Drug Development Company Commercialising Topical Products for Global Markets [Interview][Transcript]

Michael_Kotsanis_AcruxGuest: Michael Kotsanis
Presenter: Wayne Bucklar
Guest Bio: Michael Kotsanis is the Chief Executive Officer & Managing Director of Acrux. Michael commenced as CEO and Managing Director of Acrux in November, 2014. He has over 25 years of experience in the pharmaceutical industry and has significant senior Ieadership experience across the global pharmaceutical markets. Michael was formally the Chief Commercial Officer for Synthon Holding BV, a specialty pharmaceutical company based in The Netherlands, a position he held from mid-2010.
Prior to Synthon, he served as President, Europe, Middle East and Africa, for Hospira, the global leader in generic injectable pharmaceuticals. Michael joined Hospira following its acquisition of Mayne Pharma in 2007, where he served as President Asia Pacific from 2002. He joined Mayne following their acquisition of Faulding Pharmaceuticals in 2001, where he held responsibility for commercial activities in Australia and New Zealand. Prior to Faulding, Michael held a variety of sales and marketing positions with Boehringer Ingelheim over an 11 year period. Michael earned a bachelor’s degree in science from Monash University, and a master’s degree in business from the University of Technology, Sydney.

Segment overview: In today’s Health Supplier Segment, we are joined by Acrux Chief Executive Officer and Managing Director Michael Kotsanis to talk about their company’s background and drug delivery solutions. Acrux has successfully developed and licensed a number of pharmaceutical products in the US and Europe using the Patchless PatchTM, a fast-drying and invisible topical application technology. Marketed products include Axiron®, Evamist® and Lenzetto®. They also have a range of generic and patent-preferred products that are currently in development.


Health Professional Radio – Acrux

Wayne Bucklar: You’re listening to Health Professional Radio. My name is Wayne Bucklar and today my guest joins me from Melbourne in Australia, his name is Michael Kotsanis and he is the CEO of Acrux. Now Acrux is a pharmaceutical company. Welcome to the program Michael.

Michael Kotsanis: Yeah, thanks for having us.

W: My pleasure. Now Michael I’ve read on your website it says you’re a drug development company focused on commercializing topical products using its proprietary drug delivery technology. Can you explain to us what it is you do? And what’s your geographical footprint is?

M: Sure. So we take existing drugs, reformulate them and work out how they can be applied on the skin to penetrate into or through the skin to satisfy various medical conditions. And we have three different products that are approved, our main market is actually the United States although some of our products are sold in Europe and Australia as well. And our key product is “Axiron” which is a testosterone replacement therapy for men with low testosterone due to certain medical conditions. And that’s mainly sold in the US but also sold in the Metropolis, other countries around the world.

W: Okay. And it’s applied through the skin?

M: Yeah, it’s applied actually under the arms, under the armpit. Axiron is applied under the armpit, we have an estrogen spray as well which applies not under the arm but in a different part of the body, but they’re all topical or what we call “transdermal medicine,” so they’re applied onto the skin and their absorbed and have a therapeutic effect on the basis of the absorption through the skin.

W: I see. And you say you do a lot of business in the US but in fact you’re global?

M: Well we are global. Axiron in sold in 6 countries around the world including Korea, Brazil, Germany, US and Australia. Our estrogen product is sold in the US and it’s recently being launched in Europe and its first three countries but we expect that to be rolled out across the European Union. I think it has over 20 approvals, national approvals now in Europe and that will continue to grow around the world. So what we look at markets outside Australia as well as local market obviously Australia is a fairly small country, the biggest market we have is the US, for both of that our major products actually.

W: Michael that’s a very impressive story but I understand you’ve also been recently recognize as one of the top 25 firms through the academic sector, can you tell us a little bit about that recognition?

M: Yeah, look it’s an interesting story. Acrux is originally formed at the company in 1998 so we’ve been around, sometime we floated on the Australian Stock Exchange in 2004, but originally the intellectual property or the patent came out of Monash University from researchers discovered that if you apply some, actually that was sun screen, so if you applied sun screen, a certain sun screen to skin it will enhance the absorption of some drug and that was how our original company was formed run around the basis of intellectual property and patents granted for penetration enhancement of drugs applied to the skin.

W: I see, and what’s the recognition that you received recently?

M: We were nominated as one of the top 25 R&D spin-offs in a publication recently and it’s nice to receive the awards but it’s even nicer to know that our products are actually approved and commercialized in the major markets of the world. And our late product has been used by well over a million American men actually.

W: As you say high price indeed have a million users.

M: Indeed.

W: Now Michael most of our audience are clinicians of one kind or another, is there a take away message for them today that you’d like them to get as a result of having heard you on Health Professional Radio?

M: Oh certainly. We’re not resting on our roles, we continue to look at what products we can develop and formulate and our R&D group is very busy looking in a range of products actually to formulate into transdermal or what we call topical application of drugs. There’s a number of very interesting projects we’re working on, we’re looking at fungal infections of the nail bed, Onychomycosis where current topic applications are not very effective actually even though some of them require a year of treatment. We believe we can improve the currently available treatments available. And we’re also looking at a range of generic products as well, we think some of the topical products in the US in particular are quite expensive. We believe we can provide more cost effective alternatives for patients in the major markets particularly in the US, some of the products. So I would say we’re a company working hard to develop additional products, not just resting on the roles of the three commercialized products that we have available today.

W: You’re listening to Health Professional Radio with Wayne Bucklar and my guest today is Michael Kotsanis. Michael is the CEO of Acrux, a pharmaceutical company and is talking to us from Melbourne in Australia. Michael in every industry, in every occupation there are misconceptions – what’s the biggest misconception about what you do amongst your customer, clients, patients, that drive you nuts and keep you awake at night?

M: Yeah, that’s a good question because often the biotech sector is considered a sector with some risk around it. Certainly not every product that is developed in this sector is commercialized, in fact a very low proportion of products, develop our over commercialized in the pharmaceutical sector. So the biggest misconception we try to address is it not all product development has the same risk profile. We look at existing drugs and think about how we can reformulate them for a better result for the patient and that’s quite a different risk profile to discovering new molecules and trying to bring them through the safety and efficacy trials required to bring the product to the market. So I think the biggest misconception is a biotech that does have some risk, I guess any industry has its risks, biotech certainly does in terms of development and failures. But our product concept and our technology has already been approved in a number of occasions and we believe that there is a lower risk in our product development candidates and a number of other discovery types of biotech that might exist in the market place.

W: Michael with a little bit of luck today we could help address some of that misconceptions amongst our audience. What’s the best way for people to get in touch with you?

M: They can find us on our website acrux.com.au. And we have a number of ways the can contact us, either by phone or by email if you wish to find anything more our website is quite a comprehensive database of what our current products are and what we’re researching and developing for the future as well.

W: Now that website is www.acrux.com.au. Michael it’s been a pleasure having you on the air with us this morning, thank you for your time.

M: Thank you Wayne, my pleasure.

W: If you’ve missed my conversation with Michael Kotsanis and you just joined us, the good news is we have a transcript, we also have an audio archive on both YouTube and SoundCloud and you can either read or hear what Michael Kotsanis, CEO of Acrux had to say about their drug delivery technologies both on text and on audio at www.hpr.fm, that’s the Health Professional Radio website. You’re listening to Health Professional Radio, it’s been a pleasure having you with us. My name is Wayne Bucklar.

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