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Post by rfogel on Oct 30, 2020 13:53:22 GMT -5
Here's the transcript: www.fool.com/earnings/call-transcripts/2020/10/28/united-therapeutics-corp-uthr-q3-2020-earnings-cal/"We expect to further penetrate that 30,000 patient market for patients with pulmonary fibrosis-associated pulmonary hypertension with the launch of our Dreamboat TreT product by the end of 2021 or possibly early 2022." Does that mean that is the only indication they looking to use TreT? Also, it sounds like MNKD can't expect much in the way of royalties until some time in 2022. Are there any further payments coming from UTHR before that? |
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Post by peppy on Oct 30, 2020 16:34:12 GMT -5
Here's the transcript: www.fool.com/earnings/call-transcripts/2020/10/28/united-therapeutics-corp-uthr-q3-2020-earnings-cal/"We expect to further penetrate that 30,000 patient market for patients with pulmonary fibrosis-associated pulmonary hypertension with the launch of our Dreamboat TreT product by the end of 2021 or possibly early 2022." Does that mean that is the only indication they looking to use TreT? Also, it sounds like MNKD can't expect much in the way of royalties until some time in 2022. Are there any further payments coming from UTHR before that? I think pulmonary fibrous is an additional indiction. INCREASE I believe showed improvement in pulmonary fibrous. mango I'll go look and post the sentences of consequence. Added; THE IMPACT OF INHALED TREPROSTINIL ON PATIENT LUNG FUNCTION: RESULTS FROM THE INCREASE STUDY PURPOSE: Inhaled treprostinil (iTRE) is approved for the treatment of Group 1 pulmonary hypertension (PH). Group 3 includes PH as a result of interstitial lung disease (PH-ILD). In preclinical studies, treprostinil has been shown to impact extracellular matrix remodeling and development of fibrosis. INCREASE evaluated the safety and efficacy of iTRE in PH-ILD patients. Post-hoc analyses were conducted on the impact of iTRE on lung function. METHODS: INCREASE was a multicenter, randomized, double-blind, placebo-controlled, 16-week study. Inclusion criteria included diagnosis by right heart catheterization and computed tomography imaging. Patients receiving treatment for underlying lung disease were on a stable and optimized dose. Exacerbation of underlying lung disease (acute, clinically significant, respiratory deterioration accompanied by evidence of new widespread alveolar abnormality) was assessed. Pulmonary function testing was conducted at Weeks 8 and 16. This analysis provides further detail on effects on forced vital capacity (FVC), the most widely accepted lung function measurement for evaluation of fibrotic lung disease. RESULTS: 326 patients were enrolled. PH-ILD etiology included idiopathic interstitial pneumonia (45%; 28% idiopathic pulmonary fibrosis), combined pulmonary fibrosis and emphysema (25%), and connective tissue disease (22%). A minority of patients received either pirfenidone (14%) or nintedanib (9%). iTRE patients experienced significantly fewer exacerbations of underlying lung disease (34% risk reduction compared to placebo; p=0.018). FVC improved with iTRE by 28.47 mL and 44.4 mL at Weeks 8 and 16, respectively, when compared to placebo. Percent predicted FVC also improved at Weeks 8 (1.79%; p=0.0139) and 16 (1.8%; p=0.0277). Subgroup analysis of patients with idiopathic interstitial pneumonia (N=146) demonstrated FVC improvements of 46.48 mL and 108.18 mL (p=0.0229) at Weeks 8 and 16, respectively, and improvements in % predicted FVC at Weeks 8 (1.95%, p=0.0373) and 16 (2.88%; p=0.0096) compared to placebo. Further analysis for patients with idiopathic pulmonary fibrosis (N=92) demonstrated FVC improvements of 84.52 mL and 168.52 mL (p=0.0108) at Weeks 8 and 16, respectively, and improvements in % predicted FVC at Weeks 8 (2.54%; p=0.038) and 16 (3.5%; p=0.0147) compared to placebo. CONCLUSIONS: iTRE was not associated with any decrement in lung function during the course of the study. Findings of improvement in underlying lung disease (improved FVC and fewer exacerbations), combined with the preclinical evidence of antifibrotic activity of treprostinil, suggest that iTRE may offer a treatment option for patients with ILD. CLINICAL IMPLICATIONS: Study results support an additional treatment avenue and might herald a shift in the clinical management of patients with ILD. Further consideration should be given to investigation of iTRE in patients with ILD in the absence of PH.
