till giving the science a break this week...tonight, let's talk about something a bit different, let's talk deals!
Yes of course I will need to touch on the science...but be prepared for some pretty pictures that I just know a lot of you haven't seen to date! Those that have, I can fairly confidently say you will be pleasantly reminded of what evidence we have already seen!
STOP PRESS: All Father's - Happy Father's day...Well it is Fathers Day in Australia! My dad was a chem and a bio teach, he taught it so well that I loved it in yr 11 and 12...I haven't used it for 30 odd years...now I use it for PAR, and I love it... the trick? Using interesting stories as examples to hammer home the theory. The theory is boring and dry...turn it into a story and the kids will remember for life!
WHAT IS A DEAL?In truth, there can be many different types of deals.
We could have a full on take over deal...we could have a joint venture...there could be some sorta of symbiotic relationship.... But what's best for us?
When are we going to see this?Well certainly a deal is a very specific in each case, each company will be different! Each drug and product warrants different pathways. We don't know exactly how this will go but that doesn't stop us from at least thinking about the different options and I will submit my humble opinion but I'm always keen to hear from YOU guys, What do you think is possible what are the pros and cons...what would you like to see and why?
From my personal point of view, for us, I think it's hands down
Distribution Partnership is the way to go.
Why?
We are little. Oh we are so little...but not unlike the David and Goliath story...mate we could pack one heck of a punch. Imagine this for a sec....you.....I...
we are owners of a drug that is having the single most beneficial efficacy in the last of the remaining big diseases...OA- so big it is, that it potentially trumps Diabetes. It's bigger than Oncology....is that possible?
Mozz, seriously, you better have done a bit of a fact check there mate, that's some well...big claims! See Appendix A for the Fact Check.
When you have a product that good....then you need to think about the issues of scaling. Yes of course we will potentially start off small.I mean look at us now...14,000 odd share holders holding only 285 million shares....to some it might sound like a lot, but 285 m isn't a whole lot.
My point here is that we are very under the radar. Not many know us, not many believe us. but what's the way to become believable?
Stay on the path.
We see the iceberg, the official announcements but what's happening under the surface....I suspect plenty...I suspect LOTS. I hold for the days we get the glimpse of not only MORE compelling data...but more compelling EVENTS! The market also is barely seeing above the water line let alone BELOW it! Wait till that lag disappears and they realise what we actually have and that we can finally say we are funded!What is the path I'm talking about?
COMPLETE THE 002 Part 1 - Minimal Effective Dose. This is a big one, we need this to progress, we need this determined to trigger a lot more discussions
COMPLETE THE 008 program, we are nearly there, a read out and we are done....Compile the data and discuss.....it's more pivotal than I thought, what is the separation, how is Rescue Medication holding up, Active -v- Placebo...are we still trumping?
KEEP THE KOL's informed...it's no doubt happening in the background, they are already firmly on board...what reactions do YOU think they will have when they are eventually privy to our data. Many of the Big Pharmas will look to these very guys for leadership and guidance.
Does PAR have what they say they have?
Is Par real?
Is the safety profile that's being trumpeted, true?
Can I talk to a patient that has tried the drug?
These and oh so many questions will get answered ...you and I kinda know the answers to these already...There are many many that will eventually come on board and these are the questions they will ask.
Already partners are swirling...discussions are no doubt taking place....remember, though the journey is ultimately long...things can still happen darned quick....
DISTRIBUTEWe have a great drug
We have a safe drug
We even have something rare that would be our next point of worry...of contention...can you guess what that logically is at our juncture?
It's usually GMP...it's manufacturing....not just any.,..but GMP, this is the gold std. but this is also the required std to progress in the USA.we already have this...we already have the ability to scale....by the tonne. I mean really really scale...
So why do we need a Distribution Partner? Well we can make the stuff ....we have the rights....we have the science...and one day we will have the green light...but we need to distribute it....we could potentially do this in some very localised regions...but to hit the really really BIG markets...it would take more than a few years to expand organically...we need a partner so we get this done literally OVERNIGHT.
