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Retigabine Significantly Reduces the Number of Seizures in Adults With Inadequately Controlled Partial-Onset Epilepsy

December 6, 2008

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 (NYSE: GSK) (LSE: GSK) and Valeant Pharmaceuticals
International (NYSE: VRX) 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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    Registered Office:
    980 Great West Road
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SOURCE GlaxoSmithKline; Valeant Pharmaceuticals International


Source: newswire



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