Norgine is reshaping its DACH business around a new growth engine, pairing a well-established portfolio with an expanded push into rare and ultra-rare diseases. Rüdiger Merkel, General Manager DACH, explores what this shift demands in practice, from navigating Germany’s increasingly complex access environment and building new capabilities to forging partnerships, finding patients and preparing for a fast-growing pipeline of highly specialised medicines.
What attracted you to Norgine after 25 years at Novartis, and what mandate did you take on?
I have always seen my career as a journey of continuous learning and reinvention. The healthcare industry is evolving rapidly, and successful leaders need to combine experience with curiosity and the willingness to embrace change. What attracted me to Norgine was the opportunity to join an organisation that combines the strengths of an established business with the agility of a growth-oriented company. It is a place where decisions can be translated into action quickly and where individuals can make a tangible impact. Today, my focus is on preparing the organisation for the next phase of growth in the DACH region. With a rapidly expanding portfolio and increasing innovation, our priority is to build the capabilities, talent and culture required to successfully bring these medicines to patients and create sustainable value for all stakeholders.
My mandate was to make the organisation future ready. Norgine already had a strong heritage and footprint in gastroenterology, particularly bowel preparation, alongside established consumer healthcare and prescription medicines businesses. As we expanded into specialty care and rare diseases, however, we needed to strengthen the capabilities required for these very different types of launches, particularly in market access and reimbursement. When I arrived, a key paediatric oncology asset was already progressing through the German market access process, which meant I had to get up to speed very quickly and engage from day one. We quickly strengthened our access capabilities, navigated the AMNOG process and established the right go-to-market model. This required us to look beyond bringing a medicine to physicians and consider the entire access pathway, including hospital reimbursement and what it takes to ensure the medicine ultimately reaches patients. The negotiations were tough, but we achieved a positive reimbursement outcome in Germany in March and also secured access in Austria and Switzerland, despite the different reimbursement pathways across the three DACH markets.
What surprised me most was the speed and agility of Norgine. Given our long heritage, I had expected a somewhat more traditional organisation, but instead found people who are entrepreneurial, take ownership and are willing to move quickly. Coming from a large pharmaceutical organisation, where some decisions can take months, I found that similar decisions here can often be made within days because there is much less distance between strategy and implementation. People feel responsible for moving things forward and are prepared to take smart risks rather than spend weeks discussing who has the authority to act. For me, that is one of Norgine’s real strengths: we combine much of the agility and entrepreneurial mindset of a biotech with the capabilities and infrastructure of an established pharmaceutical organisation.
How is Norgine’s transformation taking shape across DACH, and where does the business stand today?
The DACH region is somewhat unique within Norgine because we have a broad and diversified portfolio, with a strong, well-established bowel preparation business alongside women’s health and hepatology, including our partnership with Alfasigma. At the same time, we had already begun expanding into paediatric oncology and rare diseases. When I joined, the direction was clear and there was real openness within the organisation to move into these new areas, but it was not yet fully embedded in our DNA. What we still needed were some of the capabilities, expertise and experience required to launch and commercialise these very different types of medicines successfully.
That transformation has accelerated considerably since then. We have brought in people who understand how to launch new products and navigate a market environment that has changed significantly over the past decade, while bringing together established colleagues and new talent within the leadership team. Today, I would describe Norgine DACH as a specialty healthcare organisation focused on areas of high unmet need, combining our established brands and historical strengths in gastroenterology, hepatology and women’s health with a growing portfolio in rare diseases and specialty care. This gives us a much more diversified business and a strong foundation across Germany, Austria and Switzerland.
From a sales perspective, our established business remains considerably larger, simply because the newer medicines are still in the launch phase. However, when you look at our strategic direction and where we are building our capabilities, the focus is moving strongly towards rare and ultra-rare diseases. We now have a very strong and experienced team that understands what it takes to bring these medicines into the market and ultimately to patients. The transformation is therefore not about moving away from our established business, which remains an important part of Norgine, but about building on that heritage while developing the expertise and portfolio required for our next phase of growth.
What is your assessment of Germany’s market access environment for innovative and rare-disease medicines?
