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Post by agedhippie on Jan 6, 2019 21:05:55 GMT -5
I think I misread what you were saying. I was taking about OTC as not requiring a prescription. I think you meant could be purchase at a pharmacy without involving insurance. No, you read it right. I was referring to Afrezza one day becoming available without a prescription, such as is referred to in this article by APhA" Few patients with diabetes are aware that some forms of insulin can be purchased without a prescription. Many doctors are also not aware of this. The two types of OTC human insulin are made by Eli Lilly and Novo Nordisk. They are older versions and take longer to metabolize than prescription versions. FDA says the availability lets patients gain access to the drug "quickly in urgent situations, without delays." IMS Health reports that about 15% of people with diabetes who buy insulin make OTC purchases. The availability of OTC insulin presents a difficult issue, however. It could save the lives of patients who lack insurance or regular access to a doctor, or who otherwise do not have insulin when they need it. But use of insulin can carry major risks if patients do not get the dose or timing right. Taking the wrong dose consistently can lead to high blood pressure, kidney disease, nerve damage, loss of eyesight, or stroke.
Source: www.pharmacist.com/article/you-can-buy-otc-insulin-should-youAfrezzas API is simple Insulin (Human) delivered via an inert powder stored in unit-measure cartridges loaded into an inhaler device. Is there a safer insulin sold OTC? One key to answering that question will be completion of the lung safety study. I propose that the answer is NO. Afrezza would be a much safer alternative to the OTC insulin brands sold today without a prescription. It would be safer, but that is not the criteria for making Regular insulin OTC. It came about because insulin predated the requirement for a prescription. Then when Regular insulin was produced it was grandfathered in since " When these products went to the FDA for clearance, the developers successfully demonstrated that their discoveries so closely resembled the predecessor insulins — in their biochemical makeup, mechanism of action, and method of administration — that users needed no additional protections than had been offered under the 1941 Insulin Amendment and then-existing FDA regulation. These products, although they fit the bill as “new” drugs, were therefore found to be exempt from the legend drug labelling requirement." Source: Why is Some Insulin Available Over the Counter?Afrezza uses Regular insulin but looks, behaves, and is administered nothing like Regular insulin so it is not going to pass the test. I also suspect that if Regular was introduced today it would not get OTC status - that was a deft bit of lobbying on somebodies part!
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Post by mango on Jan 6, 2019 22:05:36 GMT -5
What if MannKind went the biosimilar route for human insulin that is currently OTC? It wouldn't matter. The exemption is specific to injectable human insulin. I think it may even be specific to Humalin/Novolin. This is a good summary - Why is Some Insulin Available Over the Counter?Don't think any of that applies here. FDA has changed the rules. Human insulin was approved under the FDC Act. Currently, human insulin is not licensed under the PHS Act, so no reference product exists. "Transitioning these drugs to the PHSA will let them to be treated as biologics under that law. And that means opening them up to competition through the biosimilars pathway. This includes insulin, which has been historically regulated as a drug and not a biologic." "Starting in March 2020, the approved marketing applications for the small subset of “biological products” such as insulin and human growth hormone – which for complex historical reasons were previously generally approved as drugs under section 505 of the FD&C Act – will be deemed to be biologics licenses under section 351 of the PHSA." "There are currently no approved insulin products that can be substituted at the pharmacy level. One reason is that it was hard to bring a substitutable generic insulin to the market under the conventional drug pathway. The biosimilar pathway should make this kind of competition more accessible. Once an interchangeable insulin product is approved and available on the market, it can then be substituted for the reference product at the pharmacy, potentially leading to increased access and significantly lower costs for patients." "The transition of biologics currently regulated under the FD&C Act to the PHSA will open the pathway to market for new insulin products that are biosimilar to, or interchangeable with, the legacy reference products."
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Post by mango on Jan 6, 2019 22:18:00 GMT -5
No, you read it right. I was referring to Afrezza one day becoming available without a prescription, such as is referred to in this article by APhA" Few patients with diabetes are aware that some forms of insulin can be purchased without a prescription. Many doctors are also not aware of this. The two types of OTC human insulin are made by Eli Lilly and Novo Nordisk. They are older versions and take longer to metabolize than prescription versions. FDA says the availability lets patients gain access to the drug "quickly in urgent situations, without delays." IMS Health reports that about 15% of people with diabetes who buy insulin make OTC purchases. The availability of OTC insulin presents a difficult issue, however. It could save the lives of patients who lack insurance or regular access to a doctor, or who otherwise do not have insulin when they need it. But use of insulin can carry major risks if patients do not get the dose or timing right. Taking the wrong dose consistently can lead to high blood pressure, kidney disease, nerve damage, loss of eyesight, or stroke.
