00:00
James Graham
That data itself is already showing uh to to have an incredibly strong efficacy signal
00:08
James Graham
and maintaining an excellent safety profile.
00:17
Jonathan
Ricky Pharmaceuticals has signed an exclusive licensing and commercialization agreement with Arrotex Pharmaceuticals. Here to discuss the highlights is managing director and CEO, James Graham.
00:26
Jonathan
James, good to see you again.
00:29
James Graham
Hi, Jonathan. Good to be with you.
00:31
Jonathan
So, let's talk about this agreement. Talk us through, I guess what it means for Rey.
00:37
James Graham
Yes, look, this is a significant licensing agreement with in fact, the largest pharmaceutical company of Australia and certainly New Zealand.
00:51
James Graham
This licensing agreement is really in support of Rey's uh first new or really the first new standard of care for the treatment of diabetic foot ulcer infections.
01:00
James Graham
So for Rey, this represents marketing and distribution opportunities and of course listing uh on the pharmaceutical benefit scheme around a potential regulatory approval.
01:11
Jonathan
And what does it give you in terms of I guess manufacturing and intellectual property as well?
01:17
James Graham
Well, we maintain our manufacturing and we maintain our intellectual property. So it really creates a scenario of utilizing what we do best, which is obviously create our our our compound and what they do best, which is sales, market and distribute that.
01:34
James Graham
We are the only uh potential diabetic foot ulcer infection treatment in their portfolio and the only uh for acute bacteria skin and skin structure infections.
01:44
James Graham
So that is a competitive advantage for ourselves and of course just a sign of how dire this uh the unmet medical need that is that we go to treat.
01:52
Jonathan
And you've kind of mentioned it here, but but let's let's uh uh set it out simply. Uh Arrotex, I mean, as you said, they're the biggest in Australia. But why are they the right partner to help you commercialize uh R327J in Australia and New Zealand?
02:07
James Graham
Look Arrotex are responsible for over 50% of the pharmaceutical benefit scheme uh approved drugs in Australia. They're also one in every two drugs or scripts written across Australia.
02:16
James Graham
So where you have a group with major uh marketing and distribution, uh and of course formulary access across uh hospitals and and clinics, pharmacies and beyond. You really well they really represent the the perfect partner for us.
02:31
Jonathan
And I just want to touch on that phase three development as well. How does this agreement help that through?
02:38
James Graham
So we have two phase 3s running at this moment. Uh one is in Indonesia for the ACR and group of countries and the Middle East. Uh we have a term sheet for that with really one of the largest uh pharmaceutical partners uh for that uh region of the Middle East.
02:51
James Graham
That data itself is already showing uh to to have an incredibly strong efficacy signal and a maintaining an excellent safety profile. So that's recently been announced.
02:59
James Graham
However, the Australian deal itself is based upon Australian data. We have a phase three running in Australia and that data, uh we expect to read out of that uh later next year.
03:08
James Graham
So, the Indonesia study data pack is of course, um acceptable, but it is not the ultimate data pack. The data itself is led out of the Australian study and complimentary to that is the words I'm looking for there.
03:20
Jonathan
Um and the key milestones now, I mean, what are the key milestones before, I guess R327J reaches the market here in New Zealand?
03:32
James Graham
There in New Zealand, here in Australia. Yes, we are in uh Indonesia, we of course are unblinding that study data at this moment. So it's an independent uh committee that does that of international infectious disease experts.
03:45
James Graham
If that data is uh as as it would appear to be, that would be uh moved to a regulatory submission.
03:52
James Graham
In Australia and New Zealand, the study itself needs to obviously run its course. Uh it is running its course and therefore between here and a potential uh market submission in our region, you would expect to have uh positive clinical data events and surrounding markets, additional license opportunities across the regions they represent, and of course, uh positioning for a a regulatory approval uh if successful down the track in in our local markets.
04:21
Jonathan
Yeah, James, uh plenty going on and plenty to look forward to. Thanks for your time today and uh uh yeah, we'll talk again shortly as more news unfolds.
04:30
James Graham
Most definitely. Many thanks.