Mental Health and the Biopharmaceutical Pipeline
Mental Illness: Promise in the Biopharmaceutical Pipeline
08.20.13 | By Salvatore Alesci
The New York Times today put a spotlight on mental health, mistakenly pointing out that we are facing a crisis in innovation for medicines that can help patients suffering from debilitating psychiatric diseases. On the contrary, biopharmaceutical researchers around the world are working in this challenging area to unravel these diseases using an array of new approaches.
I should point to two recent reports that analyzed the biopharmaceutical pipeline and showed that there are nearly 200 medicines in development in the U.S. and 240 medicines in the pipeline worldwide for psychiatric conditions such as depression, anxiety, post-traumatic stress syndrome and schizophrenia. Out of the 240 in development globally, seventy-five percent are potential first-in-class medicines for patients.
A great example of the promise that is in the pipeline is a potential first-in-class treatment for schizophrenia. According to a report by the Analysis Group, a potential agent (a glycine reuptake inhibitor) could help normalize transmission of glutamate, a chemical that is essential in allowing brain cells to communicate with each other. This potential new medicine could be one of the first to address effectively some of these particularly challenging symptoms associated with schizophrenia.
Another potential first-in-class medicine for the treatment of major depression is based on the theory that chronic exposure to stress hormones may prevent the growth of new neurons in the brain and can lead to depression, among other conditions. The medicine, which can cross the blood-brain barrier, recruits the patients’ own neural stem cells to repair or protect against damage to the central nervous system.
Despite the promising pipeline we do need more research to accelerate progress, particularly collaborative approaches between the biopharmaceutical industry, government, academia, and others to find new targets and better understand psychiatric diseases on the molecular level. We need regulatory certainty for drugs in the pipeline and innovative approaches such as surrogate endpoints to more quickly and accurately assess potential new medicines.
With one in four American adults suffering from a diagnosable mental illness, we in the health care community also need to do more to improve access and coverage to mental health treatment and identify those in need obtain appropriate treatment. The good news is that medicines currently available to patients suffering from mental illness conditions have undoubtedly made a tremendous difference in improving health and increasing workplace productivity.
Diseases of the brain are extraordinarily complex but we have come a long way. Incremental gains over time have resulted in an increase in outpatient treatment options allowing patients to remain with their families and retain their jobs.
Importantly, researchers continue to explore mental illnesses and their causes, including how the brain may be changed when a person has a mental disorder. For this reason, we expect that more potential treatment targets will be identified and explored leading to additional incremental advances for patients.
But as the author of the article rightly pointed out, there can be no innovation without financial - or scientific – risks and uncertainty. And in the area of mental health, this couldn't be more true. The reality is that most drugs in development are never approved.
It costs, on average, $2.6 billion and takes 10 to 15 years to develop just one medicine. For every 5,000 to 10,000 compounds that enter the pipeline, only one receives FDA approval. As you can imagine, developing medicines for mental illnesses brings a unique set of challenges from the complexity of the diseases to patient retention in clinical trials.
Despite the incredible hurdles in drug development, biopharmaceutical research companies, oftentimes working with other partners in the medical innovation ecosystem, keep moving forward in their mission to help patients win their battle against mental illness.