Valeant Pharmaceuticals Receives FDA Marketing Approval for Cannabinoid Cesamet(TM) (CII)

"There is still a significant unmet need in treating one of themost feared and severe consequences of life-saving cancer therapies,"said Timothy C. Tyson, Valeant's president and chief executiveofficer. "With the approval of Cesamet, Valeant is proud to offer asolution that will help alleviate one of the most common side effectsof chemotherapy."

Cesamet is a synthetic cannabinoid that is thought to act as anomnineuromodulator - interacting with the cannabinoid receptor, CB1,which is present throughout the nervous system. This receptor isinvolved in regulating nausea and vomiting. Because of thisomnineuromodulation, the mechanism of action for Cesamet issignificantly different from conventional anti-emetics. Cesamet has along duration of action, which allows for less frequent dosing,typically twice daily.

Valeant acquired Cesamet from Eli Lilly & Company in 2004 andcurrently sells Cesamet in Canada, where the product has an 86 percentshare of the cannabinoid market, according to IMS Compuscript datafrom February 2006. Last year, Valeant entered into an agreement withPar Pharmaceutical Companies, Inc. (NYSE:PRX) to promote Cesamet inthe United States. Valeant anticipates launch of Cesamet in the nextseveral weeks following approval.

"In my practice, Cesamet has been used successfully to treatpatients with chemotherapy-induced nausea and vomiting," said PaulDaeninck, M.D., assistant professor, Department of Oncology at theUniversity of Manitoba in Winnipeg, Canada. "We have found that itoffers long-acting chemotherapy-induced nausea and vomiting relief ina well-tolerated and convenient twice-a-day regimen."

The American Cancer Society estimates that there will be nearly1.4 million new cancer cases in 2006. Approximately 70 to 80 percentof all patients receiving chemotherapy experience chemotherapy-inducednausea and vomiting (CINV). Although the use of anti-emetic agentsdecreases the incidence and severity of CINV, symptoms continue tooccur in 40 to 60 percent of patients.

"There is a need for cannabinoids, such as Cesamet, for patientswho have exhausted conventional treatments but are still coping withthe debilitating side effects of chemotherapy," said Neal Slatkin,M.D., DABPM and director, Department of Supportive Care, Pain andPalliative Medicine at City of Hope. "CINV dramatically impacts cancerpatients' quality of life and can result in patients refusing coursesof chemotherapy, which minimizes chances for the best possibleoutcome."

Cesamet Clinical Trial Overview

Cesamet was evaluated for its effectiveness and safety in thetreatment of nausea and vomiting induced by cancer chemotherapy inpatients receiving a wide variety of chemotherapy regimens, includinglow-dose cisplatin (20 mg/m2) in both placebo-controlled and activecontrolled (prochlorperazine) trials. Efficacy and safety results werederived from eleven (11) well-controlled anti-emetic, double-blind,crossover studies with optional continuation into Cesamet open-labeltherapy. Either prochlorperazine or placebo was used as thecomparator. The prochlorperazine-controlled studies consisted of two(2) flexible-dose, crossover studies (143 patients of which 112 wereevaluable for efficacy) and three (3) fixed-dose, crossover studies(126 patients of which 73 patients were evaluable for efficacy). Theplacebo-controlled studies were six (6) fixed-dose, crossover studies(199 patients of which 129 were evaluable for efficacy). The crossoverstudies comprised two (2) cycles of cancer treatment, Cesamet in one(1) cycle and control drug in the other. The order of cycles for eachpatient was randomized. The most frequent dose regimen of nabilone was2 mg BID (twice-a-day), except in the two (2) flexible-dose studies,where Cesamet daily doses of over 4 mg were frequent. Efficacy wasevaluated by comparing the number of vomits and the severity ofnausea.

All statistical comparisons significantly favored nabilone, withthe exception of one (1) prochlorperazine-controlled flexible-dosestudy. However, even in this study, nabilone had a lower overallaverage frequency of vomits and a lower average severity of nauseascore than prochlorperazine.

Important Safety Information

Cesamet, a synthetic cannabinoid similar to the active ingredientfound in naturally occurring Cannabis sativa L (marijuana;delta-9-THC), is contraindicated in any patient who has a history ofhypersensitivity to any cannabinoid. Patients receiving treatment withCesamet should be specifically warned not to drive, operate machinery,or engage in any hazardous activity while taking Cesamet. Duringcontrolled clinical trials of Cesamet, virtually all patientsexperienced at least one adverse reaction. The most commonlyencountered events were drowsiness, vertigo, dry mouth, euphoria(feeling "high"), ataxia, headache, and concentration difficulties.Cesamet should not be taken with alcohol, sedatives, hypnotics, orother psychoactive substances because these substances can potentiatethe central nervous system effects of nabilone. Since Cesamet canelevate supine and standing heart rates and cause posturalhypotension, it should be used with caution in the elderly, and inpatients with hypertension or heart disease. Cesamet should also beused with caution in patients with current or previous psychiatricdisorders (including manic depressive illness, depression andschizophrenia), as the symptoms of these disease states may beunmasked by the use of cannabinoids. Caution must be used whenadministering Cesamet in combination with any CNS depressant.

Cesamet should be used with caution in patients with a history ofsubstance abuse, including alcohol abuse or dependence and marijuanause, since Cesamet is similar to the active ingredient found innaturally occurring marijuana. Cesamet should be used with caution inpregnant patients, nursing mothers, or pediatric patients because ithas not been studied in these patient populations. For product-relatedquestions, call Valeant Pharmaceuticals International at1-877-361-2719.

About Valeant

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

Cesamet is a trademark of Valeant Pharmaceuticals International orits related companies. All other trademarks are the trademarks or theregistered trademarks of their respective owners.