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Post by mnholdem on Mar 5, 2018 8:13:59 GMT -5
Many of us remember Exubera, the inhalable insulin powder that was acquired by Pfizer and failed miserably. It's developer was Nektar Therapeutics and, while Nektar did get a modest settlement from Pfizer for screwing up commercialization of Exubera, they also had a pipeline of other drugs for multiple indications that they began developing for the future.
While reading a Forbes article on Friday about 17 stocks that have takeover appeal (www.forbes.com/sites/moneyshow/2018/03/02/why-these-17-stocks-have-takeover-appeal/#37f864e7ecb3) I read that, for years, healthcare has been one of the best industries in which to invest as industry spending became a steadily larger share of the economy and that Brytol-Myers Squibb recently announced it would pay nearly $2 billion upfront for a cancer drug collaboration with Nektar Therapeutics.
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This is an example of why MannKind's development of its pipeline PAH candidate (named TreT) is so important to the future of this company. Investors are currently focusing on Afrezza and the challenges it faces in order to become a revenue generator but I think that it's imperative for MannKind to develop its pipeline candidates. The Technospere pulmonary drug delivery platform simply has so many possibilities for drugs that address unmet needs. That's also why I was thrilled to hear MannKind's new CMO Dr. David Kendall state that the company has just initiated patient enrollment into its Phase 1 trials for Trespostinol for pulmonary arterial hypertension.
In the short term, successful commercial development of Afrezza is (and must be) the focus of management. However, as a MNKD shareholder, I think that continued development of TreT and other pipeline candidates is a positive development for the future of my investment.
GLTAL
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Post by tw12 on Mar 5, 2018 9:02:38 GMT -5
Am I correct in remembering that MannKind has tested 45 drugs on Technosphere and found that 43 had no pulmonary issues?
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Post by dreamboatcruise on Mar 5, 2018 11:00:39 GMT -5
Am I correct in remembering that MannKind has tested 45 drugs on Technosphere and found that 43 had no pulmonary issues? There certainly haven't been Phase I safety studies. I think the statement that you are referring to is that of the APIs they tested almost all of them could could be bound to TS and result in particles of the correct size for inhalation. |
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Post by matt on Mar 5, 2018 15:30:46 GMT -5
The pipeline is important to any single drug company, and given the intense competition in the insulin sector, that goes double for MNKD. However, I don't know that putting generic drugs into an inhalable delivery system constitutes a pipeline.
If you look at the history of drug delivery solutions, the lion's share of the profit always goes to company developing the drug and never the drug delivery system. There are lots of ways to get a drug into the human body and for this reason there have been relatively few companies that have ever created portfolio of profitably drug delivery solutions; Alza was the notable exception. It should also be recognized that TS is an older technology and most of the key patents have lapsed at this point, so other companies don't have to deal with MNKD to access the technology unless it is cheaper for them to do so.
I would much rather see MNKD with a few developmental stage drugs in the portfolio. While drug delivery is always risky, addressing an unmet therapeutic need will create far more value that trying to package 10 already approved drugs into the TS delivery system. Both will suck down cash, but Wall Street will be more tolerant with funding a novel drug program if it is carefully selected.
