RE: Rough translation of InderesTV interview28 Aug 2021 15:10
10:35 According to the latest release (25.8), the first patient has received Traumaquina in connection with HIBISCU phase 2/3. Can you illuminate the schedule more? On what schedule the remaining doses will be given and when the data may be available for publication
This is very pivotal/crucial research in the way because we are producing a research where we put Traumakine and steroids in a collision course. In our opinion we should always start with IFRN-b which is our naturally produced product and if it doesn’t help then to start the usage of steroids. We are hoping to get 10-15 research sites up and running (we have currently 5 already) so I would imagine that IT (Markku may be referring with this to the publishing information) would be around start of year 2022. Interim and the advice from the independent body how to proceed should be ready during H1 2022 at the latest.
11:50 Is it the case that there are no originator antibodies to the Clever-1 receptor that are being developed other than by Faron? What prevents biosimilars from developing?
According to our knowledge no. Our patents in USA and Japan, and I’m confident that later also in the Europe, protects the antibody - Clever-1 interaction. Our patent is valid till 2037. This is optimal protection and we have knowingly delayed patent application (with a slight risk which was a success) because our aim was to lengthen the parent is far in the future is possible.
Verneri: How much this patent can actually protect? Can somebody circumvent the patent?
Markku: Drug regulators are respecting the patents, so we’ll meet all the offenders in the court! That is the whole point of these patents. There has also been a conversation about that this type of development would be done with taxpayer’s money but we don’t see that it is possible yet.
13:40 Is it good for the common good when Celver-1 is one's hands? Very delicious situation for the investors of course.
This is a very interesting situation. We have developed this for 10-years and all the sudden when we get good results everybody are interested. (This was followed by an analogy to the children’s old story where somebody wants to bake a bread and ask for help for farming the grains, making the dough etc. Nobody is interested in anything else than the end product (bread) which is eatable). When we started the development, we believed so strongly in this (Clever-1) that we wanted to push forward with this. Also in drug development this goes little bit like popular culture and fashion. For example, now CD-47 molecule is getting all the attention and there was just a big purchase in this area.