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Post by #NoMoreNeedles on Dec 26, 2018 10:45:59 GMT -5
Does anyone know why Europe isn't being considered as a target market? They talk about Brazil, India, Mexico and Canada. Trials in Europe will take many years and a lot of money to complete.
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Post by traderdennis on Dec 26, 2018 11:46:31 GMT -5
Does anyone know why Europe isn't being considered as a target market? They talk about Brazil, India, Mexico and Canada. Trials in Europe will take many years and a lot of money to complete. you answered your question, trials will take many years and lots of money to complete. Also Europe has very strong laws regarding the amount governments pay for prescription drugs and most people are covered on government sponsored health care. |
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Post by thereceptive on Dec 26, 2018 11:48:37 GMT -5
Does anyone know why Europe isn't being considered as a target market? They talk about Brazil, India, Mexico and Canada. Trials in Europe will take many years and a lot of money to complete. Looks like they are targeting Europe.  |
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Post by liane on Dec 26, 2018 12:03:30 GMT -5
Many of the trials already done were set up to meet the European standards. The approval process is long, but fairly transparent.
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Post by #NoMoreNeedles on Dec 26, 2018 12:12:07 GMT -5
Which year do you anticipate a launch in countries like UK, Germany, France, Italy and Switzerland?
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Post by mytakeonit on Dec 26, 2018 13:57:24 GMT -5
Why guess? I think we should just watch the partnered countries first. January here we come !!!
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Post by peppy on Dec 26, 2018 14:10:02 GMT -5
Does anyone know why Europe isn't being considered as a target market? They talk about Brazil, India, Mexico and Canada. Trials in Europe will take many years and a lot of money to complete. Europe is pay to play. Big Money has to be paid to Europe to be approved. When approved, it will not be covered by European health insurance. Sanofi and NovoNordisk both based in Europe. Europe is a bit protectionist. No Target Stores or Walmarts in Europe and a can of coca-cola will cost the same as a bottle of wine. |
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Post by matt on Dec 26, 2018 14:15:19 GMT -5
The EU process is essentially the same as the FDA process, about nine months to approval assuming the file is complete. Most drugs that get approved in the US have no issue in EU and vice versa, but as others have noted pricing is a different beast and that is done at the national level. Germany may give a reasonable reimbursement, albeit lower than in the US, but they will be the maximum price country. All others will be lower, and some places will have extremely dismal pricing (Portugal, Spain, Greece).
However, all the same issues facing Afrezza in the US like poor pricing, lack of formulary access, physician concerns, and three mega-competitors named Lilly, Novo, and Sanofi will be the same. If the company can't be successful in the US, Europe will be no easier to penetrate and in most countries harder.
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Post by seanismorris on Dec 26, 2018 14:31:29 GMT -5
Which year do you anticipate a launch in countries like UK, Germany, France, Italy and Switzerland? I wouldn’t worry about it (at this point) we have bigger problems... Lets see if we can get approved in Brazil, and see what Afrezza’s sales look like there first. Why not those other countries? We’re a bit strapped for cash... (Quote from old article on Brazil) Oct. 23, 2017 MannKind (NASDAQ:MNKD) and Biomm SA (B3:BIOM3) announced today that Afrezza has been submitted to ANVISA in Brazil for approval. Earlier this year, MannKind had stated that it anticipated filing in Brazil in Q4, and that it anticipated a decision from the South American nation by Q4 2018. Brazil is the 5th most populated country in the word and in the top 10 when it comes to people with diabetes. In the early summer of this year, MannKind announced that it had entered into an agreement with BIOMM SA. The deal brought no up-front cash, and terms of the relationship have never been disclosed. The absence of a "material event" filing has left many investors wondering what the possible terms could be. The news release today offered no additional information. What we know is that Biomm SA was responsible for submitting the drug to the regulatory body for distributing, promoting, and selling. MannKind would be responsible for the manufacture and supply of Afrezza. Brazil, with universal healthcare, has strict cost controls on the drugs that it approves. Pricing is controlled by CMED. Perhaps one reason that there is not much transparency regarding the terms of the deal is that, as yet, the pricing structure is unknown. |
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Post by jmkopp on Dec 26, 2018 14:53:59 GMT -5
Which year do you anticipate a launch in countries like UK, Germany, France, Italy and Switzerland? I wouldn’t worry about it (at this point) we have bigger problems... Lets see if we can get approved in Brazil, and see what Afrezza’s sales look like there first. Why not those other countries? We’re a bit strapped for cash... (Quote from old article on Brazil) Oct. 23, 2017 MannKind (NASDAQ:MNKD) and Biomm SA (B3:BIOM3) announced today that Afrezza has been submitted to ANVISA in Brazil for approval. Earlier this year, MannKind had stated that it anticipated filing in Brazil in Q4, and that it anticipated a decision from the South American nation by Q4 2018. Brazil is the 5th most populated country in the word and in the top 10 when it comes to people with diabetes. In the early summer of this year, MannKind announced that it had entered into an agreement with BIOMM SA. The deal brought no up-front cash, and terms of the relationship have never been disclosed. The absence of a "material event" filing has left many investors wondering what the possible terms could be. The