FOR IMMEDIATE RELEASE
PALADIN ANNOUNCES THAT HEALTH CANADA ACCEPTS REMODULIN™ NEW DRUG SUBMISSION FOR PRIORITY REVIEW
Montreal, Quebec, February 19, 2002 - Paladin Labs Inc. ("Paladin") (TSE: PLB) announced today that the Therapeutic Products Directorate ("TPD") of Health Canada has accepted United Therapeutics Corporation's (Nasdaq: UTHR) New Drug Submission for Remodulin™ (treprostinil sodium) Injection and confirmed that it will receive Priority Review.
Paladin acquired the exclusive Canadian distribution rights for Remodulin™ from United Therapeutics in February 1999. Formerly referred to as UNIPROST™, Remodulin™ is indicated for the treatment of pulmonary arterial hypertension. United Therapeutics recently announced that the U.S. Food and Drug Administration (FDA) issued an approvable letter for Remodulin™, usually the final step before FDA clearance for marketing in the United States.
Health Canada's Priority Review takes place over an approximate 180-day period following screening, as opposed to 300 days for a standard review. Priority Review status is granted to a drug submission for serious, life threatening, or severely debilitating diseases or conditions for which there is substantial clinical evidence that the drug under review provides: an effective treatment, prevention, or diagnosis of a disease or condition for which no drug is presently marketed in Canada; or, significantly improved efficacy or significantly diminished risk over existing therapies, preventatives, or diagnostic agents for a disease or condition that is not adequately managed by a drug marketed in Canada.
About Paladin Labs Inc.
Paladin Labs, headquartered in Montreal, Quebec, is a rapidly growing pharmaceutical company focused on acquiring or in-licensing innovative pharmaceutical products for the Canadian market. With this strategy, a focused national sales team and proven marketing expertise, Paladin has evolved into one of Canada's most profitable publicly-traded pharmaceutical companies. Paladin's shares trade on the Toronto Stock Exchange under the symbol PLB. For more information about Paladin, please visit the Paladin Web Site at www.paladinlabs.com.This news release may contain forward-looking statements or predictions. These statements represent our judgement as of this date and are subject to risks and uncertainties that could cause actual results or events to differ materially from those expressed in such forward-looking statements. Potential risks and uncertainties include, without limitation, those associated with product development, clinical trials, future revenues and profitability, and obtaining marketing approval.
For further information please contact:
Paladin Labs Inc.
Samira Sakhia, CFO
Tel: 514-340-5067
E-mail: info@paladin-labs.com
Web Site: www.paladin-labs.comThe Equicom Group Inc.
Joanna Longo, Investor Relations
Tel: 416-815-0700 ext.233
E-mail: jlongo@equicomgroup.com
Web Site: www.equicomgroup.com