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Neurological Diseases

Neurological diseases span a broad spectrum of brain and peripheral nervous system dysfunction, including conditions such as Alzheimer’s, Parkinson’s, depression, migraine and multiple sclerosis. Rapid aging of the global population poses growing challenges to healthcare systems. On top of the increasing cost of medicines, the cost of residential care adds to the burden. The demand for new therapies that modify disease outcome instead of just relieving symptoms is all the more urgent.

New drugs to treat conditions such as depression, schizophrenia and Alzheimer’s commonly require clinical trial programs involving large patient populations. These medical areas continue to be the domain of primarily large pharma and biotech firms because of the associated high costs. Exceptions include two BB Biotech portfolio companies. Intra-Cellular Therapeutics owns lumateperone, an investigational medicinal product that has successfully completed two Phase III trials for the treatment of schizophrenia. The substance is novel in being able to simultaneously target multiple pathways for neurotransmitters like serotonin and dopamine. The target action date for a decision by the relevant FDA panel on approval of the drug in this therapeutic indication is September 2019. Voyager Therapeutics develops gene therapies, one of which is VY-AADC, an agent to treat Parkinson’s. It works by promoting the synthesis of an enzyme designed to promote the production of an important neurotransmitter, dopamine, in the brains of patients with advanced disease.

A migraine drug developed by Alder Biopharmaceuticals is in the final preapproval stage. The antibody eptinezumab is the only drug from the class of CGRP inhibitors that involves just four infusions a year. Alder plans to file a new drug application for approval in the US in the first quarter of 2019. Sage Therapeutics made for another highlight in 2018 with its drug Zulresso for the management of postpartum depression. Up to 20% of mothers experience this psychological disorder to a greater or lesser degree. It occurs immediately after childbirth and is attributable to hormonal changes. The agent stands out from all the other treatments available through its combination of rapid efficacy and good tolerability. The FDA’s decision on approval of the injectable version is expected by March 2019. In January, the company also presented good data from its study of SAGE-217 in postpartum depression. SAGE-217 is a next-generation product for oral use.

Neurological diseases increase in frequency with age and are the most common cause of work disability. In the United States alone, neurological diseases affect one-quarter of the population and cost the country an estimated USD 800 billion a year. Approximately 15% of people in the world today can expect to experience neurological injury of one kind or another during their lifetime. The biopharmaceutical industry is correspondingly keen in its efforts to develop new forms of treatment. 537 agents for the treatment of neurological disorders were under clinical development in 2018, according to surveys by PhRMA, the trade group representing the pharmaceutical industry in the US. That is the third highest number after cancer (1 120) and rare diseases (566). The growing costs of health care for neurological and other diseases were the major impetus for the implementation of the Affordable Care Act, but it is not clear the proposed measures of this program will be sufficient to meet the daunting fiscal challenges of the near future. Given the extraordinary and rapidly growing costs of neurological disorders themselves, a concrete strategy is urgently needed to reduce the burden of neurological disease.

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