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By Jacqueline Lisk
The brain is the human body’s most complex organ. So, it’s no surprise that CNS, or central nervous system, disorders such as schizophrenia, bipolar depression, epilepsy, and Parkinson’s disease have historically been some of the most difficult to treat. Collective progress in this area has waxed and waned over the last decade. But there has been a constant driver of innovation and advancements—Sunovion Pharmaceuticals.
Since its establishment in 2010, the Marlborough, Massachusetts-based biopharmaceutical company has tackled some of the most prevalent, challenging, and underserved CNS conditions.
“We’re strongly committed to research and discovery efforts that have the potential to produce first-in-class new therapies, and to transform lives for people living with serious psychiatric and neurological conditions,” explains Sunovion president and CEO, Antony Loebel, MD.
Sunovion’s achievements have brought new hope to patients, families, and healthcare practitioners, Loebel says. These achievements include FDA-approved treatments for schizophrenia, bipolar depression, epilepsy, and Parkinson’s disease (PD), as well as COPD. Sunovion has pioneered a unique drug discovery platform and has spearheaded advocacy and educational initiatives.
As exciting as Sunovion’s progress has been, Loebel believes the next ten years could bring marked improvements for patients living with these debilitating illnesses—with Sunovion positioned to continue to lead the way.
Reflecting on a decade of innovation
Nearly one in six people worldwide live with a neurological disorder. About 29 million people worldwide have been diagnosed with bipolar disorder, and one percent of the world’s population has been diagnosed with schizophrenia. Despite clear medical needs, many companies have exited the CNS field, because it is complicated and fraught with risk, explains Robert Goldman, PhD, senior vice president, chief medical scientific affairs at Sunovion. This makes Sunovion’s commitment, expertise, and experience even more consequential.
Sunovion’s history of meaningful innovations began with a treatment for schizophrenia and bipolar I disorder in adults. Over the decade, the company has also made a difference for patients living with epilepsy with a treatment for partial-onset seizures in adults, as well as children and adolescents four years of age and older. Sunovion’s most recently approved medication is a sublingual film, the first and only under-the-tongue therapy approved by the FDA for the treatment of “OFF episodes” associated with PD.
Todd Sherer, PhD, CEO of the Michael J. Fox Foundation for Parkinson’s Research (MJFF), explains “OFF episodes” occur when a patient’s medicine stops working and symptoms reemerge. MJFF helped fund early-stage development of the treatment and supported clinical trial recruitment and patient education, in partnership with Sunovion.
Sherer notes that, in addition to the scientific achievement, Sunovion has been “very active in the patient-centered aspect of the medication” and has made “a significant commitment broadly to the patient communities in terms of education and awareness.”
A collaborative, patient-centric culture
Sunovion uses local ties and a global reach to advance its work. As a subsidiary of Sumitomo Dainippon Pharma Co., Ltd., a global pharmaceutical company headquartered in Japan, the companies share scientific and intellectual resources, as well as a collective mission to improve people’s lives.
Stacy Wu, MD, vice president, head of global clinical research, CNS, at Sunovion, explains Sunovion employees are inspired every day by the chance to make a difference for patients—and work together to do so.
“What’s really been key to our success is the collaboration across all functions in the drug development process,” she says, adding that cross-team collaboration also helps to accelerate timelines. The company feels this is important because patients and physicians are waiting for new CNS treatment options.
Sunovion’s work for patients is holistic, including a focus on eliminating stigmas and changing the conversation around these conditions. Notable patient advocacy initiatives include Be Vocal, which encourages people to use their voice in support of mental health; Talk About It for Epilepsy, a program to educate people about seizures and epilepsy; and Sunovion’s work bringing together stakeholders to develop innovations for people living with PD.
Additionally, Sunovion has been a founding partner of various Boston-area organizations, such as the Massachusetts Life Sciences Center Neuroscience Consortium, to advance CNS research.
“Education around the medical nature of both mental health and neurological conditions is key to improving outcomes and quality of life,” Loebel says. “We need to communicate what we now know: that the earlier these conditions are identified, diagnosed, and treated, the better the outcomes; that patients are not to blame for their illnesses; and that help is available.”
Preparing for a transformative future
Loebel also wants people to know that our ability to treat diseases of the brain will continue to improve. Today’s innovations in R&D are paving the way for tomorrow’s discoveries.
