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Valeant Pharmaceuticals Reports Positive Phase III Results for Retigabine in RESTORE 1



    Valeant Pharmaceuticals International (NYSE:VRX) today reported
    positive results for retigabine in RESTORE 1, the first of two Phase
    III pivotal trials, for this first-in-class neuronal potassium channel
    opener. Retigabine is being developed as an adjunctive treatment for
    adult epilepsy patients with refractory partial-onset seizures.
    RESTORE 1 evaluated the 1200 mg daily dose of retigabine (the highest
    dose in the RESTORE program) versus placebo in patients taking stable
    doses of 1 - 3 additional anti-epileptic drugs (AEDs). Retigabine
    demonstrated statistically significant results on the primary efficacy
    endpoints important for regulatory review by both the US Food and Drug
    Administration (FDA) and the European Medicines Evaluation Agency
    (EMEA). These results build upon the positive findings observed in
    Study 205 which was published in the journal Neurology in April 2007.

    "We are very pleased with the results of this important Phase III
    clinical trial," said J. Michael Pearson, Valeant´s chairman and chief
    executive officer. "These data confirm the efficacy seen with
    retigabine in earlier clinical trials and put Valeant at the forefront
    of development of neuronal potassium channel openers for the treatment
    of epilepsy and other central nervous system diseases. Results from
    RESTORE 2, our second pivotal Phase III clinical trial studying lower
    doses of retigabine, are expected during the second quarter. We
    anticipate filing a New Drug Application (NDA) for retigabine with the
    FDA and a Marketing Authorization Application (MAA) to the EMEA before
    the end of this year."

    "These results are very encouraging and support the growing body
    of evidence to suggest that retigabine may be an effective adjunctive
    therapy for partial onset seizures," said Jacqueline A French, M.D.,
    Professor of Neurology, New York University Medical Center. "There is
    a significant need for novel anti-epileptic drugs because
    approximately one-third of patients with epilepsy continue to
    experience seizures despite treatment with currently available
    medications. Retigabine works by a unique mechanism of action and it
    could potentially play a significant role in the management of
    epilepsy."

    -0-
    *T
    SUMMARY EFFICACY DATA

    RTG 1200 mg Placebo
    ----------------------------------------------------------------------

    ----------------------------------------------------------------------
    Median reduction in 28-day total 44.3%(c) 17.5%
    partial seizure frequency(a) (ITT) n=151 n=150
    ----------------------------------------------------------------------
    Median reduction in 28-day total 54.5%(c) 18.9%
    partial seizure frequency during n=119 n=137
    Maintenance Phase
    ----------------------------------------------------------------------

    ----------------------------------------------------------------------
    Responder Rate(d) (ITT) 45.0%(c) 18.0%
    n=151 n=150
    ----------------------------------------------------------------------
    Responder Rate during Maintenance 55.5%(c) 22.6%
    Phase(b) n=119 n=137
    ----------------------------------------------------------------------

    ITT population defined as all subjects taking at least 1 dose of study
    medication and having at least 1 efficacy assessment

    (a) FDA endpoint
    (b) Endpoint per EU Committee for Human Medicinal Products (CHMP)
    (c) p less than 0.0001 compared to placebo
    (d) Responder Rate defined as greater than or equal to 50% reduction
    in 28-day total partial seizure frequency
    *T

    During RESTORE 1, 26.8 percent of patients in the retigabine arm
    and 8.6 percent of patients in the placebo arm withdrew due to adverse
    events. The most common side effects associated with retigabine in
    RESTORE 1 included dizziness, somnolence, fatigue, confusion,
    dysarthria, ataxia, blurred vision, tremor, and nausea. Comprehensive
    efficacy and safety results from RESTORE 1 are planned to be presented
    at upcoming scientific meetings in the United States and the European
    Union.

    RESTORE 1 Trial Design

    The RESTORE 1 trial (RESTORE stands for Retigabine Efficacy and
    Safety Trials for Partial Onset Epilepsy) consisted of randomized,
    double-blinded, placebo-controlled, multi-center, parallel groups and
    assessed the efficacy and safety of retigabine compared to placebo in
    adult patients with epilepsy who were experiencing refractory
    partial-onset seizures despite receiving one, two or three AEDs. The
    study evaluated a fixed dose of 1200 mg/day of retigabine,
    administered in three divided doses, compared to placebo. The study
    enrolled 306 patients, ranging in age from 18 to 71 years old, and was
    conducted at 49 sites across the United States, Argentina, Mexico,
    Brazil and Canada. Study duration was 32 weeks including 8 weeks
    baseline phase, 6 weeks titration phase, 12 weeks maintenance phase
    and 6 weeks transition phase. Following completion of RESTORE 1
    patients were offered the opportunity to continue treatment with
    retigabine in an open-label extension study.

