Results of two Phase III trials found bitopertin in
combination with antipsychotic therapy did not significantly reduce
negative symptoms after 24 weeks of treatment compared with placebo.
A third late-stage study is ongoing.
Roughly 26 million people are affected by schizophrenia worldwide,
but current treatment options for the disorder's negative symptoms — which include social withdrawal, lack of motivation and reduced
emotional reactivity — are limited.
"These results are disappointing for people with negative symptoms
because more effective treatments are needed for these debilitating
effects of schizophrenia," said Sandra Horning, Roche's chief
medical officer and global head of product development.
The data are also a blow for Roche, which has upped its investment
in neuroscience in recent years as it looks to branch out beyond its
core cancer expertise. It is currently running late-stage studies in
Alzheimer's disease, multiple sclerosis and schizophrenia.
Many large pharmaceutical companies including Merck, Novartis and
AstraZeneca have cut back on research in the area as new drugs prove
hard to find.
The success rate for brain drugs in Phase III is poor, averaging
around 50 percent against 50-80 percent for other disease areas.
Kepler Cheuvreux analyst Fabian Wenner said the results showed Roche
was taking more time to succeed in new fields outside of oncology,
which he said would be critical to secure sustainable growth in the
In recent years Roche has scrapped drugs to treat diabetes and boost
levels of "good" high-density cholesterol.
[to top of second column]
While a successful treatment for schizophrenia's negative symptoms
could have notched up more than a billion dollars a year in sales,
many analysts had modest expectations for bitopertin.
Current consensus forecasts point to annual sales of $407 million by
2017, according to Thomson Reuters Cortellis.
Roche is conducting three additional Phase III studies investigating
bitopertin for sub-optimally controlled symptoms, such as
hallucinations and delusions.
The drugmaker said it would await the data from its remaining
studies before deciding on the next steps for the drug.
(Reporting by Caroline Copley; editing
by Mark Potter)
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