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Post by lakon on Jun 13, 2016 10:44:14 GMT -5
Per request: "Mannkind won’t have too much trouble meeting early demand: it built a plant to manufacture the product in Danbury, Conn., a couple of years ago and purchased enough leftover insulin from Pfizer to create $10 billion worth of marketable AFREZZA." insulinnation.com/treatment/inhalable-insulin-a-breathtaking-development/In a very careful and subtle way, Al Mann confirmed the above during the 2014 shareholder meeting Q&A session, leaving the math to do by anyone who listened. Of course, it is up to the FDA whether or not MNKD can ever use this insulin to make Afrezza. www.youtube.com/watch?v=8PcEHw5P71Y&t=41m17sHere is the original thread where this topic came up. Someone recently reminded me and requested that I create a thread just for it. Enjoy! mnkd.proboards.com/post/68203/thread |
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Post by kc on Jun 13, 2016 11:03:32 GMT -5
I don't know if that insulin will ever be used in the United States. But they should use it to enter other countries. The cost of prescription drugs in the United States is much higher than the rest of the world so this insulin should be used In countries where The need is great and can be supplied to them at a lesser cost while still providing MannKind with a profitable sale.
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Post by matt on Jun 13, 2016 12:35:50 GMT -5
I don't know if that insulin will ever be used in the United States. But they should use it to enter other countries. What you are suggesting is illegal. Either the insulin is good drug, in which case there is no reason it can't be sold in the US, or it is expired product in which case it cannot be exported. FDA applies the same quality regulations to domestic and exported drugs.
What many people don't realize is that active pharmaceutical ingredients don't permanently expire the way a manufactured product does. While raw material has a presumed life based on its stability testing, many times that testing is limited to three years. After sitting on the shelf for three years, a sample can be retested and if it passes the lot is reclassified to unexpired. This can happen multiple times and some molecules essentially never degrade. All that FDA cares about is that the medicine as released to the public will be safe and effective, and not how long the API has been sitting in inventory.
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Post by rockstarrick on Jun 13, 2016 15:19:39 GMT -5
I don't know if that insulin will ever be used in the United States. But they should use it to enter other countries. What you are suggesting is illegal. Either the insulin is good drug, in which case there is no reason it can't be sold in the US, or it is expired product in which case it cannot be exported. FDA applies the same quality regulations to domestic and exported drugs.
What many people don't realize is that active pharmaceutical ingredients don't permanently expire the way a manufactured product does. While raw material has a presumed life based on its stability testing, many times that testing is limited to three years. After sitting on the shelf for three years, a sample can be retested and if it passes the lot is reclassified to unexpired. This can happen multiple times and some molecules essentially never degrade. All that FDA cares about is that the medicine as released to the public will be safe and effective, and not how long the API has been sitting in inventory.
Thanks Matt, I have always wondered why mnkd would've purchased that product, (before FDA approval) if the possibility of expiration before any chance of using the product existed. as usual, another great comment from Matt. Good Luck Everybody !! |
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Post by Deleted on Jun 13, 2016 17:02:53 GMT -5
I don't know if that insulin will ever be used in the United States. But they should use it to enter other countries. What you are suggesting is illegal. Either the insulin is good drug, in which case there is no reason it can't be sold in the US, or it is expired product in which case it cannot be exported. FDA applies the same quality regulations to domestic and exported drugs.
What many people don't realize is that active pharmaceutical ingredients don't permanently expire the way a manufactured product does. While raw material has a presumed life based on its stability testing, many times that testing is limited to three years. After sitting on the shelf for three years, a sample can be retested and if it passes the lot is reclassified to unexpired. This can happen multiple times and some molecules essentially never degrade. All that FDA cares about is that the medicine as released to the public will be safe and effective, and not how long the API has been sitting in inventory.
The FDA cares very little about the safety of the public. The FDA will have complete regulatory control over all tobacco products starting August 8, 2016. Guess what? It's still not going to do anything to regulate what goes into cigarettes. Cigarette conpanies profit millions, are trade on the stock market (which is sickening), and thousands of people die every year from direct consequences of what the FDA "cares" to regulate. If the FDA cares about anything it's making the FDA more money. I mean no disrespect towards you, I'm just speaking out loud so please do not take offense, I value your input and knowledge on this forum. This is directly from the FDA website: " Tobacco use is the single largest preventable cause of disease and death in the United States. As part of its goal to improve public health and protect future generations from the risks of tobacco use, the FDA has extended its authority to cover all products that meet the definition of a tobacco product." The FDA is already spreading misleading information by claiming tobacco to be the direct cause of death and diseases like COPD. It's what is IN cigarettes in addition to tobacco that does this. Tobacco is natural, but is altered with harmful ingredients that effect even those whom do not smoke cigarettes via second hand smoke. People die every year from second hand smoke related conditions. Here is what the FDA thinks of their achievement: " This action is a milestone in consumer protection – going forward, the FDA will be able to:
-Review new tobacco products not yet on the market;
-Help prevent misleading claims by tobacco product manufacturers;
-Evaluate the ingredients of tobacco products and how they are made; and
-Communicate the potential risks of tobacco products.
