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Valeant Pharmaceuticals Launches Tasmar in the European Union

Posted on: Tuesday, 1 March 2005, 09:00 CST

Valeant Pharmaceuticals International (NYSE:VRX) today announced it has received approval from The European Medicines Agency (EMEA) to market Tasmar(R) (tolcapone) in the European Union and plans to begin selling the product immediately. Valeant acquired Tasmar from Roche and re-launched the product in the United States and other countries throughout the rest of the world in the summer of 2004. Tasmar will be rolled out across the European Union throughout 2005.

"Tasmar is an important part of Valeant's neurology business and we have been looking forward to globally commercializing the product since we acquired it in 2004," Valeant's President and Chief Executive Officer, Timothy C. Tyson said. "Parkinson's disease is a debilitating illness and Tasmar is an important treatment option for many Parkinson's disease patients. We are pleased to bring the product to patients suffering from Parkinson's disease in the European Union."

Tasmar is an adjunctive therapeutic agent used in combination with levodopa and carbidopa for patients with severe Parkinson's disease who are not responding satisfactorily or are not appropriate candidates for other adjunctive therapies. Tasmar is classified as a COMT inhibitor.

For additional information about Tasmar, please visit www.tasmar.com.

Additional Information about Tasmar

The most commonly observed adverse events (less than 5%) in the double-blind, placebo-controlled trials (N=892) associated with the use of Tasmar not seen at equivalent frequency among the placebo-treated patients were dyskinesia, nausea, sleep disorder, dystonia, excessive dreaming, anorexia, cramps muscle, orthostatic complaints, somnolence, diarrhea, confusion, dizziness, headache, hallucination, vomiting, constipation, fatigue, upper respiratory tract infection, falling, increased sweating, urinary tract infection, xerostomia, abdominal pain, urine discoloration.

USE OF TASMAR REQUIRES LIVER MONITORING AND WRITTEN INFORMED CONSENT BY THE PATIENT (SEE PATIENT CONSENT SECTION IN THE COMPLETE PRODUCT INFORMATION).

Warning: Due to the risk of potentially fatal, acute fulminant liver failure, TASMAR should ordinarily be used in patients with Parkinson's disease on levodopa/ carbidopa who have symptom fluctuations and are not responding satisfactorily to or who are not appropriate for other adjunctive therapies (see INDICATIONS and DOSAGE AND ADMINISTRATION). TASMAR should not be initiated in patients with clinical evidence of liver disease or 2 SGPT/ALT or SGOT/AST values less than ULN and should be discontinued if substantial clinical benefit is not seen within 3 weeks. Patients with severe dyskinesia or dystonia should be treated with caution.

Frequent laboratory monitoring is essential (see the PRECAUTIONS section of the package insert: Laboratory Tests for the recommended schedule). Liver monitoring may not prevent liver failure; however, early detection and immediate drug withdrawal are believed to enhance the likelihood for recovery. Patients should be advised to self-monitor for signs of liver disease. Discontinue TASMAR if hepatic enzymes exceed ULN or patient exhibits signs of liver failure.

Please see complete prescribing information at www.tasmar.com/pi/html.

About Valeant

Valeant Pharmaceuticals International is a global, publicly traded, research-based specialty pharmaceutical company that discovers, develops, manufactures and markets a broad range of pharmaceutical products. More information about Valeant can be found at www.valeant.com.

FORWARD LOOKING STATEMENTS

This press release contains forward-looking statements within the meaning of the federal securities laws relating to expectations, plans or prospects for Valeant Pharmaceuticals, including our ability to successfully integrate these assets into our operations and launch the product in all markets. These statements are based upon the current expectations and beliefs of Valeant Pharmaceuticals' 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 market conditions and other factors beyond Valeant Pharmaceuticals' control and the risk factors and other cautionary statements discussed in Valeant Pharmaceuticals' filings with the U.S. Securities and Exchange Commission.

Source: Business Wire

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