and store the remainder of the Seller’s bulk insulin inventory (the “Retained Insulin”) and acquired an option to purchase the Retained Insulin, in whole or in part, at a specified price, to the extent that the Seller has not otherwise disposed of or used the Retained Insulin. The total purchase price for this transaction including consideration payable to the Company for the storage and maintenance of the Retained Insulin was $3 million, which the Company paid in cash. A copy of the Insulin Agreement, which included the form of the Option Agreement as an annex, was filed as an exhibit with the Company’s Quarterly Report on Form 10-Q on May 4, 2009."
 


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?
 


Why not send an email to Dr. Mann himself?

He would probably address all of your questions.

You seem to have "questions that matter"


Anonymous said:
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?
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"Mannkind has secured cheap insulin from Pfizer. In many of the Mannkind conference calls, you can hear the management saying that they have enough insulin for $10 billion dollar worth of sales and have an option to buy some more insulin for another $8 billion dollar of sales. The insulin that is used as an ingredient is recombinant human insulin.


Are you sure?


From Pfizer?"



Anonymous said:
There is a ton available that answers your questions

To date over 5000 patients eg.

Here about what patients feel:

http://www.mannkindcorp.com/uploade...ters/2010 ADA Poster 1996-P - M.Peyrot LR.pdf

here are more scientific posters.

Most info can be found in the blog here:
One patient was interviewed exlusivly for the blog.

link to the article
http://afresa.blogspot.com/2010/09/q-wit...

main link
http://afresa.blogspot.com/
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Anonymous said:
"Mannkind has secured cheap insulin from Pfizer. In many of the Mannkind conference calls, you can hear the management saying that they have enough insulin for $10 billion dollar worth of sales and have an option to buy some more insulin for another $8 billion dollar of sales. The insulin that is used as an ingredient is recombinant human insulin.


Are you sure?


When PFE was developing Exubera, they secured insulin supply from Sanofi Aventis. There are only a handful of major bulk insulin mfg sites in the world owned by Lilly, Novo and Sanofi. PFE does not have one, but they have the long term supply agreement from Sanofi. At ~10% bioavailability vs. injected insulin, the agreement would have been for a lot of bulk for a very long time. Otherwise, Exubera would have been dead before it started. Thus, Mannkind is accessing insulin through that supply agreement.

So, will inhaled win in the market? No. Here's why...

Look at inhaled insulin's competitive advantages vs. injected insulin...

EFFICACY - Same as or no better than injected insulin
SAFETY - At 10% bioavailability in the lungs, what happens to all those insulin crystals? For Exubera, they caused cancer... Injected insulin...no issues
CONVENIENCE - Better than injected, depends on the size of the device. In this market, size matters.
VALUE - Injected insulin is very cheap while inhaled is very pricey. Most patients - and certainly payors - are not willing to pay more for inhaled convenience.

One argument is that needlephobes want this (and other needleless solutions), but these folks respresent <10% of patients and that number dwindles fast when there is a high price differential involved.

Inhaled is a wonderful idea, but the competitive dynamics and retail economics will not allow it to have major success in the market.
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Maybe you folks should hire some of the former tobacco company specialists...

They found some really kool ways to deliver the drug much more rapidly and efficiently than ever before....

Do not throw the baby out with the bathwater. But, you already did. So now you will adopt

Anonymous said:
Anonymous said:
"Mannkind has secured cheap insulin from Pfizer. In many of the Mannkind conference calls, you can hear the management saying that they have enough insulin for $10 billion dollar worth of sales and have an option to buy some more insulin for another $8 billion dollar of sales. The insulin that is used as an ingredient is recombinant human insulin.


Are you sure?


When PFE was developing Exubera, they secured insulin supply from Sanofi Aventis. There are only a handful of major bulk insulin mfg sites in the world owned by Lilly, Novo and Sanofi. PFE does not have one, but they have the long term supply agreement from Sanofi. At ~10% bioavailability vs. injected insulin, the agreement would have been for a lot of bulk for a very long time. Otherwise, Exubera would have been dead before it started. Thus, Mannkind is accessing insulin through that supply agreement.

So, will inhaled win in the market? No. Here's why...

Look at inhaled insulin's competitive advantages vs. injected insulin...

EFFICACY - Same as or no better than injected insulin
SAFETY - At 10% bioavailability in the lungs, what happens to all those insulin crystals? For Exubera, they caused cancer... Injected insulin...no issues
CONVENIENCE - Better than injected, depends on the size of the device. In this market, size matters.
VALUE - Injected insulin is very cheap while inhaled is very pricey. Most patients - and certainly payors - are not willing to pay more for inhaled convenience.

One argument is that needlephobes want this (and other needleless solutions), but these folks respresent <10% of patients and that number dwindles fast when there is a high price differential involved.

Inhaled is a wonderful idea, but the competitive dynamics and retail economics will not allow it to have major success in the market.
Click to expand...
Click to expand...
 


Anonymous said:
Maybe you folks should hire some of the former tobacco company specialists...

They found some really kool ways to deliver the drug much more rapidly and efficiently than ever before....

Do not throw the baby out with the bathwater. But, you already did. So now you will adopt



Sure who ever would have guessed nicotine could be delivered by burning the stuff...
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Re: FRAUD KHAN, the Best of LLY!

Anonymous said:
Are you referring to the CEO at Trinity?
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Yup, one-and-the-same. A funny aside--about 3 yrs ago, we were all forced to watch some sad 'diversity' dvd as part of the never-ending mandatory computer based training. "Ali-Bhabah" Khan, the Thief, had a profile on this DVD touting his DIVERSITY, about 6 months after his complicity in the Emisphere theft was revealed in court! A few weeks after that, he left LLY to "help earthquake victims in Pakistan"! I guess his earthquake-savvy coupled with his thievery will be put in good use in the new shack he runs in the Bay Area!
 




Re: IDI·AMIN·KHAN·THIEF!

IDI·AMIN·KHAN·THIEF! said:
Yup, that's the one. Runs something in a garage in the Bay Area. I wonder what the 'trinity' refers to? The Chin, The Paul and the Holy Gus?
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He "Disappeared" from Lilly after the trial. He was considered a pretty sleazy "Fellow" while at Lilly.

His LinkedIn profile indicated that he has been on a 6 month sabbatical from Trinity.
 


Re: IDI·AMIN·KHAN·THIEF!

Anonymous said:
He "Disappeared" from Lilly after the trial. He was considered a pretty sleazy "Fellow" while at Lilly.

His LinkedIn profile indicated that he has been on a 6 month sabbatical from Trinity.
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Sure, now I remember. Salt and pepper hair, seemed energetic, gave a motivational talk to a group of us where he described how benevolent Eli Lilly was after some earthquake in Pakistan that he volunteered to help with. What he did during his leave of absence, he did not say. Maybe he took expired samples to distribute to the quake victims? I am just guessing... what did he do then, and what is he doing now?

These days, you can run all you want but proverbially you cannot hide!
 


Anonymous said:
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.
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I have been a diabetic for 54 years. I have been on the pump for the last 10 years and the pump does help to control the diabetes more efficiently. But, with the humolog you still have to wait almost 2 hours to compensate for meal increases in bloodsugar levels or to bring a high bloodsugar to normal range. If the high levels could be brought down faster it would improve the health of diabetics greatly. Anyone who has lived with Type 1 diabetes and does testing for glucose levels on a regular basis understands how great Afreeza would be as long as there were not complications. Thank you, Bob Wood
 





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