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Recce's R327G gains commercial pathway with Arrotex

Recce Pharmaceuticals Ltd managing director and CEO James Graham talked with Proactive about the company's exclusive licensing and commercialisation agreement with Arrotex Pharmaceuticals for RECCE® 327 topical gel (R327G) in Australia and New Zealand.

Graham described the agreement as a significant step for Recce Pharmaceuticals, highlighting Arrotex's pharmaceutical sales, marketing, distribution and market-access capabilities across Australia and New Zealand. He said the partnership allows each company to focus on its respective strengths as R327G progresses through clinical development.

Graham also discussed Arrotex's reach within Australia's Pharmaceutical Benefits Scheme and across hospitals, clinics and pharmacies, describing the company as a strong commercialisation partner for R327G.

Graham discussed clinical work underway in Indonesia as well as the company's Australian Phase 3 study, with Australian data expected to be an important part of the regulatory pathway.

He said the Indonesian study was already demonstrating what he described as a strong efficacy signal while maintaining an excellent safety profile. The Australian study remains underway, with further clinical data expected as the program advances.

Looking ahead, Graham identified potential clinical data readouts, regulatory submissions and additional licensing opportunities in surrounding markets as important milestones for R327G.

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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.

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