Source: www.pharmacist.com/article/you-can-buy-otc-insulin-should-youAfrezzas API is simple Insulin (Human) delivered via an inert powder stored in unit-measure cartridges loaded into an inhaler device. Is there a safer insulin sold OTC? One key to answering that question will be completion of the lung safety study. I propose that the answer is NO. Afrezza would be a much safer alternative to the OTC insulin brands sold today without a prescription. It would be safer, but that is not the criteria for making Regular insulin OTC. It came about because insulin predated the requirement for a prescription. Then when Regular insulin was produced it was grandfathered in since " When these products went to the FDA for clearance, the developers successfully demonstrated that their discoveries so closely resembled the predecessor insulins — in their biochemical makeup, mechanism of action, and method of administration — that users needed no additional protections than had been offered under the 1941 Insulin Amendment and then-existing FDA regulation. These products, although they fit the bill as “new” drugs, were therefore found to be exempt from the legend drug labelling requirement." Source: Why is Some Insulin Available Over the Counter?Afrezza uses Regular insulin but looks, behaves, and is administered nothing like Regular insulin so it is not going to pass the test. I also suspect that if Regular was introduced today it would not get OTC status - that was a deft bit of lobbying on somebodies part! Afrezza would likely then become a reference product for human insulin, seperately from OTC human insulin, then. This does not mean it cannot become OTC. It is human insulin and has only two non-active ingredients and it much safer than current OTC human insulin. Once the long-term safety trial is Released by FDA, then this opens that door wide open. Good thing Mike Castagna came from the Biosimilar Dept of Amgen and knows all this better than we do.
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Post by lakon on Jan 7, 2019 8:03:59 GMT -5
I disagree with agedhippie. I never said it would be a fast or easy transition, but it is a necessary regulatory step in the right direction. I also am glad others were following along about the upcoming regulatory change proposed towards biologics. I would strongly emphasize my statement: I think RLS will get their first, and they can pave the way to an OTC Afrezza along with all the rest of the human hormones that can fit on a Technosphere. One should easily follow my implication that human hormones are not drugs by definition, and it is long overdue to make these changes to the regulatory framework. Furthermore, while I was writing in a context about the US, I never said the US would be first. For example, as soon as approved in Thailand, one can effectively buy just about any drug there OTC by going to any pharmacy and letting the Doctor of Pharmacy decide what you need. Therefore medicines can spread throughout many regions without official approval or prescriptions per se. This strategy is effective for treating many of the wealthiest from the Middle East and Asia. They love Thailand. Take a vacation, get a massage, and buy all your medicines.
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Post by travis1953 on Jan 7, 2019 9:33:11 GMT -5
I disagree with agedhippie . I never said it would be a fast or easy transition, but it is a necessary regulatory step in the right direction. I also am glad others were following along about the upcoming regulatory change proposed towards biologics. I would strongly emphasize my statement: I think RLS will get their first, and they can pave the way to an OTC Afrezza along with all the rest of the human hormones that can fit on a Technosphere. One should easily follow my implication that human hormones are not drugs by definition, and it is long overdue to make these changes to the regulatory framework. Furthermore, while I was writing in a context about the US, I never said the US would be first. For example, as soon as approved in Thailand, one can effectively buy just about any drug there OTC by going to any pharmacy and letting the Doctor of Pharmacy decide what you need. Therefore medicines can spread throughout many regions without official approval or prescriptions per se. This strategy is effective for treating many of the wealthiest from the Middle East and Asia. They love Thailand. Take a vacation, get a massage, and buy all your medicines. Would the black box hinder offering afrezza over the counter?
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Post by xanet on Jan 7, 2019 12:27:20 GMT -5
If we keep on our current trendline, we are looking at less than 33,000 scripts in 2018. Conservatively, I think we will buck the trend by mid-year. My prediction is 69,572. Just UNBELIEVABLE that we didn't break that trendline in 2018. Very disappointing, but I still believe Afrezza is the best thing running. On a side note, it's also annoying that my spell checker wants to replace 'Afrezza' with 'Freezable'. If it stores fine without refrigeration, I'm pretty sure it doesn't need freezing.
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Post by cretin11 on Jan 7, 2019 12:45:16 GMT -5
2015 - 19,604 (Sanofi Controlled) 2016 - 16,005 (Sanofi Partnership terminated Jan 2016) 2017 - 17,379 (MNKD controlled) 2018 - 27,624 (TV ads roll, STAT published) Who came the closest to predicting the correct number of scripts? Well, you did cretin11. Congrats on the guesswork. It was certainly refreshing to read so many messages from a year ago. Thanks hellodolly. I'm chagrined to have "won" this competition, I was pulling for those who guessed higher numbers. Definitely disappointed that my conservative estimate was still overly optimistic (by almost 20%).
