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For those who are interested, details of Amryt's Phase III have been posted on the FDA website (clinical trails.gov). https://www.clinicaltrials.gov/ct2/show/NCT03068780?term=amryt&rank=1. Looks like it is starting on schedule. Cookie
Birken, SomPharma and the marketing rights to Lojuxta are the three acquisitions I believe
Agree....the new results would seem to confirm that AP102 has a potential clinical advantage over Signifor, the relatively new Novartis drug developed to replace the blockbuster Sandostatin. It is important as the diabetes Signifor will likely give you, even if controlled, will shorten life expectancy more than the original acromegaly it is intended to treat. It is a key safety measure for the drug...very pleased to hear it.
...biggest hurdle in drug development is lack of cash (been there, bought the T-shirt). With access to this 20M plus the money from the RTO they should be full throttle on both developments...no excuses for not making rapid progress. The cash will easily cover the Phase III in Episalvan plus pushing AP102 through the first clinical. For me AP102 is the prize asset...by far the one with the most revenue potential and getting human data will de-risk the development substantially and make it more attractive to big pharma. I think there is probably a little cash left over for an acquisition as well to spread the risk. Feeling a lot more optimistic today...long may it continue.
Age old problem with orphan drugs...pricing. Amryt have approval for Episalvan in wounds & burns. High volume, low cost Episalvan (there is a lot of competition here and a high price wouldn't work) but are looking at epidermolysis bullosa for a new market....very few patients which means you have to charge a very high price to make a profit. Can't charge two different prices for the same therapy. If they launch Episalvan at a low price for wounds then have a success with EB they cant then crank up the price 100-fold. The mob will come at night, with flaming torches and pitchforks for exploiting poor sick people (see Martin Skhreli & Turing Pharma for an example of what happens when you do to that). Maybe they are hanging on to see what the EB data looks like before deciding on a way forward......not an easy decision, fine lines but nothing unusual. Best to take the time and get the decision right in my view.
yes agreed..sort of, it was late on Friday....FDA are indicating that based on the pre-clinical (presumably animal data) presented to them the product is potentially superior however there is still a long way to go before a product hits the shelves or even finds its way in to a human. The milestone is a critical one and achieving it is very significant for a small biotech and the price didnt move which, to me, begs the question are there enough analysts and investors on the AIM who really understand biotech and the nature of the business? I can see the attraction of the NASDAQ for Amryt if, when you put out significant positive news, it gets ignored. I am no expert here but maybe visibility and PR are the issue for Amryt???? is it only "financial news" that has an impact on here perhaps? Amicus does have an approved product but not in EB and they cannot launch anything until they have market approval which could take 6-9 months after completing the Phase III (if they ever do finish it).
just to ramble on (it is late on Friday after all)...by granting ODD the FDA have announced to the world AP102 is superior to 2 drugs from Novartis with combined sales of $2bn......and the price never moved......madness has truly gripped the planet this week.
I will be sticking around.....happy to provide an independent view. I have put my small stash of shares under the mattress for a couple of years. I dont expect a quick win here but long term I expect 2-3 fold what I put in, when and IF big pharma rolls up and buys either of the therapies. For me, the portfolio is too diverse to be sold off together as a single asset, Novartis and Shire are not going to want to try and produce a birch bark extract...this will have to go to a niche pharma with the right competences. AP102 has a more global appeal to big pharma but it is early stage. Huge market potential though. First patient in (FPI) in the EB study is a great milestone but dont expect the price to rocket. It is the end of the study and the result that matters and that is at least a year away. Look out for the clinical protocol on clinical trials.gov when it appears. This will tell you when we can expect to see data which will seriously make the price move...if positive. FPI and EMA ODD Q1 next year should take us above the IPO price...how far? who knows? it would be just a guess. I thought the FDA ODD would have had more of an impact on the price...maybe people dont appreciate how valuable that is (and how bad it would have been not to get it). Biotech is always high risk high reward. In my view Amryt are doing well and have great potential. Still very risky but as good as any small biotech out there. If a drug fails in the clinic it can kill the company...oil and gas, dont you just get your shovel out and dig another hole somewhere else? Good team and very hot field to be in. Big pharma are always looking to acquire things like this. Worth a punt I think. Just have to be patient.
not saying you cant license it early, but if you want a return which can support further developments then it will need to be post phase 1 or 2. Always been positive about ODD....very useful and a critical step. need to get on with chasing the EMA ODD now.