rfogel, try to keep up.  mnkd.proboards.com/thread/12309/chestINDICATION TYVASO (treprostinil) is a prostacyclin vasodilator indicated for the treatment of pulmonary arterial hypertension (PAH; WHO Group 1) to improve exercise ability. Studies establishing effectiveness included predominately patients with NYHA Functional Class III symptoms and etiologies of idiopathic or heritable PAH (56%) or PAH associated with connective tissue diseases (33%). The effects diminish over the minimum recommended dosing interval of 4 hours; treatment timing can be adjusted for planned activities. While there are long-term data on use of treprostinil by other routes of administration, nearly all controlled clinical experience with inhaled treprostinil has been on a background of bosentan (an endothelin receptor antagonist) or sildenafil (a phosphodiesterase type 5 inhibitor). The controlled clinical experience was limited to 12 weeks in duration. About PH-ILD Interstitial lung disease (ILD) is a group of lung diseases that are characterized by significant scarring or fibrosis of the bronchioles and alveolar sacs within the lungs. Increased fibrotic tissue in ILD prevents oxygenation and free gas exchange between the pulmonary capillaries and alveolar sacs, and the condition can present with a wide range of symptoms, including shortness of breath with activity, labored breathing, and fatigue. Pulmonary hypertension (PH) frequently complicates the course of patients with interstitial lung disease and is associated with worse functional status measured by exercise capacity, greater supplemental oxygen needs, decreased quality of life, and worse outcomes.An estimated 30,000 patients in the United States may suffer from PH-ILD, which is included within Group 3 of the World Health Organization (WHO) classification of PH. However, no treatments are approved by the FDA for patients with this disease.
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Post by matt on Oct 31, 2020 9:32:38 GMT -5
Does that mean that is the only indication they looking to use TreT? Also, it sounds like MNKD can't expect much in the way of royalties until some time in 2022. Are there any further payments coming from UTHR before that? Yes, the 30,000 patients they reference are an expanded indication for their existing drug. Don't expect significant royalties 2022, at this point the new formulation doesn't even have FDA approval and, while the drug is already licensed, UTHR has to prove equivalency to their existing product. That work is already in progress, but expect at least six months to approve the amendment once the file is submitted to FDA. Only after there is an approved marketing license and a product launch will there be sales, and it will take some time to get patients converted over to a new formulation. Remember also that royalties are on a lag basis so sales take place before royalties are paid. That is just the way it goes with drug licenses so you have to be a bit patient. |
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Post by harryx1 on Oct 31, 2020 12:44:59 GMT -5
Here's the transcript: www.fool.com/earnings/call-transcripts/2020/10/28/united-therapeutics-corp-uthr-q3-2020-earnings-cal/"We expect to further penetrate that 30,000 patient market for patients with pulmonary fibrosis-associated pulmonary hypertension with the launch of our Dreamboat TreT product by the end of 2021 or possibly early 2022." Does that mean that is the only indication they looking to use TreT? Also, it sounds like MNKD can't expect much in the way of royalties until some time in 2022. Are there any further payments coming from UTHR before that? All you have to do is read the transcript to get your answer from Dr. Rothblatt.... pretty simple.  Also PERFECT and TETON trials will pave the way for TreT to be used in a greater population of patients in the future. pipeline.unither.com/They also said doctors are prescribing Tyvaso off label for CF-ILD as they have seen positive results in patients and there are absolutely no other therapeutics for it at this point in time. |
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Post by buyitonsale on Oct 31, 2020 13:17:42 GMT -5
As soon as FDA approves TreT for Group 1, UTHR will be trying to switch all patients from Tyvaso to TreT.
