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Post by BlueCat on Jan 26, 2015 21:35:32 GMT -5
Common thread in business regarding what is 'core' and what is 'context'.
While they managed it for Afrezza, MNKD is not resourced to be a scale up manufacturing/supply chain vendor. Nor are they best suited to program managing business deals and FDA trials. Nor sales and marketing (would you hire them for PR? Be honest). Nor are they a VC able to easily scale funding. They depended on their Sugar Daddy for that, and perhaps some dubious deals and dilution.
Their core is R&D. I'm also of the mind that their best ROI will come from development on the application of the technology they've created, and the licensing of it.
Look at how many patents they've filed. Contrast that with the pain of keeping the business afloat, getting through the FDA, managing shareholder expectations and stock price, and now scaling capacity.
Follow the path of least resistance and most $ and their path seems pretty clear to me. My only question is whether they continue to fly it solo, or get acquired.
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Post by seanismorris on Jan 26, 2015 22:34:32 GMT -5
Interesting discussion...
Remember Mannkind has already made inhaled formulations (of existing drugs) upon request. What we don't know, is how many and for whom. What we can conjecture is that creating a formulation isn't terribly expensive. There may be some partners from these existing formulations already waiting in the wings. Once Mannkinds obligations for the launch of Afrezza is met (probably after production lines 2 and 3 are verified (certified?). Mannkind could and probably will advance new (or previously created) formulations through early stage clinical trials. These trials are where the costs become significant..
I was hoping Mannkind would have the report on Techosphere opportunities released by now, but that is purely from an investor standpoint. From an operations standpoint we probably won't see much until the new production lines come online...
There may be a limited production line dedicated to R&D (and I think there is) but I doubt it would produce enough to advance multiple opportunities.
There are many ways Mannkind can advance Technosphere opportunities. The low hanging fruit is the work they've already done in pain. I'd keep pain in house for now and advance it before finding a partner (Phase 2). After that migraine specific formulations using generics (off patent), would be a good choice. I'd also choose several more generics to create formulations for early trials. If the results are even somewhat promising, Mannkind may be able to force potential partners to the negotiation table. The goal of the partner would be to kill off Mannkinds effort and replace it using their own IP (which would likely have even better results).
The point here, is Mannkind could spend 50-100M over the next 2 years and target a half dozen opportunities using the milestone payments from Sanofi. And, as each new partner shows up and the costs are offloaded, we could have a pipeline of 15 drugs in 3 years. Unfortunately, 2015 will be rough but Mannkind has the cash to get through it. We (Investors) should have plenty of opportunities to trade MNKD, but Options scare me, we could experience more extreme volatility until Afrezza gets established.
Where are those continuation trials for Afrezza? They would be very helpful in evaluating our risk and stabilize the stock.
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Post by jpg on Jan 27, 2015 1:10:44 GMT -5
Actually both are good examples of what I'm talking about. Torrey-Pines (the pain peptide innovator I was referring to above) probably has little or no money (and is a non profit). From the little we (or at least that I know) they have an extraordinary and potentially revolutionary IP/ technology (if it works in humans...) that is at the very least as valuable as Technosphere. A match made in heaven if they can find the $ to push this forward. Do notice this was a 2012 article. I haven't looked in the last 6 months or so but as far as I know they are not even doing phase 1. Moving this through phase 1-3 and FDA is the real deal: long and expensive. We are looking at a class of medication that could redefine anesthesiology, post op care, chronic and a big chunk of acute outpatient pain management. I don't know who is calling the shots on this but if this stuff works partnering early could potentially be a mistake (or a good idea if the deal is right obviously). Technovax more or less same thing (in my mind less 'wow' and unique tech though and for the difficult vaccine space...). Neither Torrey Pines nor Technovax have the financial assets to get this past phase 1 let alone all the way to phase 3. I personally wouldn't touch Technovax and vaccines with my own money (or Mannkinds...) but would love to see Mannkind push Torrey-Pines past phase 1 and phase 2 trials without anyone else financing it (again unless they get a really good deal obviously). Phase 1 and 2 trials are relatively cheap and by the time they would finish the phase 1 we would be in a reasonable position and by the time phase 2 is finished we should be swimming in cash. This being said I think Mannkind could make some smart deals but I trust them to not dogmatically exclude possibly extraordinary opportunities (like the Torrey-Pines thing) because they want to save a few $. To me this would be a big mistake. Billionaires tend to see these opportunities well... Where I would see them partner with a well funded BP is to improve/ differentiate (and possibly prolong) 'me too' type drugs that are coming off patent or are already off patent. There is actually quite a long list of these drugs which could be big sellers (and significantly improve patient care) if reformulated to benefit from Technosphere. Oxytocin (wight the right funder like Gates Foundation) comes to mind. JPG |
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Post by 4allthemarbles on Jan 27, 2015 2:00:28 GMT -5
This really turned into a good thread. In hindsight, I should have posted a bit more info earlier, but I was rushing. That said, we have some very intelligent posters. And we have Baba, too.  ? |
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Post by babaoriley on Jan 27, 2015 2:35:41 GMT -5
This really turned into a good thread. In hindsight, I should have posted a bit more info earlier, but I was rushing. That said, we have some very intelligent posters. And we have Baba, too. ? Like most everything else, 4all, intelligence to excess is counterproductive. Lord knows how hard it is for me to hide it, but apparently, I'm doing a good job!  Good to have you posting again and I assume you'll be at the next Annual Meeting! |
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Post by 4allthemarbles on Jan 27, 2015 3:08:24 GMT -5
I will be at that meeting with swim trunks for the hot tubs.... nurses will be standing buy...
