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Post by dreamboatcruise on Jun 5, 2018 0:23:04 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. What is the size of the Liquidia inhaler... no indication on that diagram? It's dry powder inhaler, many of which (such as asthma inhalers) are not much larger than dreamboat. And most dry powder inhalers aren't single use... probably could be dreamboat size if they had single use cartridges, though I assume that is considered less convenient than metered doses not requiring cartridges.
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Post by dreamboatcruise on Jun 5, 2018 1:29:20 GMT -5
That's not the Liquidia inhaler.
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Post by mnholdem on Jun 5, 2018 3:18:47 GMT -5
It's the Tyvaso inhaler, which was the original topic of this thread until kastanes brought up Liquidia. I haven't managed to locate a reliable image of the device Liquidia will be using with their Trespostinil drug, though.
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Post by brotherm1 on Jun 5, 2018 3:21:43 GMT -5
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Post by mnholdem on Jun 5, 2018 3:37:45 GMT -5
Thanks, brotherm1.
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Post by uvula on Jun 5, 2018 5:54:10 GMT -5
So we have the huge nebulizer that seems to have never started clinical trials, and liquidia which is ahead of mnkd and could be just as effective as the mnkd drug. Sounds like we could be a few years late.
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Post by mnholdem on Jun 5, 2018 6:51:10 GMT -5
So we have the huge nebulizer that seems to have never started clinical trials, and liquidia which is ahead of mnkd and could be just as effective as the mnkd drug. Sounds like we could be a few years late. Nope. The MannKind trepostinil Phase 1 trial will be completed December 2018 and the Phase 3 has been estimated by CMO David Kendall MD to be complete in late 2019, which puts it slightly ahead of Liquidia's, whose clinical trial for LIQ861 has an estimated study completion date of July 2020.
MannKind anticipates filing its NDA by mid-2020 while Liquidia will only have just completed its safety study. Also, the LIQ861 has only one Primary Outcome related to adverse events and seriously adverse events. MannKind's will have a full PK study data completed in 2019.
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Post by Omega on Jun 5, 2018 11:37:03 GMT -5
That's not the Liquidia inhaler. Here are all 3 Inhalers.
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Post by dreamboatcruise on Jun 5, 2018 13:00:55 GMT -5
Thanks... not much difference between Liquidia and dreamboat. TreT would unlikely use the dreamboat, but rather one of the myriad other designs MNKD shows on their website. The nebulizer seems like it would lose out as soon as Liquidia's hits the market. I think there is usually room for more than one brand, but if Glaxo has success with Liquidia it would mean MNKD is going to have to have a BP pick it up to compete properly.
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Post by dh4mizzou on Jun 5, 2018 13:30:19 GMT -5
DBC, would you're presumption about a BP for MNKD still hold if they beat Liquidia to market as mnholdem presented above?
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Post by dreamboatcruise on Jun 5, 2018 13:44:01 GMT -5
DBC, would you're presumption about a BP for MNKD still hold if they beat Liquidia to market as mnholdem presented above? Thanks. Didn't see that. A bit surprising that would be the case, but I'd still think the best course would be finding a partner even just knowing one of the BP were reasonably close behind. Better to have hefty marketing muscle to dominate before the real competition arrives. But MNKD would certainly stand a better chance going it alone if they were first with dry powder rather than second.
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Post by dreamboatcruise on Jun 5, 2018 13:55:56 GMT -5
So we have the huge nebulizer that seems to have never started clinical trials, and liquidia which is ahead of mnkd and could be just as effective as the mnkd drug. Sounds like we could be a few years late. Tyvaso is approved. Interesting to the earlier question about dosing frequency. According to the following from Liquidia, Tyvaso does have some issue that limits the maximum tolerable dose below what can be delivered with Liquidia inhaler (50% more). Perhaps MNKD can best even that, and thereby extend the interval between dosing. liquidia.com/wp-content/uploads/2016/10/Liquidia-LIQ861-PVRI-Poster-FINAL-20180124.pdf
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Post by mytakeonit on Jun 5, 2018 14:04:05 GMT -5
I stand corrected on mistaking the Tyvaso inhaler for the Liquidia inhaler. I thought the Liquidia inhaler was just one of the pieces for the Tyvaso that fell off.
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Post by dreamboatcruise on Jun 5, 2018 14:21:52 GMT -5
So we have the huge nebulizer that seems to have never started clinical trials, and liquidia which is ahead of mnkd and could be just as effective as the mnkd drug. Sounds like we could be a few years late. Nope. The MannKind trepostinil Phase 1 trial will be completed December 2018 and the Phase 3 has been estimated by CMO David Kendall MD to be complete in late 2019, which puts it slightly ahead of Liquidia's, whose clinical trial for LIQ861 has an estimated study completion date of July 2020.
MannKind anticipates filing its NDA by mid-2020 while Liquidia will only have just completed its safety study. Also, the LIQ861 has only one Primary Outcome related to adverse events and seriously adverse events. MannKind's will have a full PK study data completed in 2019.
What's going on with the FDA, giving MNKD preferential treatment... do they perhaps feel guilty about SOMETHING
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Deleted
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Post by Deleted on Jun 5, 2018 14:33:02 GMT -5
United Therapeutics bought Steadymed Ltd. for $216M. They have a TREVYENT (Dev. Stage) which is a Patch/Pump Device for PAH.
United Therapeutics To Acquire SteadyMed Ltd.
SILVER SPRING, Md. and SAN RAMON, Calif., April 30, 2018 /PRNewswire/ -- United Therapeutics Corporation (NASDAQ: UTHR) and SteadyMed Ltd. (NASDAQ: STDY) announced today the signing of a definitive merger agreement under which United Therapeutics will acquire SteadyMed for $4.46 per share in cash at closing and an additional $2.63 per share in cash upon the achievement of a milestone related to the commercialization of Trevyent®. The transaction, including the $75 million in contingent consideration, is valued at $216 million.
SteadyMed is a specialty pharmaceutical company focused on the development and commercialization of drug product candidates to treat orphan and high-value diseases with unmet parenteral delivery needs. SteadyMed's product portfolio includes Trevyent, a development-stage drug-device combination product that combines SteadyMed's two day, single use, disposable PatchPump® technology with treprostinil, a vasodilatory prostacyclin analogue, for the subcutaneous treatment of pulmonary arterial hypertension (PAH). United Therapeutics is a leading biotechnology company focused on the development and commercialization of therapies for the treatment of PAH and other orphan diseases.
"We are optimistic about acquiring SteadyMed and adding Trevyent to our pipeline of products to treat PAH," said Martine Rothblatt, Ph.D., Chairman and Chief Executive Officer of United Therapeutics. "We are especially impressed with SteadyMed's management team and global supply chain. Trevyent fits in well with our mission, and we look forward to bringing the product to the maximum number of patients as soon as possible."
"United Therapeutics has always been at the forefront of developing therapies to treat PAH, and we are delighted at the prospect of our companies coming together, as one, to continue that mission," said Jonathan M.N. Rigby, President and Chief Executive Officer of SteadyMed. "We believe that this proposed acquisition will help us realize our commitment to bring Trevyent to market to improve the lives of patients with PAH."
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