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Post by akemp3000 on May 5, 2021 6:07:10 GMT -5
Please offer input on this new 8K filed this morning...
Tyvaso in chronic fibrosing interstitial lung diseases — TETON. We are launching a new phase 3 program called TETON, which will be comprised of one or more phase 3 studies of Tyvaso in subjects with various forms of chronic fibrosing interstitial lung diseases, including patients with idiopathic interstitial pneumonias (IIP), chronic hypersensitivity pneumonitis (CHP), and environmental/occupational lung disease. The first TETON study is designed to enroll subjects with IPF. The primary endpoint of this study is the change in absolute forced vital capacity (FVC) from baseline to week 52. We expect to start patient enrollment in this study in the second quarter of 2021.The TETON program was prompted by data from the INCREASE study, which demonstrated improvements in certain key parameters of lung function in pulmonary hypertension patients with fibrotic lung disease. Specifically, in the INCREASE study, treatment with Tyvaso resulted in significant improvements in percent predicted FVC at weeks 8 and 16, with subjects having underlying etiologies of IIP showing greater improvement. Consistent positive effects were also observed in patients with CHP and environmental/occupational lung disease. These data points, combined with substantial preclinical evidence of antifibrotic activity of treprostinil, suggest that Tyvaso may offer a treatment option for patients with fibrotic lung disease. Tyvaso in PH-COPD — PERFECT. Enrollment is ongoing for the phase 3 PERFECT study
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Post by hellodolly on May 5, 2021 6:59:07 GMT -5
Is this required to expand the label use? I'm not that familiar with lung diseases.
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Post by akemp3000 on May 5, 2021 7:06:13 GMT -5
If not mistaken, this could be the third indication for Tyvaso and with a significantly larger potential patient base than the first two. If so, the significance of the relationship between UTHR and Mannkind increases once again. Comments to clarify or provide opinions on the potential significance of this would be appreciated.
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Post by uvula on May 5, 2021 7:17:53 GMT -5
TETON, PERFECT. Why do companies insist on giving their studies silly names that don't have any connection to the thing being studied?
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Post by veritasfiliatemporis on May 5, 2021 7:38:10 GMT -5
MICKEY DONALD MOUSE MINNIE DUCK
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Post by mango on May 5, 2021 12:17:42 GMT -5
If not mistaken, this could be the third indication for Tyvaso and with a significantly larger potential patient base than the first two. If so, the significance of the relationship between UTHR and Mannkind increases once again. Comments to clarify or provide opinions on the potential significance of this would be appreciated. Martine Rothblatt, CEO of UT specifically discussed using Tyvaso DPI for PH-COPD in a recent presentation or call—cannot remember which it was. I wrote about it at the time. We will have 3 years exclusivity when this happens, as well as, zero competition as we would be the very first and only FDA approved treatment option for PH-COPD. |
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Post by jlaw277 on May 5, 2021 13:46:08 GMT -5
If not mistaken, this could be the third indication for Tyvaso and with a significantly larger potential patient base than the first two. If so, the significance of the relationship between UTHR and Mannkind increases once again. Comments to clarify or provide opinions on the potential significance of this would be appreciated. Martine Rothblatt, CEO of UT specifically discussed using Tyvaso DPI for PH-COPD in a recent presentation or call—cannot remember which it was. I wrote about it at the time. We will have 3 years exclusivity when this happens, as well as, zero competition as we would be the very first and only FDA approved treatment option for PH-COPD. Wouldn't it get 7-year exclusivity? Tyvaso for COPD would seem to fit the criteria for ODD being the first FDA approved treatment for PH-COPD. ===== SILVER SPRING, Md. and RESEARCH TRIANGLE PARK, N.C., Dec. 9, 2020 /PRNewswire/ -- United Therapeutics Corporation (Nasdaq: UTHR) announced today that the United States Food and Drug Administration (FDA) has granted orphan drug designation to treprostinil for the treatment of patients with idiopathic pulmonary fibrosis (IPF). United Therapeutics intends to initiate a phase 3 study, called TETON, to evaluate the use of Tyvaso® (treprostinil) Inhalation Solution in patients with IPF. FDA recently cleared United Therapeutics' investigational new drug application (IND) for the TETON study, and the company expects to commence enrollment in 2021. Orphan drug designation is the first step in receiving orphan drug exclusivity following approval, which confers seven years of market exclusivity for the relevant indication. This exclusivity would also benefit Treprostinil Technosphere®, United Therapeutics' next-generation dry powder inhalation form of treprostinil, upon FDA approval of that product for the IPF indication. "We're excited that treprostinil has received orphan drug designation, as it validates our drive to address orphan diseases, like IPF, with a significant unmet need," said Martine Rothblatt, Ph.D., Chairman and Chief Executive Officer of United Therapeutics. "TETON represents a significant move outside the pulmonary hypertension space, but based on data collected during the recent INCREASE study we're confident that inhaled treprostinil can help address clinical gaps presented by existing therapies in IPF." Orphan drug designation is granted by the FDA Office of Orphan Products Development (OOPD) to advance the evaluation and development of safe and effective therapies for the treatment of rare diseases or conditions affecting fewer than 200,000 people in the U.S. Under the Orphan Drug Act, FDA may provide grant funding toward clinical trial costs, tax advantages, FDA user-fee benefits, and seven years of market exclusivity in the United States following marketing approval by FDA. The granting of an orphan drug designation request does not alter the standard regulatory requirements and process for obtaining marketing approval. For more information about orphan drug designation, please visit the OOPD |
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Post by mytakeonit on May 5, 2021 14:07:11 GMT -5
TETON, PERFECT. Why do companies insist on giving their studies silly names that don't have any connection to the thing being studied? I guess you haven't heard of Grand Teton  Makes perfect sense to me. But what would an asian guy living in Hawaii know But, that's mytakeonit |
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Post by ktim on May 5, 2021 14:07:55 GMT -5
TETON, PERFECT. Why do companies insist on giving their studies silly names that don't have any connection to the thing being studied? It's common in engineering world as well, especially when sponsored research. In our world they were capitalized because they were clever, or tortured, acronyms somehow related to the topic. I still remember program acronyms from decades ago, despite not being able to remember the full name which it represented. So I guess one answer might be ease of remembering. |
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Post by buyitonsale on May 5, 2021 15:30:14 GMT -5
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Post by longliner on May 5, 2021 16:02:36 GMT -5
Once initial approval for Tyvaso DPI is reached in December the earnings trajectory for Mannkind should be impressive going forward. |
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Makes perfect sense to me. But what would an asian guy living in Hawaii know 
