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Theratechnologies Inc T.TH

Alternate Symbol(s):  THTX

Theratechnologies Inc. is a Canada-based clinical-stage biopharmaceutical company. The Company is focused on the development and commercialization of therapies addressing unmet medical needs. It markets prescription products for people with human immunodeficiency viruses (HIV) in the United States. The Company's research pipeline focuses on specialized therapies addressing unmet medical needs in HIV, nonalcoholic steatohepatitis (NASH) and oncology. Its medicines include Trogarzo and EGRIFTA SV (tesamorelin for injection). Trogarzo (ibalizumab-uiyk) injection is a long-acting monoclonal antibody which binds to domain 2 of the CD4 T cell receptors. EGRIFTA SV (tesamorelin for injection) is approved in the United States for the reduction of excess abdominal fat in people with HIV who have lipodystrophy. Its portfolio includes Phase I clinical trial of sudocetaxel zendusortide (TH1902), a novel peptide-drug conjugate (PDC), in patients with advanced ovarian cancer.


TSX:TH - Post by User

Bullboard Posts
Comment by bfwon Apr 03, 2019 3:53pm
83 Views
Post# 29578257

RE:RE:RE:RE:RE:RE:RE:RE:RE:RE:RE:If I understand well....

RE:RE:RE:RE:RE:RE:RE:RE:RE:RE:RE:If I understand well....
Yes.

It is all here.

https://www.madrigalpharma.com/wp-content/uploads/2018/11/MGL-3196-Plenary-presentation-Nov-10-NASDAQ.pdf

bfw



SPCEO1 wrote: Great info from all of you - thanks! 

TH's fat at baseline was 13.8% or 14% if you are going to round it off. 

Also, should it not be easier to lose a greater percent of fat when you start with more in the first place (20% in MDGL's case vs 14% for TH)? Then you have the issue of fat accumulation is a bigger issue among HIV patients and therefore may be harder to eliminate as JFM pointed out.

The other data yet to be released is going to be important in this debate. I think the company gave us a hint that htere may be more good info to come when they noted that 35% ended up with fat under 5%. There is a whole lot of good that comes from that in metabollic and cardiovascular terms. Did MDGL have any such data reported?  

qwerty22 wrote: You're right about relative to placebo numbers. We could argue the finer points of the two studies forever.
Mdgl was week 36, Grinspoon week 52.
Mdgl was NASH patients, Grinspoon NAFL/NASH,
mean liver at outset - 13% Grinspoon, 20% mdgl

The point is we really need the other metrics to be a hit as well and I would give more value to mdgl liver fat reduction data from the fact that they have the other metrics already in the bank.

bfw wrote: The data data is comparable and possibly better for TH.

Egrifta reduced fat by 37% when considering that placebo gained by 5%.

MDGL’s drug in the high dose reduced by 42% but only by about 33% when you consider that the placebo also lost over 9%!

So, Egrifta patients ended up 37% ahead....MDGL 33% ahead.

The biopsy data will be very helpful as will biomarkers.

A patent protected version of tesamorelin has a legitimate chance to enter a large Phase 3 for general NASH with high expectations.

bfw



qwerty22 wrote: I dont think its true that mdgl has worse results. They have their full data set from phase II. On liver fat reduction their numbers seem to be slightly better than egrifta in the higher dose group, worse in the low dose and overall slightly worse. Ultimately they'll go forward with one dose.

They also have positive data on NAS reduction, NASH resolution, fibrosis resolution, improving metrics in the worse disease scenarios etc. These metrics are ultimately the ones that matter. Reduced fat is ultimately not enough if you go with the fda's draft document. This was point iv) one of the analysts made in their response to the results. The fat reduction for egrifta certainly is strong, and bodes well for the other metrics in the full data release but we aren't there quite yet. Having said that its true to say there's far more NASH players flying high with far less tangible results.

https://www.streetinsider.com/dr/news.php?id=15306732&gfv=1



SPCEO1 wrote: I have viewed the general NASH market as a long shot opportunity for TH, but the data appears to be so good that it is defintely in play. On the 4Q18 conference call, Marsolais mentioned it. Then I believe it was you that parsed out that it was in the press release as well. So, perhaps the whole NASH market will be in play for TH. To get there, however, you have to resove the patent issue, at elast as it relates to the US market. TH can pursue the European NASH market and get 10 years of marketing protection with any Egrifta formulation they would use. Which, by the way, not a single analyst has noted in their reports when questioning the relevance of the NASH data based on patent issues. If all we got out of this NASH study was the european NASH market for 10 years, the stock should be soaring.

But of course, we can get sales right awway, without any regualtory authority saying r doing anything, from US patients willing to pay cash for the drug and, more importantly, from lipo patients who also have NAFLD/NASH since these can get reimbursed right now. Like today if their doctor wanted to do it. 

So, every single analyst added nothing to their valuation for TH based on the NASH results even though the results were great, there are instant opportunities to make money from it (admittedly not huge opportunities) and a strong possibility that they have the best drug so far for NASH in the general population out there at the moment. These analysts need to ask questions of patent experts and think thru what the company's options might be on the patent front rather than just throw up a red flag on the patent front without thinking it through. That, my friends, is bad analysis, especially when MDGL has a $2 billion market cap and all they have is a drug with not quite as good results just now entering phase III. 

It will take some time to get to the promised land but those results were great and even without the general NASH market, the HIV NASH market is hardly a niche. There are plenty of ways to win with these NASH results and the company just has to sort them all out.   

bfw wrote: I’m not really following you here.

It is clear that some analysts will not buy in to the story if TH does not tell us there is an option to extend the patent or use another formulation. Do you think the competitors would be generic drug makers looking to produce Egrifta?

My thought would be that you would have another already patent protected formulation that you would use in a large Phase 3 for the general NASH market.

The HIV NASH market would remain niche and I don’t think a generic drug maker would go to the trouble or making Egrifta only for the HIV market.

bfw


jfm1330 wrote: No! This is the last thing they should do. It's a highly strategic information. The last thing you want to do is to tell potential competitors something like that. 


bfw wrote:

They should also update on us patent extension possibilities vs different formulations.

 

 

 

 

 

 




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