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Post by dreamboatcruise on Jul 18, 2017 16:15:15 GMT -5
There is plenty of time to inhale before things get so bad you can't even breath. Most episodes start of small and and you usually have plenty of time to treat before you can't inhale. Carrying both would be advised but the cheaper inhalable version would more then likely be used first.. So there is a very huge market for the epihale! Common sense would tell me if I thought I was having a allergic reaction to use the less expensive and less painful treatment first. Common sense people! I went through it with my x-husband. He almost died. Bee sting. Throat closed up and had to be rushed to ER. But it was 45min before that happened. Plenty of time. These are valid arguments... as are the arguments that Afrezza doesn't pose long term respiratory risks and provides clinical benefits to users compared to subq... and yet look at resistance from insurance/PBMs and doctors. The question isn't whether epihale would be very useful, I think obviously it would... the question is in practice how large of a market there might be. If it has to be prescribed in combination with an injection pen, that is a big deal when it comes to its market potential. At least a big unknown.
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Post by me on Jul 18, 2017 16:40:58 GMT -5
Wow, (i) matt threw out an abominable straw man, (ii) @kastanes thrashed it furiously and (iii) dreamboatcruise chastised @kastanes for taking the bait (while providing the actual position that @kastanes thought he was attacking)! I still believe it's always better to think before typing. Well, I would certainly dispute it being some sort of abominable straw man... it is simply a fact. [snip] DBC, a straw man argument almost always references a fact...that's why it is so effective. The value of a straw man argument, if it is not recognized by an opponent, is that the opponent loses sight of the original position by arguing against what is almost assuredly a fact...and against what was not the opponent's original position, hence my characterization of Kastanes' "thrashing." matt's straw man fact is beyond reproach. The OP's argument of being a "no-brainer" was based upon numerous posts on this board previously, and reinforced by jmkopp's post above, as well as your very own view that perhaps reasonable arguments can be made for the use of an inhaler prior to a severe situation. The OP's argument was not that using an inhaler when someone is in anaphylactic shock is a "no-brainer..." this was the straw man argument. In his zeal to counter matt, @kastanes missed the boat.
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Post by seanismorris on Jul 18, 2017 16:41:22 GMT -5
I think the reality here is an Epi product is not necessarily a slam dunk. The generic Epi is available for $55 (I don't know how much of that is covered by insurance) it is also more versatile that an inhaled product can be. (Someone else can inject you).
If episodes are common, I can totally see someone both having a painless inhaled product, and cary an injectable version as a backup. If Epi is used a few times a year, I'd be carrying the injectable version. Schools I expect would solely purchase the injectable... though the kids could bring their own inhaled.
I'm pessimistic on our ability to find a partner and bring an Epi product to market. If we can't find a partner I suspect the effort is DOA.
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Post by dreamboatcruise on Jul 18, 2017 16:41:28 GMT -5
matt "in a severe episode of anaphylaxis there is no substitute for the injector pens; inhaled drugs are simply not sufficiently reliable with severe bronchospasm." Really? Please provide a link to a peer-reviewed study that demonstrates your claim. Have no idea what the details are of this as the full article must be paid for, and whether the issues identified would equally apply to a hypothetical epihale formulation, but it certainly shows that concern over suitability of inhalation of epi is something that doctors think about, not just people out to get MNKD. www.ncbi.nlm.nih.gov/pubmed/19054424But here at proboards anything that seems an issue for MNKD must be generated by shorts. This one I guess a very clever short with a time machine able to generate an article casting shade on epihale long before MNKD ever discussed it.
