Valeant Pharmaceuticals Initiates Infergen Phase 4 Study

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Valeant Pharmaceuticals Initiates Infergen Phase 4 Study

Study Will Evaluate Patients Who Have Partially Responded to Therapy

at Week 12

COSTA MESA, Calif., December 12, 2006 -- Valeant Pharmaceuticals

International (NYSE:VRX) today announced its plans to initiate a

phase 4 study of Infergen® (Consensus Interferon), which is in

development for daily use in combination with ribavirin in the

treatment of hepatitis C in patients who were non-responsive to

previous pegylated interferon and ribavirin therapy. The study will

evaluate the use of Infergen 15 µg/day plus ribavirin (1.0-1.2

g/day) in patients who did not have an optimal response at week 12 of

treatment with pegylated interferon and ribavirin.

“Approximately 50 percent of patients do not respond to initial

pegylated interferon and ribavirin therapy. Week 12 has been shown to

be a pivotal time point in determining the likelihood of responding

to therapy. Patients who still have detectable virus at week 12 have

less chance of sustaining an SVR than those who are undetectable at

week 12. These patients are in need of a new treatment regimen to

improve their chance at achieving a sustained response,†commented

L. Shiffman, the study's principal investigator and Chief of

Hepatology at Virginia Commonwealth University Medical Center.

The multi-center, randomized U.S. study will enroll patients who

received initial treatment with pegylated interferon and ribavirin

and achieve a >2log10 decline in HCV RNA at week 12 but still have

detectable virus. The patients will be immediately randomized to

receive Infergen 15 µg/day plus ribavirin (1.0-1.2 g/day) for 36 or

48 weeks or continue on their pegylated interferon and ribavirin

regimen for an additional 36 weeks of therapy. All treatment groups

will have a 24 week follow up period to measure sustained virologic

response.

“Based on interim results from the DIRECT trial, a shorter washout

period from previous pegylated interferon and ribavirin therapy and

the degree of fibrosis, may affect response to daily Infergen and

ribavirin. This study is the next step in the development of Infergen

in patients who exhibit a poor response to initial treatment with

pegylated interferon and ribavirin,†said Wesley P. Wheeler,

Valeant's President of North America and Global Product Development.

About Infergen

Infergen, or consensus interferon, is a bio-optimized, selective and

highly potent type 1 interferon alpha originally developed by Amgen

and launched in the United States in 1997. It is currently indicated

for the treatment of adult patients suffering from chronic hepatitis

C viral infections with compensated liver disease and is dosed three

times per week. Infergen is the only interferon with data in the

label regarding use in patients following relapse or non-response to

non-pegylated interferons.

Infergen is being studied in ongoing clinical trials to evaluate its

potential for daily use with ribavirin. Enrollment in the Phase 3

IHRC-001 (DIRECT) trial was completed in mid-2005 with 513 patients

at 45 sites in the United States. The DIRECT trial, which should be

completed in 2007, is evaluating the safety and efficacy of both 9

µg and 15 µg doses of daily Infergen in combination with ribavirin

in pegylated interferon and ribavirin non-responders.

About Hepatitis C

According to the Centers for Disease Control and Prevention, an

estimated 3.9 million Americans (1.8 percent) have been infected with

the hepatitis C virus (HCV). HCV causes an estimated 10,000 to 12,000

deaths annually in the United States and is the leading cause of the

need for liver transplants. The prevalence of HCV is increasing and

approximately half of all patients with compensated liver disease do

not respond to first-line treatment. The treated non-responder

patient population is expected to grow from 15,000 patients in 2003

to 161,000 patients in 2013.

Important Safety Information

Alpha interferons, including Interferon alfacon-1, cause or aggravate

fatal or life-threatening neuropsychiatric, autoimmune, ischemic, and

infectious disorders. Patients should be monitored closely with

periodic clinical and laboratory evaluations. Patients with

persistently severe or worsening symptoms of these conditions should

be withdrawn from therapy. In many but not all cases, these disorders

resolve after stopping Interferon alfacon-1 therapy.

INFERGEN® is contraindicated in patients with known hypersensitivity

to alpha interferons or to any component of the product, in patients

with decompensated hepatic disease and autoimmune hepatitis.

Development of or exacerbation of autoimmune disorders (e.g.

autoimmune thrombocytopenia, idiopathic thrombocytopenic purpura,

psoriasis, rheumatoid arthritis) have been reported in patients

receiving alpha interferon therapies, including INFERGEN.

