ATLANTA, April 21, 2017 /PRNewswire/ -- UCB is pleased to announce that 12 scientific abstracts have been accepted for presentation at the upcoming Annual Meeting of the American Academy of Neurology (AAN) to be held April 22 to 28, 2017 in Boston, USA.1-12
Data being presented include posters further describing the efficacy and tolerability profile of VIMPAT® (lacosamide) CV and BRIVIACT® (brivaracetam) CV.
Posters will be presented describing the efficacy and tolerability of lacosamide monotherapy in elderly newly diagnosed epilepsy patients and in newly diagnosed epilepsy patients with psychiatric comorbidities. Pooled results from long-term follow-up studies of adjunctive brivaracetam in patients with secondarily generalized tonic-clonic seizures and a poster comparing the healthcare utilization and direct medical costs in newly diagnosed epilepsy patients compared to a non-epilepsy population will also be presented.
In the U.S., VIMPAT® is approved as monotherapy or adjunctive therapy in the treatment of partial-onset seizures in patients 17 years and older.13 BRIVIACT® is approved in the U.S. as adjunctive therapy in the treatment of partial-onset seizures in patients 16 years of age and older with epilepsy.14
"At UCB, we are committed to finding solutions for people living with epilepsy. We are therefore excited to share further data at this important meeting that will continue to expand our understanding and enable us to bring new scientific advances to the epilepsy community," explained Jeff Wren, Executive Vice President, Neurology Patient Value Head at UCB. "Around thirty percent of people with epilepsy have seizures that remain uncontrolled on currently available therapies. By sharing our research with the wider neurology community, and by focusing on improving patient treatment journeys, we believe we can make a real difference to the millions of people with epilepsy around the world."
The following is a guide to the 12 UCB-sponsored poster presentations at the Annual Meeting of the American Academy of Neurology (AAN) to be held April 22 to 28, 2017 in Boston, USA.
VIMPAT® (lacosamide):
About Epilepsy15,16,17
Epilepsy is a chronic neurological disease of the brain, defined as one or more unprovoked seizures with a risk of further seizures, and is characterized by the neurobiological, cognitive, psychological, and social consequences of this disorder. Epilepsy is the fourth most common neurological condition worldwide, affecting an estimated 65 million around the world. In the U.S., more than 3 million people have epilepsy. Between 4 and 10 people out of every 1,000 in the world live with active seizures at any one time. Anyone can develop epilepsy; it occurs across all ages, races and genders. One third of patients with epilepsy live with uncontrolled seizures.
About UCB in Epilepsy
UCB has a longstanding commitment to improving the lives of people with epilepsy around the world. With over 20 years of experience in the research and development of antiepileptic drugs, our goal is to become a preferred partner for the global epilepsy community, improving knowledge about and access to effective solutions to help patients better manage their individual epilepsy journeys. We strive to partner and create super-networks with world-leading scientists and clinicians in academic institutions, pharmaceutical companies and other organizations who share our goals. At UCB, we are inspired by patients, and driven by science in our commitment to support people with epilepsy.
About UCB
UCB, Brussels, Belgium (www.ucb.com) is a global biopharmaceutical company focused on the discovery and development of innovative medicines and solutions to transform the lives of people living with severe diseases of the immune system or of the central nervous system. With more than 7500 people in approximately 40 countries, the company generated revenue of € 4.2 billion in 2016. UCB is listed on Euronext Brussels (symbol: UCB). Follow us on Twitter: @UCB_news
About VIMPAT®13
VIMPAT® is approved in the U.S. as film-coated tablets, injection for intravenous use and oral solution, as monotherapy or adjunctive therapy in the treatment of partial-onset seizures in people with epilepsy ages 17 years and older. VIMPAT® injection is indicated as short-term replacement when oral administration is not feasible in these patients.
A single loading dose administration option is also approved in the U.S. for all formulations of VIMPAT® when used as monotherapy or adjunctive therapy in the treatment of partial-onset seizures in patients with epilepsy aged 17 years and older.
Important Safety Information about VIMPAT® in the U.S.13
Warnings and Precautions
Adverse Reactions
Dosing Considerations
The loading dose should be administered with medical supervision considering the VIMPAT® pharmacokinetics and increased incidence of CNS adverse reactions. Dosage adjustments are recommended for patients with mild or moderate hepatic impairment or severe renal impairment. Use in patients with severe hepatic impairment is not recommended. Perform dose titration with caution in all patients with renal and/or hepatic impairment.
