|16th July 2019
Europe spends £690 billion a year on brain disorders, more than both cardiovascular disease and oncology combined. According to Dr. Rehm, professor at the University of Toronto, “This is by far the disease category that has the most disability and disease burden associated with it”. However, despite this huge unmet need, big pharma has reduced its investment in this area significantly during the past twenty years.
Neurological and psychiatric disorders (collectively known as neuropsychiatric disorders), such as Alzheimer’s disease and schizophrenia can affect any part of the brain or nervous system function. They greatly impair the health of those affected, impacting their ability to learn, work, and emotionally cope.
Alongside the distressing impact of these disorders on patients, their carers and families, from a health economics standpoint this therapy area presents a high market need which should translate into high return for pharmaceutical investment.
However, sales growth for mental health therapies is only 0.6% in comparison to 12.2% for oncology. A quick look at the recent investments of the top 10-pharma companies can shine light on these numbers. In 2010, GlaxoSmithKline (GSK) announced that they would be discontinuing their research into depression treatment, and AstraZeneca announced the closure of their neuroscience research and development (R&D) sites in Sweden and Canada. Not long after, Novartis announced the closure of its neuroscience facility in Switzerland. Other key players such as Pfizer, Merck and Sanofi have made similar recent moves and cut down research efforts for brain disorders.
According to Harry Tracy, whose newsletter NeuroPerspective tracks developments in drug treatments for psychiatric and neurological conditions, in the past decade the number of psychiatric health research programmes in larger drug firms has shrunk by 70% (The Guardian, 2016).
The neuropsychiatric market is complex and extremely challenging. It is filled with risks from the clinical trial stage, right through the commercialisation process. Here, we explain the challenges hampering innovation and the opportunities for getting a neuropsychiatric launch right.
Even today, despite the leaps and bounds made globally in medicine, the brain remains a mystery. While neuroscience has progressed significantly in the past 20 years, our understanding of the underlying pathophysiology of neuropsychiatric disorders is poor.
As a result, target identification is often a serendipitous process and it is much more challenging than in other disease areas. This means that while successful drugs for psychiatric diseases have been introduced into the market, subsequent new drugs are based on similar mechanisms of actions or therapeutic targets.
Unlike the other organs in our body, the central nervous system (CNS) is surrounded by the Blood Brain Barrier (BBB). It’s a highly selective and difficult to permeate fortress designed to defend the CNS against foreign and harmful substances. To say the BBB presents a formidable challenge in CNS drug development is an understatement.
Recent studies have investigated the use of biotechnology and nanotechnology for targeting CNS drug delivery, for example looking at whether biopolymeric nanoparticles can be used for diagnosis, detection and imaging. However, while these techniques show promise, they are still at a nascent stage. Importantly, these innovations are not stirring excitement among pharmaceutical companies.
Another consequence of the unknown pathophysiology of neuropsychiatric diseases is the ‘shotgun approach’ in treatment measures, in which doctors look at the symptoms rather that the root cause of the disease. For example, depression is diagnosed by looking at a patient’s behaviour and deciding if that behaviour is indicative of low mood.
Doctors do not explore the genetic or physiological factors that could be the cause of this disorder. Instead, they prescribe a medicine based on the behavioural symptoms. This is similar to prescribing antibiotics to a patient with fever-like symptoms without understanding if the cause is viral or bacterial – the therapy would not improve patient’s outcomes (Chandler, 2013).
So why don’t doctors look at the biological cause when treating neuropsychiatric disorders? The answer is simple, while bacterial and viral infections could be distinguished through characteristic biomarkers, reliable biomarkers for psychiatric diseases are almost non-existent.
|27th August 2020
Precision and personalised medicines are more than products, they are services in their own right. So, how should pharma approach this uncharted territory to ensure targeted therapies work for patients?