|
Post by jmkopp on Jul 18, 2017 12:01:41 GMT -5
I am wondering if we can make a comprehensive list of past partnerships and what happened to them:
Gates Foundation/Mintaka - Oxytocin Rose Pharma - Inhaled GLP-1 Treating IBS &/Or Functional Dyspepsia Tolero - BTK Inhibitors LifeSci Partners - I am not sure what this is. Torrey Pines - Pain Medicine Colby Pharma (Allecures/CancerVacs) - Cancer TechnoVax - Influenza Vaccine VLP-based Respiratory Syncytial Virus (RSV) Vaccine
RLS - Medicinal Marijuana? One Drop -
Please add anything if you know of additional partnerships that are not listed or the status of the partnership.
I wonder if Rose would send us an update on each of these past partnerships. It seems odd that we never hear anything about them. And, it is astonishing that we can't easily find a partner for EpiHale to me. This should be a no-brainer for any company with a fair amount of upfront cash unless MNKD wants to try to keep it all to themselves.
|
|
|
Post by madog365 on Jul 18, 2017 12:56:18 GMT -5
JDRF - No idea what is happening here, but will somehow be related to the pediatric trials BIOMM - Brazil distribution
|
|
|
Post by matt on Jul 18, 2017 12:58:00 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.
|
|
Deleted
Deleted Member
Posts: 0
|
Post by Deleted on Jul 18, 2017 13:01:57 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.
|
|
|
Post by brentie on Jul 18, 2017 13:32:58 GMT -5
I am wondering if we can make a comprehensive list of past partnerships and what happened to them: Gates Foundation/Mintaka - Oxytocin Rose Pharma - Inhaled GLP-1 Treating IBS &/Or Functional Dyspepsia Tolero - BTK Inhibitors LifeSci Partners - I am not sure what this is. Torrey Pines - Pain Medicine Colby Pharma (Allecures/CancerVacs) - Cancer TechnoVax - Influenza Vaccine VLP-based Respiratory Syncytial Virus (RSV) Vaccine RLS - Medicinal Marijuana? One Drop - Please add anything if you know of additional partnerships that are not listed or the status of the partnership.I wonder if Rose would send us an update on each of these past partnerships. It seems odd that we never hear anything about them. And, it is astonishing that we can't easily find a partner for EpiHale to me. This should be a no-brainer for any company with a fair amount of upfront cash unless MNKD wants to try to keep it all to themselves. The Leukemia & Lymphoma Society and MannKind Corporation Announce Collaborative Research Agreement investors.mannkindcorp.com/releasedetail.cfm?ReleaseID=791873
|
|
|
Post by jmkopp on Jul 18, 2017 13:57:08 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.
|
|
|
Post by agedhippie on Jul 18, 2017 14:01:36 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. Really? Are we playing " I know you are but what am I" now? Let's at least hear your argument as to why bronchospasm is not a risk when you are taking an inhaled drug to stave off anaphylactic shock.
|
|
|
Post by drman7 on Jul 18, 2017 14:02:56 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. I think the former CEO made a valid point. Remember, that our previous CEO said that he is starving the development of other TS applications to focus on Afrezza.
|
|
|
Post by dreamboatcruise on Jul 18, 2017 15:00:38 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. What a silly question. Here is a typical description of respiratory effects of anaphylaxis: Lower airway: bronchospasm with wheezing or cough, chest tightness, tachypnea, decreased peak expiratory flow, cyanosis, respiratory collapse/arrest Upper airway: sensation of throat constriction; dry cough; difficulty breathing, swallowing, speaking; changes in voice; stridor; cyanosis; respiratory collapse/arrest Do you honestly not understand that this description includes a full range of decreased respiratory function including the total inability to breath? Do you have so little understanding of TS and inhalation that you can't understand the very logical conclusion that if one is turning blue from inability to get oxygen into their blood, an inhaled drug is not going to work? There will never be any peer-reviewed study of this because it would be unethical to induce such a serious condition and then provide an obviously ineffective treatment. There are perhaps reasonable arguments that an inhaled solution is still a viable/valuable product as people may well be much more willing to use it before the situation gets severe, and in fact that might lead to better overall outcomes... but give it a rest with ham handed attempts to discredit people that point out the obvious.
|
|
|
Post by me on Jul 18, 2017 15:15:25 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. What a silly question. Here is a typical description of respiratory effects of anaphylaxis: Lower airway: bronchospasm with wheezing or cough, chest tightness, tachypnea, decreased peak expiratory flow, cyanosis, respiratory collapse/arrest Upper airway: sensation of throat constriction; dry cough; difficulty breathing, swallowing, speaking; changes in voice; stridor; cyanosis; respiratory collapse/arrest Do you honestly not understand that this description includes a full range of decreased respiratory function including the total inability to breath? Do you have so little understanding of TS and inhalation that you can't understand the very logical conclusion that if one is turning blue from inability to get oxygen into their blood, an inhaled drug is not going to work? There will never be any peer-reviewed study of this because it would be unethical to induce such a serious condition and then provide an obviously ineffective treatment. There are perhaps reasonable arguments that an inhaled solution is still a viable/valuable product as people may well be much more willing to use it before the situation gets severe, and in fact that might lead to better overall outcomes... but give it a rest with ham handed attempts to discredit people that point out the obvious. 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.
