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Post by beardawg on May 4, 2016 10:17:34 GMT -5
Manufacturing Afrezza in China is not needed when MNKD can ship dry powder over as I think we both know... I don't think I am explaining this right. You can manufacture insulin anywhere and ship it without problem, Afrezza or analogs. The manufacturing issue with China is that the government health systems buys local products where possible which is why the big three manufacture there for the domestic market. If that is the case, why don't we have Chinese knockoffs of their insulin products, but we can surely expect it for Afrezza? |
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Post by peppy on May 4, 2016 10:31:20 GMT -5
I don't think I am explaining this right. You can manufacture insulin anywhere and ship it without problem, Afrezza or analogs. The manufacturing issue with China is that the government health systems buys local products where possible which is why the big three manufacture there for the domestic market. My uneducated guess. Big pharma sells Patented insulin analogs different from generic insulin. Afrezza is made using generic insulin.
Correct me where I am mistaken.
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Post by lakon on May 4, 2016 10:48:31 GMT -5
Manufacturing Afrezza in China is not needed when MNKD can ship dry powder over as I think we both know... I don't think I am explaining this right. You can manufacture insulin anywhere and ship it without problem, Afrezza or analogs. The manufacturing issue with China is that the government health systems buys local products where possible which is why the big three manufacture there for the domestic market. You explained it just fine. I didn't need an explanation, but it's fine for those who might not already know how the Chinese operate. Where we differ is in our assessment of the issue. Since protected IP is an oxymoron in China, it is best to not export your most important secrets there. I was suggesting that bulk dry powder shipments of Afrezza could be shipped there to complete the "manufacturing" process, if "needed", in country to fulfill "local customs" of letting the Chinese have their cut. Therefore, the in-country manufacturing would be the less important IP of running fill-lines to meet local demand of specific IU cartridges, dreamboats, etc. Unless MNKD acted out of character and became very naive, they would not manufacture the TI there for a long time. Mann knew this. Kresa knows this. Of course, the API insulin could come from a Chinese manufacturer, which was already pointed out. That would be a fairly Chinese-like compromise as the bulk of the cost comes from the API, thus, the Chinese would get their fair share. It's also worth noting that AMPH has a Chinese unit for making other API. They recently got FDA approval as part of their vertically integrated supply line. The logistical advantages of dry powder and plastic without replacement needles, pens, etc. should not be discounted too much. Anyway, I'm looking long-term while I wait for short-term solutions to be announced. You have an opinion. I have an opinion. We will see how it plays out in time. Good luck. |
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Post by kc on May 4, 2016 10:57:00 GMT -5
Generic Insulin in Late Stage Development-----more disruption coming for the major US pharmaceutical producers of insulin:
Lannett To Co-Develop Generic Insulin Product For $21 Billion U.S. Market
Lannett Has Exclusive U.S. Marketing Rights to Insulin Product; Fifth Project with Strategic Partner--
The Chinese company would be better off buying a 50% stake in MannKind and have a branded patented product in the USA and then do the generic injected insulin. It would not surprise me to see the money behind AMPH get a piece of MannKind and the market in China would be huge and Lannett and their partner YiChang HEC ChangJiang Pharmaceutical Co., Ltd can get into the use market instantly with buying 50% of MannKind or more. We just don't know what is ahead for MannKind but something will happen that will give us a clear path to the future. |
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Post by mnholdem on May 4, 2016 11:28:17 GMT -5
Amphastar Nanjing Pharmaceuticals, Inc., (ANP), located in the Nanjing Economic and Technological Development Zone in Nanjing, Jiangsu Province of China, is an FDA registered manufacturer of active pharmaceutical ingredients (API) and intermediates. The products manufactured at ANP are intended only for use by Amphastar and its wholly owned subsidiaries. This assures that Amphastar maintains traceability and control of its supply chain back to the starting material.
