Where are the phase IIb results for Bimatoprost?

[macbeth81]

"Section 801 of the Food and Drug Administration Amendments Act (FDAAA 801) (PDF) requires Responsible Parties to register and submit summary results of clinical trials with ClinicalTrials.gov. The law applies to certain clinical trials of drugs (including biological products) and medical devices."

https://clinicaltrials.gov/ct2/about-site/results

From my sample above, with exception to three studies, the remaining seven were received at about a year. ClinicalTrials.gov is a government ran site, so I don't know how well this is enforced. What is required and what actually happens are sometimes two different things. For example, look how many people don't file their income tax return. Government doesn't track requirements very well and is generally inefficient.

[FearTheLoss]

I thought they were required to release results in a year?

[macbeth81]

Someone provide me a better argument why they haven't released results, even to shareholders, in 6+ months and I'll shut up.

Because they don't always release results within months of trial completion. Just a quick sample of previous Allergan trials demonstrates this fact (below). The average from the sample provided is over 15 months. Now Allergan has completed many trials and this was just a sample, but enough to demonstrate they release results at their own leisure. I don't understand all the theories behind something that is not unusual.

[B]
Primary		Received	Months
Completion	Results		Apart	Identifier[/B]
--------------------------------------------------------
5/2012		5/21/2013	12  	NCT01391286
1/2011		6/24/2013	29  	NCT01189279
2/2014		1/27/2015	11	NCT01698554
5/2014		4/21/2015	11	NCT01830140
10/2011		8/13/2013	22	NCT01291108
4/2013		2/18/2014	10	NCT01646151
12/2013		1/16/2015	13	NCT01863953
11/2010		8/21/2012	21	NCT00907426
9/2010		12/13/2011	15	NCT01068964
7/2010		8/18/2011	13	NCT01064882

[It's2014ComeOnAlready]

From our perspective sure. From their perspective probably not so much because they are directly competing against each other for same market most likely. It could be a lot of reasons, but competition could also be one. Who knows really.

I agree with your statement, but at the moment the potential market for universal, side effect free hair loss treatment is wide open and vast. Who knows if competition is even a deciding factor. The actual market is HUGE, but everyone knows that not much works at all. If two different companies were aiming to release a treatment, I think it would only be an issue if one is far superior to the other.

Maybe if SM proves to be game-changing, extremely effective, and has a more quickly seen effect, we can forget about bim. Who knows.

[burtandernie]

The more, the merrier

Also depends on what kind of regrowth they can give. SM has potential to be great in this regard.

From our perspective sure. From their perspective probably not so much because they are directly competing against each other for same market most likely. It could be a lot of reasons, but competition could also be one. Who knows really.

[It's2014ComeOnAlready]

Personally I think there waiting for phase 2 trial results from CB and SM which I think are announced fall 2015 , it would be pointless to create a product and commercialize it if those 2 products are going to out perform it.

The more, the merrier

Also depends on what kind of regrowth they can give. SM has potential to be great in this regard.

[lifelonglearning]

Personally I think there waiting for phase 2 trial results from CB and SM which I think are announced fall 2015 , it would be pointless to create a product and commercialize it if those 2 products are going to out perform it.

[It's2014ComeOnAlready]

So, here is a possible challenge to your argument:

1) Information about bimatoprost being "complex" is almost completely useless in context. The representative was clearly giving a vague, standard line to get an anxious shareholder off the phone. She wasn't giving secret hints about the progress of bimatoprost. There is nothing to see here.

2) If the product worked as planned, competition and patent concerns would only lead Actavis to accelerate the development of bimatoprost - not decelerate it.

3) Companies in the aesthetic space almost never release the results of failed products outside of traditional channels (clinicaltrials.gov, etc.). Doing so in this instance would be almost completely without precedent.

4) Shareholders are almost never made privy to detailed information related to the development of proprietary technologies. Being a shareholder is pretty easy. If shareholders were immediately given access to every piece of strategic information available, competitors would just buy shares in their competition to learn everything there is to know about the business strategies of their rivals. People speculating on this board have a very flawed understanding of fiduciary duties.

