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Post by patten1962 on Jan 31, 2019 20:23:30 GMT -5
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Post by patten1962 on Jan 31, 2019 20:44:55 GMT -5
I feel this is good for Mannkind. Good to see Trepostinil is working well.
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Post by jkendra on Jan 31, 2019 21:10:38 GMT -5
However, in participants for which data are available (89%), Orenitram was associated with a 37% decreased risk of mortality compared with placebo (p=0.0324) at study closure (which includes additional data accrued in the open-label extension study).
"We are thrilled that the FREEDOM-EV study has shown that not only does Orenitram delay disease progression but is the first and only oral prostacyclin-class therapy to indicate a positive impact on survival at study closure," said Martine Rothblatt, Ph.D., Chairman and Chief Executive Officer of United Therapeutics. "These data build off the foundation of the FREEDOM-M study and will bolster Orenitram's perceived value for payors and prescribers, opening the door for more patients to benefit from this medicine."
Wow. Looking very good.
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Post by patten1962 on Jan 31, 2019 21:24:09 GMT -5
However, in participants for which data are available (89%), Orenitram was associated with a 37% decreased risk of mortality compared with placebo (p=0.0324) at study closure (which includes additional data accrued in the open-label extension study). "We are thrilled that the FREEDOM-EV study has shown that not only does Orenitram delay disease progression but is the first and only oral prostacyclin-class therapy to indicate a positive impact on survival at study closure," said Martine Rothblatt, Ph.D., Chairman and Chief Executive Officer of United Therapeutics. "These data build off the foundation of the FREEDOM-M study and will bolster Orenitram's perceived value for payors and prescribers, opening the door for more patients to benefit from this medicine." Wow. Looking very good. So interesting, I am getting mixed opinions from people. Most are thinking this is bad for Mannkind. I see it as positive news. Would love to know what others are thinking.
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Post by tiberious on Jan 31, 2019 21:29:59 GMT -5
So this helps us in that the API has shown more value overall and will undoubtedly be wonderful if delivery is facilitated by Mr. Technosphere directly to the lungs. TrepT!
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UTHR News
Jan 31, 2019 21:36:11 GMT -5
via mobile
Post by patten1962 on Jan 31, 2019 21:36:11 GMT -5
So this helps us in that the API has shown more value overall and will undoubtedly be wonderful if delivery is facilitated by Mr. Technosphere directly to the lungs. TrepT! Thank you
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Post by mnkdfann on Jan 31, 2019 21:38:18 GMT -5
So interesting, I am getting mixed opinions from people. Most are thinking this is bad for Mannkind. I see it as positive news. Would love to know what others are thinking. I don't see how it could be bad news. It's nice that the study was good. But I can't help wonder why UTHR signed a $1.2 billion deal ($800 million plus up to $400 million in milestone payments) to license a drug (Ralinepag from Arena) intended to replace Orenitram (treprostinil). I think THAT was bad for Mannkind.
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Post by tiberious on Jan 31, 2019 21:40:14 GMT -5
However, in participants for which data are available (89%), Orenitram was associated with a 37% decreased risk of mortality compared with placebo (p=0.0324) at study closure (which includes additional data accrued in the open-label extension study). "We are thrilled that the FREEDOM-EV study has shown that not only does Orenitram delay disease progression but is the first and only oral prostacyclin-class therapy to indicate a positive impact on survival at study closure," said Martine Rothblatt, Ph.D., Chairman and Chief Executive Officer of United Therapeutics. "These data build off the foundation of the FREEDOM-M study and will bolster Orenitram's perceived value for payors and prescribers, opening the door for more patients to benefit from this medicine." Wow. Looking very good. So interesting, I am getting mixed opinions from people. Most are thinking this is bad for Mannkind. I see it as positive news. Would love to know what others are thinking. so...... if it works this good going thru the gut...with all the side effects associated going thru the gut... how much resistance do you think they will get from the FDA on life extension benefits thru direct API placement on the lung via TrepT when the time comes?
These results were largely driven by delay in disease progression; Orenitram decreased the risk of disease progression by 61% compared with placebo (p=0.0002). Mortality was similar between Orenitram and placebo groups at the end of randomized treatment. However, in participants for which data are available (89%), Orenitram was associated with a 37% decreased risk of mortality compared with placebo
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Post by brotherm1 on Jan 31, 2019 21:47:59 GMT -5
So interesting, I am getting mixed opinions from people. Most are thinking this is bad for Mannkind. I see it as positive news. Would love to know what others are thinking. I don't see how it could be bad news. It's nice that the study was good. But I can't help wonder why UTHR signed a $1.2 billion deal ($800 million plus up to $400 million in milestone payments) to license a drug (Ralinepag from Arena) intended to replace Orenitram (treprostinil). I think THAT was bad for Mannkind. s it a fact they intend to replace Trepostinil with it? Can you provide a link?
