UTHR BREEZE Trial NCT03950739

[spikespiegel]

It looks like United is going a step forward with its TrepT Trail


Open-label, Clinical Study to Evaluate the Safety and Tolerability of TreT in Subjects With PAH Currently Using Tyvaso (BREEZE)

Brief Summary:

This is a Phase 1b safety and tolerability single-sequence study in which PAH subjects on a stable regimen of Tyvaso will switch to a corresponding dose of TreT
link

If this is all what its needed as of the last 10Q, United is not far behind Liquidia

"Under our agreement with MannKind, we are responsible for global development, regulatory and commercial activities related to Treprostinil Technosphere, and we share manufacturing responsibilities with MannKind. We plan to commence a clinical study (called BREEZE) during the first half of 2019 to evaluate the safety and pharmacokinetics of switching PAH patients from Tyvaso to Treprostinil Technosphere, as well as a pharmacokinetic study in healthy volunteers. The FDA has indicated that these two studies, if successful, will be the only clinical studies necessary to support FDA approval."

Liquidia
Estimated Study Completion Date : July 31, 2020
United
Estimated Study Completion Date : August 2020

[spikespiegel]

IF the Trail starts in August, the production Site an Mannkind for the new Inhaler must be ready.
does this mean the next 12,5Mio$ are to pay an we get som revenue for products sold to United for the Trail?

[Clement]

What a relief to see this posted on clinicaltrials.gov! ..... not recruiting yet but at least it's posted!

[rossomalley]

Yes, thanks for posting, it is good news, but does anybody know what is going on with UT? Their SP hit a new low today, $89.33 IIRC. This unremitting slide is starting to make me anxious.

[ktim]

May 15, 2019 15:14:02 GMT -5 rossomalley said:

Yes, thanks for posting, it is good news, but does anybody know what is going on with UT? Their SP hit a new low today, $89.33 IIRC. This unremitting slide is starting to make me anxious.

Getting really beat up on looming competition.  A truly ugly stock chart.  With the TrepT story it could be a good investment once it finds support, but right now it seems to be in the category of catching a falling knife.

[boca1girl]

May 15, 2019 7:28:27 GMT -5 spikespiegel said:

IF the Trail starts in August, the production Site an Mannkind for the new Inhaler must be ready.
does this mean the next 12,5Mio$ are to pay an we get som revenue for products sold to United for the Trail?

They are building a separate line to produce TreT for trials and early production volume.  They don’t want any co-mingling of product.  UTHR may decide to contract MNKD for on going production volumes to avoid the cost.

[agedhippie]

May 15, 2019 15:25:02 GMT -5 ktim said:

May 15, 2019 15:14:02 GMT -5 rossomalley said:

Yes, thanks for posting, it is good news, but does anybody know what is going on with UT? Their SP hit a new low today, $89.33 IIRC. This unremitting slide is starting to make me anxious.

Getting really beat up on looming competition.  A truly ugly stock chart.  With the TrepT story it could be a good investment once it finds support, but right now it seems to be in the category of catching a falling knife.

A quarter of their revenue last year came from from Adcirca which is now off patent. Last quarter it was just 5% of revenue - generics tore that revenue stream apart.

[matt]

Generics have a predictable effect on sales and it is always negative, and the more successful a drug the more intense the competition. When Lipitor went off-patent it was a $14 billion a year drug, 18 months later Pfizer had lost 95% of that revenue and was doing just $700 million. Reformulating drugs for new delivery methods can buy the owner of the molecule some extra years of patent life which is why TS holds value for partnering of novel drugs, but not much value for already generic medications like epinephrine.

[travis1953]

I read somewhere that tre-t couldn't expect an NDA until 2022-2023 -- is that correct? Why so long? I saw Liquidia reporting phase 3 results back in March and claiming its NDA was coming this fall -- how'd they get so far so fast?