As I see it AP102 is at least 18 months away from being "licensable" (if that is a word). A pre-clinical drug like this would have little value until completion of a first-in-man trial to demonstrate safety and efficacy in the human setting to generate big pharma interest (Orphan designation alone is not enough...they will want efficacy data as a minimum). Given the start of that is at least a year away then another 6-12 months to do a clinical study. They are not going to generate money any time soon that way sadly. It also depends on the type of study they do. A healthy volunteer study may be necessary but will add little value (as this is safety and not efficacy). If they can start in real patients and get a feel for efficacy there may be a chance to out-license after that. There will be no big pharma partner to develop that for quite some time sad to say. ...outlicensing Imlan to someone who can commercialise it globally would make more sense.
Pleasant surprise this morning, first tangible sign of progress...excellent news. Apart from the reduction in regulatory fees, taxes, scientific support and an accelerated review process etc, orphan designation has two main points... Firstly, it is a recognition by the FDA that the data presented to them by Amryt supports the prospect of AP102 being superior in terms of efficacy and/or safety to the current standard of care, Novartis' Sandostatin and Signifor. These drugs between them have around $2bn in sales. Sandostatin has been in the top 10 block busters for Novartis for over 20 years....its time is coming to an end and Signifor has failed to replace it due to safety issues. Secondly as the press release says, it gives AP102 10 years market exclusivity which is important as this means it gives extended patent life. Nobody will be allowed to license a generic biosimilar for a period of 10 years after market approval has been granted, which, if you have taken 15 of the 20 years patent life of your drug to bring it to the market this stops the Indian or Chinese generics companies copying it and selling it for a fraction of Amryt's price for an additional 5 years thereby protecting revenues. Having the FDA approve this strengthens the EMA application significantly. Surprised we don't have a timeline on that. If they are waiting for the FDA result before submitting, probably looking at 3-4 months before a result. Great credibility boost for the company, I think the Novartis execs in Basel will be looking nervously into their smartphones on the tram this morning... Cookie
I was reading up on Imlan...essentially it is Episalvan-lite with half the bioactive. There are a few German publications on investigator-led clinical studies (not as good as a proper clinical study...but more data than most in the same field) with various Imlan formulations which show good efficacy in a variety of inflammatory skin conditions including chemo-radiation-induced dermatitis ie cancer therapy-induced skin damage. Looks effective yet it is registered as a cosmetic and only sold in Germany & Austria. I presume this was Birken in the early days taking a short-cut to generating revenues locally rather than registering at as a medical device (which I believe Amryt is now doing). I think this cosmetic route is only do-able in Germany hence the restriction to sales in that area and places a severe limit on the claims they can make about the product. Seems a bit of s short sighted thing to do but I guess they needed the cash at the time. Data shows Episalvan works well for treatment of burns and epidermolysis bullosa - heavy duty stuff, but the diet version, Imlan, should be reasonably effective in most less serious inflammatory conditions (the underlying mechanisms are the same for most mild/moderate skin diseases) including psoriasis. I also saw it can reduce bacterial and viral contamination levels of skin in a couple of papers too. Many pharmacies in Germany stock Imlan as do many dermatology clinics. It is quite a crowded market but Imlan is one of the few with a credible bioactive (betulin) compared to the herbal hippy stuff out there with a mild placebo effect. I can foresee decent EU sales for a variety of dermatology indications if they keep the price reasonable.
