Category Archives: Allergan

Bimatoprost Results are Finally Out

At the beginning of this year, I published a detailed post on Allergan’s Bimatoprost product. In that post, I stated the following:

My feeling is that Bimatoprost may result in slightly superior results to Minoxidil, but nothing extraordinary.

I am pleased as well as disappointed to say that I was correct (read the rest of this post). At the end of January 2015, Allergan finished its phase II clinical trials regarding using Bimatoprost to treat scalp hair loss.

Update: January 18, 2022 — Preparation of topical Bimatoprost with enhanced skin infiltration for hair growth.

Bimatoprost Hair Growth
Bimatoprost hair growth mechanism. Source: FASEB Journal, Randall et al, Feb 2013.

Allergan Releases Bimatoprost Results

On November 4, Allergan published two interesting pdfs on its website (can no longer be downloaded). On pages 16 and 17 of one of those pdfs, there is a surprising and unexpected summary of the initial results of using Bimatoprost to treat people with hair loss. I am assuming that these results are from the earlier mentioned clinical trials.

Update: March 2016 official safety and efficacy clinical trial results.

It seems like Bimatoprost 1% and Bimatoprost 3% both result in slightly superior hair growth in comparison to Minoxidil 5%. This is based on an “Expert Panel Review” and based on an “Investigator Global Assessment.”  Hopefully the experts and investigators involved in those reviews are unbiased and not employed or funded by Allergan.

Funnily enough, Bimatoprost 1% has slightly better results than the higher dose Bimatoprost 3% according to the “Expert Panel Review”. However, the “Investigator Global Assessment” finds the opposite to be true as one would have expected. When it comes to actual volunteer opinions based on non-scientific self-assessments, Minoxidil results seemed to be slightly better than Bimatoprost results.

We Have Become Spoilt

The overall mood of hair loss forum members regarding this news has been slightly pessimistic per my analysis. This is a bit surprising considering that to date there have only ever been two FDA approved drugs to treat hair loss on the market: Finasteride and Minoxidil. Bimatoprost will match or slightly exceed the results of one of those two (Minoxidil), and work via a different mechanism.

Just a few years ago, millions of people around the world were delighted that Minoxidil (Rogaine brand) was finally released in a foam version. The old liquid version was extremely irritating for many people and often dripped down people’s foreheads. Last year, women were also pleased that Rogaine had finally released a 5% version for females. All in all, there are numerous people out there who find Minoxidil to be very useful to slow their hair loss progression and sometimes even halt it entirely. I hope that Bimatoprost finds similar success.

At the same time, I can also understand some of the pessimism. In today’s extremely fast paced world, groundbreaking medical and technological advances are announced on a weekly basis (and popular smartphone brands come out with new versions every year). Many hair loss sufferers expect a 100 percent foolproof hair loss cure immediately. Nothing less is worth getting excited over.

While not particularly impressed by these results, I am still pleased that we could finally have a third FDA approved weapon in the fight against hair loss. And one that acts via an entirely different mechanism (prostamide F2α analog) to Finasteride or Minoxidil. With hopefully even fewer side effects.

Bimatoprost and Allergan Notes

— Even if Bimatoprost does consistently produce superior results to Minoxidil with no significant side effects, we are still at least 2-3 years away from actual product release. However, lower dose versions of Bimatoprost have already been in use for eyelash growth (via the brand name Latisse) for a few years now. I am guessing that some hair loss forum members will continue to try to make their own higher dose versions and play around with topical delivery mechanisms for the scalp. Do note that the current cost of Bimatoprost makes it very prohibitive at higher doses.

— In my post on Allergan from a month ago, I was thinking that it was worth buying the company’s stock. Since then, AGN has gone up by 10 percent. The main reason for this is due to the fact that the world’s largest drug company, Pfizer, has recently expressed interest in purchasing Allergan for $160 billion.

The primary reason given is that Pfizer would then benefit by drastically lowering its tax bill by adopting Allergan’s headquarters in Ireland. The US corporate tax rate is 35%, while Ireland’s corporate tax rate is 12.5%. However, it remains to be seen if the US government will allow Pfizer to get even bigger than it already is and also pay far less taxes to Uncle Sam. Update: Merger plans cancelled in 2016.

— Allergan plans to commence further clinical trials for Bimatoprost on scalp hair in the first quarter of 2016.

Is it Time to buy Allergan (AGN) Stock?

Note: I am no expert in stock market trading and I currently hold no Allergan (AGN) shares in my portfolio.  If I were a bit wealthier, I would seriously consider buying a few hundred shares of the pricey AGN stock.

