|
Post by brotherm1 on Feb 24, 2020 10:04:18 GMT -5
I’m a little slow this morning yet, though I don’t see how improvements to their pump system and pre-filled cassettes for it will help MNKD
|
|
|
Post by mango on Feb 24, 2020 10:12:59 GMT -5
I’m a little slow this morning yet, though I don’t see how improvements to their pump system and pre-filled cassettes for it will help MNKD This directly affects MannKind: 2/24/20 United Therapeutics Announces INCREASE Study Of Tyvaso® Meets Primary And All Secondary Endpoints~ First pivotal clinical trial to demonstrate a benefit in PH-ILD ~ ~ NDA supplement to be filed by mid-year SILVER SPRING, Md. and RESEARCH TRIANGLE PARK, N.C., Feb. 24, 2020 /PRNewswire/ -- United Therapeutics Corporation (NASDAQ: UTHR) today announced that preliminary analysis indicates that the INCREASE clinical study of Tyvaso® (treprostinil) Inhalation Solution in patients suffering from World Health Organization (WHO) Group 3 pulmonary hypertension associated with interstitial lung disease (PH-ILD) has met its primary efficacy endpoint of demonstrating improvement in six-minute walk distance (6MWD). Tyvaso increased six-minute walk distance by 21 meters versus placebo (p=0.0043, Hodges-Lehmann estimate) after 16 weeks of treatment. Benefits of Tyvaso were observed across several key subgroups, including etiology of PH-ILD, disease severity, age, gender, baseline hemodynamics, and dose. Significant improvements were also observed in each of the study's secondary endpoints including reduction in the cardiac biomarker NT-proBNP, time to first clinical worsening event, change in peak 6MWD at Week 12, and change in trough 6MWD at week 15. Treatment with Tyvaso of up to 12 breaths per session, four times daily, in the INCREASE study was well tolerated and the safety profile was consistent with previous Tyvaso studies in PAH and known prostacyclin-related adverse events (see the discussion of adverse events below under "About Tyvaso"). "Patients with both interstitial lung disease and pulmonary hypertension have worse clinical trajectories and earlier death than patients with interstitial lung disease alone. There are currently no approved therapies for these patients and so there is a tremendous unmet need," said Aaron Waxman, M.D., Ph.D., Director of the Pulmonary Vascular Disease Program at Brigham and Women's Hospital and the chair of the INCREASEStudy Steering Committee. "This is the largest clinical trial in this population, and the first to demonstrate a clear benefit. As a clinician, I look forward to soon having an approved treatment to offer these patients with this life-threatening disease." "I am pleased to announce the successful outcome of the INCREASE phase III trial of Tyvaso in a unique kind of pulmonary hypertension, a variant that has no approved therapy," said Martine Rothblatt, Ph.D., Chairman and Chief Executive Officer of United Therapeutics. "Some 30,000 Americans suffer from this disease, called WHO Group 3 Pulmonary Hypertension. It is a tremendous testament to our head of product development, Dr. Leigh Peterson, that her team used the unique characteristics of our inhaled medicine to achieve a highly statistically significant proof of efficacy while seeming to avoid the safety issues that have plagued systemic therapeutics." "The results of the INCREASE study present a powerful message of efficacy in the interstitial lung disease patient population," said Gil Golden, M.D., Ph.D., Chief Medical Officer of United Therapeutics. "I congratulate the patients and families who participated in this study, along with our principal investigators who produced a clear outcome that we think could change the lives of ten times the number of patients who are on Tyvaso today. This is what we mean at United Therapeutics when we say we 'identify the corridors of indifference and run like hell down them.'" United Therapeutics plans to submit the results to the U.S. Food and Drug Administration by mid-year in support of an efficacy supplement that is expected to result in revised labeling that reflects the outcome of the INCREASE study. -------------------------------------------------------------------------------- There is currently no FDA approved medication for PH-ILD (pulmonary hypertension associated with interstitial lung disease) and Tyvaso will soon become the very first one. Once TreT is approved, those patients will move to the new therapy, Technosphere Treprostinil, significantly increasing the patient base and thus significantly increasing royalties. 😎 ir.unither.com/file/Index?KeyFile=402936972
|
|
Deleted
Deleted Member
Posts: 0
|
Post by Deleted on Feb 24, 2020 10:31:35 GMT -5
I’m a little slow this morning yet, though I don’t see how improvements to their pump system and pre-filled cassettes for it will help MNKD You're looking at a different press release. The one you are thinking about is United Therapeutics and DEKA Announce Additional FDA Clearance Related to the Unity Subcutaneous Delivery System for Remodulin®. This is their New Pump. The other press release (INCREASE Trial) is for the treatment of PH-ILD with Tyvaso. This could be another indication for TreT which will triple MNKD's royalties if approved.
