Developing a drug can take up to fifteen years and requires an investment of 2.5 billion euros...

The recent health alarm caused by Covid-19 is a clear example of how necessary research into innovative drugs is. Martín Selles is one of the leading experts in the field of new drug development. He is the head of Janssen (a Johnson & Johnson pharmaceutical company) in Spain and president of the National Business Association of the Pharmaceutical Industry (Farmaindustria).

Are pharmaceutical companies and official disease control agencies sufficiently connected internationally in order to collaborate quickly and effectively in global health emergencies, such as the recent Covid-19 outbreak?

This was precisely one of the issues discussed extensively a few weeks ago with world leaders and the World Economic Forum in Davos. During these discussions, the need for collaborations at a global level between different organisations is highlighted in order to establish cohesive actions in the face of possible health crises. 

The Mega Interesting team conducted an interview with Martín Selles, head of the Johnson and Johnson pharmaceutical company. 

Q: How is your company reacting to the crisis?

A: At Johnson & Johnson, we are already putting our efforts into being prepared and responding when it is necessary, through collaborating with regulators, health agents, institutions and communities around the world. Thus, we have already begun research into the development of a possible vaccine, using our platform, which provides the capacity 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 drugs to the Shanghai Clinical Public Health Center to support efforts to find a solution for Covid-19.

Q: Is Johnson is developing a preventive vaccine against HIV-1?

A: Developing a preventive HIV vaccine has been one of the greatest scientific challenges of the past 35 years. We currently have two active trials following several pre-clinical and clinical studies that have allowed Janssen (Johnson) to identify a four-dose vaccine regimen administered over twelve months with favourable safety, tolerability and immunogenicity profile. In May 2019, 2,600 young women from five southern African countries were recruited as patients, for the first efficacy study, Imbokodo, with results expected in 2021. More recently, we announced the start of Mosaic, the first phase III clinical trial to assess the vaccine's efficacy which will include men who have sex with men and transgender people. This program is expected to include 3,800 people, from eight different countries on different continents. It is already active in the United States and is expected to begin in Spain in the first quarter of this year, although results will not be available until 2023.

Q: If development is successful in all its phases, when do you estimate the population could have the vaccine?

A:At this stage of development, it is difficult to make an estimate.

Q: Is it expected to be effective against all subtypes of HIV-1? If proven effective, would an HIV-2 vaccine also be developed?

A: The vaccine is designed to have broad coverage to protect against infection by multiple globally relevant HIV-1 strains. Currently,  we do not have a candidate vaccine for HIV-2 in development.

Q: Janssen is also researching a vaccine against the Ebola virus. What is the timeline and investment projections you are managing for that development?

A: We are aware that the Ebola threat is one of the most urgent challenges we are facing today. That is why, in response to the outbreak that occurred in West Africa between 2014 and 2016, we accelerated the development of the Ebola vaccine and have recently been able to contribute to the fight against this disease by donating half a million doses of the vaccine in the Democratic Republic of 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 to date indicate that the vaccine has an adequate tolerability profile and that it induces strong and long-lasting immune responses against the Zaire strain of Ebola virus, which is the cause of the outbreak in the Democratic Republic of Congo.

Q: Eroom's law states that, unlike in other areas of research, new drug discovery slows down and becomes more expensive year after year, despite technological improvements. Do you think this is true? What is the reason?

A: It's true and it's due to many factors. Regulatory requirements are increasing, clinical trials are longer and include a greater number of patients, and that increases costs and development time considerably.

Q: 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 wide profit margins and that could actually lower the cost of their drugs without jeopardising their viability. Is there any truth in this?

A: It is increasingly difficult to obtain medicines that exceed those already in existence; furthermore, the regulatory requirements are increasing and all this means that developing a new medicine takes a long time - between ten and fifteen years - and requires an investment of some EUR 2.5 billion. Only a few drugs manage to cover the entire investment in their clinical development. In practice, only one in five drugs on the market generates revenue that exceeds 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.

Q: To what extent does the promotion of generic and biosimilar drugs affect the viability of companies that research and develop new drugs in Spain?

A: In our country, the price of the generic drug and the price of the branded drug are the same. When a drug loses its patent, the generic drugs are marketed and the brand name has to lower its price at 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 favoured. If privileges are granted to generics, it is to the detriment of innovative companies in general, which are the only ones that will paradoxically ensure that there are generics in the future and especially innovative Spanish companies that invest significantly in our country.

Q: In your opinion, what would need to be changed in Spain to increase investment in pharmaceutical R&D?

A: The innovative pharmaceutical industry invests a lot in research and development in our country. Some 1,150 million euros a year. This represents around 21% of all industrial R&D carried out in Spain. No other sector in Spain invests as much in R&D as the pharmaceutical sector. 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. It takes many months from the time a new drug is approved at European level until patients can benefit from it, and this does not leave our country in a good position and does not encourage new investment to come to Spain. This is relevant, but the most important thing is that patients are not having access to medicines they need and which are already available.

Q: As you stated at the 16th Seminar on the Pharmaceutical Industry and the Media, a Spanish patient has to wait between fifteen and twenty months to access an innovative medicine. What kind of measures could be used to shorten these deadlines?

A: When there is already evidence of the efficacy and safety of a new drug, it is evaluated and approved by the regulatory agencies in the United States (FDA) and Europe (EMA). After that, in Spain, we begin a process of re-evaluating the drug and setting its price, which in many cases lasts eighteen to twenty-four months. And during those eighteen to twenty-four months the patient in our country cannot benefit from that new drug. The local evaluation aims to determine the value of the medicine and therefore its price. One possible solution would be to increase resources to make this local assessment 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 adjustments/returns as appropriate. In this way, patients could quickly benefit from the innovations.