April 12, 2000
(“Paladin”) (TSE:PLB) announced today that two products in Paladin's pipeline, Uniprost® and Synsorb Cd®, reached important clinical milestones.
Uniprost,® a product designed to be a non-intravenous treatment of pulmonary hypertension (PH), achieved positive preliminary results from its pivotal Phase III trial. Uniprost® is being development by United Therapeutics Corporation and Paladin maintains the exclusive Canadian distribution rights.
SYNSORB's Cd,® a product designed to prevent recurrent Clostridium difficile antibiotic associated diarrhea (CDAD), has initiated Phase III trials, the final stage of clinical testing prior to filing a New Drug Application. SYNSORB Cd® is being developed by SYNSORB Biotech Inc. and Paladin maintains the exclusive Canadian licensing rights.
Jonathan Goodman, President and CEO of Paladin stated, "Uniprost® and SYNSORB Cd® represent two of 10 products that Paladin enjoys the exclusive Canadian rights and are in late-stage clinical development. We are pleased with our partner's performance in moving these products closer to Canadian commercialization."
Uniprost®
United Therapeutics' pivotal trial for Uniprost® was an international, randomized, placebo-controlled, double blind study involving a total of 470 patients with pulmonary hypertension. Preliminary data from this trial demonstrated a significant improvement in the patients' ability to exercise, the primary endpoint of the study. Affecting more than 50,000 sufferers in the US and Europe, PH is a chronic, life-threatening condition. Uniprost® is a stable structural analogue of prostacyclin, a molecule naturally produced within the body to keep blood vessels healthy. Prostacyclin is currently given intravenously to patients with primary pulmonary hypertension, who are believed to suffer from diminished levels of this molecule. United Therapeutics will continue to analyze the data from this trial in greater detail and anticipate filing the application for marketing approval in the third quarter of 2000.Synsorb Cd®
SYNSORB is conducting two identical Phase III clinical trials for SYNSORB Cd®. The primary endpoint for these trials is a clinically significant reduction in the rate of Recurrent CDAD, a common hospital-acquired infection usually associated with antibiotic use, AIDS and chemotherapy. The most severe form of the disease affects upwards of 800,000 patients annually worldwide. There is no current satisfactory treatment for those suffering from Recurrent CDAD. SYNSORB Cd® is the most advanced of any product under development to address this disease. SYNSORB intends to conduct the Phase III trials aggressively and anticipates filing the application for marketing approval in 2002.About Paladin Labs Inc.
Paladin Labs, headquartered in Montreal, Quebec is a Canadian developer, marketer and distributor of innovative pharmaceuticals, currently offering products in urology, dermatology, rheumatology and other specialty markets. For more information about Paladin, please visit the Paladin Web Site at www.paladin-labs.com or send e-mail to info@paladin-labs.com.Paladin Labs Inc. is a public company whose shares trade on the Toronto Stock Exchange and the Canadian Venture Exchange under the symbol PLB.
For Information about Paladin Labs Inc.:
Lennie Ryer, CA, CFE
Jason Hogan
Chief Financial Officer
Investor Relations
Paladin Labs Inc.
The Equicom Group Inc.
514-340-5067
416-815-0700 ext. 222
Fax:514-344-4675 Fax:416-815-0080 Email:lryer@paladin-labs.com
Email:jhogan@equicomgroup.com
Internet: www.paladin-labs.com
Internet: www.equicomgroup.com
PALADIN LABS INC.
The Toronto Stock Exchange has not reviewed and does not accept responsibility for the adequacy or accuracy of this release. 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