Lilly Discontinues Schizophrenia Trials29 Aug 2012-nbsp;-nbsp;-nbsp;
Eli Lilly and Company says it has decided to discontinue trials for schizophrenia drug pomaglumetad methionil (mGlu2/3) because of unfavorable results. The company says that two pivotal studies did not look as though they would have positive results regarding their primary efficacy endpoint.
The company stresses that the discontinuation was not due to any safety issues.
It's recent Phase II study which looked at using pomaglumetad methionil alongside antipsychotic medications did not meet its primary endpoint either.
This is the third experimental drug that has not met its primary endpoint in a clinical trial this month. Last week solanezumab, an experimental drug with great hopes for Alzheimer's disease treatment, did not meet its endpoints in two Phase III trials. Also this month, Forteo, a medication for back pain, was compared with a bone-strengthening medication; no difference was detected between them in osteoporotic vertebral fracture risk for postmenopausal females.
The company says it is contacting investigators explaining what has to be done in order to close down each study. Lilly says it is liaising closely with investigators to make sure trial participants gradually return to their medical treatments outside of the trials.
Jan Lundberg, Ph.D., executive vice president, science and technology, and president, Lilly Research Laboratories, said:
"I'm disappointed in what these results mean for patients with schizophrenia who still are searching for options to treat this terrible illness. While there are many challenges in this complex field of research, neuroscience remains a core area of focus at Lilly.
Our clinical development pipeline includes nearly a dozen neuroscience molecules being studied to treat illnesses such as depression, bipolar disorder and cognitive impairment associated with schizophrenia."
In a communiqué today, Lilly says that this decision will probably result in a third-quarter charge to R-D of between $25 million and $30 million (before tax), or about $0.02 per share (after tax).
Lilly had been hoping that pomaglumetad methionil might make up for the loss in revenue when Zyprexa, its blockbusting antipsychotic medication lost patent protection in the third quarter of last year. Zyprexa used to bring in revenue of about $5 billion annually.
Lilly says it has some promising new molecules in the pipeline in the following therapeutic areas, diabetes (4 drugs), cancer (3 drugs), neuroscience (2 drugs) and autoimmune disease (2 drugs) - all of them currently undergoing Phase III trials.
Written by Christian Nordqvist
Copyright: Medical News TodayNot to be reproduced without permission of Medical News Today
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