SEATTLE, Dec. 6 /PRNewswire-FirstCall/ -- Results from RESTORE 2, a placebo-controlled, Phase III study demonstrated that the investigational compound retigabine significantly reduced the number of seizures in adult patients with refractory partial-onset epilepsy when a 600 mg or 900 mg dose was added to a patient's current anti-epileptic drug (AED) therapy. Prior to enrollment in the retigabine clinical trials, patients were experiencing seizures despite taking stable doses of up to three AEDs.
Retigabine has a different mechanism of action than currently approved AEDs. Retigabine is a neuronal potassium channel opener, which helps control neuronal excitability. In epilepsy patients, brain cells can become overly excited, disrupting normal brain activity and causing seizures.
"Approximately 30 percent of epilepsy patients are not well-controlled despite treatment with existing anti-epileptic drugs," said Jacqueline A. French, M.D., Professor of Neurology, New York University Medical Center and an investigator in the study. "Many of the currently available AEDs regulate sodium channels or calcium channels in the brain to help reduce seizures. Given the unmet medical need, it is hoped that medications with novel mechanisms of action, like retigabine, will improve outcomes in patients with refractory epilepsy."
The RESTORE 2 study results were presented at the 62nd Annual Meeting of the American Epilepsy Society in Seattle on Saturday December 6, 2008. In addition to the Phase III results, five other studies of retigabine were presented at AES.
About the Clinical Trials
The Phase III program for retigabine consisted of two randomized, double- blind, placebo-controlled, multi-center, parallel-group studies that assessed the efficacy, safety and tolerability of retigabine as an adjunctive treatment for adult epilepsy patients with refractory partial-onset seizures. The program, called RESTORE (Retigabine Efficacy and Safety Trial for Partial- Onset Epilepsy) 1 and 2, involved approximately 120 sites in more than 17 countries worldwide.
RESTORE 1 evaluated a 1200 mg daily dose of retigabine (the highest dose in the Phase III program) versus placebo, while RESTORE 2 evaluated 600 mg and 900 mg daily doses of retigabine versus placebo. In these studies, retigabine demonstrated a statistically significant reduction in seizures compared to placebo at all three doses when added to patients' current AED therapy. Additionally, RESTORE 2 showed a dose-dependent response when the dose of retigabine was increased from 600 mg to 900 mg daily.
Tolerability of retigabine was generally dose-dependent. The most common side effects associated with retigabine in the RESTORE trials occurring in greater than or equal to 10 percent of patients included dizziness, somnolence, fatigue, confusion, dysarthria (slurred speech), ataxia (loss of muscle coordination), urinary tract infection, blurred vision, tremor, and nausea. Urinary bladder effects, while monitored during the studies, were uncommonly reported.
GlaxoSmithKline and Valeant Pharmaceuticals International entered into an exclusive worldwide collaboration agreement for retigabine earlier this year. The companies plan to file a New Drug Application in the United States and a Marketing Authorization Application in Europe in 2009.
About Epilepsy
Epilepsy, defined by recurrent, unprovoked seizures, is a change in sensation, awareness or behavior caused by an electrical disturbance in the brain. The kind of seizure a person has depends on which part and how much of the brain is affected by the disturbance. Primary generalized seizures involve the entire brain from the outset, while partial-onset seizures begin in a focal area of the cerebral cortex. In most cases, however, the cause of epilepsy is unknown.
Epilepsy affects more than 50 million people worldwide, including 3 million Americans. Approximately 30 percent of epilepsy patients are not adequately controlled with currently prescribed AEDs.
About GlaxoSmithKline
One of the world's leading research-based pharmaceutical and healthcare companies, GSK is committed to improving the quality of human life by enabling people to do more, feel better and live longer. For further information please visit http://www.gsk.com/.
About Valeant
Valeant Pharmaceuticals International is a multinational specialty pharmaceutical company that develops, manufactures and markets a broad range of pharmaceutical products primarily in the areas of neurology and dermatology. More information about Valeant can be found at http://www.valeant.com/.
Inquiries: GSK US Media inquiries: Robin Gaitens (919) 483 2839 Holly Russell (919) 483 2839 GSK US Analyst/ Investor inquiries: Tom Curry (215) 751 5419 Valeant Media and Investor inquiries: Laurie W. Little (949) 461 6002 GSK cautionary statement regarding forward-looking statements
Under the safe harbor provisions of the U.S. Private Securities Litigation Reform Act of 1995, GSK cautions investors that any forward-looking statements or projections made by GSK, including those made in this announcement, are subject to risks and uncertainties that may cause actual results to differ materially from those projected. Factors that may affect GSK' s operations are described under 'Risk Factors' in the 'Business Review' in the company' s Annual Report on Form 20-F for 2007.
Valeant Pharmaceuticals forward-looking statements
This press release contains forward-looking statements, including, but not limited to, statements regarding expectations or plans of development program for retigabine and the potential role retigabine could play in managing epilepsy and in treating other indications, and the commercial opportunity retigabine may present for Valeant. These statements are based upon the current expectations and beliefs of Valeant's management and are subject to certain risks and uncertainties that could cause actual results to differ materially from those described in the forward-looking statements. These risks and uncertainties include, but are not limited to, risks and uncertainties related to the clinical development of retigabine, the fact that adverse events are not always immediately apparent even in well designed clinical trials, regulatory approval processes, the potential that competitors may bring to market drugs or treatments that are more effective of more commercially attractive than retigabine, and other risks and uncertainties discussed in the company's filings with the SEC. Valeant wishes to caution the reader that these factors are among the factors that could cause actual results to differ materially from the expectations described in the forward- looking statements. Valeant also cautions the reader that undue reliance should not be placed on any of the forward-looking statements, which speak only as of the date of this release. The company undertakes no obligation to update any of these forward-looking statements to reflect events or circumstances after the date of this release or to reflect actual outcomes.
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