Curosurf saves lungs of premature babies. Difficult drug development path. 3

Curosurf saves lungs of premature babies. Difficult drug development path. 3

Curosurf saves lungs of premature babies. Difficult drug development path. 3

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Dr. Anton Titov, MD. You already had a medication that worked not only in animals. Dr. Anton Titov, MD. You have done research over decades. But you show that it dramatically reversed the life and saved the life of premature baby at your hospital. Medical second opinion is important. Now you have to produce it and make it available. But. The story's amazing because both the academia and industry initially turned down the opportunity to make this medication and. Dr. Tore Curstedt. That already worked. How did it happen that the medication became available? Look at this, it is in that phase. Dr. Tore Curstedt. We produced, for the first clinical trials, we produced the medication ourselves. Dr. Tore Curstedt. We got pig lungs. It is produced from pig lung. Dr. Tore Curstedt. We got pig lungs from the slaughterhouse in Stockholm. The slaughterhouse in Uppsala. Perhaps every time we took lungs. Dr. Tore Curstedt. We had about 50-100 kilogram of lungs in the hospital laboratory. During five years, we produced about 3,000 4,000 vials of surfactant to treat 3,000 4,000 preterm babies. It was our maximum. But if you will have a trial, you must produce millions.Scaling up the production. Scaling up the production. It was impossible in our hospital laboratory. For the first clinical trials, we did it, it is no problem. But then we talked to the Swedish pharmaceutical company, Pharmacia and they said yes and no. After two years, they said no. The market is too small. It is no more than 20 million Euros per year. The marketing cost is perhaps 100 million Euros. They are not interested.Even though everyone knew that the medication dramatically saved the life within minutes.at that time, when we talked to Pharmacia, we had made our first clinical trials. Dr. Tore Curstedt. That showed that we had decreased the mortality. Our control groups had 51% death rate and in the treated group, down to 30%.Amazing result for the medication in the clinical trials in humans!Yes, because if you look at our first clinical trials, it started in 1985, in the beginning of 1985. Then we had already started a network of neonatologists in different parts of Europe. But it was one hospital that was not interested to participate in the clinical trial.Even though they knew that the medication worked.the hospital was Karolinska University Hospital. They were not interested. Medical second opinion is important. Dr. Anton Titov, MD. They knew that local scientist invented the medication that worked and--Yeah. But they didn't know so much at that time because it was in the beginning. Dr. Tore Curstedt. We had treated in another hospital, Saint Göran Hospital, nine babies, on a "vital indication" permission. It worked very well. Not all of these babies survived. Six out of nine survived.[Anton] That is still pretty good--They are very good results. But they said no. But others, in Lund in the south of Sweden, Oslo, Germany, England, Italy, France. The Netherlands, participated in the first clinical trial. But not Stockholm.Everybody but the home institution.No, no, they were not interested.What happened then?Then we started it with this other and we produced a surfactant at Karolinska University Hospital in the laboratory and send it to different parts of Europe. In the first clinical trial we had to treat about 150 babies and 150 controls. Dr. Tore Curstedt. We only had all the most sick premature babies according to permission of our ethical committee. After I treated half, 75. 75 babies were "control" [untreated], we had an interim analysis. Then we had to stop it because we had reduced the mortality in the treated group so much so it was not ethical not to treat everybody.This is very dramatic, so the clinical trial could not continue not because the medication didn't work, you knew it worked. But because it worked very well.Worked very well, too well.It was not ethical anymore not to give this medication to the control group.No.Dr. Anton Titov, MD. You have to give them.We had to give it, so we had to give it to the other. This is the only clinical trial with the control group and the surfactant group. Then it was not ethical for all. All had to be treated. Then we start with other types to not only give it once, to give it twice. Give it three times. The prophylaxis. So we made clinical trials. But it was impossible to scale up in our hospital laboratory. Dr. Tore Curstedt. We had to have the company. Pharmacia [company] was not interested.Still not interested?No, no. It was not interested.The companies should be banging on your door.Yeah. But it is such a small product. They said, "In Sweden, how many?" Perhaps 300, 500 in Sweden. But you have the whole Europe. Dr. Anton Titov, MD. You have the US and many others. Then we came in contact with Chiesi Farmaceutici in Parma, private-owned small company at that time. They were interested.[Anton] They had incentives to move fast and become bigger.Yes. Because it is fast and it is it was good, nowadays, it was good that we had Chiesi instead of Pharmacia. It is better to make a bigger product in a small company, than a marginal product in a big company.They took the product and they managed to scale up the production, so it became available and you probably led that process as well.Yes, yes, we have been there many times and now that they can do it there because you see, in five years, we produced 3,000 4,000 vials.saved 3,000 4000 babies.Yes, part of it. Some of them have survived, anyway. Dr. Tore Curstedt. We have treated today nearly four million preterm babies. For us to make three, four million vials in a hospital, it would have taken us a thousand years. It had been totally impossible.

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