Key person interview
Agile global development
Koji Fukushima
Question 1. Please tell us about the potential of brincidofovir is awaited by the world.
brincidofovir has broad antiviral activity. This is a very big feature, and the first big theme was which virus to develop against. After the introduction of the drug, a global advisory board meeting was held, and there were many doctors from various countries, especially from the United States. It was impressive to be told.
Adenoviruses cause mild illness when infected by the general public, but when infected by hematopoietic stem cell transplantation or immunodeficiency, the fatality rate is high, and up to half of the people die. I know it's going to be a very serious illness like that. I was told that there was a very strong need for development, so I took it home and carefully examined it within the company, and decided to target this adenovirus first.
Also, regarding the BK virus, there is no drug right now. For example, if the BK virus appears in a patient after kidney transplantation, the transplanted kidney itself will be destroyed, requiring a retransplantation, and the burden on the patient will be considerable. Doctors are having a hard time figuring out how to deal with nephropathy caused by this virus in countries around the world. However, since there is no definitive drug, it is very much needed.
Initially, when we were developing the BK virus, we first received a proposal from a professor in Australia to see if we could develop it here. With such an enthusiastic teacher and the desire to develop a drug, I finally decided to work on the development of the BK virus.
Then there's cancer. The question of why cancer develops has long been a hot topic in medicine. For example, hepatitis C, hepatitis B, papilloma virus, EB virus, etc., have a very close relationship with, for example, hepatitis and liver cancer, as has been said for some time. Therefore, I think that viruses and cancer can always be viewed as cause and effect.
This time, we also examined various cancers, but brain tumors are the first to come to mind as a human cancer with a very poor prognosis. As for this, the treatment methods are very limited, and drugs are not readily available. It is said that viruses may be involved in some of these brain tumors, especially viruses such as cytomegalovirus, which are very common. brincidofovir is also effective against these. Therefore, if tumors mediated by such viruses can be suppressed, it will be a great blessing for patients.
Question 2. Tell me more about your first global product brincidofovir.
There is a drug called cidofovir, which is indicated for retinitis in AIDS patients, but the problem with this drug is that it damages the kidneys. Although it is an injectable drug, brincidofovir is cidofovir attached with a fatty chain in order to find a way to use it effectively. The addition of fatty chains significantly reduces kidney damage and makes it much easier to enter the cells of the body. brincidofovir is considered to be a very revolutionary drug because it exerts its effects only after it enters the cells.
brincidofovir was in-licensed from Chimerix, which was developing an oral formulation. The oral formulation is currently indicated for smallpox, and although smallpox has been eradicated, it has been approved for national stockpiling in the United States as a measure against bioterrorism.
Various oral formulations of brincidofovir had been tested by then, but even this oral formulation had some problems. This means that side effects such as diarrhea occur considerably in the gastrointestinal tract, and considering this point, it was decided to develop formulations that can be directly infused into the blood and intravenous formulations that can easily enter the body. rice field.
Regarding the introduction, Japanese doctors also said, "If it is effective against adenovirus, doctors are very worried about viral hemorrhagic cystitis after hematopoietic stem cell transplantation. It is also very difficult for patients. It is a terrible pain and some people die. If there is such a drug, I would like you to develop it.”
It is a product that was introduced under such circumstances, and the doctors of each department on the advisory board consistently said that it should be developed first against adenovirus, and especially the pediatricians are currently promoting it in the United States. From the beginning of the phase II clinical trial for adenovirus, we have received advice on details such as planning and drafting. We are currently registering the most difficult patients at our facility. With such great enthusiasm and support, we are now working diligently to develop this drug.
Question 3. How will you take the path to becoming a global specialty pharmaceutical company?
The most difficult thing in global development for a specialty pharma that is not a large company or a mega pharma is that they do not have such skills and knowledge. think.
Therefore, while listening to the opinions of outside experts and consultants, the actual clinical trials are outsourced to a company that specializes in clinical operations. I think it's a common problem that you can't proceed with the exam as you want due to different habits, different ways of thinking, etc. After solving such problems, we are very happy to have an excellent employee join SymBio USA. Although we have been collaborating together for the past few months, they are extremely intelligent and support us in every detail of development.
We are currently opening a site in the United States, but we are planning to expand to the United Kingdom again this time. As for the BK virus, Australia and others. Also, since the tests are conducted in a wide range of regions, there are time differences, and I believe that building good cooperative relationships is essential.
After all, I think that brincidofovir is a drug that is highly desired. Every teacher I talk to is very supportive. A professor of the SAB (Scientific Advisory Board) recently informed me that a new paper was published. Then there is COVID-19, which unfortunately is sweeping the world right now. You have brought up a very recent topic, such as the possibility that the EB virus is also involved in the "Long COVID", a sequelae of the coronavirus, as a topic, and whether or not we will actually develop it. Until now, we are taking a process such as going into consideration in just a few days.
Question 4. What is the appeal of SymBio Pharmaceuticals?
Currently, we are selling TREAKISYM in-house, and President Yoshida has consistently and systematically handled everything from the introduction, approval, expansion of indications, in-house sales, and the addition of liquid formulations. is not it. I think that management philosophy is very wonderful. So even now, we have to look far ahead and think strategically about development. This can be very difficult at times, but in development, it is often difficult to see the future, so I am learning every day that this way of thinking is extremely important.
Science is the basis for this, and we place great importance on it. And it's logical. It goes without saying, but we have a corporate culture that places importance on this aspect of development, and we have a governance system that ensures the agility to carry out development very quickly. This is a great boost to development and allows us to reach global development in a short period of time.
Question 5. Please tell us about your aspirations and enthusiasm as the head of the Global Development Division.
"Global" has been added to the Development Division, and now the awareness of the members has changed considerably. I believe that the experience of global expansion will also lead to a very high level of motivation. At that time, we must not forget the “Underserved Therapeutic Areas”. This is a therapeutic area, not a disease area. Always look for this. If a certain drug emerges, a therapeutic area that matches the characteristics of that drug will emerge. From that point of view, it is also important to assess the appropriateness of newly in-licensed products, whether they can be delivered to Underserved Therapeutic Areas, and how quickly they can be delivered. We would like to be able to deliver medicines to patients as soon as possible.