Allergan Purchases Kythera Biopharmaceuticals

Allergan Purchases Kythera

The biggest news so far this month is Allergan’s purchase of Kythera Biopharmaceuticals yesterday. While Allergan is largely known for its blockbuster Botox product, the company’s Bimatoprost product is what we hair loss sufferers care about. While Kythera’s most well known product is its recently approved ATX-101 (brand name Kybella) china fat reducing topical product, the company’s Setipiprant product is what we hair loss sufferers care about.

Bimatoprost is essentially (but not exactly) a prostaglandin E2 (PGE2) analog and Setipiprant is a prostaglandin D2 (PGD2) antagonist. The latter holds far greater potential to be a cure for hair loss compared to the former. A combination treatment with the two drugs (i.e, increase PGE2 and decrease PGD2) has in the past been postulated to be the perfect treatment to regrow hair. I would urge all blog readers to listen to this encouraging audio segment on Setipiprant from an investor call earlier this year.

PRP and Hair Loss Updates

— An interesting article on Dr. Joseph Yaker in Texas using PRP along with stem cells derived from a donor’s placenta to treat hair loss.

— The renowned Dr. John Cole is planning to do a major study on the effectiveness of platelet-rich plasma (PRP) therapy. The PRP treatment will entail three sessions (once a month for three months) costing a total of $750, an absolute steal. Moreover, it seems like Dr. Cole will even refund that $750 if you show up for a follow-up session 6-12 months after the first set of injections. Dr. Cole will test many different treatment protocols, including using a variety of extracellular matrix (ECM) products and activation methods.

PRP is still fairly new when it comes to the hair loss world, with many significant differences in methodology and ingredients existing between different doctors and hair transplant surgeons. Such a study needed to be done a few years ago. If you do volunteer for this study, please make sure you know exactly what Dr. Cole will inject into your scalp. He is very well respected and unlikely to do anything even remotely risky, but when you are injecting something into your scalp, it is best to be very cautious.

And now on to medical items of interest:

— A new study finds that keeping PGE2 levels high in mice by reducing 15-PGDH promotes tissue regeneration. It seems like PGE2 has many benefits besides hair growth.

— A groundbreaking new $25 blood test called VirScan that can tell you every virus you have had. An average person has been exposed to 10 of the 206 known viruses that infect humans.

— An update on the patient who might get a full body transplant (always inaccurately referred to as a head transplant by the media).

— Since I already covered the above story several times this year, the one on a Chinese surgeon who has performed 1,000 head transplants in mice and plans to move on to monkeys next is more interesting. Albeit revolting and slightly discouraging since the mice usually only survived for minutes, with the record being 10 days.

The excellent WSJ article with a video on this requires a subscription. I did not realize the now obvious conclusion that a full body transplant would be revolutionary when it comes to most types of cancer treatment. However, even I do not foresee a successful long-lasting full body transplant in a human for many decades to come. Nevertheless, what an insane era we are living through.

42 thoughts on “Allergan Purchases Kythera Biopharmaceuticals”

  1. Admin, you should take note and keep track of the “21st Century Cures Act.” It passed through Energy and Commerce unanimously (51-0) with a lot of bi-partisan support. It’s going to go before congress soon, and many are confident it will pass. If it’s signed into law by the President, it will mean that clinical trials will be sped up and streamlined in an effort to modernize. Could reduce the amount of time it’ll take to see a drug like Setipiprant on the market.

    I guess it’s our way to keep up with innovation. Other countries have taken measures, and the US means to compete.

  2. Admin, although I am most excited for setipriprant, doesn’t it scare you that kythera was bought out by the company that made Botox? To me, it seems like they simply want to control the injectables market like they have been. This acquisition could possibly put setipriprant on the back burner while they focus on the release and profit margin to be made with kybella..

  3. Emperor I am totally with you on this one. It too believe, and am fearful that they will focus mostly on kybella since it is ready to go and will make them lots of $. Also allergan seems to have a history of taking a while to get things going with delays and poor public communication (little or no updates) on their newer developing products. I am very very disapointed by this transaction. I wish they never bought setipiprant!

