ChemRar Group presented their innovative developments at the Biotechmed-2017 Conference
On September 14–15, 2017 ChemRar Group presented their innovative developments at the Biotechmed-2017 conference in Gelendzhik, and already registered innovative and import-substituting drugs, whose full production cycle, including the active substance, took place in Russia. The main topics of discussion at the conference this year were a transition from generic import substitution to the development of our own innovative products, export development.
Among its innovative developments, ChemRar Group also presented a promising innovative drug, quisinostat, an HDAC inhibitor developed in partnership with Janssen (the Pharmaceutical Division of Johnson & Johnson) and with the support of the Ministry of Industry and Trade of the Russian Federation within the Federal Targeted Program “Pharma-2020”. The drug has demonstrated high efficacy and a favorable safety profile in patients with platinum-resistant ovarian cancer in combination with standard chemotherapy. The results of this study were presented recently at the world-famous Congress of the American Society of Clinical Oncology (ASCO 2017). Next year it is planned to continue clinical trials for this indication. In addition, the quisinostat clinical trial program was developed after a publication by Canadian scientists about pre-clinical effectiveness of this molecule in some types of sarcoma. This gave a new impetus to international cooperation. If the drug demonstrates efficacy in a clinical trial, there will be a possibility of accelerated registration in the United States.
The topic of fast-tracks was actively discussed by the market participants in the plenary session. It was attended by the Minister of Industry and Trade of the Russian Federation Denis Manturov, the Minister of Healthcare of the Russian Federation Veronika Skvortsova, the General Director of Rostec State Corporation Sergey Chemezov, the Governor of the Krasnodar Krai Veniamin Kondratyev and the heads of the leading Russian pharmaceutical enterprises.
“Thanks to the Federal Program “Pharma-2020”, a real breakthrough was achieved in the production of medical equipment and pharmaceuticals in our country. The issue of generic import substitution has already been resolved, with the exception of the production of synthetic substances that are still more profitable to make in China. Further development of the industry will continue based on the production of innovative medicines. However, a limiting factor of this development may be the lack of fast-tracks for breakthrough drugs in the domestic regulatory system, as it exists in the US and Europe. Besides, it is necessary to develop tools to combat so-called “green patents”, using which foreign corporation can delay the market launch of import-substituting drugs for several years”, said in his speech Andrey Ivashchenko, the Chairman of the Board of Directors of ChemRar.
The Minister of Healthcare of the Russian Federation Veronika Skvortsova supported the need for accelerated fast-track registration of innovative medicines. She said that the Ministry of Healthcare of the Russian Federation had already investigated the experience of the American regulator FDA and the Association of the European Self-Medication Industry. “If we see such fantastic results, when the risk/ benefit ratio raises no questions, we may issue a conditional registration. But you must continue and bring the study to the end. I think this issue we can solve in the foreseeable future”, said Veronika Skvortsova.
About ChemRar Group
ChemRar Group unites R&D service and investment companies in the field of innovative pharmaceuticals for the development and commercialization of innovative medicines, diagnostics, preventive care and new treatments of life-threatening diseases in Russia and abroad. www.en.chemrar.ru