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Post by liane on Jan 27, 2015 6:07:54 GMT -5
It is not an all or nothing situation. I would hope they tailor each deal based on the unique circumstances of the potential partner and drug. In some cases, it might make sense to be a full-fledged partner, even from the early stages. I would put Torrey Pines in this category. The pay-off could be very large, but so is the risk. For other drugs - especially established drugs owned by large pharmas that need an extension of patent, I think the best route would be a licensing deal. Let the pharma pick up the development costs, and once approved, they (the large pharma) already have their marketing in place. We just sit back and collect the royalty.
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Post by gomnkd on Jan 27, 2015 7:40:38 GMT -5
As I think about it more, I'm getting more skeptical in short term. the potential partners may want to wait a year or two and see how TI is working in broader population. mannkind can use this opportunity to do more ph1 trials.
Also the credit line from sanofi can only be used for Afrezza activities and not for others.
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Post by BlueCat on Jan 27, 2015 22:10:26 GMT -5
As I think about it more, I'm getting more skeptical in short term. the potential partners may want to wait a year or two and see how TI is working in broader population. mannkind can use this opportunity to do more ph1 trials. Also the credit line from sanofi can only be used for Afrezza activities and not for others. Will they really need to wait to see TI in action? I mean, there are already many, many inhaled and nebulizer-based medications on the market, as well as nasal flu vaccine. Not just for asthma, but antibiotics, etc. TI is just a delivery mechanism that is highly effective and tuned to certain, fast-acting, into the bloodstream applications ... Outside of my expertise and showing my ignorance, but for those less frequent medications (like migraine), I imagine a lot less fretting over cancer and cough. Then there's the medical maryjane for cancer patients. And so on. If you are already in hospice .... ? |
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Post by jpg on Jan 27, 2015 22:33:46 GMT -5
As I think about it more, I'm getting more skeptical in short term. the potential partners may want to wait a year or two and see how TI is working in broader population. mannkind can use this opportunity to do more ph1 trials. Also the credit line from sanofi can only be used for Afrezza activities and not for others. Will they really need to wait to see TI in action? I mean, there are already many, many inhaled and nebulizer-based medications on the market, as well as nasal flu vaccine. Not just for asthma, but antibiotics, etc. TI is just a delivery mechanism that is highly effective and tuned to certain, fast-acting, into the bloodstream applications ... Outside of my expertise and showing my ignorance, but for those less frequent medications (like migraine), I imagine a lot less fretting over cancer and cough. Then there's the medical maryjane for cancer patients. And so on. If you are already in hospice .... ? I think pot already has some rather effective modes of delivery. I hate to be a party pooper but doubt pot will be high on the list of Technosphere applications... Sorry. As for migraine (and pain in general) getting relief much faster makes a big difference on the overall experience and on the 'positive' feedback loops that pain often create. Going from a 1 hour start of pain relief to a few minutes pain relief is a very big deal to breaking the positive feedback loop that frequently occurs. I suspect many people would be very happy to pay significantly more especially since this would be a relatively infrequent need/ expense. |
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Post by BlueCat on Jan 27, 2015 23:22:32 GMT -5
Indeed.
I used to suffer from migraines. And I would have paid retail at Afrezza cost to take it out - fast.
I also had a colleague, a young man, whose migraines were so bad he gave up. Entirely. A very sad story.
There are so many potential life changing, life-saving applications for this.
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Post by suebeeee1 on Jan 28, 2015 2:53:47 GMT -5
A cursory review of both of these organizations shows that, currently, neither is working on Technospere related trials. Technovax is in a pre-clinical (not even Phase I) stage of researching inhalable insulins, the same place they were in over a year ago. Would be nice to see someone with money pick up a trial or two. If sharing the profits along with the costs of trials gets our Dreamboat out there, the face of how a medication is delivered would change. Eventually, instead of taking a cholesterol pill that causes stomach upset, you just inhale....... Half (or even a third) of that market is more than enough for me. Why? There will be plenty of other meds following. Would we be happy if we only sell the medicine bottle? Image where we would be if there was indeed a patent for it and we owned it! |
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