Zogenix Acquires U.K.-Based Brabant Pharma
Obtains global rights for treatment option in development for Dravet syndrome, a rare and catastrophic form of epilepsy that begins in infancy
Plans to initiate Phase 3 clinical studies of Brabafen™ in second quarter of 2015
Conference call and webcast today,
Children with Dravet syndrome, also known as Severe Myoclonic Epilepsy of Infancy (SMEI), experience frequent, severe and potentially life-threatening seizures that typically start in the first year of life. These seizures do not respond to standard anti-epileptic medications and current treatment options are very limited.
The latest results from an ongoing, long-term clinical study in 15 Dravet syndrome patients treated with Brabafen show that 93% of patients were either seizure-free or had greatly reduced seizure frequency, during an average treatment period of greater than 12 years. The results also demonstrate the safety of Brabafen, which was shown to be well tolerated and treatment side effects were mild and transient for the entire study treatment period.
The safety and effectiveness of Brabafen has been evaluated in a continuing, long-term, open-label, study in 15 Dravet syndrome patients. The average duration of treatment in this study is currently more than 12 years, with the longest duration of treatment at more than 26 years. More than two-thirds (67%) of patients were seizure free for at least a year after the latest assessment with an average seizure free period of 5.5 years. The majority (87%) of patients had a greater than 75% reduction in seizure frequency. There were no reports of pulmonary hypertension and there were no deaths. Two patients showed sub-clinical evidence of cardiac valve thickening that was judged to be clinically insignificant following detailed investigation by independent cardiologists. Similar findings spontaneously resolved in a third patient.
"Since securing an exclusive license from the Universities of
"This is a transformational acquisition for
"We believe the positive, durable long-term results of Brabafen place us in a leadership position within the Dravet syndrome community. We are fully committed to bringing this promising therapeutic to market for the benefit of these children and their families," added Mr. Hawley.
In addition to the
Expenses related to the Phase 3 clinical programs for Brabafen are estimated at
Conference Call & Webcast
Zogenix will hold a conference call today, October 27, 2014 at 4:30 p.m. ET to discuss the acquisition of Brabant Pharma. To participate, please dial (877) 417-5253 (U.S.) or (315) 625-3082 (International); participant pass code: 24426098. To access the live webcast, please visit the Zogenix Investor Relations website at http://ir.zogenix.com.
A replay of the conference call will be available beginning October 27, 2014 at 7:30 p.m. ET until November 3, 2014, by dialing (855) 859-2056 (U.S.) or (404) 537-3406 (International); pass code: 24426098. A replay of the webcast will also be accessible on the Investor Relations website for one month, through November 27, 2014.
Discussion during the conference call may include forward-looking statements and any comments the Company may make about its future plans or prospects in response to questions from participants on the conference call.
Brabafen is low-dose fenfluramine currently under evaluation for the reduction of seizures in Dravet syndrome patients. Fenfluramine was originally developed and approved as an anoretic agent for the treatment of obesity. Although fenfluramine was withdrawn from the market in 1997 due to risk in the treated patient population of serious heart valve defects, preclinical and clinical evidence of the drug's ability to abolish epileptic seizures had previously been described. In
About Dravet Syndrome
Dravet syndrome (also known as Severe Myoclonic Epilepsy of Infancy) is a rare, severe and therapy-resistant form of epilepsy most often caused by an identifiable gene defect that results in abnormal functioning of a sodium channel in the brain. Children with Dravet syndrome experience severe, long-lasting, fever-related seizures in the first year of life. Other seizures typically arise later, including myoclonus (involuntary muscle spasms) and status epilepticus (prolonged seizures), which often result in severe cognitive and developmental impairment. Episodes of status epilepticus require immediate emergency care and can be fatal.
Individuals with Dravet syndrome face a higher incidence of SUDEP (sudden unexplained death in epilepsy) and have associated conditions, which also require proper treatment and management. Children with Dravet syndrome do not outgrow this condition and it affects every aspect of their daily lives.
For more information, visit www.zogenix.com.
1Ceulemans, Berten, et al. Successful use of fenfluramine as an add-on treatment for Dravet syndrome. EPILEPSIA.
Brabafen is a trademark of Brabant Pharma
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