|
|
|
Post by sellhighdrinklow on Feb 24, 2020 10:39:01 GMT -5
Veins of gold....?
|
|
|
Post by brotherm1 on Feb 24, 2020 10:53:48 GMT -5
DOW currently down 2.78%. UTHR up 7.50%
|
|
|
Post by brotherm1 on Feb 24, 2020 11:29:07 GMT -5
I’m a little slow this morning yet, though I don’t see how improvements to their pump system and pre-filled cassettes for it will help MNKD This directly affects MannKind: 2/24/20 United Therapeutics Announces INCREASE Study Of Tyvaso® Meets Primary And All Secondary Endpoints~ First pivotal clinical trial to demonstrate a benefit in PH-ILD ~ ~ NDA supplement to be filed by mid-year SILVER SPRING, Md. and RESEARCH TRIANGLE PARK, N.C., Feb. 24, 2020 /PRNewswire/ -- United Therapeutics Corporation (NASDAQ: UTHR) today announced that preliminary analysis indicates that the INCREASE clinical study of Tyvaso® (treprostinil) Inhalation Solution in patients suffering from World Health Organization (WHO) Group 3 pulmonary hypertension associated with interstitial lung disease (PH-ILD) has met its primary efficacy endpoint of demonstrating improvement in six-minute walk distance (6MWD). Tyvaso increased six-minute walk distance by 21 meters versus placebo (p=0.0043, Hodges-Lehmann estimate) after 16 weeks of treatment. Benefits of Tyvaso were observed across several key subgroups, including etiology of PH-ILD, disease severity, age, gender, baseline hemodynamics, and dose. Significant improvements were also observed in each of the study's secondary endpoints including reduction in the cardiac biomarker NT-proBNP, time to first clinical worsening event, change in peak 6MWD at Week 12, and change in trough 6MWD at week 15. Treatment with Tyvaso of up to 12 breaths per session, four times daily, in the INCREASE study was well tolerated and the safety profile was consistent with previous Tyvaso studies in PAH and known prostacyclin-related adverse events (see the discussion of adverse events below under "About Tyvaso"). "Patients with both interstitial lung disease and pulmonary hypertension have worse clinical trajectories and earlier death than patients with interstitial lung disease alone. There are currently no approved therapies for these patients and so there is a tremendous unmet need," said Aaron Waxman, M.D., Ph.D., Director of the Pulmonary Vascular Disease Program at Brigham and Women's Hospital and the chair of the INCREASEStudy Steering Committee. "This is the largest clinical trial in this population, and the first to demonstrate a clear benefit. As a clinician, I look forward to soon having an approved treatment to offer these patients with this life-threatening disease." "I am pleased to announce the successful outcome of the INCREASE phase III trial of Tyvaso in a unique kind of pulmonary hypertension, a variant that has no approved therapy," said Martine Rothblatt, Ph.D., Chairman and Chief Executive Officer of United Therapeutics. "Some 30,000 Americans suffer from this disease, called WHO Group 3 Pulmonary Hypertension. It is a tremendous testament to our head of product development, Dr. Leigh Peterson, that her team used the unique characteristics of our inhaled medicine to achieve a highly statistically significant proof of efficacy while seeming to avoid the safety issues that have plagued systemic therapeutics." "The results of the INCREASE study present a powerful message of efficacy in the interstitial lung disease patient population," said Gil Golden, M.D., Ph.D., Chief Medical Officer of United Therapeutics. "I congratulate the patients and families who participated in this study, along with our principal investigators who produced a clear outcome that we think could change the lives of ten times the number of patients who are on Tyvaso today. This is what we mean at United Therapeutics when we say we 'identify the corridors of indifference and run like hell down them.'" United Therapeutics plans to submit the results to the U.S. Food and Drug Administration by mid-year in support of an efficacy supplement that is expected to result in revised labeling that reflects the outcome of the INCREASE study. -------------------------------------------------------------------------------- There is currently no FDA approved medication for PH-ILD (pulmonary hypertension associated with interstitial lung disease) and Tyvaso will soon become the very first one. Once TreT is approved, those patients will move to the new therapy, Technosphere Treprostinil, significantly increasing the patient base and thus significantly increasing royalties. 😎 ir.unither.com/file/Index?KeyFile=402936972Mango, you know more about this than I do. Are you certain though that patients with both PAH and interstitial lung disease will be able to use MNKD’s inhaler? I don’t know much about ILD, though I think patients with it have an intractable cough?
