Q&A: Renée Aguiar-Lucander, CEO, Calliditas Therapeutics

Calliditas Therapeutics is about to bring its treatment for IgA nephropathy to the market – addressing a significant unmet medical need.

Calliditas, formed in 2004, is a Swedish clinical-stage biopharmaceutical company focused on identifying, developing and commercializing 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.

In 2018 the company was listed on Nasdaq Stockholm’s main list. In December 2020 the company announced it had acquired a controlling interest of 86.2 percent of the shares in the Geneva-based Genkyotex, a leader in NOX therapies. The company also recently received the SwedenBIO Award 2020 in recognition of its successful clinical development program for Nefecon. Nordic Life Science asked its CEO, Renée Aguiar-Lucander, about the company’s recent progress and what lies ahead.

Image caption: Johan Christenson, partner, HealthCap, Renée Aguiar-Lucander, CEO Calliditas Therapeutics and Lars Adlersson, Chairman of SwedenBIO. Photo: SwedenBIO

How would you describe the development of Calliditas since you became CEO?

“Very exciting! A lot of things have happened over the past three years. The company has successfully carried out a complex late stage clinical development project and also 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 our lead product candidate, Nefecon, through a large global Phase 3 clinical trial, which read out top line data recently. We have also cost effectively 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.”

“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.”

What’s next for Calliditas and 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 and 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 startup companies?

“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.”

“Clearly define your strategy from an international perspective: what will make you able to compete in an industry that by definition is global.”

Is it hard to find the right competencies in Sweden/the Nordics, and if so, how do you solve this? If it is not, why do you think that is?

“We have been very fortunate to have attracted very skilled and experienced people, both here 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.”

“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.”

Renée Aguiar-Lucander. Photo Jann Lipka