The 43,023 square foot facility is comprised of several buildings that house all operations such as manufacturing and packaging, laboratories, raw material and finished goods warehousing, and distribution. Like Amphastar, ANP is supported by on-site QC chemistry, microbiology and R&D laboratories. These resources provide ANP the ability to develop, perform scale up and manufacture at one location.
www.amphastar.com/facilities.html
---
Jun 22, 2015
Amphastar Pharmaceuticals Receives Approval for AMPHADASE(R) Supplement, Marking the First Product From Its China Facility
RANCHO CUCAMONGA, Calif., June 22, 2015 (GLOBE NEWSWIRE) -- Amphastar Pharmaceuticals, Inc. (Nasdaq:AMPH) ("Amphastar" or the "Company") announced today that the U.S. Food and Drug Administration ("FDA") granted approval of the Company's New Drug Application ("NDA") supplement for Amphadase® (hyaluronidase injection). This marks the first FDA approved starting material from the Company's subsidiary, ANP, located in Nanjing, China, and signifies that this facility has been qualified by the FDA.
ir.amphastar.com/releasedetail.cfm?releaseid=918786
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Post by agedhippie on May 4, 2016 11:48:39 GMT -5
If that is the case, why don't we have Chinese knockoffs of their insulin products, but we can surely expect it for Afrezza? My uneducated guess. Big pharma sells Patented insulin analogs different from generic insulin. Afrezza is made using generic insulin.
Correct me where I am mistaken.
That is pretty much right. Regular insulin is cheap to make, analogs are not which is why biosimilars are priced as they are. Currently insulin is not strategic to the Chinese government so it is easier for them to partner with big pharma provided big pharma manufactures in China and funds joint ventures and knowledge transfers with official bodies. If insulin became strategic then they will already have acquired the knowledge of both research and manufacturing required. The key to the China is what can you offer the government - generally speaking they don't really want product, they want the means to make the product even if they don't immediately follow up. Since it is still a command economy the government controls the markets, not the consumer. |
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Post by _neil on May 4, 2016 12:57:10 GMT -5
Any thoughts on Oramed's oral insulin pill? Results to be published soon (weeks?). If they show promising results, that would be a far bigger challenge to status quo than MNKD ever promised to be. Afrezza might still have an advantage in being monomer insulin but it might be addressing a far smaller market if Oramed is able to crack this challenge.
One binary event after another.. biotech is a far harder investing arena than I ever imagined it would be.
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Post by agedhippie on May 4, 2016 13:18:11 GMT -5
Any thoughts on Oramed's oral insulin pill? Results to be published soon (weeks?). If they show promising results, that would be a far bigger challenge to status quo than MNKD ever promised to be. Afrezza might still have an advantage in being monomer insulin but it might be addressing a far smaller market if Oramed is able to crack this challenge. It's an interesting product but they have only just completed Phase IIb so they are a long way off yet even if it works. |
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Post by cm5 on May 4, 2016 13:47:07 GMT -5
Re: Oral Insulin---
There as a recent thread about Mannkind's patent on oral insulin.
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Post by peppy on May 4, 2016 13:50:46 GMT -5
Any thoughts on Oramed's oral insulin pill? Results to be published soon (weeks?). If they show promising results, that would be a far bigger challenge to status quo than MNKD ever promised to be. Afrezza might still have an advantage in being monomer insulin but it might be addressing a far smaller market if Oramed is able to crack this challenge. One binary event after another.. biotech is a far harder investing arena than I ever imagined it would be. MNKD has a patent for a buffered technosphere oral insulin monomer that is absorbed into the portal circulation, right to the liver. Stops neoglucogenesis. Oramed isn't delivering a monomer. ? .