www.fda.gov/TobaccoProducts/Labeling/RulesRegulationsGuidance/ucm388395.htmTo get an idea about how corrupt and hypocritical the FDA is here is one of the FAQ regarding their regulation of tobacco: — Question: How does the regulation of tobacco products differ from FDA’s regulation of drugs or medical devices?—Answer: FDA's regulatory role for drugs and devices is usually based on a safety and effectiveness standard. The tobacco control act establishes a new standard: to regulate tobacco products based on a public health and population health standard.
www.fda.gov/AboutFDA/Transparency/Basics/ucm194451.htmAnd then there is this: The decisions made by FDA in the regulation of tobacco products are grounded in science.
—FDA's traditional "safe and effective" standard for evaluating medical products does not apply to tobacco products. FDA evaluates new tobacco products based on a public health standard that considers the risks and benefits of the tobacco product to the population as a whole, including users and nonusers The FDA again is lying to the public and spreading false information. Tobacco products must be pretty safe, seeing how the FDA claims they made make their regulatory decisions of tobacco products grounded in "science", and despite millions that die every year they also base these same decisions on public health. You cannot get anymore sinister than that. www.fda.gov/TobaccoProducts/Labeling/RulesRegulationsGuidance/ucm283974.htm |
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Post by mnkdfann on Jun 13, 2016 19:35:33 GMT -5
I don't know if that insulin will ever be used in the United States. But they should use it to enter other countries. What you are suggesting is illegal. Either the insulin is good drug, in which case there is no reason it can't be sold in the US, or it is expired product in which case it cannot be exported. FDA applies the same quality regulations to domestic and exported drugs. Playing devil's advocate, I think kc never said anything about the REASON it might not be used in the United States. He might have meant something other than it possibly being expired. Perhaps he just meant there was so much of it that it could never all be used up inside the U.S. alone. |
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Post by mnkdfann on Jun 13, 2016 19:41:14 GMT -5
Per request: "Mannkind won’t have too much trouble meeting early demand: it built a plant to manufacture the product in Danbury, Conn., a couple of years ago and purchased enough leftover insulin from Pfizer to create $10 billion worth of marketable AFREZZA." insulinnation.com/treatment/inhalable-insulin-a-breathtaking-development/In a very careful and subtle way, Al Mann confirmed the above during the 2014 shareholder meeting Q&A session, leaving the math to do by anyone who listened. Of course, it is up to the FDA whether or not MNKD can ever use this insulin to make Afrezza. www.youtube.com/watch?v=8PcEHw5P71Y&t=41m17sHere is the original thread where this topic came up. Someone recently reminded me and requested that I create a thread just for it. Enjoy! mnkd.proboards.com/post/68203/threadThe links have to do with 2014 news about insulin purchased from Pfizer in 2009. What is the status of that insulin TODAY? More recently (last year I think), Mannkind announced it wrote off some insulin inventory. What was up with that? Was that insulin expired? Was that connected to the insulin purchased from Pfizer? |
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Post by Deleted on Jun 13, 2016 19:52:15 GMT -5
From MannKind's investor FAQ:
Just prior to the agreement with Sanofi, MannKind completed CMC studies and a clinical bioequivalence study leading to a potential submission of the HMR 4006 insulin acquired from Pfizer. Based on the current age of the HMR 4006 inventories, MannKind is evaluating various options and utility for future use. There is currently sufficient inventory of Amphastar insulin for near term needs.
