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Post by brotherm1 on Jan 31, 2019 22:23:02 GMT -5
Don’t know if it can be inhaled, but if UTHR wants to make Ralinepag inhalable, it’s in the sales contract that UTHR needs to pay extra to ARNA for UTHR to make it inhalable.
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Post by tiberious on Jan 31, 2019 22:27:22 GMT -5
Don’t know if it can be inhaled, but if UTHR wants to make Ralinepag inhalable, it’s in the sales contract that UTHR needs to pay extra to ARNA for UTHR to make it inhalable. ....and pay extra to good old Mannkind as well no?
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Post by mnkdfann on Jan 31, 2019 22:41:06 GMT -5
Don’t know if it can be inhaled, but if UTHR wants to make Ralinepag inhalable, it’s in the sales contract that UTHR needs to pay extra to ARNA for UTHR to make it inhalable. ....and pay extra to good old Mannkind as well no? Inhalable doesn't necessarily mean using technosphere. Though they certainly might use it. xconomy.com/san-diego/2018/11/15/arenas-comeback-continues-with-800m-deal-for-blood-disease-drug/"A securities filing shows, for instance, shows that Arena will be eligible for a $150 million payment upon the first approval of ralinepag in a “major non-U.S. market,” and another $250 million if the FDA approves an inhaled version of the drug. Arena would get royalties from sales as well." www.sec.gov/Archives/edgar/data/1080709/000156459018029645/arna-8k_20181114.htm"Arena will be eligible to receive a payment of $250 million upon U.S. marketing approval of an inhaled formulation of ralinepag" I think (but have no handy link) that Arena is working on a non-technosphere inhaled option.
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Post by mnkdfann on Jan 31, 2019 22:51:33 GMT -5
But to continue from my last post, it seems reasonable to me to believe that UTHR hopes to use technosphere to deliver an inhaled form of Ralinepag.
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Post by patten1962 on Jan 31, 2019 22:56:38 GMT -5
Well, I guess we will see tomorrow in the stock price.
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Post by goyocafe on Feb 1, 2019 1:14:15 GMT -5
What's stopping Arena from contracting with Mannkind for the T-Ralinepag? That money could easily pass through as far as I'm concerned, and would not object for an instant.
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Post by awesomo on Feb 1, 2019 1:36:24 GMT -5
Please provide at least a little supporting data when suggesting UTHR might not move forward with TrepT. There's too much fake news already. When you pay 10x for something over something else, you're gonna prioritize the 10x thing or investors are going to be all over you.
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Post by uvula on Feb 1, 2019 9:30:56 GMT -5
Please provide at least a little supporting data when suggesting UTHR might not move forward with TrepT. There's too much fake news already. When you pay 10x for something over something else, you're gonna prioritize the 10x thing or investors are going to be all over you. No necessarily. You pay what you have to. Mnkd was desperate. The other company was not so uthr had to pay more. Also, mnkd did not sell an actual drug. They sold a drug delivery system that uses an existing drug that uthr already had.
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Post by brotherm1 on Feb 1, 2019 11:40:48 GMT -5
So Ralinepag might be the “undisclosed molecule” from UTHR that MC stated UTHR is planning to advance with MNKD Technosphere?
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Post by matt on Feb 1, 2019 12:18:52 GMT -5
So Ralinepag might be the “undisclosed molecule” from UTHR that MC stated UTHR is planning to advance with MNKD Technosphere? Maybe, maybe not. There are a lot of ways to get a drug into the human body, and even lots of ways to do it via the lungs. There is no single technology that can do it all. Pharma manufacturers typically test several different alternatives to see which one is best at accurately and consistently delivering the required dose, and then they go with the best choice. There are a lot of variables that go into that analysis such as the size of the molecule, whether it is an active chemical substance or a pro-drug, the pH, whether it is hydrophilic or lipophilic substance, and many others. Without knowing all those details assuming what a third-party is up to is necessarily pure speculation.
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Post by brotherm1 on Feb 1, 2019 12:28:54 GMT -5
True. So if one were to be short MNkD, they should just be somewhat more than nervous right now.
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Post by mango on Feb 1, 2019 12:46:08 GMT -5
What the FREEDOM trial shows is that early intervention with Treprostinil slows the progression of the disease process. United's BEAT clinical trial also has the same endpoint, except it uses the combination of Inhaled Treprostinil and Esuberprost (a modified release prostacyclin analogue oral tablet). Positive results from BEAT would support the use of inhaled Treprostinil as an early intervention treatment option.
Rothblatt believes people with PAH need to be treated with Treprostinil at the beginning stages of the disease and does not need to be delayed. Rothblatt believes Treprostinil plays a key role in PAH and inhaled treprostinil is also being evaluated in clinical trials for PAH+COPD and PAH+ILD.
Anyways, MannKind can formulate Technosphere to be used with any route of administration and with various delivery devices. For example, micro-needle patches, controlled-extended release oral tablets, and infusion devices like a pump.
MannKind's technology is protected by over 800 patents. Rothblatt calls it revolutionary and has continued to speak very highly of it, going so far as showcasing MannKind's BluHale technology and inhaler in a slide as part of a keynote presentation for a massive government-related event late last year.
So, based on everything I see, everything considered, Rothblatt intends to utilize Treprostinil in every aspect of PAH, and MannKind will be a long-term strategic and key player in their future R&D and growth opportunities....with no indications that I can see that suggests otherwise.
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Post by radgray68 on Feb 1, 2019 12:59:55 GMT -5
The best news is for people with PAH. I'll take a cut of that market, whatever the %.