    RESTORE 1 was designed to meet regulatory guidance from both the
    FDA and the CHMP. The trial was conducted under a Special Protocol
    Assessment by the FDA.

    At the completion of the RESTORE trials, retigabine will have been
    studied in more than 1,750 subjects, including more than 1,350
    patients with epilepsy. More than 350 of these patients will have
    taken retigabine for twelve or more months, including a few who have
    taken retigabine for six or more years.

    Retigabine has not been found by the FDA or any other regulatory
    agency to be safe or effective in the diagnosis, mitigation, treatment
    or cure of any disease or illness. It may not be sold or promoted in
    the United States unless and until the FDA has approved an NDA.
    Similar restrictions apply in other countries.

    Conference Call and Webcast Information:

    Valeant will host a conference call and webcast on Thursday,
    February 14, 2008 at 12:00 p.m. EST (9:00 a.m. PST) to discuss the
    results from its Phase III clinical trial. A webcast of this event
    will be available live over the Internet along with a slide
    presentation. The webcast may be accessed through the investor
    relations section of Valeant´s corporate Web site at www.valeant.com.
    The dial-in number to participate on this call is (877) 295-5743,
    confirmation code 34933527. International callers should dial (706)
    679-0845, confirmation code 34933527. Interested parties will have
    access via the Internet and on the conference call to ask questions
    following the presentation. A replay will be available approximately
    two hours following the conclusion of the conference call and can be
    accessed by dialing (800) 642-1687, or (706) 645-9291, confirmation
    code 34933527.

    About Epilepsy

    Epilepsy is one of the most common neurological diseases,
    affecting approximately 50 million people worldwide. It is a brain
    disorder in which clusters of nerve cells, or neurons, in the brain
    sometimes signal abnormally. In epilepsy, the normal pattern of
    neuronal activity becomes disturbed, causing a seizure. Seizures can
    cause changes in behavior and emotions, strange sensations and
    sometimes convulsions, muscle spasms and loss of consciousness.

    Approximately 30 percent of people with epilepsy experience
    seizures that are not adequately controlled with currently prescribed
    AEDs. Individuals with epilepsy who do not achieve remission with AEDs
    are often severely disabled by their condition, have an unsatisfactory
    quality of life and are at increased risk of sudden unexpected death.
    Refractory epilepsy is associated with memory loss, lower levels of
    school performance, depression and impaired psychosocial skills.

    About Potassium Channel Openers

    Potassium channels are one of the voltage-gated ion channels found
    in neuronal cells and are an important determinants of neuronal
    activity. Numerous ion-channel mutations have been linked to epilepsy,
    and many antiepileptic medications modulate sodium or calcium
    channels. Potassium channels have been demonstrated in animal models
    to be critical in regulating membrane potential. Retigabine is the
    first potassium channel opener to reach late stage clinical
    development. It is believed that by facilitating the opening of
    specific neuronal potassium channels, retigabine causes a
    hyperpolarizing shift in the potassium current and thereby reduces the
    excitability of neuronal cells. Dampening of neuronal excitability is
    an important mechanism for reducing the potential for seizures.

    About Valeant

    Valeant Pharmaceuticals International (NYSE:VRX) is a global
    specialty pharmaceutical company that develops, manufactures and
    markets a broad range of pharmaceutical products primarily in the
    areas of neurology, infectious disease and dermatology. More
    information about Valeant can be found at www.valeant.com.

    FORWARD-LOOKING STATEMENTS

    This press release contains forward-looking statements, including,
    but not limited to, statements regarding expectations or plans of the
    company´s Phase III program for retigabine and the potential role
    retigabine could play in managing epilepsy. These statements are based
    upon the current expectations and beliefs of 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, including that RESTORE 1 results are not
    necessarily predictive of RESTORE 2 results, and that adverse events
    are not always immediately apparent even in well designed clinical
    trials, regulatory approval processes, 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.