Valeant Pharmaceuticals Receives FDA Approval of Zelapar(R) for Patients with Parkinson's Disease; Zelapar Significantly Reduces ``Off'' Time through Unique Delivery Mechanism

Valeant Pharmaceuticals International (NYSE:VRX) todayannounced that the U.S. Food and Drug Administration (FDA) approvedZelapar(R) (selegiline HCl) Orally Disintegrating Tablets, aonce-daily adjunct therapy for Parkinson's disease patients beingtreated with levodopa/carbidopa who exhibit deterioration in thequality of their response to this therapy. Zelapar, a monoamineoxidase-B (MAO-B) inhibitor, is the first Parkinson's diseasetreatment to use a novel oral delivery system called Zydis(R)Technology, which allows the tablets to dissolve within seconds in themouth and deliver more active drug at a lower dose.

"With more than 1.5 million Americans with Parkinson's disease,and 60,000 new cases diagnosed each year, having new treatment optionsavailable to help manage the symptoms associated with the disease arecritical," said Valeant president and chief executive officer, TimothyC. Tyson. "The approval of Zelapar means that patients now have anadditional alternative that can help them significantly reduce theirdaily 'off' time during waking hours. Zelapar is the second therapyValeant has brought to market to help in the treatment of Parkinson'sdisease, and we remain committed to the Parkinson's disease communityand to providing therapies that fill the tremendous unmet medicalneed."

The use of Zelapar as adjunctive therapy to levodopa/carbidopa hasbeen shown to reduce "off" time, on average, by 2.2 hours per day.Levodopa/carbidopa is commonly used early in the treatment ofParkinson's disease, but as the disease progresses it becomesincreasingly difficult to adequately control symptoms with thismedication. Parkinson's disease patients may endure many hours of"off" time each day in which their symptoms return as a result oflevodopa/carbidopa wearing off.

"Patients with Parkinson's disease still experience many hours aday during which their treatment wears off," said Cheryl H. Waters,M.D., F.R.C.P. (C), Albert B. and Judith L. Glickman professor,Department of Neurology, Columbia University Medical Center. "Theunique formulation of Zelapar allows the orally disintegrating tabletto dissolve within seconds. By delivering more active drug at a lowerdose, Zelapar significantly reduces 'off' time, giving valuable hoursback to the patient."

Zelapar Clinical Trial Overview

The effectiveness of Zelapar as an adjunct to levodopa/carbidopain the treatment of Parkinson's disease in patients who exhibitdeterioration in the quality of their response to this therapy wasestablished in a 12-week multi-center, double-blind, randomized,placebo-controlled, parallel-group study. Patients received either1.25 mg of the drug or placebo each day for the first six weeks andthen 2.5 mg of the drug or placebo once-daily for the following sixweeks. Zelapar was shown to significantly reduce "off" time after oneweek of treatment. At the end of 12 weeks, Zelapar treated patientshad, on average, 2.2 hours per day less "off" time compared tobaseline, and placebo-treated patients had 0.6 hours per day less"off" time. The observed reduction in "off" time between the twotreatment groups compared to baseline was statistically significant (pless than 0.001).

The most common adverse events reported by patients treated withZelapar were comparable to placebo and included nausea (11%),dizziness (11%), pain (8%), headache (7%), insomnia (7%), rhinitis(7%), dyskinesia (6%), skin disorders (6%), stomatitis (5%), back pain(5%) and dyspepsia (5%).

About Zelapar

MAO inhibitors have been used as an adjunct therapy in Parkinson'sdisease since the first clinical trials of levodopa therapy in theearly 1960s. Selegiline, the active ingredient in Zelapar, is an MAO-Binhibitor that prevents the breakdown of dopamine, the keyneurotransmitter in the brain controlling movement. Using aninnovative transbuccal drug delivery system called Zydis Technology,Zelapar Orally Disintegrating Tablets dissolve within seconds in themouth and deliver more active drug at a lower dose. Zelapar is thefirst Parkinson's disease treatment to use Zydis, and due to itsfast-disintegrating technology, Zelapar significantly bypasses the gutand first-pass hepatic metabolism. It is primarily absorbed into thesystemic circulation through the oral mucosa, thereby potentiallyenhancing the therapeutic effect and reducing side effects.

About Parkinson's disease

Parkinson's disease is a chronic, progressive disorder of thecentral nervous system that belongs to a group of conditions calledmotor system disorders. The symptoms of Parkinson's disease appearwhen approximately 80 percent of neurons in an area of the braincalled the substantia nigra become impaired.

In the United States, 1.5 million Americans currently haveParkinson's disease. It is estimated that 60,000 new patients arediagnosed each year. While the condition usually develops after theage of 65, 40 percent of people diagnosed are under age 60.Parkinson's disease affects nearly equal numbers of men and women,with no obvious social, ethnic, economic or geographic boundaries.There presently is no cure for the disease, and the cause is unknown.

Important Safety Information

Zelapar is contraindicated in patients with a knownhypersensitivity to any formulation of selegiline or any of theinactive ingredients of Zelapar. Serious, sometimes fatal reactionshave been precipitated with the concomitant use of meperidine (e.g.,Demerol(R) and other tradenames) and MAO inhibitors includingselective MAO-B inhibitors. These reactions have been characterized bycoma, severe hypertension or hypotension, severe respiratorydepression, convulsions, malignant hyperpyrexia, excitation,peripheral vascular collapse and death. In addition, the combinationof MAO inhibitors and dextromethorphan has been reported to causebrief episodes of psychosis or bizarre behavior. Severe toxicity hasalso been reported in patients receiving the combination of tricyclicantidepressants and conventional selegiline and selective serotoninreuptake inhibitors and conventional selegiline. Zelapar should not beadministered along with other selegiline products.

Zelapar may potentiate the dopaminergic side effects of levodopaand may cause or worsen preexisting dyskinesia. Decreasing the dose oflevodopa may improve this side effect.

5.2 percent of patients discontinued Zelapar therapy due toadverse events (versus one percent with placebo). Zelapar should beused during pregnancy only if the potential benefit to the motherjustifies the potential risk to the fetus. For full prescribinginformation, please visit www.zelapar.com, or 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.

Zelapar is a registered trademark of Valeant PharmaceuticalsInternational or its related companies. All other trademarks are thetrademarks or the registered trademarks of their respective owners.