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Post by brentie on May 4, 2016 15:24:38 GMT -5
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Post by kbrion77 on May 4, 2016 15:25:36 GMT -5
Any thoughts on Oramed's oral insulin pill? Results to be published soon (weeks?). If they show promising results, that would be a far bigger challenge to status quo than MNKD ever promised to be. Afrezza might still have an advantage in being monomer insulin but it might be addressing a far smaller market if Oramed is able to crack this challenge. It's an interesting product but they have only just completed Phase IIb so they are a long way off yet even if it works. How about this quote: "Oramed's aim is early intervention and better patient compliance before organ damage can be done. Most beneficial: pill-form insulin has appeal to diabetics who abhor needle sticks, reminding them and others that they are sick."Wow that's funny because we heard for a year from other analysts, experts, bashers, etc. that needles are so small nowadays that they don't even bother diabetics anymore. |
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Post by agedhippie on May 4, 2016 21:14:15 GMT -5
It's an interesting product but they have only just completed Phase IIb so they are a long way off yet even if it works. How about this quote: "Oramed's aim is early intervention and better patient compliance before organ damage can be done. Most beneficial: pill-form insulin has appeal to diabetics who abhor needle sticks, reminding them and others that they are sick."Wow that's funny because we heard for a year from other analysts, experts, bashers, etc. that needles are so small nowadays that they don't even bother diabetics anymore. I agree. That sound you hear is me beating my head against the desk. Whenever you see people talking about needles you just know they are confusing features with benefits and that seldom ends well. The article is impressively bad. I sincerely hope she was dumbing it down and went to far and not that she thought it was accurate. Ketoacidosis is a kind of blood poisoning? Not really, it's a biological imbalance. And I cannot see there being a serious market in India, the cost will be to high. Lots of other errors. |
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Post by beardawg on May 5, 2016 16:20:33 GMT -5
If that is the case, why don't we have Chinese knockoffs of their insulin products, but we can surely expect it for Afrezza? My uneducated guess. Big pharma sells Patented insulin analogs different from generic insulin. Afrezza is made using generic insulin.
Correct me where I am mistaken.
I was thinking the process to make it powdered and attached to Technosphere is what would have to be copied. If insulin analog is hard, i'd imagine Afrezza would be too. |
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Post by peppy on May 5, 2016 16:37:49 GMT -5
My uneducated guess. Big pharma sells Patented insulin analogs different from generic insulin. Afrezza is made using generic insulin.
Correct me where I am mistaken.
I was thinking the process to make it powdered and attached to Technosphere is what would have to be copied. If insulin analog is hard, i'd imagine Afrezza would be too. Through genetic engineering of the underlying DNA, the amino acid sequence of insulin can be changed to alter its ADME (absorption, distribution, metabolism, and excretion) characteristics. Officially, the U.S. Food and Drug Administration (FDA) refers to these as "insulin receptor ligands", although they are more commonly referred to as insulin analogs. en.wikipedia.org/wiki/Insulin_analog 1978 Genentech develop biosynthesis of recombinant human insulin in Escheria coli bacteria using recombinant DNA technology
1981 Novo Nordisk chemically and enzymatically converts porcine insulin to 'human' insulin (Actrapid HM)
1982 Genentech synthetic 'human' insulin approved, in partnership with Eli Lilly and Company, who shepherded the product through the U.S. Food and Drug Administration (FDA) approval process
1983 Lilly produces biosynthetic recombinant "rDNA insulin human INN" (Humulin)
1985 Axel Ullrich sequences the human insulin receptor
1988 Novo Nordisk produces synthetic, recombinant insulin ("insulin human INN")
1996 Lilly Humalog "insulin lispro INN" approved by the U.S. Food and Drug Administration
2003 Aventis Lantus "glargine" insulin analogue approved in USA [22]
2004 Sanofi Aventis Apidra insulin "glulisine" analogue approved in the USA.
2006 Novo Nordisk's Levemir "insulin detemir INN" analogue approved in the USA-
2013 Novo Nordisk's Tresiba "insulin degludec INN" analogue approved in Europe (EMA with additional monitoring]
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