Australian export case study It's been a big year for West-Melbourne company Acrux and its innovative spray and liquid medical treatments. On the 23 November it was announced that the drug, Axiron®, developed by the ASX-listed Acrux had received US Food and Drug Administration approval. Axiron® is a hormone replacement therapy for men with low testosterone levels. It is the first testosterone topical solution approved for application through an underarm applicator. The approval allows marketing, sales and distribution of the product in the US – the largest pharmaceutical market in the world.  In March this year, Axiron® was the subject of the largest product licensing deal in the history of Australian biotechnology when the global pharmaceutical company, Eli Lilly acquired the marketing rights to Axiron® from Acrux for US$335 million plus royalties on worldwide sales. The deal saw a dramatic increase to Acrux’s export revenue in 2009-10 which is set to continue once Axiron® is launched into the billion dollar US market in 2011. Axiron® is just one of a suite of pharmaceutical topical solutions being developed by Acrux from technology originally developed at Monash University. The treatments deliver medicine transdermally into the bloodstream helping patients to avoid painful injections or multiple pills. Acrux’s recent successes have seen the company shortlisted for an Australian Export Award* after winning the 2010 Large Services Export and Innovation Excellence Awards at the state-based Governor of Victoria Export Awards in October. Acrux’s success factors Jon Pilcher, Acrux CFO said the company’s success lies in its approach in developing innovative products and seeking partnerships to commercialise and enter overseas markets. “For us, the business is all about export markets. However the pharmaceutical industry is highly regulated across the world, and regulations and market factors are extremely varied. It’s not possible to take a ‘one size fits all approach’,” Mr Pilcher said. “Add to that the fact the market is dominated by big players, particularly in the US, and it becomes very clear that you need to have a highly targeted approach which centres on partnerships with established and like-minded companies that have increased marketing capabilities. “Our approach focuses on not just selling a concept to a potential partner but on presenting a complete package. We make sure that we have thought through every step of the development, manufacturing and marketing process before making approaches to commercial partners. “With Lilly, we have a highly committed and capable partner through which the full potential of Axiron® can be achieved for all our stakeholders.” Pilcher also credits Acrux’s success to its long-term strategy of building a team of world-class technical and scientific experts, as well as individuals with commercial experience in pharmaceutical markets overseas. “Acrux is in many ways another product of Australia’s fabulous scientific heritage. Australia has world leading experts across many biotech fields,” said Pilcher. “Australia’s entrepreneurial and hardworking culture has also played its part in our success. Lilly for example has been astounded by what our small team of 27 can deliver.” How did Austrade assist? Pilcher says that in the initial stages of approaching overseas markets, the key question was how to cast a wider enough net to attract the interest of potential partners. “We have benefited from a number of Export Market Development Grants (EMDG) since 2003. They have been a great help in funding our promotional work overseas and our attendance at a number of in-market events with potential investors.” It was at once such event in the US, where Acrux first made contact with its future partner, Lilly. “It’s all about getting heard by the right people. You need to have a thorough understanding of the market and the key players through extensive market intelligence,” Pilcher said. What’s the future for Acrux? Acrux’s range of treatments also includes animal health products, with one currently waiting for US FDA approval. In total, Acrux now has two products approved for marketing in the lucrative US market, one product in registration in the US and further products at earlier stages of development. Acrux is also awaiting approval for an Estradiol spray by the MPA in Sweden. “We see Sweden as our gateway to the wider European market,” adds Pilcher. “We are about to make a big splash in the US. But in the longer term we would like to target what we see as the big growth markets for our products, that being China, India and South America, particularly Brazil.” *The Australian Export Awards celebrate Australia’s best exporters, commending them for their achievements and commitment. By recognising successful exporters, the Awards highlight the critical role these companies play, both in the community and for our national prosperity.
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