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Post by compound26 on Jan 7, 2019 14:50:32 GMT -5
2015 - 19,604 (Sanofi Controlled) 2016 - 16,005 (Sanofi Partnership terminated Jan 2016) 2017 - 17,379 (MNKD controlled) 2018 - 27,624 (TV ads roll, STAT published) Who came the closest to predicting the correct number of scripts? Well, you did cretin11. Congrats on the guesswork. It was certainly refreshing to read so many messages from a year ago. Thanks hellodolly. I'm chagrined to have "won" this competition, I was pulling for those who guessed higher numbers. Definitely disappointed that my conservative estimate was still overly optimistic (by almost 20%). Assuming we are going to grow at the same rate each year after 2018 (about 58.95% (or about 60%) year over year when comparing 2018 to 2017, just looking at scripts growth, not revenue growth) and assuming the net revenue for 2018 is $16 million, here are the net revenue for the coming years based on such growth in total prescriptions year over year: year | net revenue | 2019 | 25 million | 2020 | 40 million | 2021 | 63 million | 2022 | 100 million |
So even if we grow at this snail pace, Mannkind will be able to break even on Afrezza alone in about 4 years. Not too bad. When you consider that there are multiple other pipeline drugs aside from Afrezza. Mannkind's future looks pretty promising to me. I recall that in terms of timeline of approval, Afrezza is approximately 7-8 years behind Dexcom CGM. Dexcom finally started to break even and be profitable in 2018. If we push that forward by 7-8 years, that's around 2025. If Mannkind is able to break even on Afrezza by 2022, it is not too slow if we compare that with Dexcom CGM.
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Post by InvesterSam on Jan 7, 2019 15:24:56 GMT -5
When do we start to see sales outside of US (Brazil and India)?
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Post by goyocafe on Jan 7, 2019 15:42:56 GMT -5
When do we start to see sales outside of US (Brazil and India)? That is one of 20 questions you will be asking throughout 2019.
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Post by InvesterSam on Jan 7, 2019 18:05:00 GMT -5
Thanks hellodolly. I'm chagrined to have "won" this competition, I was pulling for those who guessed higher numbers. Definitely disappointed that my conservative estimate was still overly optimistic (by almost 20%). Assuming we are going to grow at the same rate each year after 2018 (about 58.95% (or about 60%) year over year when comparing 2018 to 2017, just looking at scripts growth, not revenue growth) and assuming the net revenue for 2018 is $16 million, here are the net revenue for the coming years based on such growth in total prescriptions year over year: year | net revenue | 2019 | 25 million | 2020 | 40 million | 2021 | 63 million | 2022 | 100 million |
So even if we grow at this snail pace, Mannkind will be able to break even on Afrezza alone in about 4 years. Not too bad. When you consider that there are multiple other pipeline drugs aside from Afrezza. Mannkind's future looks pretty promising to me. I recall that in terms of timeline of approval, Afrezza is approximately 7-8 years behind Dexcom CGM. Dexcom finally started to break even and be profitable in 2018. If we push that forward by 7-8 years, that's around 2025. If Mannkind is able to break even on Afrezza by 2022, it is not too slow if we compare that with Dexcom CGM. Remember that there was a significant change in packaging during 2017 Q4 (from one month to 3 months supply). So 2018 script contains more cartridges. I guess, in old script value, the equivalent 2018 scripts is over 30k, more than 59% script increase.
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Post by compound26 on Jan 7, 2019 19:02:26 GMT -5
Assuming we are going to grow at the same rate each year after 2018 (about 58.95% (or about 60%) year over year when comparing 2018 to 2017, just looking at scripts growth, not revenue growth) and assuming the net revenue for 2018 is $16 million, here are the net revenue for the coming years based on such growth in total prescriptions year over year: year | net revenue | 2019 | 25 million | 2020 | 40 million | 2021 | 63 million | 2022 | 100 million |
So even if we grow at this snail pace, Mannkind will be able to break even on Afrezza alone in about 4 years. Not too bad. When you consider that there are multiple other pipeline drugs aside from Afrezza. Mannkind's future looks pretty promising to me. I recall that in terms of timeline of approval, Afrezza is approximately 7-8 years behind Dexcom CGM. Dexcom finally started to break even and be profitable in 2018. If we push that forward by 7-8 years, that's around 2025. If Mannkind is able to break even on Afrezza by 2022, it is not too slow if we compare that with Dexcom CGM. Remember that there was a significant change in packaging during 2017 Q4 (from one month to 3 months supply). So 2018 script contains more cartridges. I guess, in old script value, the equivalent 2018 scripts is over 30k, more than 59% script increase. @investersam Yes, I am totally aware of the package change. There was also some significant price increase of Afrezza kits that occurred in summer and fall of 2017. As a result, the year over year gross sale revenue (reported by Symphony) grew about 135% while the TRX grew about 60%. However, I will be happy if the TRX and revenue each can continue to grow at 50% plus annually going forward. datastudio.google.com/u/0/reporting/13xt2__SjNRjk1uBRcaUJiowb7P-iW9F_/page/C0kK
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