Germany’s speed of access to innovative medicines remains an important strength, although bringing new products through the system has become more challenging. For a mid-sized company, one difficulty is that you often have to work with the clinical evidence available to you. Large pharmaceutical companies can design trials with the requirements of AMNOG in mind, whereas smaller companies may rely on studies designed primarily around FDA requirements and conducted across the US and Europe. You therefore need experienced partners to prepare the dossier and support the negotiations, together with close involvement from senior management. The difference is that you cannot simply decide to run another clinical trial costing millions to address a specific German requirement. You have to work with what you have and understand how to navigate the process effectively.
The policy environment has also become more demanding. AMNOG has been in place since 2011, but the 2022 Statutory Health Insurance Financial Stabilisation Act (GKV-Finanzstabilisierungsgesetz) introduced tighter rules linking the appropriate comparator therapy, the level of additional benefit demonstrated and the reimbursement price that can subsequently be negotiated. Alongside higher manufacturer rebates, selective contracts for patented medicines and the extension of the price moratorium, this is putting additional pressure on innovative pharmaceutical manufacturers. It also affects our established portfolio, where increases in mandatory rebates can translate directly into lower sales and are very difficult to compensate for.
For rare and ultra-rare diseases, the framework recognises some of the challenges of generating evidence in very small patient populations. For orphan medicines, an additional benefit is initially recognised through marketing authorisation, although medicines exceeding EUR 30 million in sales within the German statutory health insurance system over a 12-month period must undergo a full benefit assessment against an appropriate comparator therapy. Many ultra-rare medicines remain below that threshold because patient numbers are so small. Germany therefore retains the important advantage of relatively fast access to innovation, but successfully bringing these medicines to patients requires strong market access capabilities and an increasingly sophisticated understanding of the reimbursement environment.
As Norgine expands further into rare diseases, how are you adapting your approach to highly specialised patient populations and engaging with key stakeholders across the healthcare ecosystem?
The integration of our newly acquired rare disease portfolio is an important milestone for the DACH organisation. It not only expands our presence in highly specialised therapeutic areas but also accelerates our transformation towards a business increasingly focused on rare and ultra-rare diseases.
One of the most exciting aspects of this journey is the opportunity to bring innovative therapies to patient populations that have historically had very limited treatment options. These launches are fundamentally different from traditional pharmaceutical launches. Success is driven by scientific expertise, strong stakeholder engagement and the ability to identify and support very small patient communities.
For us, this is about much more than introducing new medicines. It is about building the right organisation, capabilities and culture to succeed in a rapidly evolving healthcare environment and ultimately improving outcomes for patients with significant unmet medical needs.
Rare diseases require a completely different approach, particularly when you consider the patient journey. Around 60 percent of patients with a rare disease are initially misdiagnosed with another physical condition, and receiving the correct diagnosis can take up to five years on average. It is therefore essential to understand where patients first enter the healthcare system, how they move through it and how we can help them reach the right specialists earlier. Patient organisations often have valuable knowledge of these pathways, so we work closely with them, as well as specialist centres, expert physicians and scientific societies, with a strong focus on scientific exchange, education and awareness. Digital channels are also becoming more important for connecting experts and facilitating knowledge sharing, which is why we established Patient Plus as a knowledge and service platform in DACH that we intend to develop further as our rare-disease portfolio grows.
As a relatively new player in rare diseases, credibility and established relationships are equally important. We need people who understand these communities and already have strong connections with patient organisations and other stakeholders, because entering this space without that experience is extremely difficult. Bringing this expertise into Norgine allows us to build trust and establish the long-term partnerships that are fundamental to improving diagnosis, referral pathways and, ultimately, access to treatment.
Where do partnerships fit into Norgine’s growth strategy and the development of its portfolio?
Our model is strongly partnership-led, as many innovative therapies originate in smaller biotech companies that may not have the resources or infrastructure to bring them to patients across Europe. This is where Norgine can play an important role, providing a bridge between scientific innovation and patient access through our commercial, regulatory, medical and market access capabilities. Being mid-sized allows us to remain selective, focused and closely engaged with our partners. Acquisitions and in-licensing are managed internationally rather than at the local level, and since I joined, the portfolio has expanded very quickly through this approach.
We have integrated the Theravia portfolio and recently expanded our pipeline through several strategic licensing agreements in rare diseases and supportive care. In addition, our research partnerships include innovative therapies currently in clinical development for serious unmet medical needs. Further innovation is also planned in bowel preparation, while the majority of new pipeline assets are focused on rare and ultra-rare diseases. The pipeline remains strong, and as the portfolio continues to grow, developing the capabilities required to support these medicines and ensure successful patient access is a key priority for us in DACH.
