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Post by ashiwi on Sept 1, 2014 23:32:57 GMT -5
technovax.com/inhaled-powder-vaccines/There is so much potential for Technoshere. The vaccine market is in the multiple $ billion's An inhaled flu virus vaccine via the Cricket would ultimately be huge.
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Post by gamblerjag on Sept 1, 2014 23:47:50 GMT -5
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Post by seanismorris on Sept 2, 2014 0:12:58 GMT -5
While I'll agree that vaccines is a potential market for Technosphere, until Mannkind has a major partner in this area my enthusiasm will remain muted. There are better areas to target...
Technovax is operating from a research grant. They've never had a product just an idea. They call themselves a "virtual" company, basically (my impression) a bunch (OK a couple) of very smart people working on this in their spare time. They are years away from seeing if their idea bears fruit and Technsphere may not even be part of their long term plans. Until they announce a clinical trial using Technosphere I wouldn't get to excited.
Sorry to be a downer, I'm extremely excited about opportunities for Technosphere but just not this one...at least not yet.
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Post by dreamboatcruise on Sept 3, 2014 14:29:07 GMT -5
It is hard to figure out how much this is worth. In developed countries insurers aren't going to pay a lot more for an inhaled option. In countries where the non-refrigeration might be important... there isn't a lot of money to be paid. So question is, what would be the selling price and what cut does MNKD get for the delivery platform... and how long before it gets through clinical trials. These are reasons it likely gets little or no value being factored into MNKD overall valuation at this point.
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Post by paradigm on Sept 3, 2014 15:20:27 GMT -5
I believe Sanofi's flu vaccines made over $1 billion last year, while all of their vaccines combined made under $5 billion. A partnership with a BP for inhaled vaccines would be big, not to mention, partnerships in other areas such as pain management.
For me, the big element to inhalable flu vaccines is the self-administration. My employer has someone come out to our office every year to administer flu shots; how much easier (and presumably cost efficient) would it be to ship these tiny cricket inhalers and get vaccinated on your own terms.
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Post by mannmade on Sept 3, 2014 15:44:14 GMT -5
It is hard to figure out how much this is worth. In developed countries insurers aren't going to pay a lot more for an inhaled option. In countries where the non-refrigeration might be important... there isn't a lot of money to be paid. So question is, what would be the selling price and what cut does MNKD get for the delivery platform... and how long before it gets through clinical trials. These are reasons it likely gets little or no value being factored into MNKD overall valuation at this point. dreamboatcruise I actually tend to agree with you except for one thing... The major developed countries in the world should have both a real and perceived incentive to distribute in the 3rd world as should China (who can afford it and where there is a lack of electricity and refrigeration in there rural farm lands where many of these bird flu pandemics begin). Seems to me that the real reason would be to prevent a pandemic from being worse in the States etc by limiting the outbreak in the 3rd world where it most likely will originate. Let's call it preventative medicine. The "perceived" value is in saving lives all over the world and not just valuing lives in the developed world. Plus with numerous organizations such as Doctors w/o Boarders, WHO, Unicef etc... I think it could very well find its way into the 3rd world... imho...
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Post by dreamboatcruise on Sept 3, 2014 17:43:26 GMT -5
Mannmade... Yes, hopefully there is some solution that would make a game changing technology available to the 3rd world. I'm just suggesting that the solution may be one that doesn't necessarily translate into a windfall for Mannkind. One may make the argument that stopping many diseases around the world is actually in developed countries' best interests... but I don't have a lot of knowledge as to how that plays out with pricing. Do you know of precedents regarding what level of discount drug companies must offer... e.g. HIV, polio, etc. I'm sure it involves lengthy negotiation between funding sources wanting to cover as many people as possible with limited budgets and companies that wish to make profit (while also helping people). I just suspect that in most cases drug companies' margins are far smaller than normal at the end of that negotiation process.
