Lundbeck Inc. Initiates Clinical Trial Evaluating Clobazam For Dravet Syndrome

DEERFIELD, Ill.--(BUSINESS WIRE)--Lundbeck LLC today announced the initiation of the CLOVER I Study to investigate the use of clobazam for the treatment of children and adolescents with Dravet syndrome — a rare and severe form of intractable epilepsy that begins in infancy.¹ Clobazam is already approved in the United States (U.S.) for seizures associated with another epilepsy syndrome.

“Dravet syndrome is one of the more challenging forms of epilepsy and has a profound impact on an individual’s life, requiring constant care that can take a significant emotional toll on caregivers”

“Dravet syndrome is one of the more challenging forms of epilepsy and has a profound impact on an individual’s life, requiring constant care that can take a significant emotional toll on caregivers,” said Elaine Wirrell, MD, lead investigator of the study and pediatric neurologist at the Mayo Clinic. “The CLOVER I Study will help us better understand the effect of clobazam on Dravet syndrome in this patient population, and hopefully provide more information for both physicians and their families when considering treatment options.”

The CLOVER I Study is designed to evaluate the efficacy, safety and tolerability of clobazam as adjunctive therapy in pediatric patients aged one to 16 years of age with Dravet syndrome. The primary objective of the study is to investigate the effect of clobazam on the frequency of tonic-clonic and clonic seizures after 16 weeks of treatment.² The multicenter study will enroll 54 patients in approximately 25 sites in three countries: Argentina, Mexico and the United States.³ At the end of the study, participants may have the option of joining the CLOVER II study (a 52-week, open-label extension study).

“Lundbeck has a deep commitment to the epilepsy community, with a particular focus on those living with rare forms of epilepsy associated with frequent, severe seizures,” said Deborah Lee, MD, PhD, senior medical director, clinical research at Lundbeck in the U.S. “As a pediatric neurologist, I am particularly driven to address the needs of these courageous patients who take on so much adversity at such a young age.”

For more information about the CLOVER I study, visit www.lundbeck.com/clintrialrecruit or contact Lundbeck at 866.402.8520.

About Dravet syndrome

Dravet syndrome is a rare and severe form of intractable epilepsy that typically begins in the first year of life in an otherwise healthy infant and persists into adulthood.^1,4 It is also known as Severe Myoclonic Epilepsy of Infancy (SMEI).¹ Most children have some level of behavioral and developmental delays that begin in the second year of life.¹ Other conditions that are associated with the syndrome include movement and balance issues, orthopedic conditions, chronic infections and delayed language and speech issues, among others.¹ There are currently no treatments approved by the U.S. Food and Drug Administration (FDA) for the treatment of Dravet syndrome.

About Lundbeck in the U.S.

Lundbeck in the U.S., headquartered in Deerfield, Illinois, is a wholly-owned subsidiary of H. Lundbeck A/S in Denmark. Globally, our mission is to help people suffering from psychiatric and neurologic disorders. To drive this mission in the U.S., nearly 800 employees are engaged in the research, development, production, marketing and sale of innovative specialty therapies that fulfill unmet medical needs. We see the person behind the disease and how it affects the lives of patients, families and caregivers. Lundbeck is actively involved with hundreds of local and national U.S. events each year that support our patient communities. To learn more, visit us at www.LundbeckUS.com and connect with us on Twitter at @LundbeckUS.

About H. Lundbeck A/S

H. Lundbeck A/S (LUN.CO, LUN DC, HLUYY) is a global pharmaceutical company specialized in brain diseases. For more than 50 years, we have been at the forefront of research within neuroscience. Our development and distribution of pioneering treatments continues to make a difference to people living with brain diseases. Our key areas of focus are alcohol dependence, Alzheimer's disease, depression/anxiety, epilepsy, Huntington's disease, Parkinson's disease, schizophrenia and stroke.

Our approximately 6,000 employees in 57 countries are engaged in the entire value chain throughout research, development, production, marketing and sales, and are committed to improving the quality of life of people living with brain diseases. Our pipeline consists of several late-stage development programs and our products are available in more than 100 countries. We have research centers in China, Denmark and the United States, and production facilities in China, Denmark, France, Italy and Mexico. Lundbeck generated revenue of approximately DKK 15 billion in 2013 (EUR 2.0 billion; USD 2.7 billion).

Lundbeck’s shares are listed on the stock exchange in Copenhagen under the symbol “LUN”. Lundbeck has a sponsored Level 1 ADR program listed in the US (OTC) under the symbol “HLUYY”. For additional information, we encourage you to visit our corporate site www.lundbeck.com.

Sources

1. Dravet Syndrome Foundation. What is Dravet Syndrome? http://www.dravetfoundation.org/dravet-syndrome/what-is-dravet-syndrome. Last accessed 12/12/14.

2. U.S. National Institutes of Health. Clobazam as Adjunctive Therapy in Paediatric Patients Aged =1 to =16 Years With Dravet Syndrome. https://clinicaltrials.gov/ct2/show/NCT02174094. Last accessed 12/12/14.

3. Lundbeck Data on File.

4. Epilepsy.com. Dravet Syndrome. http://www.epilepsy.com/learn/types-epilepsy-syndromes/dravet-syndrome. Last accessed 12/12/14.

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