United Therapeutics' Trevyent NDA for PAH Accepted by FDA

[thekindaguyiyam]

United Therapeutics' Trevyent NDA for PAH Accepted by FDA
September 12, 2019, 11:25:00 AM EDT By Zacks Equity Research, Zacks.com


United Therapeutics Corporation 's UTHR new drug application for its drug-device combination product, Trevyent, was accepted for review by the FDA. The FDA is expected to give its decision on Trevyent NDA on Apr 27, 2020.

Trevyent is a single-use, pre-filled pump that has been developed by SteadyMed to deliver a two-day supply of treprostinil subcutaneously using SteadyMed's PatchPump technology to treat pulmonary arterial hypertension (PAH). Trevyent was added to United Therapeutics' portfolio following the August 2018 merger with SteadyMed.

In 2017, SteadyMed received a refuse-to-file letter from the FDA for Trevyent NDA for want of further information. United Therapeutics resubmitted the NDA in June 2019.

United Therapeutics markets treprostinil under the trade name Remodulin as an injectable formulation, Orenitram for oral use, and Tyvaso as an inhaled formulation to treat PAH.

Shares of United Therapeutics have declined 23.9% this year so far against the industry 's increase of 5.4%.



United Therapeutics has developed another pre-filled, semi-disposable pump system, RemUnity for subcutaneous delivery of Remodulin in partnership with DEKA. In February 2018, DEKA filed RemUnity with the FDA (510(k) filing) that was cleared by the FDA in May 2019. United Therapeutics intends to launch the product after it gets an FDA clearance for a special 510(k) filing, which DEKA plans to submit to the FDA shortly.

RemUnity and Trevyent, if approved, will provide two expanded options for patients on subcutaneous Remodulin.

United Therapeutics has also developed Remodulin Injection in the Implantable System for Remodulin (ISR) in collaboration with Medtronic MDT . It gained FDA approval for this implantable pump for delivering Remodulin intravenously in July 2018.

United Therapeutics and Medtronic pursued parallel regulatory filings related to the device and the drug. The system has been developed to eliminate two biggest problems with Remodulin, subcutaneous pain and life-threatening sepsis risk. The company expects to launch ISR in 2020. RemoPro, a pain-free subcutaneous Remodulin prodrug, is in phase I studies.

In 2018/early 2019, United Therapeutics signed four major agreements to acquire new product candidates including Trevyent.

In January 2019, United Therapeutics acquired worldwide rights to manufacture and develop/commercialize Arena Pharmaceuticals' ARNA oral, potent, once-daily IP receptor agonist ralinepag. Ralinepag is being developed in late-stage studies for PAH.

In October 2018, United Therapeutics in-licensed MannKind's MNKD phase III-ready investigational drug-device combination product, Treprostinil Technosphere. The product combines MannKind's dry inhalation technology with treprostinil for the treatment of PAH. In September, it in-licensed the U.S. and Canadian rights to Samumed's SM04646, a phase I development-stage oral Wnt pathway inhibitor, to treat idiopathic pulmonary fibrosis.

www.nasdaq.com/article/united-therapeutics-trevyent-nda-for-pah-accepted-by-fda-cm1211281

[mytakeonit]

With all the good news coming out ... it is difficult for me to believe that $1.60 warrants can hold the pps down. Should the pps take off, wouldn't the warrants be eliminated?

Only warrants I know of ... is when the sheriff is at your door.  And yes, the warrants will be eliminated.

But, that's mytakeonit

[aceton3]

Sept 12, 2019 15:15:49 GMT -5 mytakeonit said:

With all the good news coming out ... it is difficult for me to believe that $1.60 warrants can hold the pps down. Should the pps take off, wouldn't the warrants be eliminated?

Only warrants I know of ... is when the sheriff is at your door.  And yes, the warrants will be eliminated.

But, that's mytakeonit

The warrants should only suppress the price through the volume they represent. If there are 10 million shares represented by warrants pricing shares at 1.60, you'd need at least 10 million +1 shares in buy volume to get above the plateau. No?

[uvula]

This "good news" is for a drug that competes with mnkd's PAH drug.

[peppy]

Trevyent is a single-use, pre-filled pump that has been developed by SteadyMed to deliver a two-day supply of treprostinil subcutaneously using SteadyMed's PatchPump technology to treat pulmonary arterial hypertension (PAH).

Remodulin® (treprostinil) Injection

Tyvaso® (treprostinil) inhalation solution

ORENITRAM (treprostinil) extended-release tablets,
=========================================================================

same chit given four ways soon to be five ways.

[paul]

I presume Wall Street wasn't impressed since UTHR got nailed pretty hard today -- down almost 4%.

[wsulylecoug]

Sept 12, 2019 16:24:26 GMT -5 uvula said:

This "good news" is for a drug that competes with mnkd's PAH drug.

Let's not forget that the classifications of PAH WHO Groups 2 and 3 are relatively new and described as virgin territory by Martine, not to mention patient populations that are far greater than Group 1. While it would be pretty great to think that TreT could/would be effective for every person with PAH, that seems a bit unreasonable. I doubt Ralinepag will be the magic bullet either. The different WHO groups at different stages of progression may all react differently to each treatment. These deals for different methods of delivery of treprostinil aren't new info to Martine and she hasn't backed down from her message of TreT playing a big part in the future growth of UTHR. 

