The recent health alarm caused by 2019-nCoV, the Wuhan coronavirus – which at the time of this interview was beginning to spread internationally – is a clear example of how necessary research into innovative drugs is . As the head of Janssen (a Johnson & Johnson pharmaceutical company) in our country and president of the National Business Association of the Pharmaceutical Industry (Farmaindustria), Martín Sellés is one of the leading experts in the field of new drug development.
Are pharmaceutical companies and official disease control agencies sufficiently connected internationally to collaborate quickly and effectively in global health emergencies, such as the recent case of 2019-nCoV?
This was precisely one of the issues that was widely discussed a few weeks ago with world leaders at the World Economic Forum in Davos. Our company participated in these discussions and we believe that all the agents involved are mobilizing , working on a common front as quickly as possible to arrive at diagnoses, new drugs and interventions to prevent more people from becoming infected. Global collaborations between different organizations are essential to establish actions in the face of possible health crises.
How is your company reacting to the crisis?
Currently, at Johnson & Johnson we are already putting our efforts in order to be prepared and give a response if necessary, collaborating with regulators, health agents, institutions and communities around the world. Thus, we have already begun to investigate the development of a possible vaccine , using our platform, which provides the ability to rapidly increase production if there is an optimal candidate. In parallel, we are reviewing known pathways of coronavirus pathophysiology to determine whether antiviral agents previously discovered by us can be used to help patients with the infection. In addition, we will make a donation of one of our HIV medications to the Shanghai Public Health Clinical Center to support efforts to find a solution against 2019-nCoV.
Janssen is developing a preventive vaccine against HIV-1. At what point is this investigation?
Developing a preventive vaccine against HIV has been one of the greatest scientific challenges of the last 35 years. We currently have two active trials that follow several preclinical and clinical studies and that have enabled Janssen to identify a four-dose vaccine regimen administered over twelve months with a favorable safety, tolerability, and immunogenicity profile. In May 2019, we reached the recruitment of patients – 2,600 young women from five countries in southern Africa – for the first efficacy study, called Imbokodo, the results of which are expected in 2021. More recently, we have announced the start of Mosaico , the first clinical trial phase III to evaluate the efficacy of the vaccine and which will include men who have sex with other men and transgender people. This program is expected to include 3,800 people, from eight different countries on different continents. Today it is already active in the United States and it is expected that in Spain it will begin in the first four months of this year, although to have results we will have to wait until 2023.
If the development is successful in all its phases, when do you estimate that the population will be able to have the vaccine?
At this point in development it is difficult to estimate.
Is it expected to be effective against all subtypes of HIV-1? If it proves effective, would a vaccine for HIV-2 also be developed?
The vaccine is designed to have broad coverage in order to protect against infection caused by multiple worldwide relevant strains of HIV-1. As of today, we do not have a candidate vaccine for HIV-2 in development.
Janssen is also researching a vaccine against the Ebola virus. What are the temporary and investment forecasts for this development?
We are aware that the Ebola threat is one of the most urgent challenges we are facing today . Therefore, in response to the outbreak that took place in West Africa between 2014 and 2016, we accelerated the development of the Ebola vaccine and recently we have been able to contribute to the fight against this disease with the donation of half a million doses of the vaccine in the Democratic Republic of the Congo and 200,000 in Rwanda . To date, more than 6,500 volunteers from the United States, Europe and Africa have participated in various clinical studies on the vaccine, and we are now awaiting approval from the European authorities. The results of the studies available to date indicate that the vaccine has an adequate tolerability profile and that it induces robust and long-lasting immune responses against the Zaire strain of the Ebola virus, which is the cause of the outbreak in the Democratic Republic of the Congo.
Eroom’s law states that, contrary to what happens in other areas of research, the discovery of new drugs slows down and becomes more expensive year after year, despite technological improvements. Do you think it is true? For what is this?
It is true and it is due to many factors. Regulatory demands are increasing, clinical trials are longer and include a greater number of patients, and this increases considerably the costs and development time.
