Daniel Camardo is the President of Immedica Pharma US Inc. (Immedica), the US affiliate/subsidiary of Immedica Pharma AB, a Sweden-based rare disease company that entered the American market in 2024. Bringing together his experience building Astellas’s US presence and leading rare disease commercialization at Horizon, Camardo joined Immedica to lead its North American launch. In this interview, he discusses Immedica’s US build-out, its two marketed products, the company’s disciplined approach to asset acquisition, and how Immedica’s Swedish culture is shaping its approach to the rare disease community in the US.
Immedica made its US debut in 2024, entering from Sweden. Can you introduce yourself and share your initial priorities in getting the organization established here?
Collectively, I have over 30 years in the pharmaceutical and biotech industry, across both commercial and executive leadership roles. One of the more memorable experiences in my career was being part of the US entry of Astellas Pharma, which was formed through the combination of two Japanese companies, Yamanouchi and Fujisawa, in the early 2000s.
Another formative part of my experience was my executive role at Horizon, where I helped lead the company’s transition from a largely mass-market product portfolio into one more focused on rare diseases. That work allowed me to become deeply immersed in rare disease communities, and it remains an area I am personally passionate about.
Immedica represents an opportunity that combines both of those experiences: the excitement of building a US organization and the opportunity to do so in support of rare disease communities with significant unmet needs. After speaking with Immedica’s global leadership team and learning more about their vision, it felt like a natural fit.
Can you give us an introduction to Immedica, its positioning, and its mission?
Immedica was founded in 2018 with the intention of building commercial capabilities primarily across Europe and the MENA region while in-licensing products from US partners. In 2024, Immedica Pharma AB recapitalized, with Impilo, the private equity firm originally behind Immedica Pharma AB, bringing in KKR as a second investor. That was an exciting moment because it expanded the company’s ambition beyond identifying and scaling assets across Europe and MENA toward entering the United States and building a truly global presence. I joined the Immedica team at that inflection point.
One of my initial priorities was preparing the organization for the potential US launch of pegzilarginase-nbln, marketed as Loargys®. Immedica Pharma AB had already commercialized the product in parts of Europe, having first acquired the rights to the asset in Europe and the MENA in 2021, and then securing global rights in 2023. Having already navigated the approval process in European markets, Immedica was well positioned to replicate that success in the US. Preparing for US approval and launch became the foundation for establishing Immedica Pharma US.
Can you walk us through the journey of building Immedica’s US presence and how the portfolio has taken shape?
I started by identifying the capabilities needed to successfully launch Loargys, then reached out to people in my network who I believed had the right skills and mindset to help build something unique. Shortly thereafter, we saw an opportunity to acquire Marinus Pharmaceuticals, a Pennsylvania-based company with an asset called ganaxolone, marketed as Ztalmy®.
The acquisition, finalized in first quarter of 2025, fit precisely within our rare disease focus, and significantly accelerated our infrastructure build-out. We were able to draw on Marinus’s established internal processes, incorporating key lessons learned that helped compress what would otherwise have been a much longer organizational build. Today, we have two FDA approved products: Ztalmy as noted previously, and Loargys.
Immedica has a broad global portfolio spanning metabolic disease, neurology, hematology & oncology as well as, endocrinology. What does the pipeline look like for the US, and what are the upcoming milestones?
Because most of the assets Immedica has in Europe are already available in the United States through partner companies, our pipeline strategy looks a little different from that of a traditional rare disease company with focus in the preclinical stage. Rather than focusing on one, two, or three molecules in early-stage development, we have built a strong commercial, medical, and regulatory platform, designed to acquire or in-license assets that are late in development, either completing Phase 3 and approaching registration, or already approved but in need of a more focused investment and sustained engagement. With established commercial presence across Europe, the MENA region, and now the US, we believe Immedica is well positioned as a partner for rare disease assets currently on market or moving through the later stages of development. Our current portfolio – and its continued evolution – demonstrate that strategy in action.
There has also been significant investment in rare disease research in recent years, including by companies founded by parents of children with limited or no viable treatment options. Our intention is to be a credible partner or potential acquirer for those assets when the originating company is seeking a commercialization partner with the scale, infrastructure, and rare disease expertise needed to bring the product to patients. I believe that Immedica has what it takes to successfully navigate that final stage and commercialize rare disease products more effectively, particularly where a focused investment, specialized expertise, and sustained engagement with small patient communities are essential.
What does commercial excellence look like in the rare disease space, and what is Immedica’s approach to winning on access in the US?
Rare diseases are difficult to diagnose and treat by nature. They are typically chronic conditions, often diagnosed very early in a child’s life. From a commercial standpoint, that requires people who understand the importance of supporting patients through the entire journey, from appropriate diagnosis, through understanding available treatment options, and continuing that support across the patient’s lifetime. It also requires an understanding that the patient journey includes not only the patient, but also caregivers and family members who are often deeply involved in care decisions and day-to-day disease management.
Commercial excellence requires the right skill set, expertise, and mindset, and it is reflected in the people we hire. A lot of companies talk about putting patients first; our goal is to apply that principle in a meaningful and practical way every day. Almost everything we consider commercially is viewed through the lens of understanding the challenges patients, caregivers, prescribers, and payers face, and determining how we can help address those needs compliantly and responsibly.