mytrader: Cushings is a nasty disease, more so than acromegaly and may well be fatal in some cases. It is the result of a tumour that secrets large amounts of steroids into the body with all the associated problems that may cause. Half of patients will also develop diabetes. If the tumour that causes Cushings in inoperable, there is only one therapeutic option, Novatis' Signifor, approved in 2014. It controls the disease in only about 20% of patients and if you didnt have diabetes before, the drug will cause it or make the existing diabetes worse. Because Cushings is so severe the EMA and FDA approved Signifor on a marginal risk-benefit analysis (basically there is nothing else available). AP102 data that SomPharma presented previously showed it did not affect blood glucose levels although they had not yet studied efficacy in treating the disease. The biochemical approach to the treatment of Cusings is similar to that of acromegaly which Amryt are focusing on bit if it works with that then it may well work for Cushings (like Signifor does...sort of) and if it doesnt make the diabetes worse...then its a winner. Signifor sales are currently very poor (in pharma terms), around $200M per year due to the reluctance of clinicians to use it because of the diabetes issue and poor efficacy. Data I have seen presented show there is potential for AP102 to beat Signifor on efficacy and safety (and the older drug Sandostatin also from Novartis on efficacy). Still a long way to go on the development though as it hasnt yet been tested in humans according to the clinical trials database. Cookie
Sompharma licensed its therapeutics from University California San Diego who actually own the IP according to UCSDs website.....I presume this is the main asset Amryt bought when they acquired SomPharma. I believe there was little in the way of people or infrastructure associated with the company (this is why I am interested in asking who do they have available to develop the drug)
last I saw was a total headcount of around 30 ish....strip out the boys in Dublin, plus a dozen or so producing Imlan, IT, admin, finance, the cleaner......leaves the resource cupboard pretty empty....I know the effort it takes to develop a drug and run clinical studies, it is difficult, complex, resource intensive and people have to be hands-on. I would like to know the strength of the operational team, not info on ever more high profile appointments to the Board. Cosmetic (pardon the Imlan pun) appointments to the Board wont develop AP102 or Episalvan which is ultimately the value driver for the company.....if they are short of people to do the clinical work then we wont see first patient in the EB study in Q1 I suspect.
...just to be provocative, it is all well and good hiring expensive big name big pharma guys to impress the city but these old grey guys in expensive suits are not going to do the real day-to-day work of drug development. They will not dirty their hands. (great to have them on board if Amryt wants to negotiate the sale of the company tho). To run a global phase III study with Episalvan in epidermolysis bullosa requires teams of people in clinical, regulatory, safety, manufacturing etc etc.....plus Amryt is trying to develop AP102 with a clinical late next year, as well as producing, selling and distributing Imlan. Does Amryt have enough people on the ground doing the work, if so who and where?....I presume the operation is happening at Birken in Germany (Amryt's head office is a terraced house in Dublin according to Google maps)....although Birken is mainly a manufacturing facility as far as I can see. What is the real headcount of people actually working day-to-day moving these projects along? Birken have done clinical studies before but on a much smaller scale. Cookie
I also assume Amryt will try and get orphan designation for AP102. Will be interesting to see what the FDA & EMA make of it. Pre-clinical data I saw SomPharma present on several occasions showing the drug was effective in animal models without the hyperglycaemia that Novartis' pasireotide causes should give it superiority. Swapping acromegaly for diabetes with pasireotide is never going to be a winner. IF the regulators grant ODD...will be interesting to see how Novartis react.
so just a quick look at the FDA clinical trials database shows that they completed a Phase 2 study in EB with 10 patients https://clinicaltrials.gov/ct2/show/NCT01294241?term=birken&rank=5. Off the back of that data they gained FDA and EMA Orphan Designations according to the databases. Both the FDA and EMA require that the data shows superiority (or clinical advantage) to that of existing therapies. There is currently no standard of care or registered product in EB although there is one other product called Zorblisa in Phase III....dont know how effective that is but it needs applying every day unlike the Amryt product. Anyhow, the regulators must have liked the Phase 2 (unpublished) data from Birken as they granted it ODD and the amount of times you have to apply it wouldnt be enough alone to receive the designation.
...seems obvious to me that they will launch Imlan across Europe soon. Currently it is only sold in Germany and seems to be profitable. Could be a decent revenue generator to fund other projects.
maybe...but I didnt see much, if anything, of people buying Fastnet shares on the run up to the RTO. The owners/founders/senior managers have almost all the stock. Employees with stock options will have got scraps worth a few 10's of K euro each...I guess about 100 people in total allowed to cash out immediately.