FYI — The most important part of this lengthy post is probably right towards the end in red.

I have discussed Allergan (of Botox fame) several times on this blog during the past year. The company has had an extremely eventful 2015.  In March of this year, it was acquired by Ireland’s Actavis, but the acquiring company then changed its name to Allergan, probably because the latter is so much more widely known than the former. More importantly for us hair loss sufferers, in June of this year Allergan acquired Kythera Biopharmaceuticals.  As a result, Allergan now holds the rights to three potentially blockbuster products (first two are related to hair loss):

  1. Bimatoprost (prostamide — aka prostaglandin-ethanolamide  — analog).  This is not exactly a PGE2 analog as is often mistakenly cited on internet forums.  Sales will depend on the clinical trial results that I hope will be published any day in the next several months.  If effective, I would guess that sales will be drastically higher than lower-dose Bimatoprost products currently sold by Allergan = i.e., Latisse (around $150 million annual sales) and Lumigan (around $600 million annual sales). Maybe $1 billion in 2017 sales if the product really has a better effect than Minoxidil and it is released in 2016?  I am just throwing around numbers here so a financial expert can perhaps post comments with better forecasting.
  2. Setipiprant (KYTH-105 — selective oral antagonist to the PGD2 receptor).  Still several years before clinical trials for hair loss are completed, but numerous other clinical trials for other conditions have been completed on humans with no major side effects. Maybe this pre-existing safety profile will speed up Allergan’s trials, especially in combination with newer regulations from the 21st Century Cures Act.  Kythera also submitted an Investigational New Drug Application (IND) for Setipiprant to the US FDA a few weeks ago.  If extremely effective, sales would easily hit a few billion dollar per year in say 2020, but this is too much speculation so early in the process.  Note: Numerous people on hair loss forums are already testing Setipiprant, but I have not closely followed how they are getting their product and whether its topical or oral.  If there are many positive anecdotal reports on this in the next year, I will have to seriously consider borrowing money to buy at least several hundred shares of AGN stock.
  3. KybellaTM (ATX -101 — a patented formulation of deoxycholic acid) injected into the face to eliminate double chins.  This product was approved by the FDA in April 2015 and is already in use at 100s of clinics in the US.  Unlike the case with Botox, results from Kybella supposedly last for years.  Waiting lists are already being created in countries that have not yet been granted licenses to use Kybella.  It is worth following realself Kybella reviews to see if the product is all that it is touted to be (keeping in mind fake or flaky reviews). One article I read suggests that Allergan expects annual sales of $500 million for this product in a few years, and the patents on it run out around 2025-2030. However, there are some sources that suggest that that this product could be used for other purposes (love handles?) illegally/with doctor approval too.  Is it possible that Allergan can make much more in Kybella sales than they expect?  Moreover, it seems like it is fairly simple and cheap to manufacture this Kybella product.

Note: Allergan’s total company sales in the first half of 2015 were $10 billion.

Like many hair loss forum members, I have been much more optimistic about Setipiprant than about Bimatoprost.  Clinical trial results of Bimatoprost used at a higher dose on scalp hair have been delayed for many months, although that does not necessarily mean that the results were too weak.  I should note that I have read some positive testimonials about Bimatoprost on hair loss forums, and it is almost impossible that an Allergan representative is posting such testimonials.  Hopefully Bimatoprost turns out to be at the very least as effective as Minoxidil, while Setipiprant turns out to be even more effective and capable of growing new hair (or turning vellus hair back into terminal hair).

Is Allergan Preparing to Release Bimatoprost for Hair Loss?

In any event, the main reason for writing this post was because several days ago a member on the Baldtruthtalk forums posted an interesting link regarding Allergan expanding its plant in Waco, Texas.  The expansion is due to the addition of new processing equipment for packaging.  While the company’s VP of operations declined to name the products for which the packaging would be needed, there is a good chance that it might be for Bimatoprost. The plant already makes weaker versions of Bimatoprost (Latisse and Lumigan).  Moreover, the VP of operations said something very interesting:

We will be producing new packaging for new and existing products, and we could see the need to hire more people by the third quarter of 2016 if demand for these products increases.

Blog readers who live in Texas, please go to Waco and do some ground research!  Buy one of the workers at this plant lunch and beer to get some inside information.  Look around for any paper trails or early arrival of packaging material labeled with anything with the words “Bimatoprost” or “hair” in it.  It might seem like I am joking but I would definitely do this if I were living in Texas.  Why not spend a day in Waco?