Our medical and regulatory team in Stockholm deserves credit for the work that ultimately led to the accelerated approval of Loargys in the United States, building on the product’s prior development history and advancing it through the final stages of clinical development. Our teams worked through the approval process with the FDA over a considerable period of time, addressing questions and requirements with persistence, discipline, and scientific rigor. The result was the approval of an asset that had previously received an FDA ‘Refuse-To-File’ letter. That outcome speaks to the culture of the organization and the willingness of our teams to do the difficult work required to help bring important therapies to patients.
In rare disease, bringing a product to market is only one part of the work; the next challenge is helping ensure that patients, families, and clinicians can navigate the path to care. How do we make the access process easier to navigate for patients, prescribers, and payers? How do we engage each of those stakeholders in a responsible way with the shared goal of improving patient care? At Immedica, we are intentional about engaging responsibly with stakeholders to help support appropriate access, education, and resources that may contribute to improved patient care.
If there is a differentiating factor, it is how Immedica engages with its stakeholders and the values we operate by. Across the organization, we are focused on addressing difficult rare disease challenges in a way that supports patients, families, caregivers, healthcare professionals, and the broader healthcare system, with everyone focused on solving these difficult problems for patients and their families.
How does Immedica evaluate and identify assets for acquisition, and what makes something a good fit for the portfolio?
It requires the active coordination across functional teams within the organization, all aligned with Immedica’s broader vision. One distinctive aspect of Immedica, which may reflect both the Swedish culture and the private equity discipline behind the company, is the rigorous fiscal assessment that is incorporated into every evaluation. The excitement around the scientific value of an asset is real, but we think just as carefully about what it would actually take to commercialize that asset successfully. What financial commitment would be required? What is the therapeutic area? Is the unmet need genuine and significant? Those are the core questions we revisit throughout the evaluative process.
That discipline also means being careful not to overextend ourselves. A number of US peer companies may spend heavily on an asset simply to add something to their portfolio. That is not the approach we take at Immedica. We engage in rigorous internal debate about whether an asset truly makes sense, and we are deliberate about not scaling too quickly. That approach was evident in how we prepared for the Loargys launch. We took a measured approach to spending and held off on significant financial commitments until we had greater certainty around the path and timing of FDA approval.
How do you see the US contributing to Immedica’s global growth, both as a commercial market and as a source of business development opportunities?
The US remains the most attractive market in the world for pharmaceuticals and biotechnology. Although there is a lot of complexity, including ongoing changes related to access, reimbursement, and the FDA regulatory landscape, the investment environment for innovative assets remains strong.
Now that Immedica has been operating in the US for over a year, we see a real opportunity to identify partners and assets that can further strengthen our rare disease portfolio. Unlike a USoriginated company evaluating whether and how to expand internationally, Immedica comes to the US from a position of established strength in Europe. That gives us a strong platform for growth in the US, while also making us an attractive global partner for predominantly US-focused companies that may not want to build an international presence themselves. Over the next five years, we expect our US business to contribute meaningfully to Immedica’s global performance.
That does not mean we intend to build a direct presence in every market. In some countries, we hope to work with in-country partners rather than establishing our own infrastructure. In the US, however, we have made a deliberate decision to build our own presence because we view the market as central to the future of the global organization.
How do you establish Immedica as a credible player in the US rare disease space when entering therapeutic areas with very high unmet need?
It comes down to building trust across all key stakeholders, and in the US, that starts with patient advocacy groups. In our therapeutic areas, including rare metabolic and rare neurology, there are several patient advocacy groups we work with closely to understand the challenges patients and caregivers face day to day. Because rare diseases often have few, if any, approved treatment options, trust is especially important – and we believe trust is built through action. That means showing up consistently, working compliantly, and partnering on meaningful solutions with advocacy groups, specialists, and the broader care community, particularly in areas where patients may go undiagnosed or misdiagnosed for years before receiving an accurate diagnosis.
Part of that work includes supporting education around the importance of appropriate genetic testing, which may help identify a diagnosis earlier or rule out certain genetic diseases. The earlier a patient can be appropriately identified, the sooner patients, caregivers, and healthcare professionals can understand the condition and evaluate care and treatment options. Right now, too many patients and caregivers are sent on a difficult and lengthy journey trying to understand what disease they are dealing with before any treatment conversation can begin. Raising awareness of earlier and more comprehensive genetic testing is one way we seek to support these communities, in addition to the therapies we bring to market.
What is your final message to the US rare disease community and to potential partners about how Immedica wants to be seen and received here?
We are proud to bring what makes Immedica distinctly Swedish to the United States. Beyond the portfolio, we invest heavily in making sure our culture travels with us. A recent example is our CEO, Anders Edvell, spending a full day in Chicago with our newly hired employees, immersing them in our company values and reminding them what those values mean in practice. That level of hands-on commitment to culture was not a one-time exercise. It is something we return to constantly and helps remind our team of why we do what we do.
There is no easy path in the rare disease space. Every patient, every physician, every payer presents their own distinct challenges and requirements. That dynamic demands a team that is genuinely comfortable rising to each challenge as it comes, with the resilience and sense of purpose that must be rooted in culture. We are committed to scaling that culture as we scale our business.
We are excited to have solidified our presence in the US with two important products: Ztalmy and Loargys. We are equally excited about what will come next and how we can continue to support the rare disease community in a meaningful way. I, along with the rest of our team, believe we are building something truly special.
