President, in the midst of a coronavirus emergency, a 5-year chapter ended in which investments have not brought results. What is left of that spin-off of the entire Rottapharm | Madaus Research and Development Center and where is the future going?
“We have invested € 20 million a year developing internally and without any external financial contribution over a dozen drug projects in different therapeutic areas, but none has brought concrete results. However, that business model no longer exists in the world. the truth no longer existed 5 years ago, but we tried to protect the researchers of the group in the medium term. Today we have maintained the strongest skills, in the managerial field, to be able to work with the outside world, dedicating ourselves to the scouting of new innovative and highly specialized proposals from university spin-offs or small national and international biotech companies to invest in. Today, generalist research leads nowhere. Medicine is so complex that it requires us to rely on scientists who put it on the bench. super specialized ideas “.
As is the case with the new coronavirus vaccine study …
“Vaccines have never been our field, rather immunology, inflammation, rheumatology (so we have two products in clinical development) and oncological diseases treated with immunotherapy. But Covid-19 has added interest that led us to enter into an agreement with Takis for the development of the vaccine called COVID-eVax “.
We are facing a pandemic and researchers around the world are studying a vaccine, with different approaches. Someone is also already in the clinical phase, where are you at?
“In the field of vaccines against the new coronavirus there are several technological platforms. In some, the virus protein is injected even if it has been seen that the response is a bit weak, others foresee the use of virus vectors injected directly into the body Ours, however, is based on DNA: a fragment of DNA is injected into the muscle and promotes the synthesis of a portion of the Spike protein of the virus, stimulating by the body a strong immune reaction (both antibody and cellular) which prevents The efficiency of the process is increased by the “electroporation” technique, which favors the passage of DNA inside the cells in a simple, rapid and without side effects thanks to mild and short electrical stimuli. “electroporation” Takis has been collaborating for years with IGEA, an Italian company whose electroporator is already available in over 200 hospitals in Europe “.
What are the first findings?
“The results of the administration of the vaccine in the experimental animal have shown a strong immune response that neutralizes the virus, blocking its replication in the cells. Moreover, the technology in development has many advantages compared to others, including the possibility of being able to be repeated for increase and maintain the immune response, and be easily adaptable in case the virus “changes” its genetic code over time. The development program now includes the completion of laboratory studies and the production of the first quantity of the vaccine, already started to get to the first clinical study in the autumn on a few hundred subjects. Between February and March 2021 we will see how it works on humans. Subsequently we will have larger studies, on thousands of subjects, to verify the effective protection provided by the vaccine “.
How long does it take to get to production and distribution?
“Typically it takes 4-5 years for a vaccine. In this emergency, times have reduced to 18-24 months. And the collaboration of international scientific institutions and the World Health Organization will be important to contribute to a single large study. common in which to insert the various promising vaccines and compare them. It will be very important to have different vaccines available and on different technological platforms in order to better prevent a possible return of the emergency “.
This on the vaccine front, while what about the therapies? To date, the cure at Covid-19 has not yet been found: are you also engaged on this front?
“The whole world was unprepared for this emergency, but because of nobody. It is a virus that we are still struggling to understand. And to let the guard down on drug development would be a mistake. Therapy research will go into three areas: first of all on the general support against the infection (anticoagulant drugs), or on specific antivirals since currently valid drugs have been used for other viruses which, however, have not proved particularly effective. We are then studying drugs that go to antagonize, that is, contrast, the powerful immunological response that the virus determines in the human organism. In some cases it was the very strong immunological response that aggravated the patient’s condition. Here, we are collaborating on this third type of drug with an American biotech “.
A commitment of skills, but obviously also economic.
“My investment plan does not want to change. I want to keep the commitment of 20 million euros per year, but looking for the most favorable and promising projects. With knowledge, technologies and capital, today we can make great strides, even if for many diseases it remains the most complicated part to reach 100% recovery. Taking into account that today developing a drug costs 2 and a half billion euros and 12 years of time “.
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