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Post by Deleted on Jun 4, 2018 17:32:42 GMT -5
Is TreT a realistic drug MannKind wants to market or is it a proof of concept? For those that think TreT is marketable, what would a partner pay MannKind for the rights?
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Post by dreamboatcruise on Jun 4, 2018 18:14:03 GMT -5
Is TreT a realistic drug MannKind wants to market or is it a proof of concept? For those that think TreT is marketable, what would a partner pay MannKind for the rights? What might be reasons it wouldn't be marketable?
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Post by Deleted on Jun 4, 2018 18:17:28 GMT -5
United Therapeutics, Liquidia.
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Post by dreamboatcruise on Jun 4, 2018 18:26:30 GMT -5
It seems that the form factor would be much improved. The treatment needs to be done every 4 hours, so a lot easier with a pocket sized device.
Also seems there wouldn't be the same, perhaps misplaced, concern about lung safety as this API is already established for inhalation.
So even if it is deemed merely non-inferior I'd guess they could achieve market success.
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Post by Deleted on Jun 4, 2018 18:50:50 GMT -5
It seems that the form factor would be much improved. The treatment needs to be done every 4 hours, so a lot easier with a pocket sized device. Also seems there wouldn't be the same, perhaps misplaced, concern about lung safety as this API is already established for inhalation. So even if it is deemed merely non-inferior I'd guess they could achieve market success. Form factor will be a huge advantage with TrepT. Also I believe the patients might not have to take 4 treatments a day with TrepT. The reason now is because the nebulizer is limited in the amount of drug that can reach the lung. Hopefully TrepT will give them more than enough medicine so they don't have to do it 4x a day. Regarding partnership deals? Well Liquidia got $200M+ for a pump that is attached 16 hours a day. If MNKD can get a clean Phase 3 READOUT they could get 4x that amount.
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Post by mango on Jun 4, 2018 18:52:09 GMT -5
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Post by dreamboatcruise on Jun 4, 2018 19:02:03 GMT -5
It seems that the form factor would be much improved. The treatment needs to be done every 4 hours, so a lot easier with a pocket sized device. Also seems there wouldn't be the same, perhaps misplaced, concern about lung safety as this API is already established for inhalation. So even if it is deemed merely non-inferior I'd guess they could achieve market success. Form factor will be a huge advantage with TrepT. Also I believe the patients might not have to take 4 treatments a day with TrepT. The reason now is because the nebulizer is limited in the amount of drug that can reach the lung. Hopefully TrepT will give them more than enough medicine so they don't have to do it 4x a day. Regarding partnership deals? Well Liquidia got $200M+ for a pump that is attached 16 hours a day. If MNKD can get a clean Phase 3 READOUT they could get 4x that amount. That would really boil down to a question of the range of therapeutically beneficial blood concentration vs the half life. It would seem that if it were only an issue of how much could be delivered, patients could simply use the nebulizer for longer periods of time in fewer sessions and then not need to carry it around... so I suspect it isn't that simple. Here is an article discussing pk of Trep. It seems to indicate less than 1 hour half life when inhaled, though I find that hard to square with a much longer half life for IV (4.6h).
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Post by mnholdem on Jun 4, 2018 19:12:39 GMT -5
It seems that the form factor would be much improved. The treatment needs to be done every 4 hours, so a lot easier with a pocket sized device. Also seems there wouldn't be the same, perhaps misplaced, concern about lung safety as this API is already established for inhalation. So even if it is deemed merely non-inferior I'd guess they could achieve market success. Form factor will be a huge advantage with TrepT. Also I believe the patients might not have to take 4 treatments a day with TrepT. The reason now is because the nebulizer is limited in the amount of drug that can reach the lung. Hopefully TrepT will give them more than enough medicine so they don't have to do it 4x a day. Regarding partnership deals? Well Liquidia got $200M+ for a pump that is attached 16 hours a day. If MNKD can get a clean Phase 3 READOUT they could get 4x that amount. A collaborating partner could step in based on preliminary results. The Antipated Readout of the Phase 1 SAD Study is slated to be completed by the 3rd Quarter of this year and the Phase 3 "PROs, Safety and Tolerability Study" is scheduled to begin with the 1Q19 Start Switch Study and conclude later that same year with The Pivotal PK Trial. At the ASM Kendall announced an anticipated NDA submission for TreT sometime in 2020. I would expect a collaborative partner partner to be announced in mid- to late 2019 if primary targets from the trial are met.
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Post by mango on Jun 4, 2018 19:46:13 GMT -5
I think the phone will be ringing the moment Phase 1 results come out the oven—this is a super duper tight, highly competitive therapeutic area, and it is essentially a given that MannKind product will become Standard of Care. Mike Q1 Earnings Call: The TreT, a Treprostinil Phase 1 single ascending dose study has started, and we are excited about that. As you may have seen last week, the United Therapeutics did a deal for $200 million for a pump. We believe this asset is a significant opportunity for us. We can put a Phase 1 readout that will be Phase 3-ready as soon as we get those results. We believe it's a three-player market with intense competition for differentiation. Mike Twitter:
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Post by gareaudan on Jun 4, 2018 21:19:15 GMT -5
it is essentially a given that MannKind product will become Standard of Care. not saying it wont be the case but that is also what I thought with afrezza and here we are many years after the launch... still waiting. I Do believe that many products coming from technosphere will become the standard of care but saying that it is ''essentially a given'' is a bit overconfident at this point imo. Nothing is a given if BP are going to lose millions in the process.