5) Taking all of the above together, we know absolutely nothing about the development of bimatoprost. The only thing we know is that almost no new hair loss products ever work - even the ones with good track records in preclinical trials (see: ICX, Aderans, Follica, Histogen, etc.). There is no reason to assume bimatoprost will be any different.

I knew you'd be coming out of the woodwork, Joker!

1) That's completely open to interpretation. I know she wasn't giving secret hints; I never suggested she was. What I took from her answers, was an employee of a company being as helpful and gracious to a shareholder as possible. It's doubtful that an employee would lie to a shareholder to get him off the phone. So, I took her at her word - the issue of bimatoprost is complex. You've also completely disregarded the fact that many other parties have access to mass production of this particular drug, and there have been some recent legal battles between Allergan and these companies. The issue would be complex if they were on the verge of producing a drug that's already in the hands of others.

2) There's no evidence that the program has been decelerated.

3) Nobody expects them to release failing results through press release, I know that. We're expecting results through traditional channels. The final data collection for primary outcome measure was completed nearly 10 months ago. They still can't tell shareholders?

4) Bimatoprost is not a proprietary technology. Many companies can legally produce this drug. Being a shareholder isn't necessarily easy, since you have to have the money to invest in the first place (and at over $200 a share!). Shareholders haven't been given immediate access to information about this trial, Allergan knew the outcome nearly 10 months ago.

5) We do know some things about the development about bimatoprost - the science behind it, the fact that in a new patent they stated the optimal concentration range for safety and efficacy (and included a penetration enhancer in a new formula), and that it was previously thought that the concentration should be much lower.

As for ICX and Aderans: yea those failed, but they weren't great to begin with. Bimatoprost actually works reasonably well at 100X less then what they were testing in 2b. Histogen has had delays, but isn't necessarily dead. Follica is actually still alive - if you look on grantome.com, Cotsarelis has a grant that lasts through 2018 to research follicular neogenesis through his wound healing technique. It's just going to take more time. Also, his work and funding with Kythera proves that if he's able to further that technology, they could be the company to bring it to fruition.

By the way, I'm not assuming anything about the function or efficacy of bimatoprost. It works, I use it, I've seen results. The question is whether or not it's a product that's worth it for them to produce. Just because others have failed doesn't mean the next to come will fail as well, that's very flawed thinking.

[Joker]

Going to reiterate my reasoning to be positive about this drug, and I welcome someone to challenge my argument, using facts and logic.

Investor relations person says they haven't released phase 2b results, even to shareholders, because of the "complexity of bimatoprost." They've known the results of the trials for about 7 months, but haven't said a word to anyone, not even their beloved shareholders.

This is a strange case, but I side with optimism because we know the drug works. Also, several other companies can produce generic bimatoprost, so I'm beginning to believe it's a legal issue. In the past, what set Allergan's products containing bimatoprost apart were licensed trademarks (Lumigan, Latisse). I'm not certain things succeeded, but it may take being closer to having an actual product with an actual licensed trademark to release results, if it did in fact succeed.

Someone provide me a better argument why they haven't released results, even to shareholders, in 6+ months and I'll shut up. Convince me I'm wrong, I'm very open to it. Again, what's the harm in releasing the results of this one if it didn't work, when 70 other of their applications have worked, 50 of which are late stage?

So, here is a possible challenge to your argument:

1) Information about bimatoprost being "complex" is almost completely useless in context. The representative was clearly giving a vague, standard line to get an anxious shareholder off the phone. She wasn't giving secret hints about the progress of bimatoprost. There is nothing to see here.

2) If the product worked as planned, competition and patent concerns would only lead Actavis to accelerate the development of bimatoprost - not decelerate it.

3) Companies in the aesthetic space almost never release the results of failed products outside of traditional channels (clinicaltrials.gov, etc.). Doing so in this instance would be almost completely without precedent.