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Post by dreamboatcruise on Jul 18, 2017 16:58:17 GMT -5
Well, I would certainly dispute it being some sort of abominable straw man... it is simply a fact. [snip] DBC, a straw man argument almost always references a fact...that's why it is so effective. The value of a straw man argument, if it is not recognized by an opponent, is that the opponent loses sight of the original position by arguing against what is almost assuredly a fact...and against what was not the opponent's original position, hence my characterization of Kastanes' "thrashing." matt 's straw man fact is beyond reproach. The OP's argument of being a "no-brainer" was based upon numerous posts on this board previously, and reinforced by jmkopp 's post above, as well as your very own view that perhaps reasonable arguments can be made for the use of an inhaler prior to a severe situation. The OP's argument was not that using an inhaler when someone is in anaphylactic shock is a "no-brainer..." this was the straw man argument. In his zeal to counter matt , @kastanes missed the boat. You say Matt's fact is beyond reproach and yet Kastanes was clearly questioning it's validity... or doing exactly what you accuse Matt of in raising a straw man of whether there are clinical trials proving the obvious in order to discredit Matt. We have been seeking a partner for epihale for quite some time and haven't found one, or at least haven't found one offering whatever MNKD felt necessary. Asking the question why isn't a straw man. It is a reasonable to ask when trying to assess potential prospects for ephihale, and subsequently the financial situation of MNKD. Assuming Mike isn't hiding some terrific epihale deal from shareholders, why is finding a partner proving to be difficult? Matt raised two potential viable issues... whether inhalation would be accepted as a sole rescue device and whether reentry of primatene might bring into question market share capture. Matt himself said that the market may still be large enough even with the known problem of becoming ineffective in severe cases. Matt's own post acknowledged that there might be a large enough market. Hardly the typical straw man argument tactic. He was merely pointing out issues that may make the market potential for epihale something short of a no-brainer. And the fact that we've gone this long without a partner certainly makes me feel there is something about the potential market size for epihale that is making it appear less than a no-brainer investment for potential partners. [sarcasm] I know I know, an adviser was hired not because of lack of finding a partner but because Mike has been inundated with an embarrassment of offers. I think Matt actually left after having a panic attack seeing so many offers piled up on his desk and not knowing what to do with them all.
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Post by me on Jul 18, 2017 17:39:49 GMT -5
DBC, a straw man argument almost always references a fact...that's why it is so effective. The value of a straw man argument, if it is not recognized by an opponent, is that the opponent loses sight of the original position by arguing against what is almost assuredly a fact...and against what was not the opponent's original position, hence my characterization of Kastanes' "thrashing." matt 's straw man fact is beyond reproach. The OP's argument of being a "no-brainer" was based upon numerous posts on this board previously, and reinforced by jmkopp 's post above, as well as your very own view that perhaps reasonable arguments can be made for the use of an inhaler prior to a severe situation. The OP's argument was not that using an inhaler when someone is in anaphylactic shock is a "no-brainer..." this was the straw man argument. In his zeal to counter matt , @kastanes missed the boat. You say Matt's fact is beyond reproach and yet Kastanes was clearly questioning it's validity [snip] I apologize if my prior posts did not make it clear that I was criticizing Kastanes for "thrashing" at the straw man argument and "missing the boat." Hence, my comment that it's always better to think before typing. To be clear about my sentiments, the OP's "no-brainer" was not that the inhaler is for someone in anaphylactic shock, matt threw out a straw man that while impeccably true, was not the original proposition and Kastanes in his rush to criticize all that is matt, blew it...on three counts: (i) not identifying and dismissing the straw man, (ii) not then redirecting the discussion and (iii) foolishly challenging a self-evident truth. I actually thought that you would agree with this wholeheartedly. Not everyone on the board thinks you are a Fudster.
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Post by mnkdfann on Jul 18, 2017 18:39:49 GMT -5
Carrying both would be advised but the cheaper inhalable version would more then likely be used first.. So there is a very huge market for the epihale! My understanding is that cheap epi 'pen' devices are already on the market. E.g.: "CVS pharmacies around the U.S. are now offering generic Adrenaclick—the cheaper alternative to EpiPen—for just $10 per two-pack." ($110 less $100 from a manufacturer's coupon.) Can an epihale really come in at a retail price below that?
