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IQ Innovation Award of Central Germany for Novel Pharmaceutical Ingredient against Tuberculosis

The prize-winners of the IQ Innovation Award of Central Germany 2019 (from right to left): Dr Florian Kloß, head of the transfer group of anti-infectives at the Leibniz Institute for Natural Product Research and Infection Biology of Jena, Dr Julia Dreisbach, clinical centre of the Ludwig Maximilian University of Munich, Dr Uwe Müller, Chief Executive Officer of HAPILA GmbH of Gera together with his colleagues Dr Steffen Wittmann, Head of Quality Assurance and Quality Control and head of development at HAPILA (Source: Tom Schulze)

The innovation of the year 2019 in central Germany is a novel active pharmaceutical ingredient against tuberculosis pathogens. It is being developed as a drug by a team of researchers of the Leibniz Institute for Natural Product Research and Infection Biology (Leibniz-HKI) of Jena together with partners at the clinical centre of the University of Munich and the enterprise HAPILA GmbH of Gera.

It was exciting until the very end: in a multilevel competition 10 participants out of 155 applications had qualified for the final round. Two applicants each belonged to one of the industry-sector-specific cluster. On the occasion of yesterday‘s award ceremony at the Paulinum assembly hall of the University of Leipzig, the jury nominated the overall winners of the fifteenth IQ Innovation Award of central Germany. They are Dr Florian Kloß of Leibniz-HKI of Jena, Dr Julia Dreisbach of the clinical centre of the University of Munich and Dr Uwe Müller, Chief Executive Officer of HAPILA GmbH of Gera. They stand for a great team of scientists who together want to get the new active pharmaceutical ingredient ready to be marketed.

The substance discovered at the Leibniz HKI with the identification BTZ-043 has already successfully completed the clinical trial of phase I. Presently the partners prepare the entry into the clinical phase II during which the active pharmaceutical substance is administered to tuberculosis patients. BTZ-043 shows a completely novel mode of action and is thus also effective against tuberculosis pathogens which are resistant to conventional antibiotics. In the face of approximately 1.5 million fatal casualties caused by tuberculosis worldwide this is an important advantage. What makes this so special is the financing of the drug development by public funding. Thus the BMBF financed research groups InfectControl 2020 and the Deutsches Zentrum für Infektionsforschung [German Centre for Infection Research] as well as the Free State of Thuringia support the expensive development each with multi-million contributions, in addition to that there are high contributions by the partners listed above.

This new course of development became possible due to the good cooperation of the cross-regional and interdisciplinary team. At the Leibniz-HKI, for instance, mainly valid bioanalytical methods are established and the metabolization of BTZ-043 in the organism is researched. The clinical centre of the University of Munich acts as a sponsor and thus takes over the overall responsibility with the performance of the clinical studies in particular. The colleagues there deal with the preclinical and clinical development.  HAPILA GmbH of Gera as an established manufacturer of active pharmaceutical ingredients takes the responsibility for the development of a synthesis process according to the directive and the GMP manufacturing of the ingredient. It is only the close coordination and the continuous exchange of information between the teams that enables them to cope with the complex program of a drug development in the first place.

The Metropolregion Mitteldeutschland [Metropolitan Region Central Germany] Management GmbH, the organiser of the competition, and the high-profile jury panel with experts from economy and science thus appreciate the initiative of publicly financed institutes in the field of the development of antibiotics unique to Germany. As the better part of the global pharmaceutical companies has withdrawn from this not very lucrative business, it is in particular up to the political establishment to take countermeasures.

The award for this project has a strong signalling effect for central Germany as there is a good chance to serve the global market when the tuberculosis drug is admitted to the market. This goes along with a chance to create sustainable qualified jobs in the region.

“This award is important to show the players in society, politics and economy alternative ways of development for urgently needed medication. Moreover, we want to demonstrate the creative potential of central Germany in the field of infection control and pharmaceutical development “, declares Dr Kloß of the Leibniz-HKI of Jena.

The total prize of the IQ competition worth €15,000 was jointly awarded by the Chambers of Industry and Commerce of Leipzig, Halle-Dessau and Eastern Thuringia of Gera. In addition to that, the winners become members of the European Metropolitan Region Central Germany for one year.