Hungary's largest drugs maker Gedeon Richter and U.S.-based Forest Laboratories, Inc. have announced on Tuesday the preliminary top-line results from a U.S. conducted study of RGH-188, a novel antipsychotic, in 389 schizophrenia patients. The companies, which have only been able to review top-line results, said further analyses would be completed in the coming weeks to examine the results in greater detail.
The companies did a patient randomized, double-blind, three-arm placebo-controlled study of RGH-188. “The protocol-specified primary endpoint was change from baseline to Week 6 on the Positive and Negative Syndrome Scale (PANSS) and RGH-188 demonstrated a nominally statistically significant (i.e., not adjusted for multiple comparisons) therapeutic effect compared to placebo in the treatment of schizophrenia in the low dose arm and a numerical improvement compared to placebo in the high dose arm that did not reach nominal statistical significance."
“Based on the initial positive results [...] the Companies intend to continue the development of RGH-188 as a treatment for schizophrenia and will determine the appropriate development activities over the coming months."
Additionally, the Companies expect to receive topline results for the proof of concept study for RGH-188 in bipolar mania in by the middle of calendar 2008.
RGH-188 (INN: cariprazine) discovered by researchers at Gedeon Richter in 2003, is a novel antipsychotic which preferentially binds to D3 receptors and acts as a dopamine system stabilizer.
Zsuzsa Beke, head of Richter's PR department told Portfolio.hu that the completion of the phase II-B study left the companies only with preliminary results and detailed data will not be at hand before end-November.
The companies are to decide in early 2008 how to go on with the project. Available data have proven the efficiency of the compound but at this level there is no milestone payment from Forest to Richter. The next milestone payment may take place following the obtainment of clinical phase III FDA protocol. It is not known when this will happen, but certainly not in the first half of 2008.
We believe the news is positive for shareholders, since it is a clear indication of Richter's success in one of its most important activities, Research & Development. We must note, however, that the drug will not be marketed - even under the best-case scenario - for a few more years therefore there will be no signs of the new medicine either in Richter's revenues or profit. Due to the great number of risks, we would not expect analysts' long-term projections to change for the better any time soon. We expect a positive impact on the share price today, primarily on the news that chances for yet another milestone payment in 2008 have increased considerably.
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