Where are the phase IIb results for Bimatoprost?

[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.

[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]

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.

[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]

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.

[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

[FearTheLoss]

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

[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.

[Keki]

If it worked why waste a year? It needs to pe public the eventual phase 3 anyway, so i don't understand, the complexity of bim and their patent issue are easily fixed by one of the top 5-6 pharma company

[Keki]

ok guys i found some info http://ec.europa.eu/competition/merg...4195749_EN.pdf

this document explain the "complexity", very interesting let me know what do you thing about this

[It's2014ComeOnAlready]

ok guys i found some info http://ec.europa.eu/competition/merg...4195749_EN.pdf

this document explain the "complexity", very interesting let me know what do you thing about this

Yea it definitely points to an issue with other companies being able to produce bimatoprost. No way to tell if the trial went well, but it does tell us that the issue with this drug is legally complex.

Just speculating, but if their explanation is that they haven't released results because of these "complexities," then it probably did well. Makes no sense to guard a failure, if overall, there is an issue where other companies can produce the drug themselves. If it didn't work for hair loss, I think we'd know by now. No money to be lost.

[FearTheLoss]

Has anyone got a definitive answer on when these results will, or have to be released? or are we still shooting in the dark?

[It's2014ComeOnAlready]

Has anyone got a definitive answer on when these results will, or have to be released? or are we still shooting in the dark?

Biqqie Smalls is a shareholder, and he contacted investor relations. The person he spoke with said "in a few months," this was last month. So hopefully sometime in August or Sept.

[FearTheLoss]

Biqqie Smalls is a shareholder, and he contacted investor relations. The person he spoke with said "in a few months," this was last month. So hopefully sometime in August or Sept.

I'm with you in believing the results are positive. There is no reason for a company of their size to hold back negative results. I would say 1. the results are great and they are keeping it silent because of patent issues and other companies being able to produce bim. 2. the results are good and they are waiting to see how other trials pan out before spending money on a phase III...either way, it will be interesting to see

[It's2014ComeOnAlready]

Allergan is buying Kythera for $2.1 billion. I find this very interesting, given that Kythera's Chief Medical Officer worked at Allergan for over a decade. Also, they announced trials for Setipiprant soon after the phase IIb studies for bimatoprost were complete for Allergan. I'm sure they knew the results, given the company ties. This is very interesting given the mutual reliance on prostaglandin science.

It looks like Allergan may be trying to corner the hair loss market. Look at this quote in April 2014 from Bosley Medical Director, Ken Washenik:

" 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."

Looks like Allergan is trying to corner the hair loss market. Sure, nobody wants a double chin either, but if Setipiprant is successful, it would shatter any earnings made by that injectable fat-burning drug. I really hope this means bim was successful, it may mean just that.