or a successful Bio Pharma play you need a lot of things to go...

or a successful Bio Pharma play you need a lot of things to go right and it takes time, don't we know it!

Of the many aspects that are required, three of the more important ones include:

1. Great Product that's efficacious and not harmful, has some therapeutic benefit, hopefully a lot of benefit
2. We need a partner or some sort of funding to keep us going while we don't have revenue, preferably this is non dilutive, specially when we have been a few rounds in the boxing ring of dilutive capital raises on the share market - *ugh*
3. We don't want there to be a lot of competition for our newly founded (repurposed) product when it eventually gets to market.

Tonight, let's take a look at that 3rd point.

To fit it all in I'm breaking it up into two parts. We'll first take a higher level look at some competition. In Part 2 I'll drill down a bit more to give you guys an impression of where we stand and why I reckon we are a good case for the Authorities. As per usual, I'll make it personal, how does it relate to iPPS and your investment into PAR?


Please do now enjoy



PART 1


INTRO

Primarily we are tackling pain and function. These two are our stated primary endpoints, it's what we are being tested for. In fact the FDA are acutely aware that there is a gaping big hole in the world as far as decent but safe pain management is concerned.
.
We have the main indication as OA which abounds in pain, specially as you inevitably progress through the levels of OA. This has the deleterious effect of making you slow down and eventually grind down in your physical activities that we all take for granted. A mate of mine used to tell me that pre iPPS he used to wince out aloud just from going from a seated position to standing up.....even getting in and out of cars becomes painful, stairs, and finally just walking and sleeping. It affects a broad range of our activities.

No wonder the FDA have classified this as a Serious disease. It's also an unmet one.

So what is out there and how do we compare?

Certainly I don't have the bandwidth to cover every form of competition but think of this as a sampler of some of the bigger and prominent ones.



JUST THE OTHER DAY...


I was getting some prescriptions filled for my dad and while I was waiting at the Pharma I wandered over closer to the counter and saw all the available painkillers, all lined up on the shelves right there in front of me. The first thing I thought of was our Global Head of OA, Dr Mukesh Ahuja.

Huh?

Yeah...let me elaborate.


This is what I saw in front of me:


_{Actual pic from Mozz's phone while I was waiting around...right in front of a section titled "Inflammatory"... hmmmm}


The three I want to pick out are three of the more popular items often prescribed for over the counter pain.

Ibuprofen (1)


Voltaren - main active ingredient is diclofenac (2)


Naprogesic - main active ingredient is naproxen (3)



Now wouldn't it be great to just have some sort of comparator analysis out there that compares how these drugs perform against our ol' Pentosan.

That's where Dr Ahuja enters in. He went one better, he not only presented it in slides, he presented it to the OA scientific heavy weights at Oarsi in Vienna earlier this year.

This is what we saw....and for your reference, I will put those little numbers above, 1,2,3 so you can really see how we compare.






The 1, 2 and 3 relate back to the three bullet points above.


Yeah but Mozz, our iPPS ain't that great on that chart above, the others ones are better??

Not necessarily true - those others are taken daily, ours is just the initial course and look at the time frame, that's in 2 to 3 months!The other thing you are forgetting is that 1, 2 and 3 all have side effects and aren't meant to be taken daily for....well, for.....forever! You need to think about the toll it's taking slowly but surely, on your liver, on your kidneys...

Take a look at function improvement:




So despite taking a number of those medications daily, in terms of functionally we trumped them all!!

I ask of you - What do I want as a patient? I want pain relief primarily, but I need function improvement. But none of those are relevant really if they aren't safe. No point in bringing me pain down and increasing my function and I'm going to accelerate kidney failure!!


And finally the longer term, mate this chart does wonders for me. It also did wonders for the audience as this was the single most photographed slide.



_{(Single left click to enlarge)}


Yeah but Mozz, how many actually take 1 2 3 ?

Is the market decently sized?

*incredulous looks*

Yeah it's big:


1) Ibuprofen 8.7 Million²

2) Voltaren/diclofenac 4.11 Million³

3) Naprogesic/Naproxen 3.53 Million⁴



Don't forget those dosings above are only for the USA.

One I have to add in is corticosteroids. This little beauty (not) deserves it's own section.



CORTICOSTEROIDS

This one is fairly big out in the prescribing world. It's a big deceiver in my mind as you typically get three awesome months of no pain...blissful...but...

Then the pain often comes back. The problem that a lot aren't aware of is that it actually can accelerate cartilage loss! The one thing we want to protect. For this reason most Docs will limit the amount of shots over one year to two or three max. In fact some insurers won't cover anything more than that anyway.


"Aseptic necrosis Steroids, particularly at higher doses for long periods of time, can sometimes lead to damage to bones, called aseptic necrosis (also known as osteonecrosis or avascular necrosis). This can happen in a number of joints, but the hip is the most common".⁵

...and also...


"Corticosteroid use increases the risk of osteoporosis, which weakens the bones. In turn, this increases the risk for bone fractures. This risk seems to be highest in older adults who take high doses for longer periods of time". ^5.5



_{Ref 5.6}




That concludes Part 1.

In Part 2 I will reveal a surprise about a very popular drug...a stat you just won't believe (I tested this stat on a mate a few days ago and he was also very surprised though he too has been following our story for quite a number of years).