UTHR Tyvaso Approval

[sportsrancho]

Did they buy shares of Mannkind on the open market or did they get awarded shares for part of a transaction?

Big difference.

[neil36]

Interesting comments during the Q&A when asked about whether Tyvaso DPI would be marketed internationally.  


MC said that UTHR is focused exclusively on getting this right in the United States.  He said that UTHR could look at non-USA markets, but he framed that as unlikely.  Then he said that in their agreement, if UTHR decides not to pursue an international market, then MNKD could enter that market with Tyvaso DPI. It sounded like very low probability that it will be marketed internationally, but I thought it is an interesting provision of their collaboration agreement.

[neil36]

Here is a link to the 92 page user guide for the current Tyvaso nebulizer. Don’t have to scroll too far through it to get an appreciation for how much the DPI inhaler will simplify things.


www.tyvaso.com/pdf/TD300_instructions_for_use.pdf

[neil36]

TETON study enrolls first patient with IPF.  The study is expected to take 52 weeks.  IPF estimated to affect 100,000 patients.


ir.unither.com/news/press-releases/press-release-details/2021/United-Therapeutics-Announces-First-Patient-Enrolled-In-Phase-3-TETON-Study-Of-Tyvaso-In-Patients-With-Idiopathic-Pulmonary-Fibrosis/default.aspx

[Clement]

Jun 3, 2021 5:35:08 GMT -5 neil36 said:

TETON study enrolls first patient with IPF.  The study is expected to take 52 weeks.  IPF estimated to affect 100,000 patients.


ir.unither.com/news/press-releases/press-release-details/2021/United-Therapeutics-Announces-First-Patient-Enrolled-In-Phase-3-TETON-Study-Of-Tyvaso-In-Patients-With-Idiopathic-Pulmonary-Fibrosis/default.aspx

"Despite the availability of two approved products in the therapeutic category, there remains a critical unmet need in IPF," said Steven Nathan, M.D., the Medical Director of the Advanced Lung Disease and Lung Transplant Program at Inova Fairfax Hospital in Falls Church, Virginia, who is also chair of the TETON trial steering committee. Dr. Nathan further added, "We were pleasantly surprised to note the intriguing post-hoc analysis of safety data collected from the INCREASE study that showed a positive impact of inhaled treprostinil on FVC in IPF patients with pulmonary hypertension. In follow-up to this, the TETON study has been designed to validate the potential antifibrotic effects of inhaled treprostinil in IPF patients."

[Clement]

Re: TETON phase 3 clinical trial
Each subject (patient) is evaluated over a 52 week period.
396 subjects
just now enrolling first subject(s)
Uthr thinks long-term.
I think the following link is it (needs update): clinicaltrials.gov/ct2/show/NCT04708782?term=treprostinil&cond=IPF&draw=2&rank=1

[porkini]

Jun 3, 2021 7:40:29 GMT -5 Clement said:

Re: TETON phase 3 clinical trial
Each subject (patient) is evaluated over a 52 week period.
396 subjects
just now enrolling first subject(s)
Uthr thinks long-term.
I think the following link is it (needs update): clinicaltrials.gov/ct2/show/NCT04708782?term=treprostinil&cond=IPF&draw=2&rank=1

Sorry, I might be confused, the link you posted up is for inhaled with the nebulizer... now I will go try to read it more thorougly, thanks for the link!

[Clement]

Jun 4, 2021 9:46:23 GMT -5 porkini said:

Jun 3, 2021 7:40:29 GMT -5 Clement said:

Re: TETON phase 3 clinical trial
Each subject (patient) is evaluated over a 52 week period.
396 subjects
just now enrolling first subject(s)
Uthr thinks long-term.
I think the following link is it (needs update): clinicaltrials.gov/ct2/show/NCT04708782?term=treprostinil&cond=IPF&draw=2&rank=1

Sorry, I might be confused, the link you posted up is for inhaled with the nebulizer... now I will go try to read it more thorougly, thanks for the link!

Yes, TETON study is for Tyvaso-nebulizer. But, assuming it will be approved for this indication (PH-IPF), eventually this big market will open up for Tyvaso DPI.

[mango]

Things just keep looking worse and worse for Liquidia.




www.prnewswire.com/news-releases/united-therapeutics-pursues-new-claims-for-trade-secret-misappropriation-against-liquidia-301306478.html

[sportsrancho]

Thanks Mango!

[biffn]

I was wondering if this was going to happen. It was too much of a coincidence.

[longliner]

Negotiations for a buyout IMHO.  They are all to similar. (One happy family🤣)

[mango]

Wow.

✅ During discovery in the patent infringement case, United Therapeutics uncovered evidence that a former United Therapeutics employee took United Therapeutics' trade secrets when he left the company and joined Liquidia to develop LIQ861.

✅ The former employee, who was central to Tyvaso's development, brought to Liquidia confidential United Therapeutics documents, including confidential FDA submissions and detailed financial forecasts relating to Tyvaso.

✅ On June 4, 2021, United Therapeutics filed a motion alleging that Liquidia used these trade secrets in the development of LIQ861 and seeking permission from the court to pursue these additional claims based on this newly-discovered information.

✅ The case is currently scheduled for trial in March 2022.

www.prnewswire.com/news-releases/united-therapeutics-pursues-new-claims-for-trade-secret-misappropriation-against-liquidia-301306478.html

[factspls88]

Jun 7, 2021 11:56:06 GMT -5 mango said:

✅ The case is currently scheduled for trial in March 2022.

Not a moment too soon. 

[buyitonsale]

In March 2022 the MNKD short thesis will have been dead for about 3 months... after potential Tyvaso DPI approval and launch in December.

In my opinion, this trial will not effect the adoption of Tyvaso DPI even if ruled in favor of LQDA.

UTHR already has an existing PAH patient base and additional potential 30K new patients for PAH-ILD. They are projecting to double Tyvaso patients in 2022 and 70% conversion to Tyvaso DPI.

Looking forward to Tyvaso DPI acceptance by FDA and PDUFA date announcement... should be within 2 weeks from today.