Innovation and the research of original drug molecules have been key elements in the Company’s strategy since its foundation in 1901. With 900 employees in the field of research and development, Gedeon Richter today is the most significant pharmaceutical research base in the Central and Eastern European region. Pharmaceutical R&D covers three strategic areas, notably research and development of new chemical entities (NCEs), recombinant biotechnological activities and development of generic products.

Proprietary research activities are focused exclusively on compounds for the diseases of the central nervous system (CNS), primarily on schizophrenia, depression, anxiety and chronic pain. The Company has a portfolio of 18 ongoing projects, of which one is in clinical Phase III trials, two are in clinical Phase II and three are in clinical Phase I. The remainders are in the preclinical phase. 

 At the end of 2009 the clinical portfolio was the following:

Following the publication of positive results for Phase II clinical trials of RGH-188 in the indication of bipolar mania in 2008, the Phase II/b trials of the same compound for schizophrenia also showed positive results in late 2009. For the primary endpoint, the Positive and Negative Syndrome Scale (PANSS), the data showed that patients with schizophrenia treated with Cariprazine experienced significant symptom improvement compared to placebo patients within the first week of treatment and at each subsequent time point studied. Cariprazine (RGH-188) clinical Phase III trials in the indication of bipolar mania have started in the first quarter of 2010, while for the schizophrenia indication Phase III trials are expected to start during the second quarter of 2010. Cariprazine is currently also undergoing Phase II clinical trials in patients with bipolar Depressive Disorder and as adjunctive therapy in Major Depressive Disorder.

In order to ensure that our research activities targeting NCEs continuously meet the highest quality standards, we further improved our technical infrastructure during 2009 and created an experimental MRI laboratory which is unique in our region.

based on our long term almost 50 year experience in the area of classical fermentation, combined with molecular biological knowledge, a strategic decision was made by the management in 2006 to start recombinant biotechnological activities at the Company. The Hamburg based Richter-Helm biologics, established jointly with Helm AG carries out development and manufacturing of microbial proteins. In addition, a biotechnology laboratory and pilot plant in Budapest became operational in 2009. Meanwhile a greenfield investment which was commenced in Debrecen in 2008, progresses according to the plans. This facility will enable us to produce the most complex mammalian cell products from 2012 onward. These monoclonal antibodies are considered to be one of the most up to date areas of pharmaceutical therapies.

The Company considers it essential to establish partnerships to facilitate the development and marketing of new molecules. We join forces with academic and university institutions in the early phase of our research activities, while we make efforts to establish cooperation with other pharmaceutical companies when it comes to the development of molecules in clinical phases. In this regard partnerships with the US-based Forest Laboratories and with the Japanese Mitsubishi-Tanabe Pharmaceuticals have contributed substantially to the Company’s research activity. In particular Richter’s experience in preclinical trials has complemented well with Forest’s experience in clinical trials.

Generic development work in several therapeutic areas continued in 2009 at the Parent company and at its two subsidiaries in Poland and Romania, all of which is coordinated by the Director of Development. The Group’s target is to launch 5-7 new generic and branded generic products per year on its traditional markets, i.e. Hungary, CEE and CIS. Licensing-in activity increasingly contributes to the continuous development of the Group’s product portfolio. Process development activities and bioequivalence studies on several active pharmaceutical ingredients and finished products continued during the year so as to create opportunities for further product introductions in the USA and EU markets. As a result of the Group’s development activity we successfully enhanced during 2009 our female healthcare product portfolio. Several products developed in-house were introduced during 2009.

The Group reported in 2009 a substantial 28.1 percent increase in its spending on research and development which totalled HUF 23,567 million (EUR 83.9 million), representing 8.8 percent of consolidated sales.