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Post by uvula on Feb 1, 2019 13:00:23 GMT -5
Anyways, MannKind can formulate Technosphere to be used with any route of administration and with various delivery devices. For example, micro-needle patches, controlled-extended release oral tablets, and infusion devices like a pump. Can you site a source for this information? I have never heard anything that sounded remotely close to this from mnkd. As far as I know technosphere is only useful when inhaled into the lungs.
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Post by mango on Feb 1, 2019 14:22:30 GMT -5
Anyways, MannKind can formulate Technosphere to be used with any route of administration and with various delivery devices. For example, micro-needle patches, controlled-extended release oral tablets, and infusion devices like a pump. Can you site a source for this information? I have never heard anything that sounded remotely close to this from mnkd. As far as I know technosphere is only useful when inhaled into the lungs. MannKind has various patents covering this stuff, but here are some examples. • Multi-spike release formulation for oral drug delivery 1. A composition comprising a drug to be orally administered to a patient comprising a first component in a form releasing a first dose of the drug immediately following ingestion of the composition; and a second component in a form rapidly releasing a second dose of the drug at a second time after release of the first dose, wherein the first and second doses provide a multi-splice pharmacokinetic profile of the drug and wherein the rapid release is achieved through the use of reagents that generate a burst of gas upon exposure to water immediately disperse or expose the second dose of the drug so that it can be absorbed through the gastrointestinal tract. 18. The method of claim 11 wherein the composition is in the form of a solid or semi-solid food or candy. 19. The method of claim 11 wherein the composition is administered in the form of a paste, jelly, suspension, or fast-dissolving wafer. 20. The method of claim 11 wherein the composition is administered in the form of a gelatinous solid. patents.google.com/patent/US6555127B2/en• Substituted diketopiperazine analogs for use as drug delivery agents Additionally, the particles containing an active agent can be made small enough for incorporation into an intravenous suspension dosage form. The substituted diketopiperazine and active agent compositions described can be administered as a liquid or solid form. These can include solutions, suspensions, dry powders, tablets, capsules, suppositories, patches for transdermal delivery, and the like. These different forms offer distinct, but overlapping advantages. The solid forms provide convenient bulk transport of active agents and can improve their stability. They can also be formed into microparticles enabling administration by inhalation specifically to the nasal mucosa or deep lung, depending on the size of the microparticle. For oral delivery the compositions disclosed herein can be incorporated into a suspension, tablets or capsules. The compositions of the disclosure can be administered to any targeted biological membrane, such as, for example, a mucosal membrane of a patient. For parenteral administration, formulations, described herein, of less than five microns readily pass through a needle for intravenous administration. Similarly, substituted diketopiperazine and active agent compositions can be injected or implanted subcutaneously, intramuscularly, or intraperitoneally. Additionally, the formulations described herein can be placed in an implantable device to facilitate sustained and/or controlled delivery. For topical or transdermal administration, formulations can be suspended in a suitable pharmaceutical carrier for administration using methods appropriate for the carrier and site of administration. The substituted diketopiperazine microparticles or aggregations of microparticles into films, disks, or tablets, with the loaded active agent can be administered to the skin in an ointment, cream, or patch. Suitable pharmaceutical carriers, for example, phosphate buffered saline, are known and commercially available. Mucosal administration, including buccal, vaginal, rectal, nasal administration is also contemplated herein. patents.justia.com/patent/10172850•Method and Composition for Treating Migraines Diketopiperazines, in addition to making aerodynamically suitable microparticles, can also facilitate the delivery of active agents by rapidly dissolving at physiologic pH thereby releasing the active agent and speeding its absorption into the circulation. Diketopiperazines can be formed into particles that incorporate a drug or particles onto which a drug can be adsorbed. The combination of a drug and a diketopiperazine can impart improved drug stability. These particles can be administered by various routes of administration. As dry powders these particles can be delivered by inhalation to specific areas of the respiratory system, depending on particle size. Additionally, the particles can be made small enough for incorporation into an intravenous suspension dosage form. Oral delivery is also possible with the particles incorporated into a suspension, tablets or capsules. patents.justia.com/patent/20120071510• Glucagon-like peptide 1(glp-1) pharmaceutical formulations 36. The method of claim 35, wherein said providing is carried out intravenously, subcutaneously, orally, nasally, buccally, rectally, or by pulmonary delivery. patents.google.com/patent/WO2007121411A2/en• Methods and compositions for treating pain Diketopiperazines, in addition to making aerodynamically suitable microparticles, dissolve rapidly at physiologic pH thereby releasing the active agent for absorption into the circulation. Diketopiperazines can be formed into particles that incorporate a drug or particles onto which a drug can be adsorbed. The combination of a drug and a diketopiperazine can impart improved drug stability. These particles can be administered by various routes of administration. As dry powders these particles can be delivered by inhalation to specific areas of the respiratory system, depending on particle size. Additionally, the particles can be made small enough for incorporation into an intravenous suspension dosage form. Oral delivery is also possible with the particles incorporated into suspensions, tablets or capsules. In one embodiment, the diketopiperazine is 3,6-bis(N-fumaryl-4-aminobutyl)-2,5-diketopiperazine, or 3,6-di(fumaryl-4-aminobutyl)-2,5-diketopiperazine (fumaryl diketopiperazine, FDKP). The FDKP can comprise microparticles in its acid form or salt forms which can be aerosolized or administered in a suspension. patents.google.com/patent/US9610351B2/en
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