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Post by anderson on Jun 13, 2016 20:36:32 GMT -5
Per request: "Mannkind won’t have too much trouble meeting early demand: it built a plant to manufacture the product in Danbury, Conn., a couple of years ago and purchased enough leftover insulin from Pfizer to create $10 billion worth of marketable AFREZZA." insulinnation.com/treatment/inhalable-insulin-a-breathtaking-development/In a very careful and subtle way, Al Mann confirmed the above during the 2014 shareholder meeting Q&A session, leaving the math to do by anyone who listened. Of course, it is up to the FDA whether or not MNKD can ever use this insulin to make Afrezza. www.youtube.com/watch?v=8PcEHw5P71Y&t=41m17sHere is the original thread where this topic came up. Someone recently reminded me and requested that I create a thread just for it. Enjoy! mnkd.proboards.com/post/68203/threadThe links have to do with 2014 news about insulin purchased from Pfizer in 2009. What is the status of that insulin TODAY? More recently (last year I think), Mannkind announced it wrote off some insulin inventory. What was up with that? Was that insulin expired? Was that connected to the insulin purchased from Pfizer? That write off had nothing to do with the Pfizer insulin and had to do with the purchase agreement with Amphastar. That was due to them having a liability to purchase insulin from Amphastar that was related to the business they were doing with Sanofi. Basically an accounting shell game. |
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Post by anderson on Jun 13, 2016 20:40:05 GMT -5
I don't know if that insulin will ever be used in the United States. But they should use it to enter other countries. What you are suggesting is illegal. Either the insulin is good drug, in which case there is no reason it can't be sold in the US, or it is expired product in which case it cannot be exported. FDA applies the same quality regulations to domestic and exported drugs.
What many people don't realize is that active pharmaceutical ingredients don't permanently expire the way a manufactured product does. While raw material has a presumed life based on its stability testing, many times that testing is limited to three years. After sitting on the shelf for three years, a sample can be retested and if it passes the lot is reclassified to unexpired. This can happen multiple times and some molecules essentially never degrade. All that FDA cares about is that the medicine as released to the public will be safe and effective, and not how long the API has been sitting in inventory.
Kc they will get that insulin approved for use in the US someday. How do I know this? investors.mannkindcorp.com/releasedetail.cfm?ReleaseID=792263"quantity of bulk insulin and a license to manufacture bulk insulin for use in pulmonary delivery pursuant to an insulin sale and purchase agreement" Not only did they purchase the bulk insulin, they bough a manufacturing license. Guess Al wanted to vertically integrate sometime in the future. |
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Post by prosper on Jun 14, 2016 7:27:35 GMT -5
Reading all the responses I couldn't find definitive statement of the viability/safety of the bulk insulin nor could I find a realistic estimate of any permanent expiration date. Also, going back some years, why did we not use this before contracting for the Amphistar?
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Post by liane on Jun 14, 2016 7:57:32 GMT -5
The only way to know the viability is to periodically test. Many proteins can be kept indefinitely in the "deep freeze". If it tests well, then it should be usable (with the FDA's blessing of course). As for Amphastar - probably a Sanofi requirement for a long term steady supplier. I suspect they did not want to risk the "old" insulin, and even if they did, would not want to switch suppliers once it ran out.
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Post by anderson on Jun 14, 2016 9:28:54 GMT -5
Reading all the responses I couldn't find definitive statement of the viability/safety of the bulk insulin nor could I find a realistic estimate of any permanent expiration date. Also, going back some years, why did we not use this before contracting for the Amphistar? If you go further back the original insulin used for Afrezza was produced by Merck. Merck's insulin business was purchased by Amphastar in 2014 for $34.4 million. Since Merck's insulin was used in the trials that is what is approved. The Pfizer insulin(was this the left over insulin base for Exubera? Btw Sanofi got the plant) was a fire sale and they got tons at a very low price($3 million) as well as the manufacturing rights. Al said at the 2014 shareholder meeting that it is tested regularly and is still good. It kept viable from 2009-2014, also Sanofi used it as collateral for part of the loan. So I am guessing they know how to store it so that is does not degrade rapidly. www.marketvis.io/stock/amph/financial/q3-2015/note/businesscombinationdisclosuretextblock |
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Post by mnkdfann on Jun 14, 2016 10:05:27 GMT -5
Reading all the responses I couldn't find definitive statement of the viability/safety of the bulk insulin nor could I find a realistic estimate of any permanent expiration date. Also, going back some years, why did we not use this before contracting for the Amphistar? If you go further back the original insulin used for Afrezza was produced by Merck. Merck's insulin business was purchased by Amphastar in 2014 for $34.4 million. Since Merck's insulin was used in the trials that is what is approved. The Pfizer insulin(was this the left over insulin base for Exubera? Btw Sanofi got the plant) was a fire sale and they got tons at a very low price($3 million) as well as the manufacturing rights. Al said at the 2014 shareholder meeting that it is tested regularly and is still good. It kept viable from 2009-2014, also Sanofi used it as collateral for part of the loan. So I am guessing they know how to store it so that is does not degrade rapidly. www.marketvis.io/stock/amph/financial/q3-2015/note/businesscombinationdisclosuretextblockI finally got around to watching the 2014 shareholder meeting video linked to in the first post. Small point, it wasn't Al who said the insulin was monitored regularly, that was someone else. See the OP's link (it is queued up to the relevant question and answer). Al actually said as a follow-up to that person's answer that there was "enough in the freezer to do about 10 million patient years, but that doesn't mean we can use it all." It seems to me that none of us here know the current status of the insulin, all we can do is hope for the best. |
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Post by tayl5 on Jun 14, 2016 11:06:51 GMT -5
What you are suggesting is illegal. Either the insulin is good drug, in which case there is no reason it can't be sold in the US, or it is expired product in which case it cannot be exported. FDA applies the same quality regulations to domestic and exported drugs.