  4. Tom, this might put some ease on both of our minds. Or, at least give us a glimpse of hope.
    This particular quote was said in 2014 before we even knew about the molecule kythera was developing.

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

    This is the quote I am referring to..

    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. “

  5. Yes I saw that emporar however I just dont see allergan as a company that moves fast. They have poor public relations and leave the public with many unanswered questions. At keast kythera was motivated and addressed the public with their plan. Kythera publicly said they would have it in their clinic by the end of the year or beginning of next. Im willing to bet Allergan tells us little to nothing so we dont know if it will be shelved or actually in their clinic with clinical trials?? We need to keep pressure on allergan to move forward with this and not let it fall to the waistside.

  6. Dear admin I recently spoke to some 1 at ziering medical I was told a new injectable was going to be released in the UK in the next 6 to 8 weeks apparently this will halt hair loss ( not regrow ) but at least stop it from getting any worse he said you would have to have this injection every couple of months in order to sustain its full potential, have u heard of this or this just another scam? The same person told me that prp is a waste of time and that he had seen no visible evidence to support prp, if you could shed some light on this it would be much appreciated cheers bud

  7. @Baldy locks : I saw similiar treatment in one of USA companies. I don’t know if it works, but the necessity of doing it every few months along with a horrible price may give a cost higher than the best HT in the long perspective. And what is more important – people who live in other country aren’t able to go for it as they would have to go there many times. I think that treatments like Replicel would be the best, because, as far as I know, it would be permanent solution. One set of injections, new healthy DHT-resistant cells added and further hairloss is impossible.

  8. Guys and gals, is there a way we can get allergan to give us a timeline on their work with septiprant? The last thing I want is to not hear anything about it for a year!!!!

  9. Yes, Tom you’re right. We need a timeline for the release of setipiprant for androgenetic alopecia in the pharmaceutical market .
    Actually, setipiprant is a drug that people want to have as soon as possible.
    Maybe it’s available before 2017. It’s noteworthy, Setipiprant has a strong safety profile.

  10. Phase to will take 1-2 years, 1 year of waiting for FDA approval. I think it wouldn’t be sooner than 2017/ 2018.

  11. They haven’t even gone into the trials i don’t think. So yeah, 2018 sounds like it may be a good guess. That new cures act would definitely speed up the trials though if passed. I really think that setipriprant will stop pattern baldness because a lot of men develop dermatitis’s of sorts at the beggining of hairloss. This is actually one of the greatest finds in hair biology for sure, if it works outside of mice.

  12. I also think that they will want to beat replicel to the market as well since cellular treatments truly hold the cure. They may become extremely aggressive in order to “win the race” so to speak. Plus, allergan has Bim and together with seti, it may just end pattern baldness for most.

  13. @ Emperor alopecia: but I don’t know how Setipiprant may be compared to Replicel. Altough it may be very good antiandrogen it remains only a drug and have to be taken and bought forever. Replicel is, according to official statements, permanent solution. So one session of injections and bye bye further hair loss. If they want to make the big money with Seti, they have to commercialise it ASAP, before arrival of cell therapies like Replicel.

    1. Barthes, that is why I was suggesting that alergan may want to beat them to the market to capitalize before replicel releases rch-01

  14. And we can’t forget that new japan law enables Replicel to skip phase 3. So 2018 is quite sure date, because their phase II (and the last one) will be organised soon. Seti maybe will come in the similiar date. If everything goes well, 2018 will be year of our awaited hair salvation!

    1. Barthes, 2018 does seem to be promising. 3 more years we have to try and not lose ground though!

      1. Don’t hold your breath on Replicel. As usual, the “we’re starting phase 2 trials etc” was all bullshit. I currently live in the catchment area for potential trial subjects, and myself and roughly 8 friends have all been registered for the trial since months…however have heard 0 back from them at all. They are much further behind than they say, plus the trial period is 36 months until completion. Forget this coming to market before 2025.

        It is all bleak, frustrating and simply bad news. Save for a HT is my advice. Or go Ketogenic diet for a while and see if it saves you.

