Theratechnologies Inc T.TH

Alternate Symbol(s): THTX

Healthcare Biotechnology

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.

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Theratechnologies Inc

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Comment by bfwon Feb 23, 2019 2:48pm

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Post# 29404425

RE:RE:RE:RE:RE:RE:RE:RE:RE:RE:RE:RE:RE:RE:RE:RE:RE:RE:RBC

I had a listen to that part of the webcast again.

Marsolais does not specifically mention filing a supplemental BLA based on the Phase 2 results but he also does say if the results are very strong that they could ask for a label expansion. It will come down to the results. Given that this is a relatively small market I wonder if the FDA would allow label expansion on very strong results if the company agrees to run a larger Phase 3. Certainly, the FDA would want the answer but Thera may be looking for more of an incentive to run another trial. This would then also allow the company to file for HIV NASH in Europe down the line based on the Phase 3.

Either way, it will come down to the strength of the results. Management seems prepared for strong results so I think we should be as well.

Also, Tanguay mentions “a new way of marketing Egrifta” this Fall. Any thoughts on this? Does he presume that the FDA will allow marketing of NASH improvement or is he just referring to a different campaign for F4?

bfw

jfm1330 wrote:
As mentionned by SPCEO, label expansion might not be possible with only the Grinspoon study since there was no preset goals for endpoints agreed to from the beginning with FDA. Even endpoints by themselves were not agreed to by the FDA. Grinsppon is doing academic reasearch, not drug development. So there is real possibility that FDA will say that the Grinspoon study is encouraging, but that they want a study made by the sponsor of the drug with parameters that FDA agreed to.

As for the F4, another important thing is the fact Thera wants to sell their inventory of the actual formulation.

bfw wrote:

I will quibble with point A.

Very good results + No extended patent + label expansion by the FDA = sizeable gains

The total addressable market for Egrifta would jump immediately and the market uptake would likely be impressive.

A potential generic competitor would be behind the 8 ball and would need plenty of time to roll out a competitor.

During that time, Egrifta might rack up a couple hundred million extra in revenue which would be a big deal for TH.

As an aside, I also am suspicious of the delay in the roll out of F4. The answer provided seems a cop out. Why where these stability studies not completed previously? They’ve had F4 available to study for a while!

bfw