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Post by Deleted on Jun 4, 2018 21:53:06 GMT -5
I think the phone will be ringing the moment Phase 1 results come out the oven—this is a super duper tight, highly competitive therapeutic area, and it is essentially a given that MannKind product will become Standard of Care. Mike Q1 Earnings Call: The TreT, a Treprostinil Phase 1 single ascending dose study has started, and we are excited about that. As you may have seen last week, the United Therapeutics did a deal for $200 million for a pump. We believe this asset is a significant opportunity for us. We can put a Phase 1 readout that will be Phase 3-ready as soon as we get those results. We believe it's a three-player market with intense competition for differentiation. Mike Twitter: Well all know DEADLINES get pushed back. They never seem to be PUSHED UP.....LOL
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Post by peppy on Jun 4, 2018 21:54:24 GMT -5
Is TreT a realistic drug MannKind wants to market or is it a proof of concept? For those that think TreT is marketable, what would a partner pay MannKind for the rights? 2.5 Administration Subcutaneous InfusionRemodulin is administered subcutaneously by continuous infusion without further dilution, via a subcutaneous catheter, using an infusion pump designed for subcutaneous drug delivery. To avoid potential interruptions in drug delivery, the patient must have immediate access to a backup infusion pump and subcutaneous infusion sets. The ambulatory infusion pump used to administer Remodulin should: (1) be small and lightweight, (2) be adjustable to approximately 0.002 mL/hr, (3) have occlusion/no delivery, low battery, programming error and motor malfunction alarms, (4) have delivery accuracy of ±6% or better and (5) be positive pressure driven. The reservoir should be made of polyvinyl chloride, polypropylene or glass. Remodulin is administered subcutaneously by continuous infusion at a calculated subcutaneous infusion rate (mL/hr) based on a patient’s dose (ng/kg/min), weight (kg), and the vial strength (mg/mL) of Remodulin being used. During use, a single reservoir (syringe) of undiluted Remodulin can be administered up to 72 hours at 37°C. The subcutaneous infusion rate is calculated using the following formula: Intravenous Infusionx 65 kg x 0.00006 5 mg/mL = 0.031 mL/hr Diluted Remodulin is administered intravenously by continuous infusion via a surgically placed indwelling central venous catheter using an infusion pump designed for intravenous drug delivery. If clinically necessary, a temporary peripheral intravenous cannula, preferably placed in a large vein, may be used for short term administration of Remodulin. Use of a peripheral intravenous infusion for more than a few hours may be associated with an increased risk of thrombophlebitis. To avoid potential interruptions in drug delivery, the patient must have immediate access to a backup infusion pump and infusion sets. The ambulatory infusion pump used to administer Remodulin should: (1) be small and lightweight, (2) have occlusion/no delivery, low battery, programming error and motor malfunction alarms, (3) have delivery accuracy of ±6% or better of the hourly dose, and (4) be positive pressure driven. The reservoir should be made of polyvinyl chloride, polypropylene or glass. Infusion sets with an in-line 0.22 or 0.2 micron pore size filter should be used. Diluted Remodulin has been shown to be stable at ambient temperature when stored for up to 14 days using high-pH glycine diluent at concentrations as low as 0.004 mg/mL (4,000 ng/mL). Select the intravenous infusion rate to allow for a desired infusion period length of up to 48 hours between system changeovers. Typical intravenous infusion system reservoirs have volumes of 50 or 100 mL. With this selected intravenous infusion rate (mL/hr) and the patient’s dose (ng/kg/min) and weight (kg), the diluted intravenous Remodulin concentration (mg/mL) can be calculated using the following formula: 5.1 Risk of Catheter-Related Bloodstream Infection Chronic intravenous infusions of Remodulin are delivered using an indwelling central venous catheter. This route is associated with the risk of blood stream infections (BSIs) and sepsis, which may be fatal. Therefore, continuous subcutaneous infusion (undiluted) is the preferred mode of administration. In an open-label study of IV treprostinil (n=47), there were seven catheter-related line infections during approximately 35 patient years, or about 1 BSI event per 5 years of use. A CDC survey of seven sites that used IV treprostinil for the treatment of PAH found approximately 1 BSI (defined as any positive blood culture) event per 3 years of use. Administration of IV Remodulin with a high pH glycine diluent has been associated with a lower incidence of BSIs when compared to neutral diluents (sterile water, 0.9% sodium chloride) when used along with catheter care guidelines.
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Post by dreamboatcruise on Jun 4, 2018 22:39:34 GMT -5
Liquidia is a dry powder inhaler like TreT. What do you see as the advantage for MNKD that would win out over simply competing on price and splitting the market in some way with Liquidia having first mover advantage?
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Post by mytakeonit on Jun 5, 2018 0:03:01 GMT -5
The Liquidia inhaler obviously has it's advantages ... with the size and shape of it, I can see it producing enough electricity to power my house. As long as you don't try to fit it in your pocket, or try to force the pieces together.
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Post by Deleted on Jun 5, 2018 0:13:33 GMT -5
Liquidia's powder tresprostinil will be first-to-market by at least a year ahead of TreT. Even if TreT is superior in efficacy will it be enough?
What is it worth to a partner?
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