Sobi is a leading integrated biopharmaceutical company dedicated to developing innovative therapies and services to improve the lives of rare disease patients and their families. Karel Fol, the country manager for Benelux shares the plans of the company for the Netherlands and Benelux, how Sobi is transforming its product portfolio, and how co-creation is at the core of this transformation.

You were appointed country manager for Benelux a few months before the joint opening of the European and Benelux offices, during the first quarter of 2015. Why did Sobi decide to deepen its presence in Brussels with the opening of the new offices?

With new products such as our  new therapy for Haemophilia A with an extended half-life allowing for prophylactic injections every three to five days – it was strategically important to have a local affiliate in the Benelux region to support this and other upcoming core product launches.

My first priority was  to build our team. We already had a small team in the region working with Sobi’s portfolio of partner products, but we needed a team dedicated to haemophilia, supportive functions, and a medical team. Subsequently, as country manager, my second priority was ensuring patients got access to these haemophilia products.

Other Benelux affiliates have highlighted difficulties in fostering synergies between Belgium and the Netherlands, because the markets are very different – from a cultural and regulatory point of view. How has been Sobi Benelux doing so far in this regard?

We see the differences in these two countries as a real challenge but also as a very interesting business opportunity – and it is precisely what makes my job particularly exciting on a daily basis! Sobi can learn from the different frameworks of both countries, so we carefully evaluate the lessons learned from each country and how we could integrate them in the future. As a small company, we have to be creative and innovative in our day-to-day operations: we do not follow the big pharma blueprint. Further, the size of our team is decisive: we have sixteen employees for the Benelux and we need to split them between our different countries, which means that we do not necessarily have support functions for each country individually. This kind of setting thus particularly forces us to foster synergies between the different territories of our cluster.

At a global level, Sobi’s revenues are split between core and partner products. What are your plans for the Netherlands and in Benelux?

We will certainly continue to add partner products to our portfolio over time, but our own pipeline of product candidates is also increasing. In the past, our emphasis in the Benelux region was on rare diseases with partner and in-house products; but in the last eighteen months, we concentrated our efforts in setting up our haemophilia branch, to notably support the launch of our first haemophilia product.

Looking ahead, deepening our commitment in haemophilia clearly marks a turning point in Sobi’s history, as it highlights our ambition to continue broadening our product portfolio of innovative treatments. We are currently in a very interesting business dynamic: even if we are growing in terms of employees and product portfolio, our first objective is to preserve and maintain our patient-centric approach in all our Therapeutic Areas – whatever they are. What truly distinguishes Sobi from other pharmaceutical companies is thus that we will stay true to our rare disease DNA in the way we approach the market, even for products that don’t fall within this category. We want to grow at our own speed, and despite our high ambitions, we will follow our own patient-centric path to continue making a real difference for the patients we serve.

At the beginning of 2016, your first haemophilia product received reimbursement approval for the Dutch market. Now that this first step has been successfully reached, what will be your main strategic areas of focus to make it a successful product launch?

The fact that this product received such an expedited reimbursement approval is in itself, a recognition for the product’s innovative nature. As a matter of fact, in the Netherlands, it received the reimbursement approval faster than across all other European countries! This success also highlights how The Netherlands remains a country that truly welcomes innovation and high-value treatments for Dutch patients.

Regarding the next steps, we are now reaching out to all of our stakeholders, especially healthcare providers, to clearly underscore the value of our product. We want to ensure that every eligible patient can access this new medicine in a sustainable way. Reimbursement approval was the first step, but now we have to provide our partners with the corresponding product education. Even if patient outcomes for this product are particularly interesting, Sobi is in a certain manner the “new kid on the block”, and is not necessarily on healthcare providers’ radar yet. Thus, we are really focusing our efforts on getting known by the stakeholders and to raise physicians’ awareness of this product, to ensure patients will ultimately benefit from this new product. Our approach in this regard is very close to a genuine co-creation process: we look to involve all stakeholders and gather their input so that we together can develop the most appropriate solution.

The Zorginstituut (Dutch National Health Care Institute) recently announced that there would not be specific assessment criteria for orphan drugs regarding the basic insurance package inclusion, despite assessing these treatments as being absolutely life-changing for patients. Do you think this policy is legitimate?

We all want to further improve our citizens’ healthcare, and I agree that we need to safeguard the affordability of treatments and the sustainability of  the Healthcare Systems. However, we can only fulfil this ambition if pharmaceutical companies continue to invest in research and development, while ensuring companies receive a fair return on investment – within certain budgetary limits. While we do have to keep in mind the macro-economic level and the current cost-containment context, patients and innovation dimensions should not be forgotten.

As country manager for Benelux, how would you welcome the initiative Minister Schippers has been championing to have joint negotiation of orphan drug pricing and reimbursement between multiple EU member states?

We believe in collaboration and in involvement of all relevant stakeholders. Particularly in the area of rare diseases, where often one has to deal with various levels of uncertainty intrinsic to the rarity, collaboration is key. If we want to strengthen a sustainable and affordable healthcare system, a larger number of stakeholders should be involved. We thus actively support collaboration initiatives aiming at finding the best possible solutions for patients in need. For instance, particularly within rare diseases, we would encourage initiatives concerning collaboration on patient registries, on the development of expert centres, as well as further collaboration within health technology assessments, which in the EU are still very individualized and different from Member State to Member State. Every country currently has different approaches to pricing, but it does not mean joint-negotiations should only be focused on cost saving: we need to integrate a broader approach, also taking into account patient welfare.

Sobi has been particularly successful in recent years by maintaining a 20 percent yearly growth rate of its revenues and 60 percent gross margin. Is it your ambition to maintain the same growing pace in the Dutch affiliate?

As country manager, my main priority is not primarily related to these types of numbers, but  to make sure that our innovative products reach the patients as quickly as possible – and in a sustainable way. In a few years’ time, I would like Sobi to be widely recognized as a company who has helped to improve the standard of care in haemophilia within our countries, and that has effectively helped people living with haemophilia to be able to lead better lives. As a new relatively small company with a real patient-centric approach, it clearly stands as our main priority and as one of the main structural drivers of our business model.

Around 60 percent of your revenues are coming from different partnerships and collaborations. How would you describe Sobi as a partner?

First, we have a dedicated and highly-skilled patient access department, managed by patient access executives – which is truly unique in the industry. Beside our patient access philosophy, we also have robust commercial and medical organisations on a European scale, in areas such as genetics, metabolism, inflammation, and haemophilia. Our objective is not only to become a key player in haemophilia, but also to help as many patients as possible affected by rare diseases, and both our own as well as our partner products will play a crucial role in achieving this objective.

What are your ambitions for the next five years?

First of all, we want to become the company that will help to further improve the treatment the standard of care in haemophilia. Our second objective is to continue broadening our product portfolio within or outside our existent therapeutic areas, thanks to a strategy based on products from our own pipeline and on strategic partner products. Finally, our overarching objective will be to maintain and strengthen our patient-centric approach for all the new products we want to bring to the market in the upcoming years.

Click here to read more articles and interviews from the Netherlands, and to download the latest free pharma report on the country.