  15. guys all of you are talking like in 2018 we will all be cured… first of all.. do you guys think you’ll be able to get the procedure done in 2018? seems to me like many won’t have the money saved up for travelling, and staying their long enough for the procedure and most importantly… this stuff will be in SUCH HIGH DEMAND when it comes out that only the first lucky thousands will get it by 2018.. just my opinion..

  16. @Gypsieshavenohairloss – I have already begun to save my money. If not for Replicel, it will be for HT. According to their estimation, price wouldn’t be very high (comparable to medium HT). The only problem is the big demand, but the whole procedure would’t be so long and time consuming like FUE for example. So the queue will be changing quickly.

  17. Lee Bucker says that in email message:

    We have no way to predict this but it is not likely to be before 2018 in most markets.

    We don’t know yet but we currently don’t expect it to be more than hair transplant surgery.

    Sorry I cannot be more specific.

    –Lee

    Best Regards.

  18. Hello everyone.

    R. Lee Buckler says that in email message:
    We have no way to predict this but it is not likely to be before 2018 in most markets.
    We don’t know yet but we currently don’t expect it to be more than hair transplant surgery.

    Sorry I cannot be more specific.

    –Lee

    Best Regards.

  19. Guys guys guys! Cmon yiur getting a little too excited hear as if its a definite thing that these treatments will arrive by 2018. Your definitely counting your chickens before they hatch. Do you have any idea how many products were shelved leaving baldies to get excited then let down?!..alot!! Stop the fantasizing and actually keep the foot on the pedal to have these companies test their products. Companies like allergan will leave us in the dark for a year before even saying a word. And I dont think they are in the rush that everyone thinks they are. They know how difficult it is to get something to work let alone approved so the odds of something coming out soon is low. Im not here to be a pessimist but I am a realist. If any of you excellent at the communication piece then please let us know what definitive plans allergan has for this product, not just that they think it has potential. We already knew that a while now. And if you want to forward their contact info for others to contribute then please do so. Thanks gentlemen have a great day!

  20. LatisseDoctor.com reports that early estimates suggest Allergan could generate upwards of $500 million a year by 2020 if they were able to get a hair loss product approved by the FDA.

    Source: http://www.prweb.com/releases/2014/03/prweb11635324.htm

    That’s real life Tom….We have a new treatment better than minoxidil and propecia by 2017 or 2018. People want to come out to something better for MPB.

    Greetings.

    1. Hi Paul thanks for the link but did you see the quote ” Allergan made the decision last year to put the third and final FDA trial phase on hold.” Thisbis exactly what im referring to. Its real life that these treatments either dissapointed or are put on hold. Thats why I think you guys are getting your hopes up prematurely for a treatment that will come out in next couple years or so. And what makes you believe it will be better then propecia? I doubt any topical can beat propecia to be honest. Unless you have seen great pictures of it effectiveness than I wouldnt get too excited about ANY product.
      Please understand im not throwing Ricks or stones here. I like you guys and the brains and knowledge that you bring to the table.
      And emporar yes if you can handle treatments like propecia but what if you cant? You just keep your fingers crossed that when a treatment eventually gets released that you aren’t too far gone to make a hairy comeback.

  21. I think replicel meant that 2018 in Japan will be the time line for them. SETI could possibly be out by then, but they made this acquisition to capitalize on all products. Unfortunately, kybella is entering the market very soon and that is where their interested is going to be focused. Once that is good, seti will have its time to fly. But once again, WE DO NOT KNOW IF IT IS A CURE. it’s based off of research just like tons of other treatments that do not work. The science has always been there, but hormone pathways and what not are very misunderstood. However, in my eyes seti does seem to be the real deal because of the inflammation aspect.

    I’m with pretty much all of you, but we should keep trying to hold on to our hair with current treatments as long as possible. However, if you did not use minoxidil, don’t because you’re on it for life. I used it to maintain my hairline along with fin and had some inflammation that I related to an allergy to propylene glycol, quit, and 7 months later today, my hair on my whole head thinned and hairline is ripped. I say stay off because If something comes out that will hold hair forever, you’d want off to try and regrow with bim or get a transplant and minix hairs are only kept by minox.