|
|
|
Post by mango on Feb 24, 2020 11:47:09 GMT -5
This directly affects MannKind: 2/24/20 United Therapeutics Announces INCREASE Study Of Tyvaso® Meets Primary And All Secondary Endpoints~ First pivotal clinical trial to demonstrate a benefit in PH-ILD ~ ~ NDA supplement to be filed by mid-year SILVER SPRING, Md. and RESEARCH TRIANGLE PARK, N.C., Feb. 24, 2020 /PRNewswire/ -- United Therapeutics Corporation (NASDAQ: UTHR) today announced that preliminary analysis indicates that the INCREASE clinical study of Tyvaso® (treprostinil) Inhalation Solution in patients suffering from World Health Organization (WHO) Group 3 pulmonary hypertension associated with interstitial lung disease (PH-ILD) has met its primary efficacy endpoint of demonstrating improvement in six-minute walk distance (6MWD). Tyvaso increased six-minute walk distance by 21 meters versus placebo (p=0.0043, Hodges-Lehmann estimate) after 16 weeks of treatment. Benefits of Tyvaso were observed across several key subgroups, including etiology of PH-ILD, disease severity, age, gender, baseline hemodynamics, and dose. Significant improvements were also observed in each of the study's secondary endpoints including reduction in the cardiac biomarker NT-proBNP, time to first clinical worsening event, change in peak 6MWD at Week 12, and change in trough 6MWD at week 15. Treatment with Tyvaso of up to 12 breaths per session, four times daily, in the INCREASE study was well tolerated and the safety profile was consistent with previous Tyvaso studies in PAH and known prostacyclin-related adverse events (see the discussion of adverse events below under "About Tyvaso"). "Patients with both interstitial lung disease and pulmonary hypertension have worse clinical trajectories and earlier death than patients with interstitial lung disease alone. There are currently no approved therapies for these patients and so there is a tremendous unmet need," said Aaron Waxman, M.D., Ph.D., Director of the Pulmonary Vascular Disease Program at Brigham and Women's Hospital and the chair of the INCREASEStudy Steering Committee. "This is the largest clinical trial in this population, and the first to demonstrate a clear benefit. As a clinician, I look forward to soon having an approved treatment to offer these patients with this life-threatening disease." "I am pleased to announce the successful outcome of the INCREASE phase III trial of Tyvaso in a unique kind of pulmonary hypertension, a variant that has no approved therapy," said Martine Rothblatt, Ph.D., Chairman and Chief Executive Officer of United Therapeutics. "Some 30,000 Americans suffer from this disease, called WHO Group 3 Pulmonary Hypertension. It is a tremendous testament to our head of product development, Dr. Leigh Peterson, that her team used the unique characteristics of our inhaled medicine to achieve a highly statistically significant proof of efficacy while seeming to avoid the safety issues that have plagued systemic therapeutics." "The results of the INCREASE study present a powerful message of efficacy in the interstitial lung disease patient population," said Gil Golden, M.D., Ph.D., Chief Medical Officer of United Therapeutics. "I congratulate the patients and families who participated in this study, along with our principal investigators who produced a clear outcome that we think could change the lives of ten times the number of patients who are on Tyvaso today. This is what we mean at United Therapeutics when we say we 'identify the corridors of indifference and run like hell down them.'" United Therapeutics plans to submit the results to the U.S. Food and Drug Administration by mid-year in support of an efficacy supplement that is expected to result in revised labeling that reflects the outcome of the INCREASE study. -------------------------------------------------------------------------------- There is currently no FDA approved medication for PH-ILD (pulmonary hypertension associated with interstitial lung disease) and Tyvaso will soon become the very first one. Once TreT is approved, those patients will move to the new therapy, Technosphere Treprostinil, significantly increasing the patient base and thus significantly increasing royalties. 😎 ir.unither.com/file/Index?KeyFile=402936972Mango, you know more about this than I do. Are you certain though that patients with both PAH and interstitial lung disease will be able to use MNKD’s inhaler? I don’t know much about ILD, though I think patients with it have an intractable cough? Don't see it being an issue at all, especially if they inhale correctly. It will be a world of difference compared to the Tyvaso inhalation system!
