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Funding Crisis Threatens Mental Illness Drug R&D

BioWorld International Correspondent

LONDON – A funding crisis is threatening the development of new drugs for treating mental illness following the "abrupt" withdrawal by pharma companies from research in the field, coupled with a reduction in public sector investment, according to the European College of Neuropsychopharmacology (ECNP).

The situation is analogous to the withdrawal from antibiotic research 15 years ago. There, the rise of antibiotic-resistant infections subsequently forced governments into action to resurrect expertise and spur drug discovery.

The ECNP is calling on the industry to hand over data on trials in mental illness that have not been published, and compounds that have not been taken forward. "We want to get hold of company databases, merge them and look for variables that are predictive of good responses to treatment," said Guy Goodwin, a member of ECNP's executive committee.

In a report published last week, the ECNP estimated that companies control 80 percent of all data relating to clinical trials in mental illness. If that was pooled, it could be used to carry out meta-analyses that would improve patient selection and trial design. Such a move would pave the way for the retesting of failed compounds in trials with different entry criteria and outcome measures. Drugs with safety and toxicology files that have failed in one indication could be tried in another.

At the same time, the ECNP would like to see incentives for companies working on novel drugs, including extensions to patent life.

"These are dark days for brain science," said David Nutt, a neuropsychopharmacologist at Imperial College London, launching the report. Pharma companies including AstraZeneca plc and GlaxoSmithKline plc have pulled out, and at the same time government funding has been cut. The UK and the Netherlands, for example, have lost, "several thousands" of research jobs in the past six months. While some biotechs have moved in to fill the vacuum, they do not have the resources to fund late-stage trials.

The U.S. National Institute of Mental Health "shares our sense of how critical this may become for the field," the ECNP said.

The crisis prompted the ECNP to convene a summit earlier this year, bringing together 60 representatives of pharma and biotech, with academics, government funding agencies, regulators and patients' groups from across Europe. Companies represented at the meeting included Pfizer Inc., Novartis Pharmaceutical Corp., Addex Pharmaceuticals Ltd., Johnson & Johnson, Actelion Ltd., Abbott, Eli Lilly and Co., Roche AG and H. Lundbeck A/S.

The report and call for action by the ECNP based on the summit pinpoints the key problem as the difficulty in identifying reliable targets and the shortage of effective biomarkers for assessing efficacy in clinical trials.

While genomics is delivering a wealth of new targets to other fields, it is yet to deliver in neurobiology. At the same time, predictive and prognostic biomarkers are largely non-existent, and there are very few good animal models. In short, the current state of knowledge in neurobiology means it is unsuited to the industry's highly rational approach to drug discovery and development.

As a result, most trials are forced to rely on subjective assessments from patients and there is a very high placebo effect. Overall, there are higher failure rates; failures often happen late in development; and the time taken to develop drugs for mental illness is longer than in other disease areas, at 13 years on average. Those difficulties mean that only one new antidepressant, agomelatine, has been licensed in Europe in the past 10 years, Nutt noted. "Neurosciences are nothing like as near [as other fields] to understanding fundamental targets for drug discovery and development. It needs more investment, and pharma pulling out will only make the situation worse. The sudden withdrawal of the private sector needs to be made up," he said.

Nutt also claimed there has been an increase in the regulatory burden "that brings no increase in safety." Currently in the UK it can take a year to get approval for a trial, added Nutt, the summit's co-organizer.

According to the ECNP, almost 80 million people in Europe, or 27 percent of the population, are affected by mental illnesses, including schizophrenia, depression, anxiety and sleep disorders, and neurological diseases including Alzheimer's and Parkinson's, each year. The total cost is estimated at €386 million (US$555.7 million) per annum, and yet only €465 million, or 8 percent, of the European Union's current Framework Programme 7 health research budget is being invested in this area.

Among the specific investments, the ECNP wants to see the formation of centers of excellence with advanced brain imaging facilities to carry out early stage clinical trials and train researchers.

Published: June 22, 2011