Kythera deal

[schtif]

Could this be a way for Allergan to overcome the issue with other companies legally being able to produce bimatoprost? They could market seti/bim together (akin to something like the Proactiv set of products), creating an uphill battle in terms of brand loyalty/market recognition for any other bimatoprost supplier.

This would mean that it may be in Allergan's interests to delay the production of bimatoprost until they can go ahead with a dual release after seti's trials have finished.

I hope that is not the case, since they are only about to file an Investigational New Drug (IND) application for seti. That would (being optimistic and assuming bim is working) delay the whole process for quite a while...

[Hankylord]

Could this be a way for Allergan to overcome the issue with other companies legally being able to produce bimatoprost? They could market seti/bim together (akin to something like the Proactiv set of products), creating an uphill battle in terms of brand loyalty/market recognition for any other bimatoprost supplier.

This would mean that it may be in Allergan's interests to delay the production of bimatoprost until they can go ahead with a dual release after seti's trials have finished.

[dus]

You know, for a guy who does a lot of bitching and moaning about the speed of FDA trials, I'm surprised you're not interested when finding out there's a strong likelihood they'll be sped up.

Quite funny really.

[It's2014ComeOnAlready]

When is that supposed to come in front of congress?
Is the exact date known?

In a couple weeks according to everything I've read

[Sogeking]

http://energycommerce.house.gov/site...5FACTSHEET.pdf

When is that supposed to come in front of congress?
Is the exact date known?

[It's2014ComeOnAlready]

Many of us, no wait.... damn near all of us don't or won't give a rats ass about accelerating setipirant as a hair loss treatment. Just release it already. The same goes for Follica and anything to do with stem cells.

I'd agree with you, but unfortunately it doesn't work that way. I'm trying to give relevant information. Yes, people will care if Setipiprant is accelerated, because the alternative is waiting longer.

You know, for a guy who does a lot of bitching and moaning about the speed of FDA trials, I'm surprised you're not interested when finding out there's a strong likelihood they'll be sped up.

[It's2014ComeOnAlready]

Can I have a new of the bill or a link to an article about it. Just curious

http://energycommerce.house.gov/sites/republicans.energycommerce.house.gov/files/114/Cures2015FACTSHEET.pdf

[HairlossAt15]

I'm not hopelessly optimistic, because I've been losing my hair for long enough (3 years). But, I gotta say, it really looks like things are falling into place.

Can I have a new of the bill or a link to an article about it. Just curious

[It's2014ComeOnAlready]

I'm not hopelessly optimistic, because I've been losing my hair for long enough (3 years). But, I gotta say, it really looks like things are falling into place.

[Ziggyz123]

I just wish that we knew how effective bim is from the trials. clearly that research that kythera did 2 years before announcing setipriprant was VERY promising.

[Ziggyz123]

Just a thought - This deal with Kythera is mostly to do with Allergan wanting to dominate the aesthetics market of the entire head. This includes the injectables for the face, and with the move to acquire Seti, they will cover hair loss as well. In order to cover hair loss properly, they will need a drug that works very well to stop it (seti), as well as a drug that's effective in regrowing (bim).

This was a genius move. I hope we'll hear something about bimatoprost soon. It's understandable why they'd want both Kybella and Seti, but in most cases bim and seti will be co-dependent. Anyone who starts losing hair, or has hair thin out, and stops it with Seti, will want their full head of hair back. They get a prescription for seti, apply some bim, and it's over.

The CEO didn't speak much about seti, because it's his job to present the case to shareholders and investors why they made the move on the drug that's already been proven in clinical trials.

Another point - both are dependent on prostaglandin science. When phase 2b was over for bim, Kythera soon after announced trials for seti. Many people at Kythera used to work for Allergan, therefore it's very likely they were in communication. Allergan then buys Kythera, and plans to develop seti, even though it's the first "hypothesis-driven" approach to drug development AND many MPB drugs have failed up to this point. They know seti will work because of the results they've seen from bim, but also because of the work and science that Cotsarelis has presented.

One last exciting point - there is a bill that was passed unanimously (51-0) by the Energy and Commerce committee in a very bi-partisan fashion (rare these days). This bill is known as the "21st Century Cures Act." It plans to do, among other things, speed up the clinical trial process by modernizing and streamlining from the time of discovery through to the time it gets to market. It's soon going to be presented to congress, and should very likely be passed. If signed into law, it's likely that the clinical trial process for a drug like setipiprant will be accelerated.

I like it when you talk dirty, it's2014comeonalready

J.k, but yeah I recently read about that bill being presented to congress. This is really great news. Thanks for that update man, much appreciated and well related.