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Post by seanismorris on Sept 3, 2014 17:52:24 GMT -5
I've never had a flu shot and have no intention of getting one until I'm at least 70. If in the other hand, I could receive a cricket inhaled flu vaccine by mail I'd seriously consider it every year.
But, until a major partner steps up I'm going to put zero value on the vaccination potential of Technosphere. There are to many problems (obstacle) with developing both a Technosphere and injection formulation for the flu. The fact remains that very young children and infants (or elderly with respitory problems) make up a large part of the market. A powered inhaled flu vaccine won't work for infants at all unless you create a device that forces the powder into the lungs, which is expensive and un appealing.
Bulk vaccinations for virus's that don't change as frequently is certainly a possibility, but I'm not sure if "doesn't require refrigeration" still applies. Afrezza requires refrigeration...so until Mannkind comes out and says otherwise, I'm going to assume assume vaccinations do also.
I hope I'm wrong, but I don't think vaccinations are going to be a focus of Mannkind. There are several other area that Mannkind can target that don't even require a partner. There are dozens of attractive off patent drugs that are appealing...
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Post by biotec on Sept 3, 2014 18:12:15 GMT -5
Couldn't agree more sean!Nice post.
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Post by lynn on Sept 3, 2014 19:03:04 GMT -5
I agree with you Seanismorris , I'd never gotten it before but all Healthcare workers are required to get the annual flu shot or else wear a mask throughout the entire flu season which is quite unpleasant , so the majority of us cave . I'm not sure of the US population of health care workers but I'd imagine there's a lot of us . I do see this being farther down the road as well though time will tell Lynn
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Post by jpg on Sept 4, 2014 0:08:55 GMT -5
The flu vaccination thing is, in my opinion, one of the most politically mismanaged medical issues in health care. Agressive flu vaccines policies in the health care system are, again in my opinion, an excellent marker of dysfunctional medical administrations. The data for mandatory vaccination of health care workers Is at best flimsy and probably more ideologically driven then science based. scary when public health morphs into dogmatic and non scientific ideologues. onlinelibrary.wiley.com/doi/10.1002/14651858.CD005187.pub4/abstract;jsessionid=B084AE64813FF268FCD0A9D79854D356.f04t04The mandatory vaccination of health care workers (if you don't get the vaccine you have to wear a medically useless and punitive 'mask of shame') is one of the big disappointments I have had about public health. As for waiting to get your first vaccine at the age of 70: they don't work very well in this age group. For a full and state of the art review of these topics: www.thecochranelibrary.com/details/collection/978807/Influenza-evidence-from-Cochrane-Reviews.htmlAs to Mannkind getting into flu vaccination: Anyone reading the above links will quickly understand the status quo sucks in flu vaccine land and that the current 'state of the art' is not very state of the art... There definetly is a need in 1st, 2nd and 3rd world for a better vaccine. There is a huge market. I don't think we know enough about MNKDs role in all this to honestly give a valid scientific opinion as to what they are thinking or doing or want to do. Maybe I am missing a piece (or a few pieces of this puzzle) but I am not certain why MNKD would be that well placed to benefit from this though? If all MNKD would add to this endevour is an inhaler that is not that big a deal. An inhaler alone would command little value in the overall 'package' of an effective, non refrigerated (and this has nothing to do with Afrezza 'needing' refrigeration), cheap and inhaled flu vaccine. If Technosphere is used and is essential to the process then that is another very different story obviously. It does also seem obvious that the MNKD partner on this is a tiny player with little money so first thing would be getting a major interested in this type of endeavor. J and J bought Crucell which was doing wonderful things in this regard (polyvalent, orals etc). I am aware of no other big player hard at work bringing the next generation of flu vaccines forward? I stopped following the field when Crucell was bought out so I might be wrong on this. Correction more then welcome. JPG Edit: just reread the above link: basically this group has what seems like, according to them anyway, an amazingly better mousetrap and are clearly stating they are looking for a big Pharma partner. Which bring us back to who else then J and J wants to take this on?