I expect that transition to be fully completed in 2022. Why would any patient using the Tyvaso nebulizer say "no" to a more convenient dreamboat device they can use anywhere and with faster dosing ?
As far as Group 3, many doctors are already prescribing Tyvaso off label for ILD population and that is why Tyvaso sales are growing... (already trending for over 500M a year).
FDA will approve Group 3 shortly thereafter, based on BREEZE 2 study, and then UTHR will have the only approved treatment available for population 10 times larger that Group 1.
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Post by agedhippie on Oct 31, 2020 18:04:18 GMT -5
... I expect that transition to be fully completed in 2022. Why would any patient using the Tyvaso nebulizer say "no" to a more convenient dreamboat device they can use anywhere and with faster dosing ?... For the same reason that diabetics have been slow to convert to Afrezza - it's something they are familiar with. The difference in this case is that the doctors all know who UTHR is and are prescribing Tyvaso today so that trust is there. The doctors in turn will recommend it to the patients which will be the driver for migration. I would expect the doctors to move a few patients and see how they do before making a wholesale switch. |
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Post by peppy on Oct 31, 2020 19:34:20 GMT -5
... I expect that transition to be fully completed in 2022. Why would any patient using the Tyvaso nebulizer say "no" to a more convenient dreamboat device they can use anywhere and with faster dosing ?... For the same reason that diabetics have been slow to convert to Afrezza - it's something they are familiar with. The difference in this case is that the doctors all know who UTHR is and are prescribing Tyvaso today so that trust is there. The doctors in turn will recommend it to the patients which will be the driver for migration. I would expect the doctors to move a few patients and see how they do before making a wholesale switch. I disagree oh Mr. agedhippee. It all comes down to money and the system. As long as it is superior and it can be proved superior? Is that the pipe dream? |
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Post by agedhippie on Nov 2, 2020 14:46:15 GMT -5
For the same reason that diabetics have been slow to convert to Afrezza - it's something they are familiar with. The difference in this case is that the doctors all know who UTHR is and are prescribing Tyvaso today so that trust is there. The doctors in turn will recommend it to the patients which will be the driver for migration. I would expect the doctors to move a few patients and see how they do before making a wholesale switch. I disagree oh Mr. agedhippee. It all comes down to money and the system. As long as it is superior and it can be proved superior? Is that the pipe dream? There is an element of trust and familiarity. If UTHR has produced good solution for their patients in the past then the doctors are inclined to give them the benefit of the doubt. That's not to say that they will drive an immediate switch, that's just a fantasy, but they will probably start to prescribe it to a few patients and see how it works in real life. Once they are happy with that they will start a faster switch. I expect UTHR will price it the same as Tyvaso to avoid pricing issues with the insurers since they don't care as long as their costs don't increase (as examples of this strategy Novolog -> Fiasp, Lantus - > Toujeo). That will ensure good coverage and minimal friction to the migration. |
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Post by mango on Nov 3, 2020 13:01:21 GMT -5
... I expect that transition to be fully completed in 2022. Why would any patient using the Tyvaso nebulizer say "no" to a more convenient dreamboat device they can use anywhere and with faster dosing ?... For the same reason that diabetics have been slow to convert to Afrezza - it's something they are familiar with. The difference in this case is that the doctors all know who UTHR is and are prescribing Tyvaso today so that trust is there. The doctors in turn will recommend it to the patients which will be the driver for migration. I would expect the doctors to move a few patients and see how they do before making a wholesale switch. They won’t have a choice. Tyvaso nebulizer is being phased out and replaced entirely with TreT according to Martine. |
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Post by agedhippie on Nov 5, 2020 17:35:18 GMT -5
For the same reason that diabetics have been slow to convert to Afrezza - it's something they are familiar with. The difference in this case is that the doctors all know who UTHR is and are prescribing Tyvaso today so that trust is there. The doctors in turn will recommend it to the patients which will be the driver for migration. I would expect the doctors to move a few patients and see how they do before making a wholesale switch. They won’t have a choice. Tyvaso nebulizer is being phased out and replaced entirely with TreT according to Martine. That's one way to do it! |
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