[hellouser]

Just a thought - This deal with Kythera is mostly to do with Allergan wanting to dominate the aesthetics market of the entire head. This includes the injectables for the face, and with the move to acquire Seti, they will cover hair loss as well. In order to cover hair loss properly, they will need a drug that works very well to stop it (seti), as well as a drug that's effective in regrowing (bim).

This was a genius move. I hope we'll hear something about bimatoprost soon. It's understandable why they'd want both Kybella and Seti, but in most cases bim and seti will be co-dependent. Anyone who starts losing hair, or has hair thin out, and stops it with Seti, will want their full head of hair back. They get a prescription for seti, apply some bim, and it's over.

The CEO didn't speak much about seti, because it's his job to present the case to shareholders and investors why they made the move on the drug that's already been proven in clinical trials.

Another point - both are dependent on prostaglandin science. When phase 2b was over for bim, Kythera soon after announced trials for seti. Many people at Kythera used to work for Allergan, therefore it's very likely they were in communication. Allergan then buys Kythera, and plans to develop seti, even though it's the first "hypothesis-driven" approach to drug development AND many MPB drugs have failed up to this point. They know seti will work because of the results they've seen from bim, but also because of the work and science that Cotsarelis has presented.

One last exciting point - there is a bill that was passed unanimously (51-0) by the Energy and Commerce committee in a very bi-partisan fashion (rare these days). This bill is known as the "21st Century Cures Act." It plans to do, among other things, speed up the clinical trial process by modernizing and streamlining from the time of discovery through to the time it gets to market. It's soon going to be presented to congress, and should very likely be passed. If signed into law, it's likely that the clinical trial process for a drug like setipiprant will be accelerated.

Many of us, no wait.... damn near all of us don't or won't give a rats ass about accelerating setipirant as a hair loss treatment. Just release it already. The same goes for Follica and anything to do with stem cells.

[It's2014ComeOnAlready]

Just a thought - This deal with Kythera is mostly to do with Allergan wanting to dominate the aesthetics market of the entire head. This includes the injectables for the face, and with the move to acquire Seti, they will cover hair loss as well. In order to cover hair loss properly, they will need a drug that works very well to stop it (seti), as well as a drug that's effective in regrowing (bim).

This was a genius move. I hope we'll hear something about bimatoprost soon. It's understandable why they'd want both Kybella and Seti, but in most cases bim and seti will be co-dependent. Anyone who starts losing hair, or has hair thin out, and stops it with Seti, will want their full head of hair back. They get a prescription for seti, apply some bim, and it's over.

The CEO didn't speak much about seti, because it's his job to present the case to shareholders and investors why they made the move on the drug that's already been proven in clinical trials.

Another point - both are dependent on prostaglandin science. When phase 2b was over for bim, Kythera soon after announced trials for seti. Many people at Kythera used to work for Allergan, therefore it's very likely they were in communication. Allergan then buys Kythera, and plans to develop seti, even though it's the first "hypothesis-driven" approach to drug development AND many MPB drugs have failed up to this point. They know seti will work because of the results they've seen from bim, but also because of the work and science that Cotsarelis has presented.

One last exciting point - there is a bill that was passed unanimously (51-0) by the Energy and Commerce committee in a very bi-partisan fashion (rare these days). This bill is known as the "21st Century Cures Act." It plans to do, among other things, speed up the clinical trial process by modernizing and streamlining from the time of discovery through to the time it gets to market. It's soon going to be presented to congress, and should very likely be passed. If signed into law, it's likely that the clinical trial process for a drug like setipiprant will be accelerated.

[HairlossAt15]

This is great news, in the conference call they said that they will speed up the double chin drug thing and file ind for setipiprant soon

[Justinian]

Are there any officially anticipated dates when it comes to commercialisation of Setipiprant? It is in which trial phase actually?

Setipiprant has completed Phase 3 for asthma. I believe Kythera stated they would start in Phase 2 for hair loss.

Here is an interesting quote: "Combination Therapy: The true Holy Grail may come from combining a drug like Latisse with a certain type of medication commonly used to treat allergies and asthma. The medication blocks a hormone-like substance that prevents hair from growing. A treatment like this might help with hair growth. 'Using these drugs in combination is like taking your foot off-break and stepping on gas at the same time,' Washenik says. "

http://www.webmd.com/skin-problems-and-treatments/hair-loss/news/20140331/hair-loss-treatments-pipeline

The negotiations of this merger probably played a role in Allergan not releasing the Bimatoprost results yet. I wonder how they are going to proceed now. Phase 3 for bim and Phase 2 for setipiprant and get them both approved separately? A phase 2 with the combination compared against Bim by itself? Or maybe a Phase 3 combination somehow?