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Post by akemp3000 on Mar 5, 2018 15:45:28 GMT -5
The pipeline is important to any single drug company, and given the intense competition in the insulin sector, that goes double for MNKD. However, I don't know that putting generic drugs into an inhalable delivery system constitutes a pipeline. If you look at the history of drug delivery solutions, the lion's share of the profit always goes to company developing the drug and never the drug delivery system. There are lots of ways to get a drug into the human body and for this reason there have been relatively few companies that have ever created portfolio of profitably drug delivery solutions; Alza was the notable exception. It should also be recognized that TS is an older technology and most of the key patents have lapsed at this point, so other companies don't have to deal with MNKD to access the technology unless it is cheaper for them to do so. I would much rather see MNKD with a few developmental stage drugs in the portfolio. While drug delivery is always risky, addressing an unmet therapeutic need will create far more value that trying to package 10 already approved drugs into the TS delivery system. Both will suck down cash, but Wall Street will be more tolerant with funding a novel drug program if it is carefully selected. Wouldn't this mean putting human insulin into an inhalable delivery system would be considered generic and not constitute a contribution to a pipeline? |
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Post by agedhippie on Mar 5, 2018 17:36:06 GMT -5
The pipeline is important to any single drug company, and given the intense competition in the insulin sector, that goes double for MNKD. However, I don't know that putting generic drugs into an inhalable delivery system constitutes a pipeline. If you look at the history of drug delivery solutions, the lion's share of the profit always goes to company developing the drug and never the drug delivery system. There are lots of ways to get a drug into the human body and for this reason there have been relatively few companies that have ever created portfolio of profitably drug delivery solutions; Alza was the notable exception. It should also be recognized that TS is an older technology and most of the key patents have lapsed at this point, so other companies don't have to deal with MNKD to access the technology unless it is cheaper for them to do so. I would much rather see MNKD with a few developmental stage drugs in the portfolio. While drug delivery is always risky, addressing an unmet therapeutic need will create far more value that trying to package 10 already approved drugs into the TS delivery system. Both will suck down cash, but Wall Street will be more tolerant with funding a novel drug program if it is carefully selected. Wouldn't this mean putting human insulin into an inhalable delivery system would be considered generic and not constitute a contribution to a pipeline? No. Matt did not say delivering a generic drug with a non-generic mechanism makes it generic. If it was then Afrezza could be sold OTC which would be really good news. What he said is that if you are looking for a drug to deliver then avoid generics because the market sets a lower value on them than on newly developed drugs. Anyway, Afrezza is released so it cannot be part of the pipeline since it's been released. |
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Post by falconquest on Mar 5, 2018 18:18:52 GMT -5
I have always felt that the key to Mannkind is Technosphere. Once they gain market acceptance of Technosphere, Mannkind could realize that "embarrassment of riches" Matt talked about. It would even help market Afrezza. To me, Technosphere has always been the key. Here's to building that pipeline!
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Post by lennymnkd on Mar 5, 2018 19:55:11 GMT -5
At one point a while ago ,Matt P I believe said , or was it Al , that patterns on existing drugs going off pattern could be renewed on the TS platform.or something to that effect.
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Post by sophie on Mar 5, 2018 20:30:59 GMT -5
At one point a while ago ,Matt P I believe said , or was it Al , that patterns on existing drugs going off pattern could be renewed on the TS platform.or something to that effect. That is correct. That happens all the time with other drugs. Whenever new formulations are discovered, they can be patented and re-branded under a new trade name. While this is a new formulation, there isn't a whole lot of inherent value in that formulation because savvy physicians usually can bypass the new drug with their cheaper generic counterparts. If drug manufacturers found value in a different formulation, they could create their own version, and many do. matt was saying that the majority of the value goes to those who develop a novel drug, not those who reformulate a generic version. And he would be correct. There are exceptions, but they are... exceptions. There are few applications of old drugs that can increase in value as new applications. The ones that are on the front of my mind right now are the long-acting antipsychotics. Many are generic right now, but because adherence is so problematic with that patient population, long-acting injectables hold immense value. Same with naloxone and opioid abusers. There are 1-6 month long-acting variants based on a generic platform that still have value because of the long-acting benefit. Patients show up monthly for their injection and you know they've been compliant until their appointment next month. It would be much cheaper to spend 1500/month for injectable vs 500/month for tablets because admission to psychiatric hospitals will approach $1000/day. Prevention is cheaper than admission. I don't mean to put words into matt's mouth, but part of his argument is that when given the choice to swallow a tablet vs inhaling a medication, there will be a very small subset of people who will find that option valuable. Unless there is a proven therapeutic benefit- which will more likely revolve around convenience and compliance than efficacy, unlike Afrezza- The same insurance nightmares seen with Afrezza will exist for those options as they will assuredly need a prior authorization from an insurance company that is going to want a good explanation for paying multiples more for the same medication. |
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Post by lennymnkd on Mar 6, 2018 8:18:41 GMT -5
Nope ! I was wrong in my thinking this whole time , I was always under the inpression that the original drug being put on the platform, kept the pattern intact longer for that drug . Sorry to hear that .