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Post by mango on Jul 18, 2017 19:04:31 GMT -5
Epi is not a no-brainer. As has been discussed here before, in a severe episode of anaphylaxis there is no substitute for the injector pens; inhaled drugs are simply not sufficiently reliable with severe bronchospasm. For less severe cases, like bronchial asthma, an inhaled product would be totally fine and that is probably the bigger part of the market anyway. The reason that is not a no-brainer is that Amphastar (MNKS's supplier of bulk insulin) also owns the trademark to Primatine Mist, which was removed from the market due to EPA regulation banning their aerosol propellant. They are working on getting FDA approval for an alternative version and plan to introduce "New Primatine" as soon as possible. A lot of companies would hesitate to jump into a project to attempt commercialization of an OTC drug that will be late to market and wind up competing with an established brand name. Those who are brave enough to take on the challenge will likely not be willing to front big dollars for the privilege. 1) Are you f*cking kidding?! 2) Bronchospasm = Asthma (Mild-Severe) 2a) Bronchospasm caused by inflammation and constricts the bronchioles = in an asthmatic = inhaled bronchodilators (i.e. inhaled beta2-adrenergic receptor agonists) 3) Bronchospasm = COPD (Mild-Severe) 3a) Bronchospasm caused by inflammation and constricts the bronchi = bronchitis = COPD exacerbation = inhaled bronchodilators (i.e. inhaled beta2-adrenergic receptor agonists) 4) Croup = Stridor (Mild-Severe) 4a) Stridor = upper airway obstruction 4b) Stridor in children with Croup is treated with inhaled epi 5) Inhale epinephrine is more rapidly absorbed, has a higher plasma concentration and not anywhere near as variable compared to intramuscular epinephrine injection 6) Bronchial Asthma = Bronchospasm
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Post by Deleted on Jul 18, 2017 20:24:47 GMT -5
I thought our former CEO explained that aspect of EpiHale very well. Most people that will potentially use and Epi pen, usually first start with a basic over the counter anti-histamine first when they suspect contact with an allergen because they don't want to take a shot and use up their costly product. The anti-histamine doesn't work and they end up having to take a shot later. They would be much more likely to truncate a potential more severe attack with earlier usage of epinephrine and a more cost effective inhalable would fill that role. Precisely! matt makes it sound as if there is no possibility for inhalable epinephrine which is why I ask for him to validate his statement. No strawman involved!
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Post by seanismorris on Jul 18, 2017 20:28:22 GMT -5
Carrying both would be advised but the cheaper inhalable version would more then likely be used first.. So there is a very huge market for the epihale! My understanding is that cheap epi 'pen' devices are already on the market. E.g.: "CVS pharmacies around the U.S. are now offering generic Adrenaclick—the cheaper alternative to EpiPen—for just $10 per two-pack." ($110 less $100 from a manufacturer's coupon.) Can an epihale really come in at a retail price below that? Sure. We're not talking about cartridges but the version available in blister packs (which I no longer see on their website). It should be very cheap... but at that low price say $20 does the expenditure make sense? In China/India they probably sell the injectable version for $5... The problem is would we sell enough at that price to make it worth it. If we developed a forced air inhaler it would probably be better, but uncompetitive price wise. It looks like 3.5-4 million people are prescribed Epi. Let's say 20 million of the pens are sold (guessing). If we sell 5 million and net $10 a piece, and split the profit 50% with a partner. 25 million - taxes 7.5 million, etc. The money isn't bad, but it's peanuts compared to Afrezza's potential. With no partner and likely higher competition than I spec'd, there has to be better opportunities to pursue. Epi feels like a generic race to the bottom, price wise... Now if the pre-clinical trial comes back with phenomenal results in effectiveness maybe a partner will show up. But a product that will likely be slapped with a lung cancer warning...meh. If someone could find the actual number of Epi sold that would be helpful...
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Post by slapshot on Jul 18, 2017 20:42:28 GMT -5
My understanding is that cheap epi 'pen' devices are already on the market. E.g.: "CVS pharmacies around the U.S. are now offering generic Adrenaclick—the cheaper alternative to EpiPen—for just $10 per two-pack." ($110 less $100 from a manufacturer's coupon.) Can an epihale really come in at a retail price below that? Sure. We're not talking about cartridges but the version available in blister packs (which I no longer see on their website). It should be very cheap... but at that low price say $20 does the expenditure make sense? In China/India they probably sell the injectable version for $5... The problem is would we sell enough at that price to make it worth it. If we developed a forced air inhaler it would probably be better, but uncompetitive price wise. It looks like 3.5-4 million people are prescribed Epi. Let's say 20 million of the pens are sold (guessing). If we sell 5 million and net $10 a piece, and split the profit 50% with a partner. 25 million - taxes 7.5 million, etc. The money isn't bad, but it's peanuts compared to Afrezza's potential. With no partner and likely higher competition than I spec'd, there has to be better opportunities to pursue. Epi feels like a generic race to the bottom, price wise... Now if the pre-clinical trial comes back with phenomenal results in effectiveness maybe a partner will show up. But a product that will likely be slapped with a lung cancer warning...meh. If someone could find the actual number of Epi sold that would be helpful... If priced reasonably, (perhaps $20-50 a pop - almost said shot) I'd be willing to bet that people would be willing to use the epihale multiple times per year as opposed to buying an epipen every year and rarely using it. (I know several people with various allergies that need epi but hold out from using the epipen as a last, last, last resort) So the potential market for epihale may be 5x or so the epipen market, even if they all get an epipen for backup and use epihale for real actual use.