It's not just about amassing a huge sales force, setting up lots of localised offices...it's about being onside with the large medical associations, having those distribution channels already set up....having the logistics already in place. There are a lot of moving parts here to feed huge areas like the US. Then there is Europe....Legislative and logistical nightmare for a start up? Yeah that's what I'm thinking. So seamless it would be to have a truly global partner that has already spent the last x decades getting these pathways up.
We just set and forget.
The trials and clinical stages have gone on for so long...once we get the green light do we really want the drug to be distributed slowly and build up the network over years and years, or do we want
overnight mass scaling? Give me a BIG DEAL !
MARKETING AND LABELLINGPut your hands up if you have seen the mini series called
Painkiller? You get a sense of just how important it is to have all the market and labelling done and the big word here that starts with C?
The Netflix's Painkiller, worth a look, great insight into the Opioid story and just how destructive opioids can be!CONSISTENCY...in the Painkillers example for OxyContin, it was that blue stuffed round pillow character....you need these little gimmicks to help sell, well they needed it more as they were selling an opioid, our drug should definitely be able to sell itself as it's safe and it works as good or better than those crazy opioids.... Opioids merely relieve pain...
...yeah we do too...but we have the BIG daddy...potential DMOAD...the actual HALTING of the disease.
THE actual ARRESTING of the of disease...THE potential REVERSING the course of the disease in one instance - that's powerful...
OH SO MUCH MOREWe all say that it's about time PAR strike a deal....
We have seen this back in the 2019's...
I literally thank goodness that we did not do a deal back then....much more water has passed this bridge....we are so much further along...we no longer command whatever it would've been back then (500 million? A Billion?)...no no no no...now we are way ahead of that,...but even so...wait a few more months, I call it 6...maybe I'm too aggressive, let's say 12 months from now.
Mozz...what happens in 12 months from now?
We potentially have those discussions not with just the FDA...we have it with separately, the EMA...we get certainty on how and what is needed for DMOAD...in 12 months from now we could potentially be selling iPPS for MPS in some areas of the world?We could be materially closer to Regional type deals?
There is so much scope, so much potential...why give this away when we are so close.
PAR holder guys, this is the darkest times for us if you look at the SP...but certainly this is the brightest times for what is coming up...Of course the share price action is important, BUT.....it's even MORE important to get these milestones done and for us to progress a bit more down the incredible pathway that we are already on...
I was asked just recently..Mozz, why aren't we pushing our message harder? Why aren't we presenting to the real big boys...mate, that will come on it's own don't worry...for now? Surely it is much more important to get these hurdles out of the way, the glorious stuff will come..(personal views expressed).
Please don't think I'm a hermit...just wanting to wait forever and then hit nirvana...do you at all understand I've been waiting since the last 5 years? I was in at IPO but I had no idea what I had till late 2018....
Then in 2019 I got excited thinking mate, we are at $4 now...surely $6 is the next stop?
But I've learnt a lot...I've understood why we are under the radar...we all have learnt lots....and there will be more hurdles and dips....its not going to be a straight path up from $0.65 straight to $10......or $10 to $50...there are going to be tremendous dips in between and sometimes for really no apparent reason...it's happened to most if not ALL stocks...heck even AfterPay...I followed it from $7 to $30...then back to $11...and then to $150...I'm getting giddy just remembering!
The $30 down to $11 wasn't fun...I had to unwind positions which was ugly enough...then to have the ability to buy back in at $11....it wasn't easy.
Mate, in regards to Afterpay, it was so easy to see the scope...it's easier with PAR.....the science is incredible....Afterpay had so so much competition - Afterpay had the ASIC potentially after them...Afterpay is a payment system. there is already a std of care!! So many...I'm not going to list all of them...Paypal, Visa, MA, AMEX, Humm, Klarna...
What std of care do we have? What other drug reverses the course of OA?
Tell me, what other Painkiller is there that reduces pain like we do...BUT.....BUT.....BUT does it safely without ramifications?
PAST 'BIG DEALS'As we know, we are the first real drug to show not only great efficacy in the Pain and Function frontier with a safety record that hasn't been seen before...BUT we have DMOAD possibilities. Look, you and I both know that what we have seen to date is DMOAD, but we do need to prove it at the highest level and that means a P3.
