Roche schizophrenia drug fails
pharmafile | January 21, 2014 | News story | Research and Development, Sales and Marketing | Roche, biopertin, schizophrenia
Roche’s investigational schizophrenia drug bitopertin has failed to help patients with the disorder’s negative symptoms when pitted against placebo.
Two Phase III trials found bitopertin, when used in combination with an antipsychotic therapy, did not significantly reduce negative symptoms in schizophrenics when compared with placebo.
There is a third late-stage study but results from that have not yet been published. This trial is looking at bitopertin for persistent, predominant negative symptoms of schizophrenia that is ongoing.
Around 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.
Roche is hoping to corner the market on this particular area of the disorder, but these results will be a setback for the Swiss firm.
Sandra Horning, chief medical officer at Roche, said: “These results are disappointing for people with negative symptoms because more effective treatments are needed for these debilitating effects of schizophrenia.
“We will await data from the remaining bitopertin studies in schizophrenia before deciding on next steps,” she added.
A successful treatment for schizophrenia’s negative symptoms could expect to yield up to $1 billion in peak annual sales, but analysts had more modest expectations for bitopertin.
Current consensus forecasts point to annual sales of $407 million by 2017, according to data from Thomson Reuters Cortellis.
Roche’s neuroscience portfolio has 10 new molecular entities, including three in late-stage programmes in schizophrenia, multiple sclerosis and Alzheimer’s disease. The company says that neuroscience is a ‘major focus of research and development’.
Although the company’s focus is predominately on cancer, Roche has in recent years tried to branch out into other areas such as diabetes and drugs aimed at reducing cholesterol.
But trial results for these medicines have also been poor. In July last year Roche was forced to halt a study of its investigational type 2 diabetes drug aleglitazar due to “safety signals and lack of efficacy”.
This is a big blow for Roche as analysts had forecast two billion Swiss francs ($2.05 billion) in peak sales from the drug.
And in 2012 the firm abandoned its Phase III anti-cholesterol treatment dalcetrapib also “due to a lack of clinically meaningful efficacy”. This was also set to reach blockbuster status, but will now sit as a failed treatment.
Ben Adams
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