At the local level, partnerships are equally important for building our presence within the rare-disease community. One example is colourUp4RARE, a multi-stakeholder initiative supported by Norgine alongside other pharmaceutical companies and patient organisations, which uses the zebra as a symbol to raise awareness of rare and ultra-rare diseases. Initiatives like this allow us to work with the wider community to improve awareness and recognition of these conditions, while the partnerships led at international level continue to strengthen and diversify our portfolio.
How does Norgine’s consumer healthcare business complement its growing focus on specialty and rare diseases?
If you look at our product mix, our consumer healthcare business remains our largest pillar. As an established non-prescription franchise, it follows a very different commercial model from our prescription and specialty medicines, with much greater emphasis on direct consumer communication, digital activation, television advertising and pharmacy engagement. Over the years, many pharmaceutical companies have separated consumer healthcare from their innovative medicines businesses, whereas Norgine has retained a mix of consumer healthcare, prescription medicines and increasingly specialty and rare-disease products. I see real value in that combination because it allows us to transfer capabilities and learnings between different parts of the organisation.
This is particularly relevant as digitalisation becomes more important across our prescription business. Consumer healthcare has considerable experience in measuring digital engagement and understanding which activities work, and we can draw on those learnings as we develop our approach in other areas. Rare diseases are a good example, because one of the fundamental challenges is finding patients and helping them reach the right pathway to diagnosis and specialist care. Patient organisations remain essential, but digital tools can complement their role and potentially help us reach patients more effectively. We are still in a learning phase, but having these capabilities within Norgine gives us an interesting opportunity to apply experience from consumer healthcare to the evolving needs of our specialty and rare-disease portfolio.
What role does Germany play within Norgine, and how are you building the organisation to deliver on its ambitions?
Germany remains Norgine’s largest affiliate, so naturally there are significant expectations, while DACH is also an important launch region because of its strong scientific community, sophisticated healthcare systems and commitment to innovation. Our priorities are to continue growing the established bowel preparation franchise, which remains an important part of our core business, while building our presence in rare and ultra-rare diseases. Having successfully brought our first rare-disease medicine through the German market access and reimbursement process, we have demonstrated that the capabilities we have built are working and that we are ready for the launches ahead. Leading the largest affiliate inevitably comes with pressure, but we also have a very constructive relationship with the international organisation. There are clear expectations of us, but the countries are listened to carefully and, when we need support, our perspective is heard.
Building the right team has been central to preparing for this next phase. We need the capabilities and knowledge to succeed in these new areas, but equally important are curiosity and a willingness to learn. My approach is to create an inclusive environment where people are encouraged to express their opinions, challenge one another and make decisions themselves, while being prepared to take smart risks and accept that sometimes we will fail. I also want people to look beyond their immediate responsibilities. If someone working in our prescription business sees something going in the wrong direction in ultra-rare diseases, for example, they should feel comfortable speaking up so that we can discuss it and improve. We have brought together younger colleagues and highly experienced people, and when those different perspectives are combined with openness and mutual respect, it creates a very strong team. As our portfolio becomes more diverse and the environment more complex, the next step is to translate that empowerment into performance, with operational excellence and digital transformation central to that journey.
Looking ahead, what are your priorities for Norgine DACH, and what would success look like over the next few years?
Our priorities are to continue strengthening our capabilities in market access and patient access, which will become even more important as the portfolio evolves, while advancing the digitalisation of our field force and making better use of digital channels to engage with physicians and other stakeholders. We also need to strengthen Norgine’s profile and make the organisation better known. I did not know Norgine myself before I was approached, and that is something we need to change. As we bring new assets to market and demonstrate that we can successfully navigate reimbursement across Germany, Austria and Switzerland, we will naturally build greater visibility and recognition for what Norgine can deliver.
What excites me most is the unique space Norgine occupies between large pharma and biotech. We have the agility to move quickly, the expertise to navigate complex healthcare systems, and the commitment to bring innovative medicines to patients who are often overlooked. For me, success means building on those strengths while showing that a mid-sized organisation can be successful and attractive without losing its entrepreneurial mindset. If we continue to strengthen our access capabilities, embrace digitalisation and successfully deliver the launches ahead, we can build a stronger Norgine presence across DACH while creating meaningful opportunities for patients.