One deal we cant forget about is Tanezumab - ten years ago for $1.8 B. At the time of the deal they prob weren't too aware of the immunosuppressant signs and what troubles they would go through, again without a DMOAD, that's quite decent numbers...Investors to us in the last year or two weren't aware of the scares and some of the fear we had with potential competition like Tanezumab, we had to take it pretty seriously at the time, the big scare for me though was a bit below..we will get to that in a few paragraphs....
Another past deal was J&J takeover for Momenta...here is a link for more details:
https://hotcopper.com.au/threads/momenta-and-the-momentum-of-par.5742381/?post_id=48713139That one was in the immune mediated disease space and was a full company take-over, certainly not what we want, maybe we may want it at some crazy price but it would have to be exactly that...Crazy good.In the case of J&J, it was a UD $6.5 Billion dollar deal.
Here is another deal that was done back in 2019...Galapagos and Gilead...First the details of the deal:
Galapagos will receive a $3.95 billion upfront payment and a $1.1 billion equity investment from Gilead. Galapagos will use the proceeds to expand and accelerate its research and development programs. Gilead will receive an exclusive product license and option rights to develop and commercialize all current and future programs in all countries outside Europe. In addition, Gilead and Galapagos have agreed to amend certain terms in the agreement governing filgotinib, the candidate being advanced for rheumatoid arthritis and other inflammatory diseases to provide a broader commercialization role for Galapagos in Europe.The high level exec summary is that it is predominantly used for Rheumatoid Arthritis.
A while after that I came across their drug called GLPG1972...
This was the one that shocked me and I nearly came close to selling some of my holding in PAR out of pure fear. I rang up a very good contact that knew PAR back then and he assured me that it really was nothing to worry about....
Mozz back story? I first rang up the Anchor man, he of course was in his roof tinkering around with some engineering aspect and he completely stopped and nearly hit his head on a rafter...he was shocked to hear my concerned account that we might be in trouble as we could have, for the first time, competition on our hands. I remember my starting line to him when he picked up the phone, I said: "Houston, we have a problem"... this was just before I rang up my ace contact. Skip forward a few years and indeed, my contact was right.... we had nothing to worry about...
Luckily I sold not one share...and Anchor Man also has been adding since that call.
The latest is that GLP1972 had an article published in the Osteoarthritis and Cartilage OARSI magazine (which I now get sent after my OARSI attendance) that states that there is no evidence of the efficacy of GLP1972. Here is the article:
Two things to note about the above figure:
1) Red Box results weren't great...
2) See the orange underline...who reading this Mozz Post understands who this guy is?
Ok for those that don't know...yeah that's Dr Thomas Schnitzer...relevance to you and me? He is our Principle Investigator for all of USA:
So what then was our own drug's action on this ADAMTS-5 ?
Here we go:
Filgotinib is what is known as a JAK inhibitor. We know these single targeting drugs can be an immunosuppressant and indeed if you have or are susceptible to an infection, this is a pass for you...ie don't take it!If you are on statins and some other drugs to treat high Blood Pressure, it's also a pass. Use with caution and your Doc will usually go through a checklist before they even begin to think about putting you on this thing.
It's another clue for us, imagine doing such lofty deals for drugs that are so-so or may help a few but certainly come with precautions and aren't for everyone that has RA. Now imagine us:
- Pain reduction better than Opioids
- Non addictive
- Function Improving
- Stable at room temp
- Works NOT via intra articular but merely sub Q
- Doesn't need to be taken every day
- Use it and patients aren't coming back to baseline...this has never been seen before in terms of pain
- Works simultaneously on MULTIPLE JOINTS...actually hold onto this idea...I'm going to revisit it at the end of these points...
- Other positive ramifications possible - think Blood Pressure, general inflammation, atherosclerosis and lower Blood Sugar connotations
Ok remember that one idea above, the simultaneous acting on multiple joints? Yeah yeah Mozz, we get it, in theory this thing doesn't have to be injected directly into each joint. Mozz -when will we get to see this as MRI's?
