March 23, 2016
The biological drug whose development started for the first time in Turkey, under the cooperation of the Ege University Drug Development and Pharmacokinetics Research – Application Center (ARGEFAR) and TR-Pharm Company, is now brought to the phase of experimentation on healthy human beings which is the next phase after the experimentation on animals. Candeğer Yılmaz, the Rector of Ege University, who made a statement regarding this issue, expressed that her dream is to witness the release of the medicine at the 100th anniversary of the Republic of Turkey.
In the press conference held at the old senate hall in Ege University, the Rector of Ege University, Prof. Dr. Candeğer Yılmaz; the head of TR-Pharm Tuygan Göker; the prelectors from the Ege University; Prof. Dr. Sibel Göksel and Assoc. Prof. Dr. Uğur Önsel Türk as the ones who took charge in the development of the drug and the company executives were present.
AGAINST THE BEHCET AND FAMILIAL MEDITERRANEAN FEVER DISEASES
Prof. Dr. Yılmaz, reminding that this biotechnological drug which is going to be used for the treatment of Behcet and Familial Mediterranean Fever diseases, has been, for the first time, developed in Turkey; expressed that it was her dream to witness the release of the medicine at the 100th anniversary of the Republic of Turkey. Assoc. Prof. Dr. Türk explained that the chronic diseases could not have been eliminated yet however with the developed therapeutic approaches, the patients had a better quality of life. She pointed out that the drug they developed would improve the quality of life of the patients suffering from the Behcet and Familial Mediterranean Fever diseases; and that while doing so, it would be target specific, without causing any of the adverse effects the current medications have.
IT IS GOING TO BE TESTED ON HUMAN BEINGS
Prof. Dr. Göksel, emphasizing that the development of a drug requires a number of substantial researches, expressed that the drug they worked on had been tested on the animals and that now they were beginning to the next phase of testing it on healthy human beings.
IT IS GOING TO BE TESTED FOR THE FIRST TIME
Rector Yılmaz stressed that, for the first time in history, this biotechnological drug came to the phase of being tested on the human beings. Prof. Dr. Yılmaz said:
“We have on our hands what we call a biotechnological product. This product, now for the first time in history, is in the phase of being tested on healthy volunteers for the treatment of the patients suffering from the Behcet and Familial Mediterranean Fever diseases. Within the process of licensing the drug, we are now standing on a certain point and working on completing the rest of this process from here onwards. The phase where experiments are made on the animals has been completed and it (the drug) has passed the first level within this process; in this next step, it needs to be tested on the healthy human beings. The further step will necessitate to make tests on the patients; then it is required to apply for the licence and subsequently it is expected to be released. The company, together with the factory that is going to commence production in 2019, carries out the production infrastructure works synchronously with the production researches that are being conducted. This drug will be the first biotechnological drug of Turkey. If we take a look at the process, after 7-8 years, we are now also on the verge of bringing a biotechnological drug to its production phase through completing all of its phases. We, too, take part in this cooperation as a university with standards that makes possible the attempt of this world first biotechnological drug trial. This event serves as an awareness to those who are willing to work and invest in this subject. What we essentially wish to underline here is that, Ege University has prepared its conditions in accordance with its goals and made feasible a world first R&D on the subject of this drug.”
THE APPROXIMATE COST IS 20 – 25 MILLION DOLLARS
Tuygan Göker, the head of TR-Pharm, expressing that his biggest desire was to see the start of the pharmaceutical R&D works in Turkey, which has now started; pointed out that depending on the drug’s development phase, no research among the likes of this kind does cost any less than 20-25 million dollars before it reaches its final stage.
FAMILIAL MEDITERRANEAN FEVER (FMF):
The patient would have complaints for a length of time and afterwards those complaints regress on their own. Recurrent attacks reveal themselves mostly as stomach-ache with fever, lower-leg pain, chest pain and joint pains. These attacks, however less likely, might also give symptoms such as testicle pain and skin redness on foot and legs. It is a genetically inherited disease. It is a disease characterized by numerous system and organ involvements. Throughout the world, it is most commonly seen in Turkey.