However, there is a popular belief that, with the current patent model, innovative pharmaceutical companies set prices for their new products that not only allow them to cover their investment costs, but also provide them with large profit margins and that, in fact, they could lower the cost of their drugs without jeopardizing their viability. What is true about it?
It is becoming more and more difficult to obtain drugs that exceed the existing ones ; Furthermore, regulatory requirements are increasing and all this means that developing a new drug takes a long time – between ten and fifteen years – and an investment of around 2,500 million euros . Only a few drugs cover the entire investment of your clinical development. In practice, only one in five marketed drugs generates revenues that exceed average R&D costs. The reality is that it is always easier to know which drugs are successful than those that do not reach patients.
To what extent does the promotion of generic and biosimilar drugs affect the viability of companies that research and develop new drugs in Spain?
In our country, the price of the generic drug and the price of the brand-name drug is the same. When a drug loses the patent, the generics are marketed and the brand has to lower the price to the same price as its generic. Therefore, when a generic is prescribed, the system saves the same as when the brand-name drug is prescribed . If the savings are the same, it is not understood that the promotion of generic drugs is favored. If privileges are granted to generics, it hurts innovative companies in general , which are the only ones that are paradoxically going to ensure that there are generics in the future, and especially innovative Spanish companies that invest heavily in our country.
In your opinion, what would need to change in Spain to increase investment in pharmaceutical R&D?
The innovative pharmaceutical industry invests a lot in research and development in our country. About 1,150 million euros per year. This represents around 21% of all industrial R&D carried out in Spain. There is no other sector that invests in our country in R&D what the pharmaceutical sector invests. In order to attract more investment to our country, it would be important to give more recognition to companies that invest in R&D and it would be necessary to improve patient access to new drugs. From the time a new drug is approved at European level until patients can benefit from it, many months pass, and that does not leave our country in a good place and does not favor new investments coming to Spain. This is relevant, but more importantly, patients are not having access to the drugs they need and are already available.
As you stated at the XVI Seminar on the Pharmaceutical Industry and the Media, a Spanish patient has to wait between fifteen and twenty months to access an innovative medicine. With what kind of measures could these deadlines be shortened?
When you already have the evidence of efficacy and safety of a new drug, it is evaluated and approved by the regulatory agencies of the United States (FDA) and Europe (EMA) . After that, in Spain we began a process of re-evaluating the drug and setting its price, which in many cases lasts eighteen and up to twenty-four months. And during those eighteen to twenty-four months the patient in our country cannot benefit from this new drug. The local evaluation aims to determine the value of the medicine and, therefore, its price. A possible solution would be to increase resources so that this local evaluation would be faster. Another possible solution would be to do what is done in other countries: make the new drug available to doctors and patients and, when the final price is determined, make the appropriate adjustments / returns. In this way, patients could quickly benefit from innovations.
Janssen laboratories are developing new drugs in the field of cancer and hematology . “In solid tumors, we continue to provide advances for patients with prostate cancer, which allows us a comprehensive approach to the disease, from the first stages to the last lines of treatment,” Sellés explains to MUY. Thus, to the therapeutic arsenal we already have, we hope to incorporate this year another new drug for patients with non-metastatic castration-resistant prostate cancer that acts by slowing down the progression of the disease. Likewise, we already have approval in the United States for the first therapy aimed at patients with metastatic urothelial carcinoma who present certain genetic alterations of FGFR and we are investigating a drug that acts simultaneously on two targets to try to prevent the growth and progression of metastatic lung cancer . In immuno-oncology , we are developing an immune checkpoint inhibitor that activates the recognition of our T cells to fight cancer cells ”.
“With regard to hematology,” Sellés continues, “in the field of multiple myeloma we want to seek regimens that are closer to cure, and therefore we continue with the clinical development of a chimeric antigen receptor T-cell therapy ( called CAR-T ); and we are also working to expand the therapeutic arsenal with bispecific antibodies . We want to improve the treatment of patients with B-cell malignancies, such as chronic lymphocytic leukemia, thanks to a group of new therapies such as MALT1 inhibitors . Another of our research areas is that of myeloid neoplasms (with pathologies such as acute myeloid leukemia), for which we are developing an innovative humanized monoclonal antibody ”.