  22. I think if the 21st century cares act passes which looks overwhelmingly likely, we could see something by the end of 2017. These trials are going to have to take a year and a half to two years because peoples hair cycles are measured in years. I for one am pretty damn excited about the possibility of seti + bim. I see bim as the minor help and seti as the major help bald scalps need. At the very least I think this will be a superior alternative to minoxidil and propecia. And best case is it reverses the hair loss by reactivating the dormant stem cells. We will have the reversibility question answered before this decade is over. And to the poster who said that this will be a race against cell technology like replicel I agree. This is the first time in a long time I’ve felt this confident about the cure being so close. It’s about time something other than the “androgen based theories” came about and was tested.

  23. “20 june – House Energy & Commerce Chair Fred Upton (R-MI) has signaled he won’t bring his 21st Century Cures bill to the floor next week as he continues to negotiate offsets,….”

    NOT overwhelming as you say. as a matter of fact it’s being held off for the moment.

    1. Is a question of time….Gypsieshavenohairloss… Are you scared?
      We all benefit from it. Hair transplant doctors, patients, pharmacies… don’t worry.

      1. Don’t think he’s scared but this is how politics works… When something good is going to happen.. It is held off for the time being so that it can be re-structured and not benefit the public as much as corporations and the richer citizens.. Just like ttip.. It was an extremely shady proposal to give companies diaproportionate power.. And alot of people rose up against it all around the world.. What has just happened? The vote to stop it has been cancelled so that the frenzy diea out and they can re-instate it when everyone forgets… You fellas need to wake up..

        1. @follicleman
          Are you saying something about a conspiracy in the United States of America against androgenetic alopecia?

  24. @Paul: How we couldn’t be scared? There are many treatments on the horizon, but we have to wait at least 3 years. During this time our hair situation may be really destroyed…

  25. Gentlemen, Replicel is partners with Shiseido. Shiseido will be beginning phase II either in July or Aug with 60 participants. This will last approximately 2 yrs. Phase III can now be skipped in Japan. This will be finally on the market “only in Japan” in the year 2018. As for aboard & the USA 8 more yrs, 2023. So those who want this done sooner will have to travel to Japan!!!

  26. Hello Admin,
    thank you for this very informative update. We would like to address a specific topic with this comment, open to discussion with anyone, and that topic is hair regrowth (re-enlargement of hair follicles after miniaturization).

    We need to be realistic and updated. Androgen-dependent genetic hair loss results in the miniaturization (shrinking) of hair follicles, which in turn produces perifollicular fibrosis (https://www.ncbi.nlm.nih.gov/pubmed/16755026).
    Can we expect an external drug to reverse this?

    Each and every step towards a cure is valuable, and at the current state of the art about hair loss treatments, we would be super glad to have at least something that completely stops the miniaturization. But the information available on the subject is making us believe that a hair follicle “genetically programmed” to miniaturize over time under androgen hormones activity could be fully cured only if genetically engineered, by means of probes/nanotechnology/others, reaching the very inside of it.
    We would really appreciate any constructive comments.

    Regards

  27. @AndroAlopecia: Not every hair follicle is programmed to miniaturize over the time. Using multiplied resistant cells it is possible to rejuvenite thinning process and stop it forever, because there will be resistant cells. As they said: you no longer have cells that are affected by androgen running in your hair follicle on top of your head. So that is a permanent solution. It’s not like you’re taking a drug, which basically juices the performance of what cells are left, but it doesn’t actually change the inevitable outcome. We’re changing, we’re going to reverse and change the inevitable outcome, so those hair follicles no longer are compromised by androgen. https://www.midasletter.com/2014/10/replicel-life-sciences-inc-ceo-david-hall-interview-podcast/

  28. Shiseido posted a video on their technology ok some Japanese talk show this month. They stated some great information and a release date of 2018. I really hope bim and setiprant fast track and come out way before that, like 2016. Cotsaleris supposedly ran trials on seti already at university of pa. Allergan would just have to run another one to max out results. The best of all would be to wake up one morning and see that histogen is releasing their product and skipping phase 3. I would fly to Japan the next day

  29. Could anyone help me what is the difference between setipiprant and RU58841 or are they the same thing?

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