What many people don't realize is that active pharmaceutical ingredients don't permanently expire the way a manufactured product does. While raw material has a presumed life based on its stability testing, many times that testing is limited to three years. After sitting on the shelf for three years, a sample can be retested and if it passes the lot is reclassified to unexpired. This can happen multiple times and some molecules essentially never degrade. All that FDA cares about is that the medicine as released to the public will be safe and effective, and not how long the API has been sitting in inventory.
The FDA cares very little about the safety of the public. The FDA will have complete regulatory control over all tobacco products starting August 8, 2016. Guess what? It's still not going to do anything to regulate what goes into cigarettes. Cigarette conpanies profit millions, are trade on the stock market (which is sickening), and thousands of people die every year from direct consequences of what the FDA "cares" to regulate. If the FDA cares about anything it's making the FDA more money. I mean no disrespect towards you, I'm just speaking out loud so please do not take offense, I value your input and knowledge on this forum. This is directly from the FDA website: " Tobacco use is the single largest preventable cause of disease and death in the United States. As part of its goal to improve public health and protect future generations from the risks of tobacco use, the FDA has extended its authority to cover all products that meet the definition of a tobacco product." The FDA is already spreading misleading information by claiming tobacco to be the direct cause of death and diseases like COPD. It's what is IN cigarettes in addition to tobacco that does this. Tobacco is natural, but is altered with harmful ingredients that effect even those whom do not smoke cigarettes via second hand smoke. People die every year from second hand smoke related conditions. Here is what the FDA thinks of their achievement: " This action is a milestone in consumer protection – going forward, the FDA will be able to:
-Review new tobacco products not yet on the market;
-Help prevent misleading claims by tobacco product manufacturers;
-Evaluate the ingredients of tobacco products and how they are made; and
-Communicate the potential risks of tobacco products.
www.fda.gov/TobaccoProducts/Labeling/RulesRegulationsGuidance/ucm388395.htmTo get an idea about how corrupt and hypocritical the FDA is here is one of the FAQ regarding their regulation of tobacco: — Question: How does the regulation of tobacco products differ from FDA’s regulation of drugs or medical devices?—Answer: FDA's regulatory role for drugs and devices is usually based on a safety and effectiveness standard. The tobacco control act establishes a new standard: to regulate tobacco products based on a public health and population health standard.
www.fda.gov/AboutFDA/Transparency/Basics/ucm194451.htmAnd then there is this: The decisions made by FDA in the regulation of tobacco products are grounded in science.
—FDA's traditional "safe and effective" standard for evaluating medical products does not apply to tobacco products. FDA evaluates new tobacco products based on a public health standard that considers the risks and benefits of the tobacco product to the population as a whole, including users and nonusers The FDA again is lying to the public and spreading false information. Tobacco products must be pretty safe, seeing how the FDA claims they made make their regulatory decisions of tobacco products grounded in "science", and despite millions that die every year they also base these same decisions on public health. You cannot get anymore sinister than that. www.fda.gov/TobaccoProducts/Labeling/RulesRegulationsGuidance/ucm283974.htmNice rant, mango, but I think your ire is misplaced. The real mission of FDA is to not run afoul of Congress. That's where the big money exchange takes place. How can FDA effectively regulate the tobacco companies when their bosses are collecting millions from the perps? It's incredibly annoying that Afrezza has to carry a warning about cancer when the initiation of that cancer is caused by another inhalation drug with extreme ADRs that you can buy at any corner grocery store. It will be a good day when tobacco company executives and their puppets in Congress are rounded up and charged with conspiracy and mass murder. |
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