Treatment with INFERGEN should be administered under the guidance of

a qualified physician, and may lead to moderate-to-severe adverse

experiences requiring dose reduction, temporary dose cessation, or

discontinuation of further therapy. Severe psychiatric adverse events

may manifest in patients receiving therapy with alpha interferons,

including INFERGEN. Depression, suicidal ideation, suicide attempt,

and suicide may occur. Other prominent psychiatric adverse events may

also occur, including psychosis, aggressive behavior, nervousness,

anxiety, emotional lability, abnormal thinking, agitation, apathy and

relapse of drug addiction. INFERGEN should be used with extreme

caution in patients who report a history of depression. Physicians

should monitor all patients for evidence of depression and other

psychiatric symptoms. In severe cases, therapy should be stopped

immediately and psychiatric intervention instituted.

Bone Marrow Toxicity: Alpha interferons suppress bone marrow function

and may result in severe cytopenias including very rare events of

aplastic anemia. It is advised that complete blood counts be obtained

pretreatment and monitored routinely during therapy. Alpha interferon

therapy should be discontinued in patients who develop severe

decreases in neutrophil (>0.5 x 10(9)/L) or platelet ounts (<50 x 10

(9)/L).

Hypertension, tachycardia, palpitation, and tachyarrythmias have been

reported in patients treated with INFERGEN. INFERGEN should be

administered with caution to patients with preexisting cardiac

disease. Supraventricular arrhythmias, chest pain, and myocardial

infarction have been associated with alpha interferon therapies.

Pneumonia and interstitial pneumonitis, some resulting in respiratory

failure and/or patient deaths, have been induced or aggravated by

alpha interferon therapy, including INFERGEN. Patients who develop

persistent or unexplained pulmonary infiltrates or pulmonary function

impairment should discontinue treatment with INFERGEN.

Chronic hepatitis C patients with cirrhosis may be at risk of hepatic

decompensation when treated with alpha interferons, including

INFERGEN. During treatment, patients' clinical status and hepatic

function should be closely monitored, and INFERGEN treatment should

be immediately discontinued if symptoms of hepatic decompensation,

such as jaundice, ascites, coagulopathy, or decreased serum albumin,

are observed.

Ophthalmologic Disorders: Decrease or loss of vision, retinopathy

including macular edema, retinal artery or vein thrombosis, retinal

hemorrhages and cotton wool spots; optic neuritis, and papilledema

are induced or aggravated by treatment with INFERGEN or other alpha

interferons. All patients should receive an eye examination at

baseline. Patients with preexisting ophthalmologic disorders (e.g.,

diabetic or hypertensive retinopathy) should receive periodic

ophthalmologic exams during interferon alpha treatment. INFERGEN

therapy should be discontinued in patients who develop new or

worsening ophthalmologic disorders.

Ischemic and hemorrhagic cerebrovascular events including hemorrhagic

stroke have been observed in patients being treated with INFERGEN. In

addition, transient ischemic attack has been reported in young

patients being treated with INFERGEN without other reported risk

factors.

INFERGEN should be discontinued immediately and appropriate medical

treatment instituted if hypersensitivity reactions occur. INFERGEN

should be administered with caution to patients with a history of

endocrine disorders and should be discontinued mmediately in patients

who develop signs and symptoms of colitis. In addition, INFERGEN

should be suspended in patients with signs and symptoms suggestive of

pancreatitis and discontinued in patients diagnosed with pancreatitis.

The most common adverse events reported for INFERGEN during clinical

studies were headache (82%), fatigue (69%), fever (61%), myalgia

(58%), rigors (57%), body pain (54%), arthralgia (51%), nausea (40%),

insomnia (39%), pharyngitis (34%), nervousness (31%), infection upper

respiratory (31%), diarrhea (29%), depression (26%), anorexia (24%),

injection site erythema (23%), granulocytopenia (23%), dizziness

(22%), cough (22%), dyspepsia (21%), thrombocytopenia (19%), anxiety

(19%), sinusitis (17%), influenza-like symptoms (15%) and leucopenia

(15%).

Physicians and patients can obtain additional prescribing information

regarding Infergen, including the product's safety profile and the

box warning for all interferon alphas regarding neuropsychiatric,

autoimmune, ischemic and infectious disorders, by visiting

www.infergen.com.

Link to NATAP report on DIRECT Study results reported at AASLD 2006:

Infergen (Consensus Interferon) Phase III DIRECT Study End of

Treatment Results

- (11/02/06)