Bitmopost (allergen)

[Person]

David Risinger - Morgan Stanley, Research Division

My question is for Scott. Scott, I'm hoping that you can comment on the timing for LATISSE for hair loss. On clinicaltrials.gov, it indicates that the 2 Phase III trials in men and women are supposed to be completing in September. So that's next month. Just wondering, specifically, what investors should expect in terms of communication i.e., would you issue a press release before you present data at a medical conference? Do you not plan to disclose that data at all? How should we think about being informed about those Phase II results later this year?

Scott M. Whitcup

Sure. So like you stated, we have 2 programs: one in typical male pattern baldness; and 1 in female hair thinning. Both of those trials are fully recruited. Our plan will be to present those data at medical conferences, and those should be next year. We won't have the data until just before that, especially for our Phase II program. We wouldn't plan to issue a press release, but are always committed to try to get those out into medical conferences as soon as we can.

[rdawg]

I heard/saw somewhere that Histogen is doing phase IIa and phase II b trials then a phase III. Does anyone know if this is true?

Noone has clarified on this yet, I had the very same question.

[Person]

I heard/saw somewhere that Histogen is doing phase IIa and phase II b trials then a phase III. Does anyone know if this is true?

[rdawg]

rdawg;75410]I believe Histogen ends phase 2 in December, saying 2017-2018 is way too far. If all goes to plan histogen will be out come late 2014-2015 in asia/europe.

"If all goes to plan" . This rarely ever happens. To think that everything will happen right on schedule is unrealistic. Even if the trials WERE right on schedule, it would not be available immediately to the public that soon after it still has to get approved by the goverment agencies. They will take alot less time than the FDA , but will still take time. Phase II did not go exactly as planned and phase 3 will be larger and even more complex.

Well essentially we'll know by october if it's continuing to do well so assuming it will or won't work right now is just silly.

If it continues like it should it will be I believe in Phase III January 2013, I highly doubt that takes 5 years to release the product. Phase III should take no more than a year as it means the product is proven to work, it just has to be tested on a larger scale.

Anyways no point in arguing now as neither of us know, I just wouldn't expect it to take another 6 years if they're already having really good results right now. I personally expect early/mid 2015 Asia/europe, late 2016 north america.

[Person]

rdawg;75410]I believe Histogen ends phase 2 in December, saying 2017-2018 is way too far. If all goes to plan histogen will be out come late 2014-2015 in asia/europe.

"If all goes to plan" . This rarely ever happens. To think that everything will happen right on schedule is unrealistic. Even if the trials WERE right on schedule, it would not be available immediately to the public that soon after it still has to get approved by the goverment agencies. They will take alot less time than the FDA , but will still take time. Phase II did not go exactly as planned and phase 3 will be larger and even more complex.

[rdawg]

I do understand that, and there are set backs.. but they are going to start Phase 3 trials in Feb, if all goes well (which we will know by Octorber).

Regardless, as far as they are in their Phase 2.. Phase 3 will start soon, and Phase 3 won't take 3-7 years.

In other words, 2014-15 is a realistic timeframe.

I believe Histogen ends phase 2 in December, saying 2017-2018 is way too far. If all goes to plan histogen will be out come late 2014-2015 in asia/europe.

The MORE important part is knowing if these products for sure are coming out, I dont mind waiting 3-4 years if next year I already know the product will be launching and say brings back 40% of your hair etc.

Allergan is good, but not anything special, essentially an alternative to minoxidil which could be slightly better.

[BoSox]

I do understand that, and there are set backs.. but they are going to start Phase 3 trials in Feb, if all goes well (which we will know by Octorber).

Regardless, as far as they are in their Phase 2.. Phase 3 will start soon, and Phase 3 won't take 3-7 years.

In other words, 2014-15 is a realistic timeframe.

[Person]

BoSox; Aderans 2017-2020? Where in god's name did you pull that time frame out? They plan to come to market 2014.. 2015-16ish by the latest.

They have always "planned" to finish trials by this date, or come to market at that time. They Never do. That means nothing. At first i thought that too. But after doing extensive research it is still far from reaching the market.

I understand everyone wants to be optimistic, but sometimes you have to be realistic.

[BoSox]

Histogen is still a long way away, realistically 2018 it will be available. Aderans realistically 2017-2020

Aderans 2017-2020? Where in god's name did you pull that time frame out?

They plan to come to market 2014.. 2015-16ish by the latest.

[Person]

Bimatoprost for scalp is the only legitimate treatment that will be out by 2015. Histogen is still a long way away, realistically 2018 it will be available. Aderans realistically 2017-2020. Why is nobody on this forum talking about Allergan's Bimatoprost for scalp?

Allergan is a multi billion dollar publicly traded company that can go through these trials quickly without having to raise money. They finished the phase II clinical trial in july and we should see results in september or october.

[Kirby_]

Any news on whether this product will be released in Europe (specifically the UK)?

[gmonasco]

For Allergan to pursue making Latisse for scalp and spend millions in clinical trials, it must be more effective than minoxidil and/or have a better side effects profile.

Not quite. It means they have a reasonable expectation it will meet those criteria. They can't know for sure until after the clinical trials.

[rdawg]

For Allergan to pursue making Latisse for scalp and spend millions in clinical trials, it must be more effective than minoxidil and/or have a better side effects profile. Also, even if it was very similar in terms of results, people will always like having another option. Especially if minox didnt work for them or gave them bad side effects.

If the Phase 2 results show that bimatoprost is more effective than minoxidil in September do you guys think that companies could start creating their own bimatoprost solutions and sell them soon after?. They wouldnt be FDA approved but neither are alot of supplements and people still buy them.

I'd imagine the price in general would go down on this stuff. Right now it's kind of a niche product IMO for the eyebrows/eyelashes but if it's approved for hair it will be mass produced on a very large scale.

Maybe it will work out better for those that didn't get many results on minoxidil. The fact alone that it'll be the first approved hair medicine in 15 years is good enough for me to try it out!

[Person]

http://www.patentstorm.us/patents/7351404/description.html

Look at the examples at the bottom

[Person]

For Allergan to pursue making Latisse for scalp and spend millions in clinical trials, it must be more effective than minoxidil and/or have a better side effects profile. Also, even if it was very similar in terms of results, people will always like having another option. Especially if minox didnt work for them or gave them bad side effects.

If the Phase 2 results show that bimatoprost is more effective than minoxidil in September do you guys think that companies could start creating their own bimatoprost solutions and sell them soon after?. They wouldnt be FDA approved but neither are alot of supplements and people still buy them.