Read the Conversation

EF: What attracted you to this new challenge in Spain? 

RO: My primary goal in Spain is to mobilize people to increase efficiency and productivity, nurture and grow our businesses in a sustainable way, and deliver innovative new solutions to challenges. I was personally excited about the untapped opportunities we still foresee in the country, even understanding all the challenges that need to be overcome. However, I strongly believe that by working in collaboration with all key stakeholders, we’ll be able to unlock most of them to benefit patients who are currently in need. 

In the upcoming three to four years, including 2024, we plan to launch products in Spain that will bring new and innovative alternatives to treatment for doctors and patients. I’m indeed thrilled to work with such leading high-performance teams we have in Spain, and I do look forward to creating a constructive and safe working environment where people can speak up freely and help the company reach its objectives by co-creating strategies and tactical plans within a global and well-integrated ecosystem.  

The Spanish organization brings a great combination of well-experienced team members and highly talented young players who work in perfect symphony, allowing our affiliate to be recognized by the corporate leaders as one of the most creative and successful executors of the company. I’m quite confident that whatever challenge we get from the company will be immediately embraced by our team, who will do their best to deliver what has been agreed upon and overcome all expectations.  

After a short period of instability, Spain has emerged again as one of the company's main growth drivers in Europe. The fiscal year 2023 has been a very successful one in all aspects, and we’ve been able to demonstrate to the company our ability to generate value for the patients and medical community and, consequently, overcome the company’s main goals. In FY 2024, we are planning to keep up the good momentum and expand our footprint in the market by accelerating the growth of our current portfolio and launching new products. We are very conscious of the hurdles we’ll face with the loss of exclusivity of some important brands from our current portfolio, but we continue to be optimistic and focused on our mission to bring innovation to the Spanish market, generate value for our customers, and launch new technologies in the future.  

We’ve been creating strategic forums where we have a chance to gather members of the middle management so that they can provide constructive feedback to the leadership team on areas in which the affiliate needs to improve in a short time. It is important to highlight how proud and glad I am with the team's openness to changes, willingness to contribute, and motivation to take on new challenges.  

To speed up decisions taken within the affiliate, as we have a senior and mature group of managers, we’ve been incentivizing them to act with urgency and take intelligent risks always having in mind common sense and accountability.  

EF: How would you describe Spain’s strategic importance to the group? How would you persuade the company's headquarters that the money spent in Spain is worthwhile? 

RO: First, it is important to emphasize that Spain presents a world-class healthcare system that is both accessible and affordable. The country provides universal coverage through a combination of public and private healthcare providers.  

On top of that the human touch and technical quality of physicians in Spain is simply amazing and widely recognized across Europe.  

Spain has also become a global leader in clinical trials, and pharmaceutical companies have been conducting studies through a public-private financing model, giving access to innovative drugs to many Spanish patients and making the country one of the most respected references in clinical research worldwide.  

For the reasons described above, we’d like to keep on offering the best experience with our products to healthcare professionals and especially to patients and become a key and strategic partner for Spain’s healthcare administrators and policymakers so that we can continue benefiting patients with highly effective, safe, and innovative medicines in a sustainable manner for payers.  

EF: In terms of the various products you are launching, what excites you the most? 

RO: We have recently got approval for pricing and reimbursement of enfortumab vedotin for the 2L/3L treatment of adult patients with locally advanced or metastatic urothelial cancer. At the European Society for Medical Oncology (ESMO) Congress in October 2023, Astellas presented practice-changing results from the Phase III EV-302 trial evaluating enfortumab vedotin in combination with MSD’s pembrolizumab as a treatment for first-line patients with locally advanced or metastatic urothelial cancer (UC) and the data shines with its efficacy as the upcoming standard of care for first-line advanced UC.  

We have also just launched fezolinetant, a drug that reduces the frequency and severity of hot flushes during menopause for 24 weeks without serious side effects, according to research presented at the 26th European Congress of Endocrinology in Stockholm. These findings provide further evidence of the benefits of using this non-hormonal preventative drug in women experiencing hot flashes during menopause.  

Thinking about the near future, we are excited about the approval of the Embark indication for enzalutamide in the US. Under this new indication, enzalutamide can now be used alone or in combination with leuprolide to treat nonmetastatic prostate cancer that is castration sensitive. Also, we recently got FDA approval for the launch of Avacincaptad pegol (ACP) for the treatment of geographic atrophy (GA), an ophthalmological disease. With more than 21 years of experience working with ophthalmic products, I look forward to the possibility of making this drug available in Spain so that we can offer an alternative to GA treatment.  

EF: What do you see for the future of gene therapy? 

RO: There are many challenges, but perhaps the most important is patient access to new treatments for rare diseases for example. In Spain, only half of the medicines authorized for the treatment of rare diseases are available, according to the latest W.A.I.T report (Waiting to Access Innovative Therapies), with significantly worse data compared to countries such as Germany, France and Italy. 

I believe that the particularity of the research and development of orphan drugs must be considered when evaluating and setting prices and national reimbursement, among other reasons due to the small number of patients and often the absence of an effective comparator, generating in sometimes more limited evidence. 

The opportunity comes if we all work in the same direction, focusing on the problem and its solution, always having the patient as the main protagonist. 

In this sense, as stated in the proposal to improve patient access to orphan drugs from Farmaindustria, it is essential to establish an early dialogue between the Administration and companies, as well as an accelerated and specific procedure for orphan drugs, including gene and cell therapies, that considers their particularities.  

One of the pillars of Astellas' philosophy is that advanced innovation offers tangible value to patients. This is the case of patients with rare diseases, for whom there is often no or very limited treatment. As they are the ones who know their disease best and who face its problems and needs daily, they must participate in the design of solutions that address their clinical problems and improve their quality of life. This is one of Astellas’ objectives: to involve patient association groups in the healthcare discussions to truly understand their priorities and needs, as well as collaborate in addressing solutions. 

Astellas has been putting effort and resources into the search for new therapies, not only in areas such as oncology or ophthalmology but also in gene therapy, cell therapy, or mitochondrial diseases. We are immersed in the search for solutions for patients with Pompe disease, X-linked myotubular myopathy, Friedreich's ataxia, etc., and we hope not to stop there but to keep on advancing in other areas. Let us not forget that one of the pillars of Astellas' philosophy is to improve patients’ outlook on the future, something that would be impossible without continuous investments in research and development. 

June 2024