|
|
|
Post by brotherm1 on Jul 18, 2017 15:27:36 GMT -5
It is a no brainer: one can always carry both (with epihale around the neck).
|
|
|
Post by dreamboatcruise on Jul 18, 2017 15:55:49 GMT -5
What a silly question. Here is a typical description of respiratory effects of anaphylaxis: Lower airway: bronchospasm with wheezing or cough, chest tightness, tachypnea, decreased peak expiratory flow, cyanosis, respiratory collapse/arrest Upper airway: sensation of throat constriction; dry cough; difficulty breathing, swallowing, speaking; changes in voice; stridor; cyanosis; respiratory collapse/arrest Do you honestly not understand that this description includes a full range of decreased respiratory function including the total inability to breath? Do you have so little understanding of TS and inhalation that you can't understand the very logical conclusion that if one is turning blue from inability to get oxygen into their blood, an inhaled drug is not going to work? There will never be any peer-reviewed study of this because it would be unethical to induce such a serious condition and then provide an obviously ineffective treatment. There are perhaps reasonable arguments that an inhaled solution is still a viable/valuable product as people may well be much more willing to use it before the situation gets severe, and in fact that might lead to better overall outcomes... but give it a rest with ham handed attempts to discredit people that point out the obvious. 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. A fact that would be hard for any of us to assess the impact of. I suspect even MNKD and potential partners are having trouble assessing the impact of that. Would insurance companies be comfortable with an inhaled product as the single rescue device they provide to patients given that it would be known that in rare severe cases it would become useless? Would insurance companies cover providing both epihale and injection pen? We've seen insurance companies aren't overly quick to adopt new solutions and certainly not quick to increase costs for themselves. If many of them only covered injection pen, what would be the market size? I know for myself if I had severe enough allergies where life threatening respiratory blockage was a concern, I'd likely want both epihale and injection... and be willing to buy one out of pocket even if not covered by insurance... but how many people can afford that? What do you do in that case... MNKD doesn't have time or money to poll doctors and/or patients to figure out what market response there would be. Obviously we are seeing medical community market acceptance of Afrezza hasn't turned out as expected/hoped for. I realize that most here look at lack of progress on partnerships, such as for epihale, and believe it can't possibly mean there are issues that are making it hard to seal a deal... thinking Mike must have secret deals already done for everything and just withholding that info from shareholders. You either have to believe that crazy notion or ask questions like, if MNKD has been seeking partner for epihale for a long time now, why are they now needing to pay advisers to shop the pipeline? Most would conclude that at the time they hired the advisers they had not yet been able to drum up any serious interest. Far from being a straw man, I can't help but think that this issue of limited time to use an inhaler in the case of respiratory distress and the impact that could have on coverage and potential market size is one that is complicating any negotiations for a partner. Might be easy to find a partner that doesn't take a big risk with upfront money... but we need upfront money. This is similar to the fact that if I or PB Matt, or anyone else were to say that Afrezza sales are hampered by the fear of long term respiratory issues, we'd get tarred and feathered as bringing up a "straw man" and being short. I think those respiratory/cancer concerns are misplaced, but it is real that it is a concern and it is affecting sales. Even management has admitted that. We have numerous anecdotal data points from people on social media that get that from their doctor. Yet here, the messenger would be shot (I probably will be) for mentioning the "fact" that this is a real issue with doctors (largely unfounded, as we have some pretty convincing safety data).
|
|
|
Post by promann on Jul 18, 2017 15:56:43 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!
|
|
|
Post by sportsrancho on Jul 18, 2017 16:05:00 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.
|
|
|
Post by dreamboatcruise on Jul 18, 2017 16:07:25 GMT -5
It is a no brainer: one can always carry both (with epihale around the neck). Hypothetical "ones" can do lots of things. Most real people are constrained by issues such as cost and whether their insurance company will cover something. Hypothetically where everyone can afford to do anything, the lack of insurance company coverage wouldn't have been an issue for Afrezza... it's a no brainer "one can always pay out of pocket for something that is better." Yet in the real world, the difficulty in getting insurance coverage and the resulting drag on sales has had a real effect on the perceived market value of Afrezza and on almost certainly on negotiations for international partners. I would certainly pay out of pocket if faced with that, but I have been very lucky in life. I think many here have been lucky but don't realize that they represent a privileged slice of the US population.
|
|