[peppy]

Sept 12, 2019 17:40:01 GMT -5 wsulylecoug said:

Sept 12, 2019 16:24:26 GMT -5 uvula said:

This "good news" is for a drug that competes with mnkd's PAH drug.

Let's not forget that the classifications of PAH WHO Groups 2 and 3 are relatively new and described as virgin territory by Martine, not to mention patient populations that are far greater than Group 1. While it would be pretty great to think that TreT could/would be effective for every person with PAH, that seems a bit unreasonable. I doubt Ralinepag will be the magic bullet either. The different WHO groups at different stages of progression may all react differently to each treatment. These deals for different methods of delivery of treprostinil aren't new info to Martine and she hasn't backed down from her message of TreT playing a big part in the future growth of UTHR. 

was UTHR losing some patents?
Technosphere Treprostnil is a new patent.

[wsulylecoug]

Sept 12, 2019 17:49:08 GMT -5 peppy said:

Sept 12, 2019 17:40:01 GMT -5 wsulylecoug said:

Let's not forget that the classifications of PAH WHO Groups 2 and 3 are relatively new and described as virgin territory by Martine, not to mention patient populations that are far greater than Group 1. While it would be pretty great to think that TreT could/would be effective for every person with PAH, that seems a bit unreasonable. I doubt Ralinepag will be the magic bullet either. The different WHO groups at different stages of progression may all react differently to each treatment. These deals for different methods of delivery of treprostinil aren't new info to Martine and she hasn't backed down from her message of TreT playing a big part in the future growth of UTHR. 

was UTHR losing some patents?
Technosphere Treprostnil is a new patent.

I believe so, don't know which ones though. Not sure I'm following you...

[peppy]

Sept 12, 2019 18:13:14 GMT -5 wsulylecoug said:

Sept 12, 2019 17:49:08 GMT -5 peppy said:

was UTHR losing some patents?
Technosphere Treprostnil is a new patent.

I believe so, don't know which ones though. Not sure I'm following you...

UTHR is losing some revenue when their products go off patent, UTHR revenue increases with the new patents. 

from the post you responded to, 
"These deals for different methods of delivery of treprostinil aren't new info to Martine and she hasn't backed down from her message of TreT playing a big part in the future growth of UTHR. "

[wsulylecoug]

Sept 12, 2019 18:16:56 GMT -5 peppy said:

Sept 12, 2019 18:13:14 GMT -5 wsulylecoug said:

I believe so, don't know which ones though. Not sure I'm following you...

UTHR is losing some revenue when their products go off patent, UTHR revenue increases with the new patents. 

True...my original post was in regard to what appeared to be a boo-bird being disappointed with the NDA for Trevyent as if it's going to take significant revenue away from TreT. I think there's lots of treatment potential for TreT to see minimal effect from this event. That's all I'm getting at. 

[peppy]

Sept 12, 2019 18:21:46 GMT -5 wsulylecoug said:

Sept 12, 2019 18:16:56 GMT -5 peppy said:

UTHR is losing some revenue when their products go off patent, UTHR revenue increases with the new patents. 

True...my original post was in regard to what appeared to be a boo-bird being disappointed with the NDA for Trevyent as if it's going to take significant revenue away from TreT. I think there's lots of treatment potential for TreT to see minimal effect from this event. That's all I'm getting at. 

agreed, our delivery system is superior.
Pulmonary veins and arteries and all. 

[uvula]

If TreT was around before the pump version Martine would never have bothered with the pump version and would never have aquired the pump company. Eventually TreT will take over but in the meantime uthr has to keep pushing the pump. Today's news is about the pump which indirectly helps mnkd because it helps keep uthr in business.

[ktim]

Sept 12, 2019 18:45:19 GMT -5 uvula said:

If TreT was around before the pump version Martine would never have bothered with the pump version and would never have aquired the pump company. Eventually TreT will take over but in the meantime uthr has to keep pushing the pump. Today's news is about the pump which indirectly helps mnkd because it helps keep uthr in business.

By virtue of the fact that someone bothered to develop an extended release tablet form, it seems that this isn't as cut and dried as you're presenting.  One would conclude there are some circumstances when an extended release (ER tablet or 2 day infusion) fits the need better than inhale and rapid absorption... or so it would logically seem to me.  Is UTHR actually saying that TreT will replace all these other modalities rather than just being a replacement for their existing inhaled Trep?  Being a replacement for nebulized Trep (especially with potential for expanded indication) seems great opportunity even without need to spin it as replacement for the extended dosing options.

Caveat, I know comparatively little about treatment regimes for PAH and when the different Trep options are used.  Eager to learn more about it, though.

[mnholdem]

Both MannKind and United touted the safety benefits of TrepT, particularly that the Phase 2 test results demonstrated that a larger dose of Treprostinil could be administered via the MannKind delivery mechanism. This equates to less daily doses and less hassle, including not having to regularly clean equipment.