|
Post by lakers on Mar 16, 2017 23:30:00 GMT -5
|
|
|
Post by lakers on Mar 17, 2017 11:53:31 GMT -5
THale's competitor is UTHR Tyvaso which targets 2 indications using the huge, cumbersome bong shown below. Because of Tyvaso mkt acceptance, THale may have an easier time than Afrezza. www.tyvaso.com/Content/dtc/pdf/TD100_Instructions_for_Use.pdfPhase III trial of Tyvaso for a version of interstitial lung disease which manifest pulmonary hypertension. This is a completely different disease from the pulmonary hypertension treated by ourselves and all of our competitors today. In fact, there is no drugs (11:28) all approved for what's called WHO Group 3 pulmonary hypertension associated with interstitial lung disease. Interstitial lung disease ranges from things like – well, probably one of the most famous is idiopathic pulmonary fibrosis. statistics show that there are 30,000 patients who are dying regularly, mean survival of just a handful of years from Group 3 PAH with no approved medicines. It would be a completely virgin so-called blue water type of opportunity for Tyvaso to move into. And capturing as few as a fourth or a third of those patients would result in revenues at the $1 billion level, not to mention the continued growth of that drug in Group 1 pulmonary hypertension. We’re involved in conversations with the FDA regarding the regulatory pathway for an anaphylaxis indication. We are also assessing the possible indications for possible other indications for epi as well. [That could be for mild asthma at low dosage.] For Treprostinil, we submitted a pre-IND meeting request with the FDA on March 8, and we expect to have the meetings with the FDA sometime in May to further articulate what the Treprostinil program may look like.
|
|
|
Post by lakers on Mar 20, 2017 11:43:48 GMT -5
We are going progress the pipeline. We’ve had to start some of these programs quite a lot because we just enough to cash to do it. We need to be successful before we go too far. But our Epi program has gotten a lot of press given the controversy around epinephrine but we do have an inhaled Epi program that’s not in the clinic yet, but we’ve shown feasibility and formulation and so forth and it’s ready to move there. We did meet with the FDA and map out a clinical strategy, so I think that’s ready to go. We also have programs in Treprostinil and Palonosetron and I could spend a lot of time talking about those. We think they are attracting targets because of the way the regulatory pathway works for those. These are essentially generics at this point. We can reformulate them into an inhaled formulation and give them some vantages. So for example for Treprostinil, this is typically done with a nebulizer today. It’s a very long involved treatment and the treatment doesn’t last terribly long. So introducing something you could do with obviously just a few seconds with Afrezza, we think we have some interesting advantages. At the same time Palonosetron typically only given in the doctor’s office. This is injection today. If we could give a home version by inhalation it has some nice advantages in the chemo-induced nausea and vomiting setting. And we continue to just look at other areas as well. And recently we showed this data. This is from an orally inhaled hormone [PTH], interesting way to get into your system and does exactly as we typically see, which is its rapid peak, since we call a pulsatile delivery which is important in these kind of settings, and then it goes away relatively quickly. So this is exactly what you want to see for a drug like this. www.seekingalpha.com/article/4054768
|
|
|
Post by seanismorris on Mar 20, 2017 12:15:41 GMT -5
Questions:
I wonder if the epi is going to require a different inhaler... (forced air)
Also, the price for epi has gone done dramatically. Is it still the most attractive of the three?
Can epi be used in a nebulizer? If so, does TS have a absorption advantage? Would epi + nebulizer have a cost advantage?
|
|