VIMPAT® is a Schedule V controlled substance.
Please refer to full Prescribing Information provided at http://www.vimpat.com/pdf/vimpat_PI.pdf.
For more information on VIMPAT®, contact 844-599-CARE (2273).
VIMPAT® is a registered trademark used under license from Harris FRC Corporation
About BRIVIACT®14
BRIVIACT® is a new molecular entity that was rationally designed and developed by UCB. Brivaracetam displays a high and selective affinity for synaptic vesicle protein 2A (SV2A) in the brain, which may contribute to the anticonvulsant effect. However, the precise mechanism of action by which BRIVIACT® exerts its anticonvulsant activity is not known. In the U.S. and European Union, BRIVIACT® is approved as adjunctive therapy (a therapy used together with primary treatment) in the treatment of partial-onset seizures in patients 16 years of age and older with epilepsy. BRIVIACT® is available in three formulations (film-coated tablets, oral solution, and injection).14
Important Safety Information about BRIVIACT® in the U.S.14
Warnings and Precautions
Adverse Reactions
The most common adverse reactions (at least 5% for BRIVIACT® and at least 2% more frequently than placebo) are somnolence and sedation, dizziness, fatigue, and nausea and vomiting symptoms.
BRIVIACT is a Schedule V controlled substance.
Please refer to full Prescribing Information at http://www.briviact.com/briviact-PI.pdf.
For more information on BRIVIACT®, contact 844-599-CARE (2273).
BRIVIACT® is a registered trademark of the UCB Group of Companies.
For further information:
Communications contacts: |
Investor Relations contacts: |
France Nivelle, Global Communications, UCB |
Antje Witte, Investor Relations, UCB |
Jim Baxter, Neurology Communications, UCB T+32.2.473.78.85.01, jim.baxter@ucb.com |
Isabelle Ghellynck, Investor Relations, UCB T+32.2.559.9588, isabelle.ghellynck@ucb.com |
Laurent Schots, Media Relations, UCB T+32.2.559.92.64, Laurent.schots@ucb.com |
References
1-12. AAN Congress posters, presentation details above. Scientific program available online: https://www.aan.com/conferences/2017-annual-meeting/abstracts/ Accessed April 18 2017
13. Vimpat® U.S. Prescribing Information. Brussels, Belgium: UCB, 2016. http://www.vimpat.com/pdf/vimpat_PI.pdf Accessed 18 April 2017
14. Briviact® U.S. Prescribing Information. Brussels, Belgium: UCB, 2016. https://www.briviact.com/briviact-PI.pdf Accessed April 18 2017
15. The Epilepsy Foundation of America. Who Gets Epilepsy http://www.epilepsy.com/learn/epilepsy-101/who-gets-epilepsy Accessed April 18 2017
16. The Epilepsy Foundation of America. What is Epilepsy? http://www.epilepsy.com/learn/epilepsy-101/what-epilepsy Accessed April 18 2017
17. The Epilepsy Foundation of America. A Revised Definition of Epilepsy webpage http://www.epilepsy.com/article/2014/4/revised-definition-epilepsy Accessed April 18 2017
Forward looking statements
This press release contains forward-looking statements based on current plans, estimates and beliefs of management. All statements, other than statements of historical fact, are statements that could be deemed forward-looking statements, including estimates of revenues, operating margins, capital expenditures, cash, other financial information, expected legal, political, regulatory or clinical results and other such estimates and results. By their nature, such forward-looking statements are not guarantees of future performance and are subject to risks, uncertainties and assumptions which could cause actual results to differ materially from those that may be implied by such forward-looking statements contained in this press release. Important factors that could result in such differences include: changes in general economic, business and competitive conditions, the inability to obtain necessary regulatory approvals or to obtain them on acceptable terms, costs associated with research and development, changes in the prospects for products in the pipeline or under development by UCB, effects of future judicial decisions or governmental investigations, product liability claims, challenges to patent protection for products or product candidates, changes in laws or regulations, exchange rate fluctuations, changes or uncertainties in tax laws or the administration of such laws and hiring and retention of its employees. UCB is providing this information as of the date of this press release and expressly disclaims any duty to update any information contained in this press release, either to confirm the actual results or to report a change in its expectations.
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