|
|
|
Post by brotherm1 on Feb 24, 2020 12:21:11 GMT -5
From the study: “Active Comparator: Active Inhaled Treprostinil Active Treprostinil for inhalation solution (0.6 mg/mL) delivered via an ultrasonic nebulizer which emits a dose of approximately 6 mcg per breath. Inhaled four times daily and titrated up to a maximum of 12 breaths four times daily.” Would you know if UTHR started testing this with MNKD’s inhaler? clinicaltrials.gov/ct2/show/NCT02630316
|
|
|
Post by harryx1 on Feb 24, 2020 12:37:16 GMT -5
From the study: “Active Comparator: Active Inhaled Treprostinil Active Treprostinil for inhalation solution (0.6 mg/mL) delivered via an ultrasonic nebulizer which emits a dose of approximately 6 mcg per breath. Inhaled four times daily and titrated up to a maximum of 12 breaths four times daily.” Would you know if UTHR started testing this with MNKD’s inhaler? clinicaltrials.gov/ct2/show/NCT02630316
|
|
|
Post by mango on Feb 24, 2020 12:43:30 GMT -5
From the study: “Active Comparator: Active Inhaled Treprostinil Active Treprostinil for inhalation solution (0.6 mg/mL) delivered via an ultrasonic nebulizer which emits a dose of approximately 6 mcg per breath. Inhaled four times daily and titrated up to a maximum of 12 breaths four times daily.” Would you know if UTHR started testing this with MNKD’s inhaler? clinicaltrials.gov/ct2/show/NCT02630316They are currently engaged in a clinical trial called, BREEZE. They are not required to do this with TreT for the PH-ILD as the two are bio equivalent and interchangeable. Patients will simply be transitioned over to the TreT inhalation system. All patients on Tyvaso will eventually be transitioned over to TreT (per Martine Rothblatt on multiple conference calls).
|
|
|
Post by brotherm1 on Feb 24, 2020 13:08:25 GMT -5
Then we should hear about it during our conference call tomorrow
|
|
|
Post by ktim on Feb 24, 2020 13:28:09 GMT -5
From the study: “Active Comparator: Active Inhaled Treprostinil Active Treprostinil for inhalation solution (0.6 mg/mL) delivered via an ultrasonic nebulizer which emits a dose of approximately 6 mcg per breath. Inhaled four times daily and titrated up to a maximum of 12 breaths four times daily.” Would you know if UTHR started testing this with MNKD’s inhaler? clinicaltrials.gov/ct2/show/NCT02630316They are currently engaged in a clinical trial called, BREEZE. They are not required to do this with TreT for the PH-ILD as the two are bio equivalent and interchangeable. Patients will simply be transitioned over to the TreT inhalation system. All patients on Tyvaso will eventually be transitioned over to TreT (per Martine Rothblatt on multiple conference calls). Given that TreT is going through 505(b)(2) route, that means it wasn't deemed bio equivalent. If it were deemed bio equivalent it would have been done as ANDA under 505(j). How TreT might be treated by FDA for indications not studied in BREEZE, but that become an approved indication for Tyvaso in the meantime, I do not know whether there is issued guidance addressing it.
|
|
|
Post by mango on Feb 24, 2020 13:49:54 GMT -5
They are currently engaged in a clinical trial called, BREEZE. They are not required to do this with TreT for the PH-ILD as the two are bio equivalent and interchangeable. Patients will simply be transitioned over to the TreT inhalation system. All patients on Tyvaso will eventually be transitioned over to TreT (per Martine Rothblatt on multiple conference calls). Given that TreT is going through 505(b)(2) route, that means it wasn't deemed bio equivalent. If it were deemed bio equivalent it would have been done as ANDA under 505(j). How TreT might be treated by FDA for indications not studied in BREEZE, but that become an approved indication for Tyvaso in the meantime, I do not know whether there is issued guidance addressing it. Oh I see what you're saying...Well, regardless, all Tyvaso patients will be transitioned over to TreT and Tyvaso will be fazed out—and that is coming directly from the source itself (Martine Rothblatt). Doesn't matter to me what path they choose to take, what it's happening regardless.
|
|
|
Post by rravis1914 on Feb 24, 2020 13:54:10 GMT -5
We are being showered with good news!!
Remember Showers bring flowers. It is good to see my garden grow.
Anybody have an insight on GNPX?? It is on a tear these several days.
|
|
|
Post by mango on Feb 24, 2020 13:56:50 GMT -5
The 505(b)(2) new drug application (NDA) is one of three U.S. Food and Drug Administration (FDA) drug approval pathways and represents an appealing regulatory strategy for many clients. The pathway was created by the Hatch-Waxman Amendments of 1984, with 505(b)(2) referring to a section of the Federal Food, Drug, and Cosmetic Act. The provisions of 505(b)(2) were created, in part, to help avoid unnecessary duplication of studies already performed on a previously approved (“reference” or “listed”) drug; the section gives the FDA express permission to rely on data not developed by the NDA applicant[/u]. A 505(b)(2) NDA contains full safety and effectiveness reports but allows at least some of the information required for NDA approval, such as safety and efficacy information on the active ingredient, to come from studies not conducted by or for the applicant. This can result in a much less expensive and much faster route to approval, compared with a traditional development path [such as 505(b)(1)], while creating new, differentiated products with tremendous commercial value.camargopharma.com/what-is-505b2
|
|