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Post by dreamboatcruise on Jul 18, 2017 20:55:44 GMT -5
I thought our former CEO explained that aspect of EpiHale very well. Most people that will potentially use and Epi pen, usually first start with a basic over the counter anti-histamine first when they suspect contact with an allergen because they don't want to take a shot and use up their costly product. The anti-histamine doesn't work and they end up having to take a shot later. They would be much more likely to truncate a potential more severe attack with earlier usage of epinephrine and a more cost effective inhalable would fill that role. Precisely! matt makes it sound as if there is no possibility for inhalable epinephrine which is why I ask for him to validate his statement. No strawman involved! Wow he is a Jedi master the way he can play mind tricks on you making it sound like "no hope for any inhaled epinephrine" to you when what he said was "an inhaled product would be totally fine and that is probably the bigger part of the market anyway." Still a question of how large the market would be for the product and what portion of the market MNKD could capture if they are perhaps behind a reintroduction of Primatene Mist into the market... and in the context that inhaled epinephrine is no longer recommended for asthma. There is a wide gap between what he stated that it isn't necessarily a "no-brainer" for market potential vs "no possibility". Simply bizarre how lack of total, utter exalt for anything MNKD gets painted here as an attack. He raised two very valid issues one or both of which very well play into why we haven't been able to close a deal on suitable terms as of now. Epi seemed really exciting back when it was in the news and people were having to pay $600 for 2 pens. Now it's $10 for 2 pens and likely another inhaled to be introduced on the market. Still could be potential but I certainly wouldn't say it is no brainer to figure out ROI for MNKD to develop it. If it were a no-brainer, what is your explanation for why we have not yet found a partner?
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Post by Deleted on Jul 18, 2017 21:03:31 GMT -5
DBC why is it you and others reply for matt? He states worse case scenarios and in some cases complete nonsense, ten million per month for the contract sales, then when challenged he never responds.
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Post by brotherm1 on Jul 18, 2017 21:04:09 GMT -5
The same as Matt Pfeffer's explanation was earlier this year
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Post by mnholdem on Jul 18, 2017 21:45:32 GMT -5
My understanding is that cheap epi 'pen' devices are already on the market. E.g.: "CVS pharmacies around the U.S. are now offering generic Adrenaclick—the cheaper alternative to EpiPen—for just $10 per two-pack." ($110 less $100 from a manufacturer's coupon.) Can an epihale really come in at a retail price below that? Sure. We're not talking about cartridges but the version available in blister packs (which I no longer see on their website). It should be very cheap... but at that low price say $20 does the expenditure make sense? In China/India they probably sell the injectable version for $5... The problem is would we sell enough at that price to make it worth it. If we developed a forced air inhaler it would probably be better, but uncompetitive price wise. It looks like 3.5-4 million people are prescribed Epi. Let's say 20 million of the pens are sold (guessing). If we sell 5 million and net $10 a piece, and split the profit 50% with a partner. 25 million - taxes 7.5 million, etc. The money isn't bad, but it's peanuts compared to Afrezza's potential. With no partner and likely higher competition than I spec'd, there has to be better opportunities to pursue. Epi feels like a generic race to the bottom, price wise... Now if the pre-clinical trial comes back with phenomenal results in effectiveness maybe a partner will show up. But a product that will likely be slapped with a lung cancer warning...meh. If someone could find the actual number of Epi sold that would be helpful... From the MannKind/R&D/Oral Inhalers web page: Single-Use Inhalers
Pre-loaded for Short-Term Use. Our Single-Use (acute treatment) Inhalers are ideal for therapies that are non-chronic, time of need or short duration. Pre-loaded with a prescribed dry powder, patients simply push a trigger and inhale their medicine.
Link: www.mannkindcorp.com/research-development/tech-platforms/oral-inhalers/COGS would very low. Regardless, I think a $50 price would be accepted by the market. Unlike insulin needles, EpiPen needles are big and invoke fear. Also, the single-use inhaler (i.e. Cricket) is smaller than any epinephrine pen currently on the market. It's easier to carry with you. Drugs.com reports that 915,000 EpiPen 2-Pak sales reached 915,000 units sold in Q3/2013 - over 3 million units annually in the U.S. market in 2013. Total units sold globally were unavailable, but all brands + generics probably exceeds 25 million units. www.drugs.com/stats/epicenter-2-pak
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