news release today offered no additional information. What we know is that Biomm SA was responsible for submitting the drug to the regulatory body for distributing, promoting, and selling. MannKind would be responsible for the manufacture and supply of Afrezza. Brazil, with universal healthcare, has strict cost controls on the drugs that it approves. Pricing is controlled by CMED. Perhaps one reason that there is not much transparency regarding the terms of the deal is that, as yet, the pricing structure is unknown. I know this sounds a little crazy conspiracy(ish), but this stock over the last 7-8 years has made me a little sensitive. Is anyone concerned that the money raise was secondary to some potentially bad news out of Brazil; like a delay in the approval? I am a little nervous about big pharma money being funneled to some of the decision makers to persuade a delay the approval. It seems to happen in other areas like bidding for World Cups and Olympics. Would that be unheard of in a drug approval? I would hope that wouldn't be the case, but again, it seems like there have been so many potentially nefarious people/incidents involved in stopping the success of Afrezza. |
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Post by peppy on Dec 26, 2018 14:58:52 GMT -5
The EU process is essentially the same as the FDA process, about nine months to approval assuming the file is complete. Most drugs that get approved in the US have no issue in EU and vice versa, but as others have noted pricing is a different beast and that is done at the national level. Germany may give a reasonable reimbursement, albeit lower than in the US, but they will be the maximum price country. All others will be lower, and some places will have extremely dismal pricing (Portugal, Spain, Greece). However, all the same issues facing Afrezza in the US like poor pricing, lack of formulary access, physician concerns, and three mega-competitors named Lilly, Novo, and Sanofi will be the same. If the company can't be successful in the US, Europe will be no easier to penetrate and in most countries harder. You left out the price of the approval process. What is the initial price tag for consideration? $250,000 dollars? |
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Post by mannmade on Dec 26, 2018 15:54:36 GMT -5
Selling in the EU is just for cash flow and volume (use up insulin supply) Price it at just above break even as the real money is here in the states just like every other drug. Once proven best in class and SoC then can rates e rates a bit as insulin shortage is predicted. Don’t mean to sound cavalier but focus needs to be in states imho with outlier countries helping with cash flow and supply consumption.
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Post by mnholdem on Dec 26, 2018 18:28:28 GMT -5
[Clipped]. What we know is that Biomm SA was responsible for submitting the drug to the regulatory body for distributing, promoting, and selling. MannKind would be responsible for the manufacture and supply of Afrezza. Brazil, with universal healthcare, has strict cost controls on the drugs that it approves. Pricing is controlled by CMED. Perhaps one reason that there is not much transparency regarding the terms of the deal is that, as yet, the pricing structure is unknown. I know this sounds a little crazy conspiracy(ish), but this stock over the last 7-8 years has made me a little sensitive. Is anyone concerned that the money raise was secondary to some potentially bad news out of Brazil; like a delay in the approval? I am a little nervous about big pharma money being funneled to some of the decision makers to persuade a delay the approval. It seems to happen in other areas like bidding for World Cups and Olympics. Would that be unheard of in a drug approval? I would hope that wouldn't be the case, but again, it seems like there have been so many potentially nefarious people/incidents involved in stopping the success of Afrezza. Any unexpected developmental costs in Brazil would be borne by Biomm SA and the financial terms (e.g. upfront payment royalties) are to be determined (and filed with the SEC) after ANVISA approves Afrezza per the collaboration agreement. Frankly, I don't see anything here that would be the catalyst for this latest share offering.  |
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Post by mnkdfann on Dec 26, 2018 20:47:52 GMT -5
Any unexpected developmental costs in Brazil would be borne by Biomm SA and the financial terms (e.g. upfront payment royalties) are to be determined (and filed with the SEC) after ANVISA approves Afrezza per the collaboration agreement. Frankly, I don't see anything here that would be the catalyst for this latest share offering. I pretty much agree with your conclusion (that Brazil is not the reason for the share offering), but I'm not so sure about your premise. Biomm may be responsible for unexpected development costs, but if such costs were much larger than anticipated couldn't Biomm also just decide to throw in the towel and say forget it? In that case, perhaps Mannkind would find it strategic to offer financial support so that Biomm would bring Afrezza to market in Brazil even if Mannkind was not contractually obligated to provide any financial support? I'm not saying this is likely, but since we are discussing hypothetical cases anyway ... |
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Post by afrezza on Dec 29, 2018 16:26:51 GMT -5
Does anyone know why Europe isn't being considered as a target market? They talk about Brazil, India, Mexico and Canada. Trials in Europe will take many years and a lot of money to complete. Europe is pay to play. Big Money has to be paid to Europe to be approved. When approved, it will not be covered by European health insurance. Sanofi and NovoNordisk both based in Europe. Europe is a bit protectionist. No Target Stores or Walmarts in Europe and a can of coca-cola will cost the same as a bottle of wine. I am European. Why should Afrezza not be covered in Europe ? There is no reason why it shouldn't. A can of Coke doesn't cost the same as wine. Please explain what You are trying to tell us here..... |
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