Nordic Life Science 1
is a Swedish clinical-stage biopharma company foc
used on novel treatments in orphan indications, with an initial focus on renal and hepatic diseases. The company’s lead product candidate Nefecon is an oral formulation of budesonide (an established, highly potent local immunosuppressant) for the treatment of IgA nephropathy (IgAN), a rare kidney disease. The company was listed on Nasdaq Stockholm’s main list in 2018. In December 2020 the company announced it had acquired a controlling interest of 86.2% of the shares in the Genevabased Genkyotex, a leader in NOX therapies. The company also received the SwedenBIO Award 2020. Nordic Life Science asked Calliditas’ CEO, Renée Aguiar-Lucander, about the company’s recent progress and what lies ahead. How would you describe the development of Calliditas since you became CEO in 2017? “Very exciting! A lot of things have happened over the past three years. The company has carried out a complex late stage clinical development project and completed two IPOs – in Sweden and the US – where we raised capital to build an integrated company focused on nephrology and orphan disease with a commercial operation in the US. We have taken Nefecon through a global Phase 3 trial, which read out top line data recently. We have built a broader pipeline with late stage assets through in-licensing and acquisition, focused on immunosuppression, inflammation and fibrosis in orphan disease.” What opportunities do you have on the market for IgA nephropathy? “As the first and only company to report positive phase 3 data, we are positioned to have the first drug approved for IgA nephropathy. Following approval, we plan to launch commercially in the US, where we believe that the core target market is over USD 4 billion. We also have a partnership in China, where Nefecon recently got break-through designation and where IgA nephropathy is a major unmet medical need, reflected in estimates of about 2 million people suffering from the disease. We also believe that there are additional major market opportunities in Europe as well as in other Asian territories.” What results can we expect during 2021? Your business strategy moving forward? “2021 will be a very exciting time as we are filing for market approval with both the FDA and EMA in H1. Depending on the review period, we could see a potential approval towards the end of the year in the US. We will also start an extended dosing study of Nefecon, as well as new clinical trials from our pipeline. Regarding our strategy, we plan to continue to build on our late stage regulatory, CMC and clinical expertise to continue to grow and drive value as an integrated pharma company focused on orphan disease and nephrology.” Advantages and disadvantages of being a Swedish life science company? “Sweden is a relatively small country, which provides both opportunities and drawbacks. One advantage is a fairly concentrated sector network, where the identification of professionals with a certain skillset is fairly easy, and a general fluency in the English language amongst professionals is extremely helpful. From a capital markets perspective, Sweden has a very well developed investor base – both private and public – willing and able to invest in life sciences, which is a big advantage, as is a growing life science community in general. Disadvantages include difficulty in finding qualified and experienced local staff, the somewhat remote location within Europe and the more generalist profile amongst investors due to the limited market size, which holds true for Europe as a whole.” Do you have any advice for Nordic life science startups? “Clearly define your strategy from an international perspective: what will make you able to compete in an industry that by definition is global. Communicate, communicate, communicate, with all stakeholders so that the goal and purpose is clear. Never underestimate the complexity, cost and time of CMC development. An experienced person will be worth it over time – making avoidable mistakes is always more expensive over time.” Is it hard to find the right competencies in Sweden/the Nordics? “We have been very fortunate to have attracted very skilled and experienced people, both in Sweden and in the US, where we are building up our commercial organization. There has long been a strong life sciences educational tradition in Sweden, and the universities still educate a lot of excellent people who are picked up by the industry. However, Sweden no longer has the benefit of large global pharma companies operating locally, which results in a lack of breadth and depth in terms of experience across roles, especially in the younger generations. This drives the need to employ foreign nationals to secure certain critical competencies, where the somewhat remote location within Europe, as well as high income tax, presents a challenge.” NLS