4) Shareholders are almost never made privy to detailed information related to the development of proprietary technologies. Being a shareholder is pretty easy. If shareholders were immediately given access to every piece of strategic information available, competitors would just buy shares in their competition to learn everything there is to know about the business strategies of their rivals. People speculating on this board have a very flawed understanding of fiduciary duties.

5) Taking all of the above together, we know absolutely nothing about the development of bimatoprost. The only thing we know is that almost no new hair loss products ever work - even the ones with good track records in preclinical trials (see: ICX, Aderans, Follica, Histogen, etc.). There is no reason to assume bimatoprost will be any different.

[rdawg]

Going to reiterate my reasoning to be positive about this drug, and I welcome someone to challenge my argument, using facts and logic.

Investor relations person says they haven't released phase 2b results, even to shareholders, because of the "complexity of bimatoprost." They've known the results of the trials for about 7 months, but haven't said a word to anyone, not even their beloved shareholders.

This is a strange case, but I side with optimism because we know the drug works. Also, several other companies can produce generic bimatoprost, so I'm beginning to believe it's a legal issue. In the past, what set Allergan's products containing bimatoprost apart were licensed trademarks (Lumigan, Latisse). I'm not certain things succeeded, but it may take being closer to having an actual product with an actual licensed trademark to release results, if it did in fact succeed.

Someone provide me a better argument why they haven't released results, even to shareholders, in 6+ months and I'll shut up. Convince me I'm wrong, I'm very open to it. Again, what's the harm in releasing the results of this one if it didn't work, when 70 other of their applications have worked, 50 of which are late stage?

So how would the company protect the product then if it does work. That would be a very good reason to withhold results and stop competitors from selling the product as well.

do they have to file a patent? get it protected? What do they do so that they are the only ones to sell it?

[It's2014ComeOnAlready]

Going to reiterate my reasoning to be positive about this drug, and I welcome someone to challenge my argument, using facts and logic.

Investor relations person says they haven't released phase 2b results, even to shareholders, because of the "complexity of bimatoprost." They've known the results of the trials for about 7 months, but haven't said a word to anyone, not even their beloved shareholders.

This is a strange case, but I side with optimism because we know the drug works. Also, several other companies can produce generic bimatoprost, so I'm beginning to believe it's a legal issue. In the past, what set Allergan's products containing bimatoprost apart were licensed trademarks (Lumigan, Latisse). I'm not certain things succeeded, but it may take being closer to having an actual product with an actual licensed trademark to release results, if it did in fact succeed.

Someone provide me a better argument why they haven't released results, even to shareholders, in 6+ months and I'll shut up. Convince me I'm wrong, I'm very open to it. Again, what's the harm in releasing the results of this one if it didn't work, when 70 other of their applications have worked, 50 of which are late stage?

[jiggo]

Propably they are waiting for the end of the SM trial and depending on that they will decide to continue or not. SM could be a big thing I hope.

[It's2014ComeOnAlready]

What do you mean its just a formality? Isn't phase 3 necessary for fda approval? Can they start selling before phase 3?

What I'm saying is that for this drug, if it made it through phase 2b (efficacy), it would almost certainly make it to market. They will do a phase 3 because they have to.

[kantian]

What do you mean its just a formality? Isn't phase 3 necessary for fda approval? Can they start selling before phase 3?

[It's2014ComeOnAlready]

This doesn't explain why refuse to even mention bim scalp trial in every recent pdf, and we can forget a fast phase3 trial and the market release soon if they refuse to even release the results, if everything goes well for us they will release the trial results maybe at the end of the year, start another year trial, then wait for fda etc etc = at least early 2018, according to their february pdf aswell

It does explain it to a certain degree - there could be a legal and/or business issue holding them back from saying anything. Investor relations even said it was a complex issue why they haven't yet released results, and it has to do with the complexities surrounding the drug itself. How complex is it if the drug failed for hair loss? It works for other indications. That's not a big deal to say so, not all is lost because it works for other things like glaucoma and eyelashes.

Don't forget that phase 2b success = launch. Phase 3 is just a formality in this case.