We have to wait for a peer review or sometime after a final read out or something, if ever?Paradigmers...I've ALREADY had a glimpse of this incredible evidence.
Yeah well Mozz you are just privileged..
Wrong...
You can too....
Huh?
For that, we need to rewind quite a number of years back to 2019....no, not from some other third party...it was PAR and I just know a LOT, a real lot of you,
haven't seen this before. I know this because to date, in all my 4 years of writing on here, NO ONE HERE HAS EVER MENTIONED THIS. NO ONE HAS EVER POSTED THESE IMAGES....
Its kinda buried....this was from a PAR Announcement way back in May 2019.
Please now enjoy:
First the announcement that iPPS has efficacy not just on one joint, but simultaneously multiple:
Two things to point out about that first image above...
1) "Material Reductions" Sweet words to my eyes. (Red box)
2) Orange Line, it was here where Tanezumab was real competition to us back then, but they missed it and then the problems of them being an immunosuppressant started emerging. It was just a bit later that Dr Krishnan and Paul Rennie started emphasising that our MOA was completely different., We weren't merely Blocking like Tanezumab and Opioids...we were
downregulating, a key change in how we allow the body to react to the damage and the pain...we still need the body to react and repair...it can't do this if the pain is totally masked. You totally block IL6 for example (An inflammatory cytokine), you will cause much more damage and side effects.
Next figure (see above), from the same announcement....I give you Clinically Meaningful as well as Statistically Significant but it three distinct simultaneous areas, not intra articular. and not required in each and every joint like all other 10 candidates at the CTS OARSI in Denver March 2023.Paradigmers, it's now pièce de résistance time....Sitting down?
You by now know that I love my science...I love the words...but a picture ...is worth so much more. Tonight, I present to you the SIMULTANEOUS pictures....
Amazing.
If I was anywhere higher on that KL scale...and I visually saw those pics above and they told me that even if it doesn't work at all, there are no AE's...I'd be queing...
Now just imagine two things...what the MRI's from 008 will be telling the authorities at the end of this year......and then imagine a potential Global Deal for us on the back of DMOAD certainty ie what is required to get this on a label?
The above are just three images....PAR will no doubt submit ALL MrI's to the FDA form both Placebo and Active cohorts (my views)...
Guys, these are big dollars that we saw above in the Big Deals section...,yes there were some other products in the suite...but at the end of the day, you show efficacy...you prove yourself safe...you address a large market (OA)...you have connotations of addressing even larger markets (Pain) and you give a prospective BP a hint that there could be other inflammatory conditions to come (HFpEF, ARDS, Hay Fever CHIK-V, Covid etc etc)...well they are going to pay at least as much (my spec views).
Big Deal for PAR one day? Well it might start small....but once we off and racing...treat it as a marathon...though, I for one can see a Finish line and the crowds just could go wild......quite wild.
Isn't it worth hanging out for just a little longer?
I would think so.
- Mozz
DYOR important
APPENDIX AFact Check - Is OA really that big?
Well yes we know it is big but the question is, how does it compare to the burden of other big diseases?
The below table from Arthritis Australia
6. Yep, at the time, no medical research future fund missions for a disease that was more costly than Cancer treatments.
REFERENCES1) https://www.versusarthritis.org/about-arthritis/treatments/drugs/filgotinib/
2) https://www.gilead.com/news-and-press/press-room/press-releases/2019/7/gilead-and-galapagos-enter-into-transformative-research-and-development-collaboration
3)https://pubmed.ncbi.nlm.nih.gov/37059327/#:~:text=Conclusions%3A%20Despite%20enrolment%20of%20participants,adults%20with%20symptomatic%20knee%20osteoarthritis.4) https://pubs.acs.org/doi/10.1021/acs.jmedchem.0c02008
5) https://app.sharelinktechnologies.com/announcement/asx/eb3c5ffe35350aebf543fc5f0dca56e3
6) https://treasury.gov.au/sites/default/files/2022-03/258735_arthritis_australia.pdf
(20min delay)