ROCHE PROVIDES UPDATE ON BITPERTIN STUDIES

     (The following press release from Roche Holding AG was received by e-mail. 
The sender verified the statement.) 
Roche provides update on the first two of six phase III studies of bitopertin 
in schizophrenia
• Two phase III studies evaluating bitopertin for persistent, predominant 
negative symptoms of schizophrenia did not meet their primary endpoints; third 
study is ongoing
• Three phase III studies evaluating bitopertin for sub-optimally controlled 
symptoms of schizophrenia are ongoing 
Roche (SIX: RO, ROG; OTCQX: RHHBY) today announced that two phase III studies 
of its investigational medicine bitopertin (RG1678) in adults with persistent, 
predominant negative symptoms of schizophrenia failed to meet their primary 
endpoints, based on the negative symptoms factor score of the positive and 
negative symptom scale (PANSS). Negative symptoms include social withdrawal and 
lack of motivation. 
In the studies, adding bitopertin to antipsychotic therapy did not 
significantly reduce negative symptoms at 24 weeks compared to placebo. 
Bitopertin was generally well tolerated and its overall safety profile was 
similar to that seen in the previously reported phase II trial (NN20372).  
A third phase III study evaluating bitopertin for persistent, predominant 
negative symptoms of schizophrenia is ongoing. In addition, three phase III 
studies investigating bitopertin for sub-optimally controlled symptoms of 
schizophrenia are in progress. Sub-optimally controlled symptoms, such as 
hallucinations and delusions, are symptoms that do not resolve despite 
treatment with an antipsychotic. 
“These results are disappointing for people with negative symptoms because more 
effective treatments are needed for these debilitating effects of 
schizophrenia,” said Sandra Horning, M.D., Chief Medical Officer and Head of 
Global Product Development at Roche. “We will await data from the remaining 
bitopertin studies in schizophrenia before deciding on next steps.” more 
With best regards,
Roche Group Media Relations 
Roche Group Media Relations
Grenzacherstrasse 124
4070 Basel, Switzerland 
Phone: +41 61 688 88 88
Fax: +41 61 688 27 75
mailto:roche.mediarelations@roche.com
www.roche.com 
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