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Post by agedhippie on Mar 6, 2018 8:45:47 GMT -5
Nope ! I was wrong in my thinking this whole time , I was always under the inpression that the original drug being put on the platform, kept the pattern intact longer for that drug . Sorry to hear that . In that case I think we are both wrong! I thought it created a new patentable drug. |
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Post by liane on Mar 6, 2018 9:05:46 GMT -5
New platform ----> extends patent for original drug. Why do you think we see all these extended release, controlled release drugs just before a patent expiration?
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Post by jonny80s on Mar 6, 2018 9:22:38 GMT -5
I was under the impression that a change in the delivery mechanism/change in formulation would classify any existing drug as new with full patent rights. Of course the original formulation would be open to generics.
Ultimately the technosphere application would reduce some unwanted side affects with certain drugs by bypassing the digestive system. As well as result in faster onset. Hopefully resulting in a better/more effective formulation.....
Unfortunately no fish are biting.
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Post by dreamboatcruise on Mar 6, 2018 12:12:05 GMT -5
I was under the impression that a change in the delivery mechanism/change in formulation would classify any existing drug as new with full patent rights. Of course the original formulation would be open to generics. Ultimately the technosphere application would reduce some unwanted side affects with certain drugs by bypassing the digestive system. As well as result in faster onset. Hopefully resulting in a better/more effective formulation..... Unfortunately no fish are biting. Agree with your assessment. Any invention that is not obvious to a normal practitioner in the field is patentable. I venture a guess that anything requiring clinical trials to prove it works as intended has a good shot at being considered a non-obvious invention. Additionally, I think there are enough parameters in manufacturing anything with TS that the manufacturing process would likely be considered patentable for each API. |
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Post by sophie on Mar 6, 2018 12:46:22 GMT -5
I was under the impression that a change in the delivery mechanism/change in formulation would classify any existing drug as new with full patent rights. Of course the original formulation would be open to generics. Ultimately the technosphere application would reduce some unwanted side affects with certain drugs by bypassing the digestive system. As well as result in faster onset. Hopefully resulting in a better/more effective formulation..... Unfortunately no fish are biting. Sorry if I wasn't clear in my post. The active ingredient is usually the only part of a drug that gets patented. The majority of a pill/suspension/liquid/patch, etc is made up of filler compounds and stabilizers. Usually, very little of the medication is actually medicine. Having said that, there are different ways to deliver that active ingredient. The longer-acting formulations are sometimes made lipid soluble, for instance, to allow for a longer duration of action. Even though it is essentially the same active ingredient, the surrounding chemicals allow for it to be a different formulation. The active ingredient itself would lose its patent, but the new way of delivering the medication would be able to renew its patent. There are several examples... Catapres (Clonidine) was first made as a tablet. Due to the absorption and metabolism of clonidine in the gut, its delivery was not as favorable as a transdermal patch, which can control the release and absorption of medication much more steadily, giving more consistent blood levels and better therapeutic effect. In that case, once clonidine, the generic chemical in Catapres lost its patent, a generic manufacturer could reformulate it as a patch and rebrand it with a new patent. This is not the best example because Catapres had first rights to rebrand as a transdermal patch, and did so, but had they not chosen to pursue a patch, another manufacturer could step in and make one. However, if someone else wanted to make it as an injection, liquid, etc, they would not be prohibited from doing so once Catapres lost its patent on clonidine. If another manufacturer thought they could make a better patch that was different enough to not infringe on the patent, they would also be allowed to create their own transdermal patch if they wanted since clonidine would still be a generic chemical. Hope that makes better sense. |
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