The clinical research is a basic and the most important one, which should prove the clinical equality with reference MabThera pharmaceutical (sales over 6 billion USD in 2011).
“We have prepared for clinical trials very intensively during last dozen or so months. The research documentation of MabionCD20 was established, applications for registration of research were submitted. We have signed also letters of intent and an agreement concerning exclusive negotiations of registration and distribution of MabionCD20 on markets with less strict registry regulations. Furthermore, our procedure was positively assessed by EMA and FDA, which confirmed the possibility of preparation of regulating and marketing plans on challenging American market. We will keep you informed about submitting documents to bioethical commissions and public institutions archiving clinical researches” - said Maciej Wieczorek, CEO of Mabion SA.
Mabion is going to conduct process of MabionCD20 registration in whole EU, where registration system of bio-derived drugs is quite well regulated. It is going to sell it in Poland and neighbouring countries by itself, while in the rest of European Union it is going to sign distributional agreements with the local operators. Mabion will conduct clinical trials in cooperation with dozens of institutions in 9 countries of Europe. Trials on people is the last stage of procedure prior to drug registration.
Clinical centres and teams of doctors responsible for clinical trials of MabionCD20 in European countries have been already recruited and trained. During science conference “MABRA Investigators’ Meeting” in January - just before first patients took this medicine – the legal, medical and ethical aspects of clinical trials were discussed. Moreover, during the direct meeting with scientists involved in those trials, topics connected with duties and responsibility research centres, logistics and safety of drug during transport to the centres, as well as with completing of research documentation were discussed. Monitoring and control system by auditors and inspectors was also the matter of conversations.150 doctors from all the countries in which the trials will be conducted took part in this meeting.
Translations from Biotechnologia.pl by Jędrzej Bąk
2018-02-24 19:40:50 +0100
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