This past year has been a transformational one for Oncopeptides highlighted by the FDA acceptance and priority review of our NDA submission for melflufen which resulted in accelerated approval and US launch in the beginning of 2021. Not many emerging biotech companies cross the finish line in terms of launching a product that can make a significant difference for patients.
From an idea back in 2000 to being on the verge of a product launch at the end of 2020 it is quite an achievement and speaks to the perseverance and commitment of a core group of leaders at the company. Across 2020, we focused on the key milestones, and delivered as one global team. The progress made to date is a source of pride for our team and further bolsters our commitment to do more, focused to fully realize the promise of our technology.
Thinking back to my decision to join an emerging oncology company last year, Oncopeptides was the perfect match. It was the technology, or simply the science, that first attracted me. Oncopeptides' peptide drug conjugate platform, its unique characteristics, and the considerable opportunities it offers to develop multiple drug candidates is exciting. Secondly, it was the broad development program of melflufen. With the data on the product already looking likely to result in regulatory approval – it subsequently received accelerated approval by the FDA by the end of February 2021 – it was exhilarating to join the company knowing that we were nearing a potential launch. To play a part in building a global biotech company to launch drugs to meet the unmet needs of patients with cancer have been a lifelong pursuit. And finally, joining the company was about the people. My thanks and gratitude to the talented, passionate, and collaborative people at Oncopeptides. I would once again like to thank Jakob Lindberg for his fantastic work with Oncopeptides. Without Jakob the company would not be where it is today.
And the people are fantastic.We have a highly skilled group of talented individuals focused on a shared goal: transforming science into hope for patients. Furthermore, our expertise and our technological platform ensured that we were able to largely mitigate the effects of the pandemic and keep on track with our efforts to ensure that we alleviate suffering in a growing population of patients in the years ahead.
Resilience in the face of the pandemic
While the pandemic did of course impact us in 2020, we were able to mitigate its most severe consequences on the company. We experienced some impact on our clinical studies and their execution and we paused studies for several months during the spring. However, we were able to execute on all our near-term goals, including the NDA submission of melflufen for accelerated approval in the US in June.
In terms of our OCEAN clinical study, we were particularly concerned about the impact of patients’ ability to visit oncology and hematology clinics. We mitigated that risk by extending patient enrolment to ensure that we could meet the statistical needs of the trial and complete the study within a reasonable timeframe. But, ultimately, the impact was minimal and temporary. The way we responded to the pandemic, and effectively minimize its impact, is a testament to the perseverance of our team.
Rapid growth to support Us launch
During 2020 we had a rapid growth of our employee base to ensure launch readiness. We welcomed physicians, clinicians, and technicians, as well as an experienced commercial team. Our personnel growth has further broadened the diversity of thought and expertise in the company and offers fantastic opportunities. During the year, we took steps to align our US and Swedish teams in terms of shared vision and values, one common culture and working routines.
Despite our rapid growth in headcount, we remain focused on maintaining our biotech start-up advantages. Being small, nimble, and functioning as a learning organization will continue to be key components of our company going forward. The right company culture retains people. We want our people to feel that they can play a role in our future success, and they can leverage the size of a small company. So, we ensure that our people see the impact we are already having on patients and will continue to do so in the future.
For all of us at Oncopeptides, the well-being of our colleagues and the societies in which we operate is of utmost importance and it influences our daily choices. Operating sustainably as a company means that we play a positive societal role and that we are committed to make a difference for people and the planet. Going forward, we aim at developing our work in all environmental, social, and governance-related areas, striving to make beneficial contributions to society, while minimizing our environmental footprint and ultimately to bring hope to patients through our science.
A UNIQUE product, great people, and a high unmet need
Our first drug candidate, melflufen – known commercially as PEPAXTO – has a unique capability to focus on cancer cells, deliver toxic “payloads” into these cells, and minimize effects on healthier cells. Melflufen is easy to administer requiring only a 30-minute infusion every 28 days which makes it a convenient treatment option for healthcare professionals and patients.
Melflufen has a predictable impact on blood cells that are easy for oncologists and hematologists to manage. The benefit-risk profile of melflufen enables us to compete with much larger rivals on the market because our product address a substantial unmet medical need – and we have a smart, experienced team in place to ensure that we make an impact on the market.
Ensuring that patients around the world benefit from our drugs
In 2021, we will continue our commercialization efforts in the US, and work towards launching in European markets. We recently hired a General Manager for Europe and a Head of Medical Affairs Europe who are heading dedicated teams with extensive experience in the multiple myeloma space and we recently submitted the file for a Conditional Marketing Authorization with the European Medicines Agency.
We will complete our phase 3 OCEAN study with the ambition to file a supplemental new drug application of melflufen to the FDA. If approved, this may potentially make the product available for treatments at earlier stages of the disease, thereby increasing the number of patients that can potentially benefit from PEPAXTO.
Looking ahead, we remain focused on bringing new products forward. We already have a second drug in early clinical development stage – OPD5 – and we have an internal commitment to bring new indications to clinical trials in the years ahead. We continue to build the pipeline through our pre-clinical drug development group to create the next candidate drugs to bring forward. We also want to improve the peptide drug conjugate itself, making it an even more effective at damaging tumor cells and minimizing impact on healthy cells.
More broadly, we want to expand into other geographies, by partnership outside Europe and the US, so that we keep ensuring that more patients around the world can benefit from our drugs once approved.
Driven by the science
We have a unique drug development platform and strong pipeline, our first regulatory approval under our belts, and more data sets on a variety of indications set to emerge in the months and years ahead. We have a great product that addresses a substantial unmet medical need. And we have a smart, experienced team, with skills and expertise to ensure that we make an impact on the market. In short, we have all the right elements in place for the next phase of our growth journey.
Lastly, I would like to thank all our physicians, partners, patients, and colleagues for their fantastic efforts in what was a uniquely challenging year. I would also like to express my gratitude to our shareholders for your continued support. Together, driven by the science, we have the tools we need to fulfill our potential and become a commercial global biotech company, bringing hope to growing numbers of patients.
April 26, 2021
Marty J Duvall, CEO