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Post by bigchungus91354 on Jan 31, 2019 21:55:09 GMT -5
However, in participants for which data are available (89%), Orenitram was associated with a 37% decreased risk of mortality compared with placebo (p=0.0324) at study closure (which includes additional data accrued in the open-label extension study). "We are thrilled that the FREEDOM-EV study has shown that not only does Orenitram delay disease progression but is the first and only oral prostacyclin-class therapy to indicate a positive impact on survival at study closure," said Martine Rothblatt, Ph.D., Chairman and Chief Executive Officer of United Therapeutics. "These data build off the foundation of the FREEDOM-M study and will bolster Orenitram's perceived value for payors and prescribers, opening the door for more patients to benefit from this medicine." Wow. Looking very good. So interesting, I am getting mixed opinions from people. Most are thinking this is bad for Mannkind. I see it as positive news. Would love to know what others are thinking. I would think it decreases the probability of then moving forward with inhaled TrepT.
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Post by mnkdfann on Jan 31, 2019 21:58:39 GMT -5
I don't see how it could be bad news. It's nice that the study was good. But I can't help wonder why UTHR signed a $1.2 billion deal ($800 million plus up to $400 million in milestone payments) to license a drug (Ralinepag from Arena) intended to replace Orenitram (treprostinil). I think THAT was bad for Mannkind. s it a fact they intend to replace Trepostinil with it? Can you provide a link? Obviously I don't know what UTHR's intentions are, and I wasn't stating I knew them. Rather, I meant that the one drug (Ralinepag) is a next generation drug that targets the same market as the other (Orenitram). By definition, it was intended to be a replacement. Given the dollar amount UTHR paid, I personally believe they must think that Ralinepag is the future. The discussion below suggests it is superior (though trials may still be required to prove this). www.pharmaceutical-technology.com/comment/commentarena-pharmaceuticals-positive-topline-phase-ii-results-for-ralinepag-pose-threat-for-jjs-uptravi-5876555/"United Therapeutics’ Orenitram (treprostinil) is currently the only marketed oral prostacyclin derivative therapy for PAH. However, it has received a lot of criticism from KOLs that it is fairly inefficacious compared to infusion prostacyclins. Compared to Uptravi’s half-life of six hours, ralinepag boasts a 25-hour half-life, potentially allowing for less frequent dosing and increased patient compliance rates. Based on prior clinical trials, ralinepag is dosed once or twice daily, whereas Orenitram is usually dosed three times a day."
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Post by patten1962 on Jan 31, 2019 22:02:34 GMT -5
s it a fact they intend to replace Trepostinil with it? Can you provide a link? Obviously I don't know what UTHR's intentions are, and I wasn't stating I knew them. Rather, I meant that the one drug (Ralinepag) is a next generation drug that targets the same market as the other (Orenitram). By definition, it was intended to be a replacement. Given the dollar amount UTHR paid, I personally believe they must think that Ralinepag is is the future. The discussion below suggests it is superior (though trials may still be required to prove this). www.pharmaceutical-technology.com/comment/commentarena-pharmaceuticals-positive-topline-phase-ii-results-for-ralinepag-pose-threat-for-jjs-uptravi-5876555/"United Therapeutics’ Orenitram (treprostinil) is currently the only marketed oral prostacyclin derivative therapy for PAH. However, it has received a lot of criticism from KOLs that it is fairly inefficacious compared to infusion prostacyclins. Compared to Uptravi’s half-life of six hours, ralinepag boasts a 25-hour half-life, potentially allowing for less frequent dosing and increased patient compliance rates. Based on prior clinical trials, ralinepag is dosed once or twice daily, whereas Orenitram is usually dosed three times a day." Can Ralinrpag be inhaled?
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Post by akemp3000 on Jan 31, 2019 22:02:51 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.
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Post by mnkdfann on Jan 31, 2019 22:04:01 GMT -5
Obviously I don't know what UTHR's intentions are, and I wasn't stating I knew them. Rather, I meant that the one drug (Ralinepag) is a next generation drug that targets the same market as the other (Orenitram). By definition, it was intended to be a replacement. Given the dollar amount UTHR paid, I personally believe they must think that Ralinepag is is the future. The discussion below suggests it is superior (though trials may still be required to prove this). www.pharmaceutical-technology.com/comment/commentarena-pharmaceuticals-positive-topline-phase-ii-results-for-ralinepag-pose-threat-for-jjs-uptravi-5876555/"United Therapeutics’ Orenitram (treprostinil) is currently the only marketed oral prostacyclin derivative therapy for PAH. However, it has received a lot of criticism from KOLs that it is fairly inefficacious compared to infusion prostacyclins. Compared to Uptravi’s half-life of six hours, ralinepag boasts a 25-hour half-life, potentially allowing for less frequent dosing and increased patient compliance rates. Based on prior clinical trials, ralinepag is dosed once or twice daily, whereas Orenitram is usually dosed three times a day." Can Ralinrpag be inhaled? Good question, I don't know. But if Ralinepag is a once a day oral tablet, I'm not sure it matters.
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Post by tiberious on Jan 31, 2019 22:17:15 GMT -5
Can Ralinrpag be inhaled? Good question, I don't know. But if Ralinepag is a once a day oral tablet, I'm not sure it matters. it matters because whether its Trep or Ralinepag ORAL delivery is slow, old school and has a host of side effects, liver issues, etc... UHTR simply added to its quiver with Ralinepag to service PAH trying to be leader in market. If they can make either inhalable they will own the market IMHO.
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