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Post by jpg on Sept 4, 2014 1:22:50 GMT -5
Off topic maybe but imagine how well VLP technology and Technosphere would work well together to quickly develop a vaccine against Ebola (or many other viral pandemics)?
Significant 'targetable' mutations could have VLP vaccines custom built relatively quickly and easily shipped using Texhnosphere. Just look at the paralysis at the Winnipeg lab (in Canada...) when they try figuring out how to ship a few thousand potentially effective (against older stains I presume) vaccines. The problem seems to be how to keep them cool all the way to the end user.
All these issues are so not new obviously but I have little faith that this endemic/ pandemic will be the one that spurs world governments into taking the necessary steps to make certain the next generation of vaccines sees some love (and money!). As a long term follower of the vaccine scene I have learnt that being invested in new innovative vaccine biotechs is a risky financial strategy. I own one small vaccine maker/ developer and consider the others to be trading stocks (which I don't do) till governments say otherwise. If that ever happens Texhnosphere is a really attractive storage and delivery platform.
JPG
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Post by 4Balance on Sept 4, 2014 2:48:27 GMT -5
JPG,
Patients need to be educated re how to use Afrezza. I would imagine, one element is the inhalation technique...for maximum, consistent doses.
Since vaccines are single doses, what do you think of the feasibility of a Technosphere application in terms of dosing efficacy? Could we ensure that the patient inhaled "enough?" Would we be able to tell when s/he didn't? If so, would a subsequent inhale be possible?
--4B
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Post by liane on Sept 4, 2014 5:28:59 GMT -5
The flu vaccination thing is, in my opinion, one of the most politically mismanaged medical issues in health care. Agressive flu vaccines policies in the health care system are, again in my opinion, an excellent marker of dysfunctional medical administrations. The data for mandatory vaccination of health care workers Is at best flimsy and probably more ideologically driven then science based. scary when public health morphs into dogmatic and non scientific ideologues. onlinelibrary.wiley.com/doi/10.1002/14651858.CD005187.pub4/abstract;jsessionid=B084AE64813FF268FCD0A9D79854D356.f04t04The mandatory vaccination of health care workers (if you don't get the vaccine you have to wear a medically useless and punitive 'mask of shame') is one of the big disappointments I have had about public health. jpg If I could, I would give you 10 "thumbs up". At best, flu vaccination is a crap-shoot as the strain is constantly morphing. The decision should be individualized between a patient and their physician, based on patient history and health status. While in training, I once had a physician preceptor who implied that by being unvaccinated, my mere (totally asymptomatic) presence could transmit the virus to patients. It is spread by aerosolized droplets from an infected person. The vaccine is not going to prevent transmission if I'm coughed upon by an infected person and am now harboring virus particles on my hands, clothing or stethoscope. It is not an antiseptic cloud that is now surrounding my being. Now - talk about "universal precautions" - hand washing, antiseptic wipes, gloves etc - there's something that actually works.
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Post by seanismorris on Sept 4, 2014 11:59:37 GMT -5
I don't think putting a flu vaccine into a Technosphere powder is a simple process. The FDA approval for something like this may take as long as Afrezza. This is something I'd wouldn't want to see spending 100 million plus on...not when an aerosolized vaccine would work just as well (except the inhaler is more complicated). And, Aerosolized vaccines (as far as I can tell) have been a complete failure.
When I referred to considering injected flu vaccines when I'm 70..I'm saying when pigs fly. Unless there a serious health threat (I.e. potentially fatal) it's not going to happen.
Now, when we are talking about disease prevention I'm all for it.
But, let's say we have a Technosphere malaria vaccine. Are we going to distribute it in mass quantities in villages in Africa without medical supervision? Probably not...we are going to need to make sure people are educated on what it is, what it does, and potential side effects. Even if there are no side effects, we'd need to make sure people use the inhaler properly or just not thrown it in the trash. We'd also need to cross off villages, etc. that have been vaccinated. Are all people getting vaccinated? What about the infants? As you can see I'm not seeing a major advantage that would justify the cost.
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