Mario Huber, general manager of PharmaMar Austria, a multinational and an innovative oncology-based Spanish company, discusses the growth of the company in Austria and the reasons behind the success of Yondelis®, the company’s flagship product. Furthermore, he provides an overview of the clinical trials the Austrian affiliate is undertaking and the importance of Austria as a bridge market so PharmarMar can gain a foothold in the eastern European markets of Hungary, Slovakia and the Czech Republic.
As the general manager of PharmaMar Austria, could you introduce our international readers to the company?
“During the first few years that followed Yondelis®’s approval in ovarian cancer, Austria was selling more, in terms of volume of units, than the UK.”
PharmaMar was founded in 1986, and our first product, Yondelis®, entered the European healthcare environment in 2007. The Austrian affiliate opened in December 2016, although, I have been working for PharmaMar since 2008. When we started distributing in central and eastern Europe, it was done under QuintilesIMS commercial sector as operations were too small to be run through an affiliate. When we reached a certain commercial point, we made the decision to be country based. By 2012, PharmaMar had opened offices in Italy and Germany, and later on in several other European countries and the latest in Austria, where we now conduct operations for the Swiss market.
Professionally, it was a great opportunity and thus far has been a great experience, carrying on from my extensive oncology background at Roche. The aim of opening the affiliate was not only to serve as a domestic office but with the intention to supervise an eastern European expansion in the near future. We are now planning on using our Vienna offices as a hub for Hungary, Slovakia and the Czech Republic.
Many innovative companies choose to locate themselves within Switzerland first. Why was Austria selected to conduct Swiss operations, rather than vice-versa?
At first, PharmaMar’s business for Yondelis® was managed regionally within the DACH region; consisting of Germany, Austria and Switzerland. At that time, there were two account managers in Germany, one in Switzerland and myself in Austria. A year after launching Yondelis® on the market, Austria was leading the sales per capita ranking between these three countries.
Furthermore, my oncology background and the extremely favourable Austrian market conditions for genuinely innovative drugs led management to split the three countries and manage them individually. Therefore, I now control Switzerland and Austria; which continues to outperform its neighbour. It has now been decided that Austria will be a hub for PharmaMar as it gains a foothold in eastern Europe.
How would you describe the growth path of the company here?
PharmaMar initially started in a very small indication of soft tissue sarcoma with our product Yondelis®. As a relatively small business, it was a great way to put our foot in the market, and when Yondelis® moved into the second indication, platinum-sensitive ovarian cancer, it helped us enormously. Austria was the perfect market to test this new indication and Austrian patients received the quickest access out of any first launch nation. The government granted us immediate reimbursement and we started selling while other affiliates still had to figure a way to get the product on the reimbursement list. During the first few years that followed Yondelis®’s approval in ovarian cancer, Austria was selling more, in terms of volume of units, than the UK.
What strategy did you use to navigate the Austrian healthcare environment and gain market access for Yondelis®?
Yondelis® was a much-needed innovation for the Austrian market in both indications; advanced soft tissue sarcoma and platinum-sensitive ovarian cancer. Due to this need, it was easily granted access – despite – approval of the ovarian cancer indication being slightly more challenging. Austria is a good country for innovation and patients as the reimbursement of innovative drugs makes treatment more available and affordable for patients, ensuring it is easier for pharmaceutical companies to gain commercial success.
We intend to bring more oncology products to the Austrian market in the years to come. It is likely there will be a larger number of pricing negotiations for our future launches, but I am prepared to negotiate with the relevant stakeholders involved to find the right compromise between affordability and rewarding innovation. It is of paramount importance we maintain high levels of service to the Austrian public.
PharmaMar is a very innovative company. Which new star products will be launched soon and do you believe the correct structures are in place to accept such innovation?
I am confident this is the case. We have successfully launched innovative drugs on the market previously, and we have witnessed Austria’s keen interest in innovation. By 2018, we expect our latest drug filed Aplidin®, used to treat multiple myeloma, to be available. However, it will be out-licensed in the Austrian market. Also, our most promising drug, Zepsyre® (lurbinectedin) should have its first indication by 2019, We will be filing indication applications for the drug to be used to treat lung, breast and ovarian cancers. This means in three to five years we should have three products, serving six different innovations.
Dr. Christoph Zielinski mentioned Austria has the real potential to establish itself as an oncology research hub within Europe. How strong are PharmaMar Austria’s clinical trial operations?
Currently, there are 13 centres participating in clinical research within Austria. This is quite a large number for a small company like PharmaMar, even more so regarding the size of the country. Six centres had been participating in clinical trials for Aplidin® and four had been testing Zepsyre®’s efficacy in the case of ovarian cancer, with a further three others currently testing the lung cancer indication.
The fact we have many trials on-going in the country is definitely an advantage when it comes to obtaining market access. The government is more likely to approve our drugs in a timely manner as results are based on Austrian patients that have already utilized the drug.
Obtaining clinical trials within a company’s structure is an extremely competitive process. How do you attract headquarters’ attention so they continually invest in Austria?
PharmaMar’s management generally looks at larger markets as a key priority. Nevertheless, the Austrian affiliate team has successfully demonstrated the nation’s favourable market access conditions as well as our ability to recruit the right patients; Austria has great potential in terms of testing, and PharmaMar acknowledges this attribute.
Additionally, my experience within the company has helped me build trust in the minds of headquarters. They know the Austrian affiliate engages with its customers and domestic medical experts; therefore, increasing the likelihood of product success. These practices are also contributing to our affiliate’s attractiveness for clinical trial investments. As a result of internal communication and negotiations, we have been able to continue growing the clinical research base in Austria. Furthermore, we are very proud to be part of the next round of breast cancer clinical trials!
Many people working in Big Pharma have aspirations to run their own affiliate. What recommendations would you give to them?
On one hand, they must know that regardless of the size of the company, the administrative work still takes up a lot of time. On the other hand, working for a smaller company gives you the opportunity to evolve in a faster and more flexible environment. Our customers have noticed we have improved our responsiveness to their needs since the affiliate opened.
Additionally, in light of the innovation-friendly Austrian environment, unsuccessful innovations here are unlikely to survive anywhere else. Companies should utilize Austria as a test market, before possibly upscaling to larger nations. Furthermore, being located in Vienna is excellent geographically as it gives companies a strategic foothold into eastern European markets.