FERTILITY CLINICS
The advanced level of assisted reproduction in Spain has meant the sector stands out for its research, professionalism, and excellence around the world.
How did the pandemic affect the company’s operations?
RAFAEL FRAILE Our first challenge was that we did not know how this disease could affect our processes. Therefore, we stopped all our activity and started some investigations. We were the first to prove scientifically that women infected with COVID-19 did not transmit the virus to their eggs; however, during the shutdown of our activity, many fertilization cycles were cancelled, which affected birth rates. In fact, birth rates fell approximately 20% in the last few months of the year, which presents a long-term problem for society as a whole. As a result of COVID-19, we took all possible actions to prevent infections. National patients have a more standardized process, as they have freer mobility, and the vaccination process is making solid progress. We adapted our methods to keep in touch with international patients and offer them medical support via telematic means. Thus, there have been patients that were able to continue the process and finish their fertilization cycle. In addition, we have facilitated the process by providing certificates that allowed our patients to cross borders by presenting a PCR test. Nevertheless, everything is gradually returning to normal.
ANTONIO PELLICER About 14,000 assisted reproduction cycles were halted in Spain due to the pandemic, which means around 4,000 fewer births. IVIRMA had to postpone 4,000 treatments and, as a result, lost at least EUR3 million. In Spain and Italy, in 2020 we were obliged to close by the Ministry of Health, just when we were about to celebrate IVI’s 30th anniversary. As a consequence of the closure, we had to furlough some of our employees, though only for two months. At the end of the year, work had fully recovered, excluding some international patients who comprise about 20% of our clients. In the US, many companies, including university programs, shut down. However, we continued to operate without significant impact from the crisis. From a business point of view, the sector has proven to be resistant to all crises. The research element has been affected in clinical trials, as some had to stop in order to use healthcare resources for COVID-19 research. In addition, we are promoting the IVI Contigo (IVI with You) plan, offering 12-month finance to ensure our clients have access to greater flexibility.
What factors make Spain such an advanced country in terms of assisted reproduction?
RF First, Spain has an advanced level of medicine. Reproductive medicine is a form of hyper-specialization in medicine. Great progress has been made in this area, and Spain is ahead of other countries in this regard. Moreover, Spanish legislation is clearly defined, which facilitates the whole process. Another factor is that in Spain, gametes, sperm, and oocytes donation are regarded as another form of donation, and we are committed to donation as a country.
AP In Spain, 33,000 babies are born every year through assisted reproduction, or one in every 10 births. Spain was fortunate to have two progressive governments, with presidents Felipe González and Zapatero, boasting the most advanced law in Europe in 1988. IVIRMA has been able to carry out research with embryos and embryo biopsies in order to select embryos, which is impossible in countries like Germany and France.
What are the company’s expansion plans?
RF We are always working at an international level while evaluating other growth options. We usually go with inorganic growth when entering foreign markets because it makes more sense to start our activity by creating a partnership with a company that is already established there, so that we have a better idea of how that country works. Besides, we always look for partners that share our views of this business.
AP IVIRMA has 65 clinics and is present in 11 countries such as Spain, the UK, Portugal, Panama, Chile, Argentina, and United States, among others. Recently, we established a strong presence in Italy, starting with Rome, Milan, and Bari. Today, the company has turned its attention to the US. In 2017, IVI Clinics merged with an American group, the Reproductive Medicine Associates (RMA) New Jersey, becoming what we know today as IVIRMA Global. There are two reasons we went to the US: research collaborations there with universities were much greater than in Europe, and the US is a market that has yet to be fully explored and is the best.
The waiting room at an assisted reproduction clinic at a hospital in Huelva
Can you give us a brief overview of the history and evolution of the company?
ALICIA FOLGUEIRA Novartis Gene Therapis is a young company that was established in Spain and the rest of Europe about two years ago. The Spanish subsidiary was founded in 2019. We have been operating for a year and a half, and I have been in this position since the beginning. We are part of the Novartis group. As a matter of fact, the change in the company’s name is to reflect this change. We are a company of the Novartis group that specializes in gene therapies on the platform AAV9, which is the platform of virus associated to serotype 9. For us, it is extremely important to have the backing of the Novartis group, while we have a light structure that allows us to remain agile in our operations. The main challenge and opportunity was to build up a company from scratch. We are building a subsidiary of a multinational from the ground up. We are talking about biotech firms that can operate with few workers and attain solid results. That initial part of establishing the company, approving the prices, and obtaining all the certificates required is a long process. That was the main challenge and opportunity, because it required a great deal of work. We are only seven workers in Spain, and this has been a beautiful story.
JORGE CAPAPEY Alnylam was founded based on extremely recent findings; 20 years ago, the mechanism by which RNA is transferred to a protein was discovered. After this, it was found that there were small RNA molecules that interfered with the transfer of the message from DNA to the protein. It quickly became clear that if we were able to generate interfering RNA, we would have a powerful tool. Therefore, it promised to be able to treat the underlying cause of many diseases. The company was created in 2002, and the discovery of RNA interference received the Nobel Prize in 2006. It is a success story if we take into account that in the history of medicine, on very few occasions have basic scientific findings been translated into clinical application and for the benefit of patients in such a short period of time. We launched our first product in 2017 and already have two products approved in Europe. A third will be approved soon.
The COVID-19 vaccine from Pfizer is an RNA vaccine, and it will be the first vaccine of its kind; the same is true for Moderna’s vaccine. RNA is a new discovery, but it is here to stay and will have a major impact on health. It will have applications far beyond what we can imagine.
The company is developing other innovative therapies for rare neurological diseases. What treatments are you focusing on?
AF Novartis Gene Therapies is focused on AAV9 scientific platform, identifying different target diseases that could potentially be treated with these therapies. We have been speaking about gene therapies for decades; we have talked about them as the future, and we are proud to have transformed that future into the present. The disease we are treating, spinal muscular atrophy, is severe and debilitating. Children with the most severe type of this disease do not live more than two years if they are left untreated. Now, it only requires a single dose of Zolgensma during the patient’s lifetime and takes one hour to administer. This is a model of gene therapy and is truly incredible. Based on this same platform of AAV9, we have selected the focus of our investigation area, namely two pathologies: Rett syndrome, which is also a neurodegenerative disease, and Friedreich’s ataxia, which is also a neuronal disease that affects children.
With COVID-19, how are you working to ensure the care of rare disease patients is not affected?
JC We have been focused on two main areas. The first is ensuring the supply of drugs to patients while the second area, which is less visible but equally important, has been trying to maintain the clinical trials already underway. With rare diseases, it is not easy to carry out clinical trials due to the limited availability of patients. They require a large logistics effort in order to target a modest number of patients. We did not want trials to be suspended due to the pandemic. Trials do not always have an immediate positive impact on patients suffering from the disease today, though they do have an immense benefit in the future. Continuing to develop therapies for rare diseases is essential. Our vision is to always remain a company that puts the patient, innovation, and science first. We want to be able to bring scientific advances to patients in the best possible way.