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 traditionally 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 20 ongoing projects, of which one is in clinical Phase III trials and three are in clinical Phase I. The remainder are in the preclinical phase.

Following the publication of positive results for Phase II clinical trials of Cariprazine (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. Clinical Phase III trials both in bipolar mania and schizophrenia indications Phase III trials were initiated during the first half of 2010. Top line data are expected to be published in the late 2011.

In August 2010 we announced preliminary top-line results from an 8-week of Cariprazine for the treatment of bipolar depression. Although the overall difference observed between the drug-treated and placebo-treated groups was not statistically significant, over the course of the trial there was evidence of a clinically relevant treatment effect in the high-dose arm of the study by comparison to placebo.  In addition, the tolerability results for Cariprazine support further investigation in this patient population.

In February 2011 we also published preliminary top-line results from a Phase II clinical trial of Cariprazine in patients as adjunctive therapy in Major Depressive Disorder. Results were similar to that reported in respect of bipolar disorder. Therefore Richter and Forest are considering conducting additional Phase II dose-response trials examining a wider range of doses in both indications.

Top-line results in June 2010 from a Phase II clinical trial of Radiprodil did not show statistically significant or clinically meaningful reductions in mean daily pain scores compared to placebo for any of the dosages studied. Following extensive review of the data base the management of Richter and Forest decided to terminate the project.