“If we take a look at the arc of discovery and development, we’re doing things differently, really at all stages,” Goldman says.
This includes pioneering an approach to discovery based on a systems neurobiology platform that allows researchers to look at how potential new medications affect behaviors in preclinical models and to identify new CNS drug candidates more quickly. The platform has enabled the advancement of promising novel compounds, including SEP-363856, in phase 3 development for its potential to treat schizophrenia. The FDA granted Breakthrough Therapy designation for SEP-363856 in 2019.
Sunovion applies a number of innovations in its CNS development approaches including using data simulation, finding biomarkers, and even its approach to clinical trials.
Wu explains Sunovion is adopting decentralized clinical trials, when possible, by using data and technology to monitor patients remotely, rather than requiring them to come to a study site as often, which is part of the company’s focus on a patient-driven approach.
Sunovion is also exploring how wearables can be used to objectively measure an individual’s symptoms and is partnering with companies to explore how software can be used as a therapeutic technique, for example, by using virtual reality to help individuals with social anxiety practice engaging in social situations.
“We see these partnerships as an opportunity to explore the application of ‘beyond the pill’ solutions that can contribute to the overall well-being of patients,” Goldman says.
This work also reflects the cultural emphasis on creativity and scientific freedom. For example, Sunovion’s team used a novel method to isolate different clusters of schizophrenia symptoms—just one way the company is paving the way toward more precise evaluations of new treatments with more specific clinical endpoints.
“One of the hallmarks of Sunovion is that we’re not constrained by outdated or conventional ideas or ways of thinking,”Loebel says. “We do want to learn from the past and bring the best of what we’ve done, and others have done, but we also encourage the freedom to rethink and reinvent the CNS discovery and development model.”
Dare to cure
While Sunovion is proud of its achievements, the team is quick to share that more work is needed.
“We have therapies that can treat symptoms and improve the day-to-day activities of patients. But I think what would be most exciting—and this is a challenging area—would be to find cures for neurodegenerative diseases, as well as other CNS disorders,” Wu explains.
Loebel doesn’t shy away from the word “cure” either.
“We still have a long way to go to address underlying causes, not just symptoms, so that ultimately we can find cures and even prevent the onset of serious psychiatric and neurological conditions,” he explains. “That is what we truly should aim for: the prevention of these serious conditions.”
1 National Institute of Mental Health. “Schizophrenia.” [Internet]. Available from: https://www.nimh.nih.gov/health/topics/schizophrenia/index.shtml. Accessed November 2019.
2 Mack J, Rabins P, Anderson K, et al. Prevalence of Psychotic Symptoms in a Community-Based Parkinson’s Disease Sample. The American Journal of Geriatric Psychiatry. 2012;20(2):123-132. doi:10.1097/JGP.0b013e31821f1b41.
3 World Health Organization. “Global Burden of Disease, 2004 Report.” [Internet]. Available from: http://www.who.int. Accessed March 29, 2013 (To Access: Health Topics, Global Burden of Disease, The Global Burden of Disease: 2004 Update).
4 Swann A.C. Long-term treatment in bipolar disorder. Journal of Clinical Psychiatry. 2005; 66(1):7–12.
5 National Institute of Mental Health. “Bipolar Disorder” [Internet]. Available from: https://www.nimh.nih.gov/health/topics/bipolar-disorder/index.shtml. Accessed June 22, 2020.
6 World Health Organization. “Epilepsy.” [Internet]. Available from: https://www.who.int/news-room/fact-sheets/detail/epilepsy. Accessed November 2019.
7 Centers for Disease Control and Prevention. “National and State Estimates of the Numbers of Adults and Children with Active Epilepsy — United States, 2015.” [Internet]. Available from: https://www.cdc.gov/mmwr/volumes/66/wr/mm6631a1.htm. Accessed November 2019.
8 Parkinson’s Disease Foundation. “New Study Shows 1.2 Million People in the United States Estimated to be Living with Parkinson’s Disease by 2030.” [Internet]. Available from: https://www.parkinson.org/about-us/Press-Room/Press-Releases/New-Study-Shows-Over-1-Million-People-in-the-United-States-Estimated-to-be-Living-with-Parkinsons-Disease-by-2030. Accessed December 2019.