The Richter Group spent HUF 35.2 billion on research and development in 2016, which amounts to 9 per cent of its consolidated sales revenue.
Drug research and development entails three strategic directions:
– research and development on original small molecules,
– recombinant biotechnology,
– generic product development.
Our original drug research traditionally concentrates on discovering and developing effective drugs to combat diseases of the central nervous system, focusing on the development of compounds for the treatment of cognitive disorders, autism, migraine and obesity. The most promising result of our original research is the antipsychotic drug Cariprazine developed for the treatment of schizophrenia and bipolar maniac disorder which was launched, after FDA approval in September 2015, in the US in March 2016. Cariprazine is currently under development by Richter in the EU for the treatment of schizophrenia and for the treatment of schizophrenia with predominant negative symptoms. Meanwhile, other ongoing clinical developments of cariprazine are being managed by Allergan and Richter for bipolar depression and as adjunctive therapy for major depressive disorder in the US and Mitsubishi-Tanabe Pharma Corporation is developing cariprazine for the treatment of schizophrenia in Japan and in other Asian countries.
At the end of 2016, besides cariprazine the Company has a research portfolio of 10 ongoing projects, two of which are in their early clinical phase. The remainder are in the preclinical research phase.
Acting on the basis of the experiences accumulated in classical fermentation over the past 50 years and our advanced knowledge in molecular biology, we took a strategic decision to begin developing and manufacturing recombinant biotechnological drugs. Richter-Helm Biologics, founded jointly with HELM AG, develops and manufactures microbial protein drugs in Germany. By the end of 2009 we established a biotechnology lab and pilot facility in Budapest, and the manufacture of commercial products with high intellectual and technological added value is slated to begin in 2018. These drugs will be protein products made of mammalian cells grown in bioreactors, such as antibodies for treating cancer and chronic inflammatory diseases.
Our research work on the development of generic products involving several areas of therapy is aimed at marketing 5–7 new generic and branded drugs every year in our traditional markets.
Since 2010 we have also been doing original R&D work in gynaecological therapy in collaboration with our Swiss subsidiary. Our leading molecule, used for the preoperative treatment of the mild and severe symptoms of uterine fibroids, is Esmya, which can significantly reduce the size of benign tumours and the associated bleeding, thereby greatly improving the patients’ quality of life. It entered the market in most European countries in 2012, and is currently being sold in 61 countries. Clinical research is currently focused on the long-term, periodic use of the product to expand the present therapeutic indication so that more patients will be able to enjoy lasting recovery without surgical intervention.